Online mixture classification calculator

Acute toxicity

According to 3.1.3.6 of Annex I to CLP calculation of Acute Toxicity classification is based on two approaches:

1)	data available for all ingredients
2)	data are not available for all ingredients

First approach applies when the total concentration of the relevant ingredient(s) with unknown acute toxicity is ≤ 10 %. In this case formula from 3.1.3.6.1 of Annex I to CLP is used (see below ).

Second approach applies when the total concentration of the relevant ingredient(s) with unknown acute toxicity is > 10 %. In this case formula from 3.1.3.6.2.3 of Annex I to CLP is used (see below ).

Relevant ingredient means ingredient present in concentration of 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases) or greater (unless there is a reason to suspect that an ingredient present at a concentration of less than 1 % is still relevant for classifying the mixture for acute toxicity) (CLP, Annex I, 3.1.3.3(a)).

Ingredient with known acute toxicity is an ingredient which:

−	has acute toxicity category, or

−	has LD₅₀ (oral, dermal) / LC₅₀ (inhalation), or

−	has established ATE value(s), or

−	is not acutely toxic (e.g., water, sugar).

If mixture contains ingredients for which you know nothing about their acute toxicity properties, they should be treated as ingredients with unknown acute toxicity.

If a mixture does not contain any ingredients with unknown acute toxicity, the first approach (data available for all ingredients) is applied. If a mixture contains substance(s) with unknown acute toxicity you should check concentrations of which is(are) ≥ 1 % and make summation of concentrations only those which are ≥ 1 %. If the sum is ≤ 10 % the first approach is applied (data available for all ingredients), otherwise the second approach is applied (data are not available for all ingredients).

Example 1

Example 2

Example 3

Example 4

Ingredient	Conc. % (w/w)	Classification
Substance A	7	Acute Tox. 1: H310
Substance B	8	Acute Tox. 2: H310
Water	85	−

Ingredient	Conc. % (w/w)	Classification
Substance A	7	Acute Tox. 1: H310
Substance B	8	Acute Tox. 2: H310
Substance C	2	no data available
Substance D	9	no data available
Water	74	−

Ingredient	Conc. % (w/w)	Classification
Substance A	7.0	Acute Tox. 1: H310
Substance B	8.0	Acute Tox. 2: H310
Substance C	0.8	no data available
Substance D	9.5	no data available
Substance E	0.8	no data available
Water	73.9	−

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance G	2.0	Acute Tox. 2: H330
		Acute Tox. 3: H301
Substance H	0.3	Acute Tox. 3: H301 oral: ATE = 300 mg/kg bw
		Acute Tox. 3: H311 dermal: ATE = 600 mg/kg bw
Substance K	0.5	LD₅₀ (oral) = 1230 mg/kg bw
Substance L	1.7	LD₅₀ (dermal) = 3100 mg/kg bw
Substance M	0.8	does not exhibit acute toxicity properties
Water	94.7	−

1) Data available for all ingredients

The below formula is applied for mixtures, where the total concentration of the relevant ingredient(s) with unknown acute toxicity is ≤ 10 % (CLP, Annex I, 3.1.3.6.1).

100

ATE _mix

C _i

ATE _i

where:

ATE _mix	−	Acute Toxicity Estimate of the whole mixture,
C _i	−	concentration of ingredient i (% w/w or % v/v),
i	−	the individual ingredient from 1 to n,
n	−	the number of ingredients,
ATE _i	−	Acute Toxicity Estimate of ingredient i.

2) Data are not available for all ingredients

If the total concentration of the relevant ingredient(s) with unknown toxicity is > 10 %, a modified additivity formula in CLP Annex I, 3.1.3.6.2.3 must be used.

100 - (Σ C _unknown if > 10 %)

ATE _mix

C _i

ATE _i

where:

ATE _mix	−	Acute Toxicity Estimate of the whole mixture,
Σ C _unknown if > 10 %	−	concentration sum of relevant ingredients with unknown toxicity (% w/w or % v/v),
C _i	−	concentration of ingredient i (% w/w or % v/v),
i	−	the individual ingredient from 1 to n,
n,	−	the number of ingredients
ATE _i	−	Acute Toxicity Estimate of ingredient i.

When approach (formula) is selected, below two questions should be answered for every ingredient with known acute toxicity:

−	what is its Acute Toxicity Estimate (ATE) value for appropriate route (oral, dermal and inhalation)?
−	is its concentration above the cut-off limit for appropriate category (1, 2, 3 and 4)?

Calculation of ingredient's ATE

●

If substance is listed in Table 3 of Annex VI to CLP, but neither acute toxicity category nor harmonised ATE are presented in the table as well as no LD₅₀/LC₅₀ value is available, this means it is known that such a substance does not possess acute toxicity properties. In this case, ATE of the substance equals to 0, therefore, such ingredient need not be considered in the calculation of mixture's acute toxicity.

Acute Toxicity Estimates (ATEs) are the way of expressing acute toxicity. ATE for mixture's ingredient may be based on LD₅₀ (oral, dermal) or LC₅₀ (inhalation) or appropriate Acute toxicity hazard category of ingredient (CLP, Annex I, 3.1.2.1).

LD means "Lethal Dose". LD₅₀ is the amount of a chemical, given all at once, which causes the death of 50 % of test animals.
LC means "Lethal Concentration". LC₅₀ is the concentration of a chemical in air, which causes the death of 50 % of test animals.

●	If substance is listed in Table 3 of Annex VI to CLP and harmonised ATE value is available for this substance in column "Specific Conc. Limits, M-factors and ATE", this value must be used. If acute toxicity category and LD₅₀/LC₅₀ are also known, the harmonised ATE has a priority.

●	If harmonised ATE is not known, but both acute toxicity category from Table 3 of Annex VI to CLP and LD₅₀/LC₅₀ are available, the LD₅₀/LC₅₀ value must be used as ATE to calculate mixture's acute toxicity.

●

If only acute toxicity category from Table 3 of Annex VI to CLP is known (no ATE, no LD₅₀/LC₅₀) you should convert the category to ATE (cATpE - converted Acute Toxicity point Estimate) based on the Table 3.1.2 of Annex I to CLP (see table below).

For example, if ingredient of a mixture is classified as 'Acute Tox. 3: H301' (H301 - oral route of exposure) based on Table 3.1.2 of Annex I to CLP the cATpE for oral route = 100.

The hazard class Acute Toxicity is differentiated into (CLP, Annex I, 3.1.1.2):

−	acute oral toxicity,
−	acute dermal toxicity,
−	acute inhalation toxicity.

Classification of a mixture must be calculated for each route of exposure, therefore, the above 4 steps of definition Acute Toxicity Estimate(s) should be considered for oral, dermal and inhalation.

Table 3.1.2 of Annex I to CLP

Exposure routes	Classification category or experimentally obtained acute toxicity range estimate	Converted acute toxicity point estimate
Oral	0 < Category 1 ≤ 5	0.5
(mg/kg	5 < Category 2 ≤ 50	5
bodyweight)	50 < Category 3 ≤ 300	100
	300 < Category 4 ≤ 2 000	500
Dermal	0 < Category 1 ≤ 50	5
(mg/kg	50 < Category 2 ≤ 200	50
bodyweight)	200 < Category 3 ≤ 1 000	300
	1 000 < Category 4 ≤ 2 000	1 100
Gases	0 < Category 1 ≤ 100	10
(ppmV)	100 < Category 2 ≤ 500	100
	500 < Category 3 ≤ 2 500	700
	2 500 < Category 4 ≤ 20 000	4 500
Vapours	0 < Category 1 ≤ 0.5	0.05
(mg/l)	0.5 < Category 2 ≤ 2.0	0.5
	2.0 < Category 3 ≤ 10.0	3
	10.0 < Category 4 ≤ 20.0	11
Dust/mist	0 < Category 1 ≤ 0.05	0.005
(mg/l)	0.05 < Category 2 ≤ 0.5	0.05
	0.5 < Category 3 ≤ 1.0	0.5
	1.0 < Category 4 ≤ 5.0	1.5

The terms 'dust', 'mist' and 'vapour' are defined as follows (CLP, Annex I, note (d) to Table 3.1.1):

−	dust: solid particles of a substance or mixture suspended in a gas (usually air),
−	mist: liquid droplets of a substance or mixture suspended in a gas (usually air),
−	vapour: the gaseous form of a substance or mixture released from its liquid or solid state.

Dust is generally formed by mechanical processes. Mist is generally formed by condensation of supersaturated vapours or by physical shearing of liquids. Dusts and mists generally have sizes ranging from less than 1 to about 100 μm.

If mixture contains ingredient without established acute toxicity category, but the known LD₅₀/LC₅₀ value is:

−	above 2 000 mg/kg bodyweight	for oral route,
−	above 2 000 mg/kg bodyweight	for dermal route,
−	above 20 000 ppmV	for inhalation (gases) route,
−	above 20.0 mg/l	for inhalation (vapours) route,
−	above 5.0 mg/l	for inhalation (dust/mist) route

such ingredient is treated as ingredient without acute toxicity properties and need not be considered in the calculation of mixture's classification. Mentioned above values are maximum values for appropriate route of exposure that lead to acute toxicity category 4 (CLP, Annex I, Table 3.1.1).

Example 5

Example 6

Example 7

Example 8

Example 9

There is a mixture:

Ingredient	Classification, ATEs, LD₅₀/LC₅₀
Substance A	Acute Tox. 3: H301 oral: ATE = 300 300 mg/kg bw LD₅₀ (oral) = 250 mg/kg bw
Substance B	Acute Tox. 2: H300 oral: ATE = 35 35 mg/kg bw
Substance C	Acute Tox. 4: H302 LD₅₀ (oral) = 1 500 1 500 mg/kg bw
Substance D	− * LD₅₀ (oral) = 1 900 1 900 mg/kg bw
Substance E	− * LD₅₀ (oral) = 2 740 mg/kg bw
Substance G	− *
Substance H	− **
Water	− **

* - substance is listed in Table 3 of Annex I to CLP, but neither acute toxicity category nor ATE are indicated.
** - substance is not listed in Table 3 of Annex I to CLP.

Following ATE values should be used for calculation of oral acute toxicity.

Substance A:	ATE = 300 300 ? ×

Substance B:	ATE = 35 35 ? ×

Substance C:	ATE = LD₅₀ = 1 500 1 500 ? ×

Substance D:	ATE = LD₅₀ = 1 900 1 900 ? ×

Substance E:	Oral LD₅₀ is > 2 000. According to Table 3.1.1 of Annex I to CLP this ingredient is not an acute toxicant, therefore, it is not taken into account.

Substance G:	Ingredient is listed in Table 3 of Annex I to CLP, but neither oral acute toxicity category nor oral ATE are indicated. This means the substance is not an acute toxicant, therefore, it is not taken into account.

Substance H:	Ingredient is not listed in Table 3 of Annex I to CLP and there is no scientific data on its oral acute toxicity category, oral ATE and oral LD₅₀. There is also no confirmation that substance does not exhibit acute toxicity properties. This means that this is an ingredient with unknown acute toxicity, therefore, it is not taken into account.

Water	Ingredient is not listed in Table 3 of Annex I to CLP, but the substance is not an acute toxicant, therefore, it is not taken into account.

There is a mixture:

Ingredient	Classification, ATEs, LD₅₀/LC₅₀
Substance A	Acute Tox. 1 Acute Tox. 1 : H300
Substance B	Acute Tox. 2 Acute Tox. 2 : H310
Substance C	Acute Tox. 4 Acute Tox. 4 : H312

Following ATE values should be used for calculation of oral acute toxicity.

Substance A:

ATE = cATpE = 0.5 0.5 ? × (Acute Tox. 1 - category 1, H300 - oral exposure route).

Following ATE values should be used for calculation of dermal acute toxicity.

Substance B:	ATE = cATpE = 50 50 ? × (Acute Tox. 2 - category 2, H310 - dermal exposure route).

Substance C:	ATE = cATpE = 1 100 1 100 ? × (Acute Tox. 4 - category 4, H312 - dermal exposure route).

Table 3.1.2 of Annex I to CLP

Exposure routes	Classification category or experimentally obtained acute toxicity range estimate	Converted ATE
Oral	0 < Category 1 Category 1 ≤ 5	0.5 0.5
(mg/kg	5 < Category 2 ≤ 50	5
bodyweight)	50 < Category 3 ≤ 300	100
	300 < Category 4 ≤ 2 000	500
Dermal	0 < Category 1 ≤ 50	5
(mg/kg	50 < Category 2 Category 2 ≤ 200	50 50
bodyweight)	200 < Category 3 ≤ 1 000	300
	1 000 < Category 4 Category 4 ≤ 2 000	1 100 1 100

There is a gaseous mixture:

Ingredient	Classification, ATEs, LD₅₀/LC₅₀
Substance A	Acute Tox. 2 Acute Tox. 2 : H330
	Acute Tox. 3 Acute Tox. 3 : H301
Substance B	Acute Tox. 4 Acute Tox. 4 : H312
	Acute Tox. 4 Acute Tox. 4 : H302
Substance C	Acute Tox. 4 Acute Tox. 4 : H332

Following ATE values should be used for calculation of oral acute toxicity.

Substance A:	ATE = cATpE = 100 100 ? × (Acute Tox. 3 - category 3, H301 - oral exposure route).

Substance B:	ATE = cATpE = 500 500 ? × (Acute Tox. 4 - category 4, H302 - oral exposure route).

Following ATE values should be used for calculation of dermal acute toxicity.

Substance B:

ATE = cATpE = 1 100 1 100 ? × (Acute Tox. 4 - category 4, H312 - dermal exposure route).

Following ATE values should be used for calculation of inhalation acute toxicity for gas physical form.

Substance A:	ATE = cATpE = 100 100 ? × (Acute Tox. 2 - category 2, H330 - inhalation exposure route).

Substance C:	ATE = cATpE = 4 500 4 500 ? × (Acute Tox. 4 - category 4, H332 - inhalation exposure route).

Table 3.1.2 of Annex I to CLP

Exposure routes	Classification category or experimentally obtained acute toxicity range estimate	Converted ATE
Oral	0 < Category 1 ≤ 5	0.5
(mg/kg	5 < Category 2 ≤ 50	5
bodyweight)	50 < Category 3 Category 3 ≤ 300	100 100
	300 < Category 4 Category 4 ≤ 2 000	500 500
Dermal	0 < Category 1 ≤ 50	5
(mg/kg	50 < Category 2 ≤ 200	50
bodyweight)	200 < Category 3 ≤ 1 000	300
	1 000 < Category 4 Category 4 ≤ 2 000	1 100 1 100
Gases	0 < Category 1 ≤ 100	10
(ppmV)	100 < Category 2 Category 2 ≤ 500	100 100
	500 < Category 3 ≤ 2 500	700
	2 500 < Category 4 Category 4 ≤ 20 000	4 500 4 500

There is a mixture:

Ingredient	Classification, ATEs, LD₅₀/LC₅₀
Substance A	Acute Tox. 2: H300 oral: ATE = 5 mg/kg bw
	Acute Tox. 2: H310 dermal: ATE = 70 mg/kg bw
	Acute Tox. 2: H330 inhalation: ATE = 0.19 mg/l (dusts or mists)
Substance B	Acute Tox. 2: H300
	Acute Tox. 4: H312
Substance C	− *
	LD₅₀ (dermal) = 2 300 mg/kg bw
	LC₅₀ (mist) = 4.4 mg/l
Substance D	− **
	LD₅₀ (oral) = 5 000 mg/kg bw
Substance E	− ** , no data

* - substance is listed in Table 3 of Annex I to CLP, but neither acute toxicity category nor ATE are indicated.
** - substance is not listed in Table 3 of Annex I to CLP.

Following ATE values should be used for calculation of oral acute toxicity.

Substance A:	ATE = 5

Substance B:	ATE = cATpE = 5 (Acute Tox. 2 - category 2, H300 - oral exposure route. CLP, Annex I, Table 3.1.2).

Substance D:	Oral LD₅₀ is > 2 000. According to Table 3.1.1 of Annex I to CLP this ingredient is not an acute toxicant, therefore, it is not taken into account.

Following ATE values should be used for calculation of dermal acute toxicity.

Substance A:	ATE = 70

Substance B:	ATE = cATpE = 1 100 (Acute Tox. 4 - category 4, H312 - dermal exposure route. CLP, Annex I, Table 3.1.2).

Substance C:	Dermal LD₅₀ is > 2 000. According to Table 3.1.1 of Annex I to CLP this ingredient is not an acute toxicant, therefore, it is not taken into account.

Following ATE values should be used for calculation of inhalation acute toxicity for mist physical form.

Substance A:	ATE = 0.19

Substance C:	ATE = LC₅₀ = 4.4

Substance E is not listed in Table 3 of Annex I to CLP. There are no information that substance is or is not an acute toxicant, therefore, it should be assumed that it is an ingredient with unknown acute toxicity. No ATE is available for Substance E.

Ingredient	Classification, ATEs, LD₅₀/LC₅₀
Substance A	Acute Tox. 2: H330 inhalation: ATE = 0.05 mg/l (dusts or mists)
Substance B	Acute Tox. 4: H332
Substance C	LC₅₀ (vapour) = 10 mg/l

Cut-off limits

Cut-off limit is a concentration limit, above which classified ingredient is taken into account for classification purposes. The generic cut-off values are listed in Table 1.1 of Annex I to CLP. In the table below cut-off limits for acute toxicity are presented.

Hazard class	Generic cut-off values to be taken into account
Acute Toxicity:
- Category 1-3: Acute Tox. 1 Acute Tox. 2 Acute Tox. 3	0.1 %
- Category 4: Acute Tox. 4	1 %

−	Ingredient of a mixture classified as Acute Tox. category 1 or 2 or 3 at concentration below 0.1 % is ignored,
−	Ingredient of a mixture classified as Acute Tox. category 4 at concentration below 1 % is ignored.

In case if there is no information on ingredient's acute toxicity, but LD₅₀ or LC₅₀ or ATE is available, this value should be used to determine acute toxicity category using Table 3.1.1 of Annex I to CLP.

If LC₅₀ is available, but without information on physical form (dust/mist or vapour) the category of acute toxicity should be determined for both dust/mist and vapour, which should be used later for calculation of inhalation acute toxicity as dust/mist and vapour. For example, LC₅₀ = 4.0 mg/l will lead to Acute Tox. 3: H331 for vapours and to Acute Tox. 4: H332 for dusts/mists. Please take into account that there is a special case of inhalation acute toxicity calculation (see below).

Example 10

Example 11

Example 12

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance A	5.3	Acute Tox. 1: H300
Substance B	0.07	Acute Tox. 3: H301
Substance C	0.5	Acute Tox. 4: H312
Substance D	1.7	Acute Tox. 4: H302
Substance E	0.9	Acute Tox. 2: H310
Substance G	0.08	Acute Tox. 2: H310
Water	91.45	−

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance A	0.5	Acute Tox. 3: H331
		Acute Tox. 4: H302
Substance B	1.1	Acute Tox. 4: H302 LD₅₀ (oral) = 1 500 mg/kg bw
Substance C	0.8	− * LD₅₀ (oral) = 1 900 mg/kg bw
Substance D	7.7	− * LD₅₀ (dermal) = 2 400 mg/kg bw
Water	89.9	−

There is a mixture:

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance A	0.5	Acute Tox. 3: H331
Substance B	0.8	Acute Tox. 4: H332
Substance C	1.1	Acute Tox. 4: H332
Substance D	0.2	− * LC₅₀ (vapour) = 11 mg/l
Substance E	0.7	− * LC₅₀ = 4.0 mg/l
Water	96.7	−

* - substance is listed in Table 3 of Annex I to CLP, but neither acute toxicity category nor ATE are indicated.

Which ingredients take into account for classification purposes?

Substance A:	Yes, for inhalation route. Concentration is above the cut-off limit 0.1 % for category 3.

Substance B:	No, for inhalation route. Concentration is below the cut-off limit 1 % for category 4.

Substance C:	Yes, for inhalation route. Concentration is above the cut-off limit 1 % for category 4.

Substance D:	No, for inhalation route for both dust/mist and vapour. According to Table 3.1.1 of Annex I to CLP the value LC₅₀ (vapour) = 11 mg/l corresponds to the category 4 (Acute Tox. 4: H332) for vapours. Concentration is below the cut-off limit 1 % for category 4.

Because for Substance E there is no information on physical form for LC₅₀, acute toxicity category for both dust/mist and vapour should be determined.

Substance E:

Yes, for inhalation route for vapour. According to Table 3.1.1 of Annex I to CLP the value LC₅₀ = 4.0 mg/l corresponds to the category 3 (Acute Tox. 3: H331) for vapours. Concentration is above the cut-off limit 0.1 % for category 3.

No, for inhalation route for dust/mist. According to Table 3.1.1 of Annex I to CLP the value LC₅₀ = 4.0 mg/l corresponds to the category 4 (Acute Tox. 4: H332) for dusts/mists. Concentration is below the cut-off limit 1 % for category 4.

All ingredients have the same category

If the converted acute toxicity point estimates for all components of a mixture are within the same category, then the mixture should be classified in that category (CLP, Annex I, 3.1.3.3.(c)). Other words, if all components are classified at the same category of acute toxicity for the same route of exposure, the mixture should be classified in that category and for that route.

For example, if all ingredients are classified as Acute Tox. 2: H300 (oral) then the whole mixture is also should be classified as Acute Tox. 2: H300.

Example 13

Example 14

Example 15

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance A	50	Acute Tox. 1: H310
Substance B	40	Acute Tox. 1: H310
Substance C	10	Acute Tox. 1: H310

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance A	20.0	Acute Tox. 4: H332
Substance B	45.0	Acute Tox. 4: H332
Substance C	33.5	Acute Tox. 4: H332
Substance D	1.5	Acute Tox. 4: H332

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance A	45	Acute Tox. 1: H300
Substance B	25	Acute Tox. 1: H300
Substance C	30	Acute Tox. 1: H310

Special case for acute inhalation toxicity

When calculating inhalation acute toxicity of a mixture the hazard arose from three physical forms should be assessed:

−	gases,
−	vapours,
−	dusts/mists.

In turn, if physical form of a mixture or knowledge on its use may exclude some route of inhalation exposure, such a route not need to be assessed. For example, for gaseous mixture inhalation acute toxicity should be calculated for a gas physical form. For liquid mixture - vapour and mist are the most appropriate. For solid mixture - dust.

If mixture contains ingredients with known inhalation acute toxicity category only (no ATE, no LC₅₀), this category should be used to determine converted Acute Toxicity point Estimate (cATpE) for every proper physical form that should to be assessed.

If ATE or LC₅₀ is available for e.g. mist, this value must be used in calculation of inhalation acute toxicity for mist physical form.

If mixture contains ingredient without established acute toxicity category, only ATE or LC₅₀ is available for e.g. mist tested form, but hazard of vapour physical form should be assessed, ATE/LC₅₀ (mist) value can not be used directly for calculation of inhalation acute toxicity for vapour physical form. This value should be used to convert it to category of acute toxicity and based on the obtained category the cATpE should be determined for vapour form. The same way the hazard for mist should assessed, when for some ingredient ATE or LC₅₀ value for vapour is available only.

−

For example, if hazard for vapour should be assessed and mixture contains ingredient with known LC₅₀ (mist) = 2.0 mg/l (no category is available), based on Table 3.1.1 of Annex I to CLP this value leads to category 4 (between 1.0 and 5.0). In turn, for vapour and category 4 converted ATE (cATpE) = 11.

If both mists and vapours may be formed during any expected use, inhalation acute toxicity categories should be calculated separately for both forms and the most severe must be selected.

Example 16

Example 17

Example 18

Example 19

Example 20

Example 21

Example 22

Example 23

There is a gaseous mixture:

Ingredient	Conc. % (v/v)	Classification, ATEs, LC₅₀
Substance A	1	Acute Tox. 1 Acute Tox. 1 : H330
Substance B	2	Acute Tox. 2 Acute Tox. 2 : H330
Substance C	3	Acute Tox. 3 Acute Tox. 3 : H331
Substance D	4	Acute Tox. 4 Acute Tox. 4 : H332
Inert gas	90	−

Cut-off limits

−	For 'Acute Tox. 1', 'Acute Tox. 2' and 'Acute Tox. 3' the cut-off limit 0.1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances A, B and C are above this value, therefore, they are taken into account.
−	For 'Acute Tox. 4' the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Concentration of Substance D is above this value, therefore, it is taken into account.

ATEs determination

The mixture is a gas and the gaseous physical form is the only proper hazard type for inhalation route. Converted ATE (cATpE) should be defined (CLP, Annex I, Table 3.1.2).

Following ATE values should be used for calculation of inhalation acute toxicity for gas.

Substance A:	ATE = cATpE = 10 10 ? ×

Substance B:	ATE = cATpE = 100 100 ? ×

Substance C:	ATE = cATpE = 700 700 ? ×

Substance D:	ATE = cATpE = 4 500 4 500 ? ×

Inert gas	Ingredient is not an acute toxicant, therefore, it is not taken into account.

Table 3.1.2 of Annex I to CLP

Exposure routes	Classification category or experimentally obtained acute toxicity range estimate	Converted acute toxicity point estimate
Gases	0 < Category 1 Category 1 ≤ 100	10 10
(ppmV)	100 < Category 2 Category 2 ≤ 500	100 100
	500 < Category 3 Category 3 ≤ 2 500	700 700
	2 500 < Category 4 Category 4 ≤ 20 000	4 500 4 500

Calculation of inhalation acute toxicity

Mixture contains no ingredients with unknown acute toxicity properties, therefore, formula from 3.1.3.6.1 of Annex I to CLP is applied.

100

ATE _mix

C _i

ATE _i

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B + ^conc. C / _ATE C + ^conc. D / _ATE D

¹⁰⁰ / _ATE mix = ¹ / ₁₀ + ² / ₁₀₀ + ³ / ₇₀₀ + ⁴ / _4 500

ATE _mix = 798.884

The value 798.884 is between 500 and 2 500 (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 3 .

There is a solid mixture:

Ingredient	Conc. % (w/w)	Classification, ATEs, LC₅₀
Substance A	1	Acute Tox. 1 Acute Tox. 1 : H330
Substance B	2	Acute Tox. 2 Acute Tox. 2 : H330
Substance C	3	Acute Tox. 3 Acute Tox. 3 : H331
Substance D	4	Acute Tox. 4 Acute Tox. 4 : H332
Inert ingredient	90	−

Cut-off limits

−	For 'Acute Tox. 1', 'Acute Tox. 2' and 'Acute Tox. 3' the cut-off limit 0.1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances A, B and C are above this value, therefore, they are taken into account.
−	For 'Acute Tox. 4' the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Concentration of Substance D is above this value, therefore, it is taken into account.

ATEs determination

The mixture is a solid and the dust physical form is the only proper hazard type for inhalation route. Converted ATE (cATpE) should be defined (CLP, Annex I, Table 3.1.2).

Following ATE values should be used for calculation of inhalation acute toxicity for dust.

Substance A:	ATE = cATpE = 0.005 0.005 ? ×

Substance B:	ATE = cATpE = 0.05 0.05 ? ×

Substance C:	ATE = cATpE = 0.5 0.5 ? ×

Substance D:	ATE = cATpE = 1.5 1.5 ? ×

Inert ingredient	Ingredient is not an acute toxicant, therefore, it is not taken into account.

Table 3.1.2 of Annex I to CLP

Exposure routes	Classification category or experimentally obtained acute toxicity range estimate	Converted acute toxicity point estimate
Dust/mist	0 < Category 1 Category 1 ≤ 0.05	0.005 0.005
(mg/l)	0.05 < Category 2 Category 2 ≤ 0.5	0.05 0.05
	0.5 < Category 3 Category 3 ≤ 1.0	0.5 0.5
	1.0 < Category 4 Category 4 ≤ 5.0	1.5 1.5

Calculation of inhalation acute toxicity

Mixture contains no ingredients with unknown acute toxicity properties, therefore, formula from 3.1.3.6.1 of Annex I to CLP is applied.

100

ATE _mix

C _i

ATE _i

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B + ^conc. C / _ATE C + ^conc. D / _ATE D

¹⁰⁰ / _ATE mix = ¹ / _0.005 + ² / _0.05 + ³ / _0.5 + ⁴ / _1.5

ATE _mix = 0.402

The value 0.402 is between 0.05 and 0.5 (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 2 .

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification, ATEs, LC₅₀
Substance A	1	Acute Tox. 1 Acute Tox. 1 : H330
Substance B	2	Acute Tox. 2 Acute Tox. 2 : H330
Substance C	3	Acute Tox. 3 Acute Tox. 3 : H331
Substance D	4	Acute Tox. 4 Acute Tox. 4 : H332
Water	90	−

It is know that only one physical form mist can occur during any expected use.

Cut-off limits

−	For 'Acute Tox. 1', 'Acute Tox. 2' and 'Acute Tox. 3' the cut-off limit 0.1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances A, B and C are above this value, therefore, they are taken into account.
−	For 'Acute Tox. 4' the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Concentration of Substance D is above this value, therefore, it is taken into account.

ATEs determination

The mixture is a liquid and the mist physical form is the only proper hazard type for inhalation route. Converted ATE (cATpE) should be defined (CLP, Annex I, Table 3.1.2).

Following ATE values should be used for calculation of inhalation acute toxicity for mist.

Substance A:	ATE = cATpE = 0.005 0.005 ? ×

Substance B:	ATE = cATpE = 0.05 0.05 ? ×

Substance C:	ATE = cATpE = 0.5 0.5 ? ×

Substance D:	ATE = cATpE = 1.5 1.5 ? ×

Water	Ingredient is not an acute toxicant, therefore, it is not taken into account.

Table 3.1.2 of Annex I to CLP

Exposure routes	Classification category or experimentally obtained acute toxicity range estimate	Converted acute toxicity point estimate
Dust/mist	0 < Category 1 Category 1 ≤ 0.05	0.005 0.005
(mg/l)	0.05 < Category 2 Category 2 ≤ 0.5	0.05 0.05
	0.5 < Category 3 Category 3 ≤ 1.0	0.5 0.5
	1.0 < Category 4 Category 4 ≤ 5.0	1.5 1.5

Calculation of inhalation acute toxicity

Mixture contains no ingredients with unknown acute toxicity properties, therefore, formula from 3.1.3.6.1 of Annex I to CLP is applied.

100

ATE _mix

C _i

ATE _i

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B + ^conc. C / _ATE C + ^conc. D / _ATE D

¹⁰⁰ / _ATE mix = ¹ / _0.005 + ² / _0.05 + ³ / _0.5 + ⁴ / _1.5

ATE _mix = 0.402

The value 0.402 is between 0.05 and 0.5 (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 2 .

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification, ATEs, LC₅₀
Substance A	1	Acute Tox. 1 Acute Tox. 1 : H330
Substance B	2	Acute Tox. 2 Acute Tox. 2 : H330
Substance C	3	Acute Tox. 3 Acute Tox. 3 : H331
Substance D	4	Acute Tox. 4 Acute Tox. 4 : H332
Water	90	−

It is know that only one physical form vapour can occur during any expected use.

Cut-off limits

−	For 'Acute Tox. 1', 'Acute Tox. 2' and 'Acute Tox. 3' the cut-off limit 0.1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances A, B and C are above this value, therefore, they are taken into account.
−	For 'Acute Tox. 4' the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Concentration of Substance D is above this value, therefore, it is taken into account.

ATEs determination

The mixture is a liquid and the vapour physical form is the only proper hazard type for inhalation route. Converted ATE (cATpE) should be defined (CLP, Annex I, Table 3.1.2).

Following ATE values should be used for calculation of inhalation acute toxicity for mist.

Substance A:	ATE = cATpE = 0.05 0.05 ? ×

Substance B:	ATE = cATpE = 0.5 0.5 ? ×

Substance C:	ATE = cATpE = 3 3 ? ×

Substance D:	ATE = cATpE = 11 11 ? ×

Water	Ingredient is not an acute toxicant, therefore, it is not taken into account.

Table 3.1.2 of Annex I to CLP

Exposure routes	Classification category or experimentally obtained acute toxicity range estimate	Converted acute toxicity point estimate
Vapours	0 < Category 1 Category 1 ≤ 0.5	0.05 0.05
(mg/l)	0.5 < Category 2 Category 2 ≤ 2.0	0.5 0.5
	2.0 < Category 3 Category 3 ≤ 10.0	3 3
	10.0 < Category 4 Category 4 ≤ 20.0	11 11

Calculation of inhalation acute toxicity

Mixture contains no ingredients with unknown acute toxicity properties, therefore, formula from 3.1.3.6.1 of Annex I to CLP is applied.

100

ATE _mix

C _i

ATE _i

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B + ^conc. C / _ATE C + ^conc. D / _ATE D

¹⁰⁰ / _ATE mix = ¹ / _0.05 + ² / _0.5 + ³ / ₃ + ⁴ / ₁₁

ATE _mix = 3.943

The value 3.943 is between 2.0 and 10.0 (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 3 .

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification, ATEs, LC₅₀
Substance A	1	Acute Tox. 1: H330
Substance B	2	Acute Tox. 2: H330 inhalation: ATE = 0.19 mg/l (dusts or mists)
Substance C	3	Acute Tox. 3: H331
Substance D	4	Acute Tox. 4: H332 LC₅₀ (mist) = 3.3 mg/l
Substance E	5	Acute Tox. 4: H332 LC₅₀ (vapour) = 11 mg/l
Substance G	6	− * LC₅₀ (vapour) = 9.5 mg/l
Substance H	7	− * LC₅₀ (mist) = 0.75 mg/l
Substance K	8	− ** LC₅₀ (vapour) = 22 mg/l
Water	64	−

* - substance is listed in Table 3 of Annex I to CLP, but neither acute toxicity category nor ATE are indicated.
** - substance is not listed in Table 3 of Annex I to CLP.

It is know that only one physical form mist can occur during any expected use.

Cut-off limits

Cut-off limit is applied to the category of ingredient's acute toxicity. Because Substances G, H and K have no established categories but their acute toxicity hazards are known (LC₅₀), these values and criteria of Table 3.1.1 of Annex I to CLP should be used to identify categories for G, H and K.

Substance G:	LC₅₀ (vapour) = 9.5 mg/l leads to inhalation acute toxicity category 3.

Substance H:	LC₅₀ (mist) = 0.75 mg/l leads to inhalation acute toxicity category 3.

Substance K:	LC₅₀ (vapour) = 22 mg/l is above 20.0, the upper value for vapour to be classified in category 4, therefore, this ingredient is not an acute toxicant and is not taken into account.

−	For 'Acute Tox. 1', 'Acute Tox. 2' and 'Acute Tox. 3' the cut-off limit 0.1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances A, B, C, G and H are above this value, therefore, they are taken into account.
−	For 'Acute Tox. 4' the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances D and E are above this value, therefore, they are taken into account.

ATEs determination

The mixture is a liquid and the mist physical form is the only proper hazard type for inhalation route.

Where ATE or LC₅₀ for mist physical form is available, this value should be used (Substances B, D and H). If only category of inhalation acute toxicity is known, the converted ATE (cATpE) should be defined from the Table 3.1.2 of Annex I to CLP (Substances A and C).

In case of Substance E both category and LC₅₀ for vapour are known. Because the hazard for the mist is calculated, LC₅₀ for vapour cannot be used. The cATpE should be determined for mist category 4.

In case of Substance G the LC₅₀ for vapour is known. Because this value cannot be used for calculation of inhalation acute toxicity for mist, the category of G should be identified (see above, category 3) and the cATpE should be determined for mist.

Following ATE values should be used for calculation of inhalation acute toxicity for mist.

Substance A:	ATE = cATpE = 0.005

Substance B:	ATE = 0.19

Substance C:	ATE = cATpE = 0.5

Substance D:	ATE = LC₅₀ = 3.3

Substance E:	ATE = cATpE = 1,5

Substance G:	ATE = cATpE = 0,5

Substance H:	ATE = LC₅₀ = 0.75
Substance K:	Ingredient is not an acute toxicant, therefore, it is not taken into account.
Water	Ingredient is not an acute toxicant, therefore, it is not taken into account.

Calculation of inhalation acute toxicity

Mixture contains no ingredients with unknown acute toxicity properties, therefore, formula from 3.1.3.6.1 of Annex I to CLP is applied.

100

ATE _mix

C _i

ATE _i

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B + ^conc. C / _ATE C + ^conc. D / _ATE D + ^conc. E / _ATE E + ^conc. G / _ATE G + ^conc. H / _ATE H

¹⁰⁰ / _ATE mix = ¹ / _0.005 + ² / _0.19 + ³ / _0.5 + ⁴ / _3.3 + ⁵ / _1.5 + ⁶ / _0.5 + ⁷ / _0.75

ATE _mix = 0.413

The value 0.413 is between 0.05 and 0.5 (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 2 .

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification, ATEs, LC₅₀
Substance A	1	Acute Tox. 1: H330
Substance B	2	Acute Tox. 2: H330 inhalation: ATE = 0.19 mg/l (dusts or mists)
Substance C	3	Acute Tox. 3: H331
Substance D	4	Acute Tox. 4: H332 LC₅₀ (mist) = 3.3 mg/l
Substance E	5	Acute Tox. 4: H332 LC₅₀ (vapour) = 11 mg/l
Substance G	6	− * LC₅₀ (vapour) = 9.5 mg/l
Substance H	7	− * LC₅₀ (mist) = 0.75 mg/l
Substance K	8	− ** LC₅₀ (vapour) = 22 mg/l
Water	64	−

* - substance is listed in Table 3 of Annex I to CLP, but neither acute toxicity category nor ATE are indicated.
** - substance is not listed in Table 3 of Annex I to CLP.

It is know that only one physical form vapour can occur during any expected use.

Cut-off limits

Substance G:	LC₅₀ (vapour) = 9.5 mg/l leads to inhalation acute toxicity category 3.

Substance H:	LC₅₀ (mist) = 0.75 mg/l leads to inhalation acute toxicity category 3.

Substance K:	LC₅₀ (vapour) = 22 mg/l is above 20.0, the upper value for vapour to be classified in category 4, therefore, this ingredient is not an acute toxicant and is not taken into account.

−	For 'Acute Tox. 1', 'Acute Tox. 2' and 'Acute Tox. 3' the cut-off limit 0.1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances A, B, C, G and H are above this value, therefore, they are taken into account.
−	For 'Acute Tox. 4' the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances D and E are above this value, therefore, they are taken into account.

ATEs determination

The mixture is a liquid and the vapour physical form is the only proper hazard type for inhalation route.

Where ATE or LC₅₀ for vapour physical form is available, this value should be used (Substances E and G). If only category of inhalation acute toxicity is known, the converted ATE (cATpE) should be defined from the Table 3.1.2 of Annex I to CLP (Substances A and C).

In case of Substances B and D both category and LC₅₀ for mist are known. Because the hazard for the vapour is calculated, LC₅₀ for mist cannot be used. The cATpE should be determined for vapour category 2 (B) and for vapour category 4 (D).

In case of Substance H the LC₅₀ for mist is known. Because this value cannot be used for calculation of inhalation acute toxicity for vapour, the category of H should be identified (see above, category 3) and the cATpE should be determined for vapour.

Following ATE values should be used for calculation of inhalation acute toxicity for vapour.

Substance A:	ATE = cATpE = 0.05

Substance B:	ATE = cATpE = 0.5

Substance C:	ATE = cATpE = 3

Substance D:	ATE = cATpE = 11

Substance E:	ATE = LC₅₀ = 11

Substance G:	ATE = LC₅₀ = 9.5

Substance H:	ATE = cATpE = 3
Substance K:	Ingredient is not an acute toxicant, therefore, it is not taken into account.
Water	Ingredient is not an acute toxicant, therefore, it is not taken into account.

Calculation of inhalation acute toxicity

Mixture contains no ingredients with unknown acute toxicity properties, therefore, formula from 3.1.3.6.1 of Annex I to CLP is applied.

100

ATE _mix

C _i

ATE _i

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B + ^conc. C / _ATE C + ^conc. D / _ATE D + ^conc. E / _ATE E + ^conc. G / _ATE G + ^conc. H / _ATE H

¹⁰⁰ / _ATE mix = ¹ / _0.05 + ² / _0.5 + ³ / ₃ + ⁴ / ₁₁ + ⁵ / ₁₁ + ⁶ / _9.5 + ⁷ / ₃

ATE _mix = 3.474

The value 3.474 is between 2.0 and 10.0 (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 3 .

Additional labelling provisions

In case if a component without any useable information for classification (unknown acute toxicity) is used in a mixture at a concentration ≥ 1 %, the label and section 2.2 of safety data sheet must contain following information: "x percent of the mixture consists of component(s) of unknown acute toxicity" (CLP, Annex I, 3.1.3.6.2.2).

Hierarchy of hazard categories

Hazard

➔

−	Acute oral toxicity, category 1 (Acute Tox. 1: H300)
−	Acute oral toxicity, category 2 (Acute Tox. 2: H300)
−	Acute oral toxicity, category 3 (Acute Tox. 3: H301)
−	Acute oral toxicity, category 4 (Acute Tox. 4: H302)

Hazard

➔

−	Acute dermal toxicity, category 1 (Acute Tox. 1: H310)
−	Acute dermal toxicity, category 2 (Acute Tox. 2: H310)
−	Acute dermal toxicity, category 3 (Acute Tox. 3: H311)
−	Acute dermal toxicity, category 4 (Acute Tox. 4: H312)

Hazard

➔

−	Acute inhalation toxicity, category 1 (Acute Tox. 1: H330)
−	Acute inhalation toxicity, category 2 (Acute Tox. 2: H330)
−	Acute inhalation toxicity, category 3 (Acute Tox. 3: H331)
−	Acute inhalation toxicity, category 4 (Acute Tox. 4: H332)

A more severe classification for a mixture overrides a less severe classification. If a mixture is classified for more than one route of exposure then all relevant classifications should be communicated in section 2.2 of safety data sheet and the appropriate hazard communication elements included on the label (CLP, Annex I, 3.1.4.2.).

For example, if ingredients of a mixture lead to classification both as acute oral toxicity category 2 (Acute Tox. 2) and acute dermal toxicity category 4 (Acute Tox. 4) the category Acute Tox. 2 must be selected. The hazard statement H300 is applied to acute oral toxicity category 2 and hazard statement H312 is applied to acute dermal toxicity category 4. Both H300 and H312 belong to different routes of exposure (oral and dermal), therefore, both of them must be indicated (Acute Tox. 2: H300, H312).

To select pictogram, signal word and precautionary statements please refer to Annex I, part 3, Table 3.1.3 of Regulation (EC) no 1272/2008 (CLP).

In addition to classification for inhalation toxicity, if data are available that indicates that the mechanism of toxicity is corrosivity, mixture should also be labelled as EUH071 - 'Corrosive to the respiratory tract'. In addition to an appropriate acute toxicity pictogram, a corrosivity pictogram (GHS05) may be added (CLP, Annex I, Table 3.1.3, Note 1; Annex II, 1.2.6).

Example 24

Example 25

Example 26

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance A	2.0	Acute Tox. 2: H330
		Acute Tox. 3: H301
Substance B	0.4	Acute Tox. 2: H330
Substance C	0.9	no data available
Substance D	5.5	no data available
Substance E	4.0	no data available
Water	87.2	−

Relevant ingredients

The concept 'relevant ingredient' is applied to ingredients with unknown acute toxicity (CLP, Annex I, 3.1.3.3(a)). Mixture contains 3 such ingredients: Substances C, D and E.

Substance C:	No. it is not a relevant ingredient since its concentration is < 1 % (the same reasoning is not applied to Substance B, because it is classified as category 2 and concentration of B should be compared to cut-off limit).

Substance D:	Yes, it is a relevant ingredient, its concentration is ≥ 1 %.

Substance E:	Yes, it is a relevant ingredient, its concentration is ≥ 1 %.

Cut-off limits

−	For 'Acute Tox. 1', 'Acute Tox. 2' and 'Acute Tox. 3' the cut-off limit 0.1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances A and B are above this value, therefore, they are taken into account.

Identification of routes of exposure

Substance A:	Acute Tox. 2 -> category 2, H330 -> inhalation exposure route.
	Acute Tox. 3 -> category 3, H301 -> oral exposure route.

Substance B:	Acute Tox. 2 -> category 2, H330 -> inhalation exposure route.

It is not known the physical form of inhalation hazard that can occur during the expected use. Because mixture is a liquid, both mist and vapour may be formed. In such case, acute toxicity categories should be calculated separately for both forms and the most severe must be selected.

ATEs determination

Following ATE values should be used for calculation of oral acute toxicity.

Substance A:

ATE = cATpE = 100 (CLP, Annex I, table 3.1.2)

Following ATE values should be used for calculation of inhalation acute toxicity for mist.

Substance A:	ATE = cATpE = 0.05 (CLP, Annex I, table 3.1.2)

Substance B:	ATE = cATpE = 0.05 (CLP, Annex I, table 3.1.2)

Following ATE values should be used for calculation of inhalation acute toxicity for vapour.

Substance A:	ATE = cATpE = 0.5 (CLP, Annex I, table 3.1.2)

Substance B:	ATE = cATpE = 0.5 (CLP, Annex I, table 3.1.2)

Calculation of acute toxicity

Mixture contains relevant ingredients with unknown acute toxicity properties (Substances D and E). The sum of their concentration (5.5 + 4.0 = 9.5 %) is ≤ 10 %, therefore, the formula from section 3.1.3.6.1 of Annex I to CLP is applied.

100

ATE _mix

C _i

ATE _i

Calculation of oral acute toxicity

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A

¹⁰⁰ / _ATE mix = ^2.0 / ₁₀₀

ATE _mix = 5000

The value 5000 is more than 2 000 (CLP, Annex I, Table 3.1.2), therefore, the mixture has no acute toxicity category for oral route.

Calculation of inhalation acute toxicity

−	calculation for mist form:

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B

¹⁰⁰ / _ATE mix = ^2.0 / _0.05 + ^0.4 / _0.05

ATE _mix = 2.083

−	calculation for vapour form:

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B

¹⁰⁰ / _ATE mix = ^2.0 / _0.5 + ^0.4 / _0.5

ATE _mix = 20.833

The value 20.833 is more than 20.0 (CLP, Annex I, Table 3.1.2, see vapours). This does not lead to inhalation acute toxicity.

A more severe classification overrides a less severe classification, therefore, the mixture is classified as inhalation Acute Tox. 4 .

Selection of hazard category

−	The mixture is classified as 'Acute Tox. 4'.

Selection of hazard statements

−	H332 corresponds to inhalation 'Acute Tox. 4'.

Selection of pictogram and signal word

−	Pictogram GHS07 and signal word 'Warning' correspond to 'Acute Tox. 4'.

Selection of precautionary statements

−	For H332 following precautionary statements are applied: P261, P271, P304+P340, P312.

Classification and labelling of the mixture

Classification:	Acute Tox. 4
Hazard statements:	H332
Pictogram:
	GHS07
Signal word:	Warning
Precautionary statements:	P261, P271, P304+P340, P312

Additional information on the label and in section 2.2 of safety data sheet

Because mixture contains 2 ingredients D and E with unknown classification and above 'relevant ingredient' concentration 1 %, following information must be indicated: "9.5 percent of the mixture consists of components of unknown acute toxicity".

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance A	4.0	Acute Tox. 2: H310
Substance B	0.6	Acute Tox. 2: H300
Substance C	0.7	no data available
Substance D	0.9	no data available
Substance E	15.0	no data available
Water	78.8	−

Relevant ingredients

The concept 'relevant ingredient' is applied to ingredients with unknown acute toxicity (CLP, Annex I, 3.1.3.3(a)). Mixture contains 3 such ingredients: Substances C, D and E.

Substance C:	No. it is not a relevant ingredient since its concentration is < 1 % (the same reasoning is not applied to Substance B, because it is classified as category 2 and concentration of B should be compared to cut-off limit).

Substance D:	No. it is not a relevant ingredient since its concentration is < 1 %.

Substance E:	Yes, it is a relevant ingredient, its concentration is ≥ 1 %.

Cut-off limits

−	For 'Acute Tox. 1', 'Acute Tox. 2' and 'Acute Tox. 3' the cut-off limit 0.1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances A and B are above this value, therefore, they are taken into account.

Identification of routes of exposure

Substance A:	Acute Tox. 2 -> category 2, H310 -> dermal exposure route.

Substance B:	Acute Tox. 2 -> category 2, H300 -> oral exposure route.

ATEs determination

Following ATE values should be used for calculation of oral acute toxicity.

Substance B:

ATE = cATpE = 5 (CLP, Annex I, table 3.1.2)

Following ATE values should be used for calculation of dermal acute toxicity.

Substance A:

ATE = cATpE = 50 (CLP, Annex I, table 3.1.2)

Calculation of acute toxicity

Mixture contains one relevant ingredient with unknown acute toxicity properties (Substance E). Its concentration is > 10 %, therefore, the formula from section 3.1.3.6.2.3 of Annex I to CLP is applied.

100 - (Σ C _unknown if > 10 %)

ATE _mix

C _i

ATE _i

Calculation of oral acute toxicity

^{100 - conc. E} / _ATE mix = ^conc. B / _ATE B

^{100 - 15} / _ATE mix = ^0.6 / ₅

ATE _mix = 708.333

The value 708.333 is between 300 and 2 000 (CLP, Annex I, Table 3.1.2). This leads to oral Acute Tox. 4 .

Calculation of dermal acute toxicity

^{100 - conc. E} / _ATE mix = ^conc. A / _ATE A

^{100 - 15} / _ATE mix = ^4.0 / ₅₀

ATE _mix = 1062.500

The value 1062.500 is between 1 000 and 2 000 (CLP, Annex I, Table 3.1.2). This leads to dermal Acute Tox. 4 .

Selection of hazard category

−	Both oral 'Acute Tox. 4' and dermal 'Acute Tox. 4' are applied, therefore, the mixture is classified as 'Acute Tox. 4'.

Selection of hazard statements

−	H302 corresponds to oral 'Acute Tox. 4'.
−	H312 corresponds to dermal 'Acute Tox. 4'.
−	Hazard statements H302 and H312 belong to different routes of exposure (oral and dermal), therefore, they both must be indicated on the label and in section 2.2 of safety data sheet.

Selection of pictogram and signal word

−	Pictogram GHS07 and signal word 'Warning' correspond to 'Acute Tox. 4'.

Selection of precautionary statements

−	For H302 following precautionary statements are applied: P264, P270, P301+P312, P330, P501.
−	For H312 following precautionary statements are applied: P280, P302+P352, P312, P321, P362+P364, P501.
−	For both H302 and H312 following precautionary statements are applied: P264, P270, P280, P301+P312, P302+P352, P312, P321, P330, P362+P364, P501.

Classification and labelling of the mixture

Classification:	Acute Tox. 4
Hazard statements:	H302 + H312
Pictogram:
	GHS07
Signal word:	Warning
Precautionary statements:	P264, P270, P280, P301+P312, P302+P352, P312, P321, P330, P362+P364, P501

If mixture has more than 6 precautionary statements, the most important should be indicated on the label and in section 2 of SDS, unless necessary to reflect the nature and the severity of the hazards (CLP, Article 28(3)). The rest may be placed in section 16 'Other information' of SDS.

Additional information on the label and safety data sheet

Because mixture contains 1 ingredient E with unknown classification and above 'relevant ingredient' concentration 1 %, following information must be indicated: "15 percent of the mixture consists of components of unknown acute toxicity".

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification, ATEs, LD₅₀/LC₅₀
Substance A	1.5	Acute Tox. 2: H300 oral: ATE = 5 mg/kg bw
		Acute Tox. 2: H310 dermal: ATE = 70 mg/kg bw
		Acute Tox. 2: H330 inhalation: ATE = 0.19 mg/l (dusts or mists)
Substance B	2.2	Acute Tox. 2: H330
		Acute Tox. 3: H301
Substance C	3.7	− * LD₅₀ (oral) = 2 740 mg/kg bw
Substance D	0.8	Acute Tox. 3: H331
		Acute Tox. 4: H302
Water	91,8	− **

* - substance is listed in Table 3 of Annex I to CLP, but neither acute toxicity category nor ATE are indicated.
** - substance is not listed in Table 3 of Annex I to CLP.

Relevant ingredients

The concept 'relevant ingredient' is applied to ingredients with unknown acute toxicity (CLP, Annex I, 3.1.3.3(a)). Because mixture does not contain any such ingredient, the classified ingredients should be compared to appropriate cut-off limits.

Cut-off limits

Cut-off limit is applied to the category of ingredient's acute toxicity. Because Substance C has no established category but its acute toxicity hazard is known (LD₅₀), this value and criteria of Table 3.1.1 of Annex I to CLP should be used to identify category for C.

Substance C:

LD₅₀ (oral) = 2 740 mg/kg bw is above 2 000, the upper value for oral to be classified in category 4, therefore, this ingredient is not an acute toxicant and is not taken into account.

−

For 'Acute Tox. 1', 'Acute Tox. 2' and 'Acute Tox. 3' the cut-off limit 0.1 % is applied (CLP, Annex I, Table 1.1). Concentrations of Substances A and B are above this value, therefore, they are taken into account. Substance D is classified as acute toxicant category 3 for inhalation (H331). Its concentration is above 0.1 %, therefore, B is taken into account for calculation of inhalation acute toxicity.

−

For 'Acute Tox. 4' the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Substance D is classified as acute toxicant category 4 for oral (H302). Its concentration is below 1 %, therefore, B is not taken into account for calculation of oral acute toxicity.

Identification of routes of exposure

Substance A:	Acute Tox. 2 -> category 2, H300 -> oral exposure route.
	Acute Tox. 2 -> category 2, H310 -> dermal exposure route.
	Acute Tox. 2 -> category 2, H330 -> inhalation exposure route.

Substance B:	Acute Tox. 2 -> category 2, H330 -> inhalation exposure route.
	Acute Tox. 3 -> category 3, H301 -> oral exposure route.

Substance D:	Acute Tox. 3 -> category 3, H331 -> inhalation exposure route.

ATEs determination

Following ATE values should be used for calculation of oral acute toxicity.

Substance A:	ATE = 5

Substance B:	ATE = cATpE = 100 (CLP, Annex I, table 3.1.2)

Following ATE values should be used for calculation of dermal acute toxicity.

Substance A:

ATE = 70

Following ATE values should be used for calculation of inhalation acute toxicity for mist.

Substance A:	ATE = 0.19

Substance B:	ATE = cATpE = 0.05 (CLP, Annex I, table 3.1.2)

Substance D:	ATE = cATpE = 0.5 (CLP, Annex I, table 3.1.2)

Following ATE values should be used for calculation of inhalation acute toxicity for vapour.

Substance A:	ATE = cATpE = 0.5 (CLP, Annex I, table 3.1.2)

Substance B:	ATE = cATpE = 0.5 (CLP, Annex I, table 3.1.2)

Substance D:	ATE = cATpE = 3 (CLP, Annex I, table 3.1.2)

Calculation of acute toxicity

Mixture contains no ingredients with unknown acute toxicity properties, therefore, the formula from section 3.1.3.6.1 of Annex I to CLP is applied.

100

ATE _mix

C _i

ATE _i

Calculation of oral acute toxicity

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B

¹⁰⁰ / _ATE mix = ^1.5 / ₅ + ^2.2 / ₁₀₀

ATE _mix = 310.559

The value 310.559 is between 300 and 2 000 (CLP, Annex I, Table 3.1.2). This leads to oral Acute Tox. 4 .

Calculation of dermal acute toxicity

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A

¹⁰⁰ / _ATE mix = ^1.5 / ₇₀

ATE _mix = 4666.667

The value 4666.667 is more than 2 000 (CLP, Annex I, Table 3.1.2), therefore, the mixture has no acute toxicity category for dermal route.

Calculation of inhalation acute toxicity

−	calculation for mist form:

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B + ^conc. D / _ATE D

¹⁰⁰ / _ATE mix = ^1.5 / _0.19 + ^2.2 / _0.05 + ^0.8 / _0.5

ATE _mix = 1.869

The value 1.869 is between 1.0 and 5.0 (CLP, Annex I, Table 3.1.2, see dust/mist). This leads to inhalation Acute Tox. 4 .

−	calculation for vapour form:

¹⁰⁰ / _ATE mix = ^conc. A / _ATE A + ^conc. B / _ATE B + ^conc. D / _ATE D

¹⁰⁰ / _ATE mix = ^1.5 / _0.5 + ^2.2 / _0.5 + ^0.8 / ₃

ATE _mix = 13.043

The value 13.043 is between 10.0 and 20.0 (CLP, Annex I, Table 3.1.2, see vapours). This leads to inhalation Acute Tox. 4 .

Calculation of inhalation acute toxicity for both forms (mist and vapour) resulted to category 4, therefore, the mixture is classified as inhalation Acute Tox. 4 .

Selection of hazard category

−	Both oral 'Acute Tox. 4' and inhalation 'Acute Tox. 4' are applied, therefore, the mixture is classified as 'Acute Tox. 4'.

Selection of hazard statements

−	H302 corresponds to oral 'Acute Tox. 4'.
−	H332 corresponds to inhalation 'Acute Tox. 4'.
−	Hazard statements H302 and H332 belong to different routes of exposure (oral and inhalation), therefore, they both must be indicated on the label and in section 2.2 of safety data sheet.

Selection of pictogram and signal word

−	Pictogram GHS07 and signal word 'Warning' correspond to 'Acute Tox. 4'.

Selection of precautionary statements

−	For H302 following precautionary statements are applied: P264, P270, P301+P312, P330, P501.
−	For H332 following precautionary statements are applied: P261, P271, P304+P340, P312.
−	For both H302 and H332 following precautionary statements are applied: P261, P264, P270, P271, P301+P312, P304+P340, P312, P330, P501.

Classification and labelling of the mixture

Classification:	Acute Tox. 4
Hazard statements:	H302 + H332
Pictogram:
	GHS07
Signal word:	Warning
Precautionary statements:	P261, P264, P270, P271, P301+P312, P304+P340, P312, P330, P501

See also Example 1 and Example 8 in section Examples.

Substance A:	Acute Tox. 1 - category 1, H310 - dermal exposure route.

Substance B:	Acute Tox. 2 - category 2, H310 - dermal exposure route.

Water:	It is known that this ingredient does not exhibit acute toxicity hazard.

Substance A:	Acute Tox. 1 - category 1, H310 - dermal exposure route.

Substance B:	Acute Tox. 2 - category 2, H310 - dermal exposure route.

Substance C:	Acute toxicity properties are not known.

Substance D:	Acute toxicity properties are not known.

Water:	It is known that this ingredient does not exhibit acute toxicity hazard.

Substance A:	Acute Tox. 1 - category 1, H310 - dermal exposure route.

Substance B:	Acute Tox. 2 - category 2, H310 - dermal exposure route.

Substance C:	Acute toxicity properties are not known.

Substance D:	Acute toxicity properties are not known.

Substance E:	Acute toxicity properties are not known.

Water:	It is known that this ingredient does not exhibit acute toxicity hazard.

Substance A:	ATE = ATE (dusts or mists) = 0.05

Substance B:	ATE = cATpE (dust/mist) = 1.5 (CLP, Annex I, Table 3.1.2)

Substance B:	ATE = cATpE (vapour) = 11 (CLP, Annex I, Table 3.1.2)

Substance C:	ATE = LC₅₀ (vapour) = 10

Substance A:	Yes, for oral route. Concentration is above the cut-off limit 0.1 % for category 1.

Substance B:	No, for oral route. Concentration is below the cut-off limit 0.1 % for category 3.

Substance C:	No, for dermal route. Concentration is below the cut-off limit 1 % for category 4.

Substance D:	Yes, for dermal route. Concentration is above the cut-off limit 1 % for category 4.

Substance E:	Yes, for dermal route. Concentration is above the cut-off limit 0.1 % for category 2.

Substance G:	No, for dermal route. Concentration is below the cut-off limit 0.01 % for category 2.

Water:	No.

−	All ingredients are classified as 'Acute Tox. 2' for oral route of exposure (H300). This leads to classification of the mixture as Acute Tox. 2 H300 .
−	Only Substance A is classified as 'Acute Tox. 2' for dermal route of exposure (H310). Formula from section 3.1.3.6.1 of Annex I to CLP and ATE = 70 mg/kg bw should be used to calculate dermal acute toxicity.
−	All ingredients are classified as 'Acute Tox. 2' for inhalation route of exposure (H330). This leads to classification of the mixture as Acute Tox. 2 H330 .

−	In Example 20 the inhalation acute toxicity for mist physical form was assessed for exactly the same mixture -> 'Acute Tox. 2'.
−	In Example 21 the inhalation acute toxicity for vapour physical form was assessed for exactly the same mixture -> 'Acute Tox. 3'.

Substance B:	LC₅₀ (vapour) = 0.75 mg/l leads to inhalation acute toxicity category 2.

Substance C:	LC₅₀ (mist) = 0.2 mg/l leads to inhalation acute toxicity category 2.