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Example 10

The purpose of this example is to show calculation of Hazard to the aquatic environment according to Regulation (EC) No 1272/2008 (CLP).

There is a liquid mixture consisting of the following ingredients:

Ingredient Conc. % (w/w) Classification Specific Conc. Limits,
M-factors and ATEs
Substance A 0.9 Carc. 2: H351
Aquatic Acute 1: H400
Aquatic Chronic 1: H410
M = 10
Substance B 1.3 Carc. 2: H351
Aquatic Acute 1: H400
Aquatic Chronic 1: H410
M = 1
M = 10 000
Substance C 0.7 Acute Tox. 3: H301
Aquatic Acute 1: H400
Aquatic Chronic 1: H410
M = 10 000
Substance D 2.5 Repr. 2: H361d
Acute Tox. 4: H302
Aquatic Acute 1: H400
Aquatic Chronic 1: H410
M = 1
M = 10
Substance E 0.6 Eye Dam. 1: H318
Aquatic Acute 1: H400
Aquatic Chronic 1: H410
M = 10
M = 10
Substance H 0.5 Lact.: H362
Aquatic Acute 1: H400
Aquatic Chronic 1: H410
Substance K 1.8 Acute Tox. 4: H302
Aquatic Chronic 3: H412
Water 91.7

Calculation of mixture classification.

Acute Toxicity

Following ingredients are classified as acute toxicants:

Substance C:   Acute Tox. 3: H301 (oral).
Substance D:   Acute Tox. 4: H302 (oral).
Substance K:   Acute Tox. 4: H302 (oral).

Because there are no data on LD50 (oral, dermal) / LC50 (inhalation) the acute toxicity category for appropriate route (oral, dermal, inhalation) should be converted to Acute Toxicity Estimate (ATE) (CLP, Annex I, Table 3.1.2).

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). Concentration of substance C is above this value, therefore, it is 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 K are above this value, therefore, they are taken into account.

Specific and Generic concentration limits

Neither specific nor generic concentration limits are applied for acute toxicity.

Calculation of oral Acute Toxicity

ATE values converted from oral acute toxicity categories:

Substance C:   Acute Tox. 3: H301 -> ATE = 100
Substance D:   Acute Tox. 4: H302 -> ATE = 500
Substance K:   Acute Tox. 4: H302 -> ATE = 500

100 / ATE mix  =  conc. C / ATE C  +  conc. D / ATE D  +  conc. K / ATE K

100 / ATE mix  =  0.7 / 100  +  2.5 / 500  +  1.8 / 500

ATE mix = 6410.254

The value 6410.254 is above 2 000 (CLP, Annex I, Table 3.1.2). This does not lead to oral acute toxicity.

Classification of the mixture

The mixture is not classified in category acute toxicity.

Serious damage to eyes / Eye irritation

Following ingredients are classified as serious damage to eyes / eye irritation:

Substance E:   Eye Dam. 1: H318.

The mixture's pH is between 2 and 11.5, this does not lead to classification 'Eye Dam. 1'. Mixture contains no ingredients leading to the application of non-additivity approach, therefore, Additivity approach is applied.

Cut-off limits

For serious damage to eyes / eye irritation the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Concentration of substance E is below this value, therefore, it is not taken into account.

Classification of the mixture

The mixture is not classified in category serious damage to eyes / eye irritation.

Carcinogenicity

Following ingredients are classified as carcinogens:

Substance A:   Carc. 2: H351.
Substance B:   Carc. 2: H351.

Cut-off limits

There is no generic cut-off limit for carcinogenicity (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with such classification is taken into account.

Specific and Generic concentration limits

Because no specific concentration limits are applied for substances A and B, their concentrations must be compared to generic concentration limits.

Calculation of 'Carc. 2'

Concentration of substance A is below the generic concentration limit 1.0 % (CLP, Annex I, Table 3.6.2). This does not lead to classification 'Carc. 2'.
Concentration of substance B is above the generic concentration limit 1.0 % (CLP, Annex I, Table 3.6.2). This leads to classification Carc. 2 .

Selection of hazard category

The mixture is classified as 'Carc. 2'.

Selection of hazard statements

H351 corresponds to 'Carc. 2'.

Selection of pictogram and signal word

Pictogram GHS08 and signal word 'Warning' correspond to 'Carc. 2'.

Selection of precautionary statements

For H351 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.
Reproductive toxicity

Following ingredients are classified as reproductive toxicants:

Substance D:   Repr. 2: H361d.
Substance H:   Lact.: H362.

Cut-off limits

There is no generic cut-off limit for reproductive toxicity (CLP, Annex I, Table 1.1), therefore, any concentration of an ingredient with such classification is taken into account.

Specific and Generic concentration limits

Because no specific concentration limits are applied to substances D and H their concentrations should be compared to generic concentration limits.

Calculation of 'Repr. 2'

Concentration of substance D is below the generic concentration limit 3.0 % (CLP, Annex I, Table 3.7.2). This does not lead to classification 'Repr. 2'.

Calculation of 'Lact.'

Concentration of substance H is above the generic concentration limit 0.3 %. This leads to classification Lact. .

Selection of hazard category

The mixture is classified as 'Lact.'.

Selection of hazard statements

H362 corresponds to 'Lact.'.

Selection of pictogram and signal word

No pictogram and signal word are applied for 'Lact.'.

Selection of precautionary statements

For H362 following precautionary statements are applied: P201, P260, P263, P264, P270, P308+P313.
Hazardous to the aquatic environment

Following ingredients are classified as hazardous to the aquatic environment:

Substance A:   Aquatic Acute 1: H400 / Aquatic Chronic 1: H410.
Substance B:   Aquatic Acute 1: H400 / Aquatic Chronic 1: H410.
Substance C:   Aquatic Acute 1: H400 / Aquatic Chronic 1: H410.
Substance D:   Aquatic Acute 1: H400 / Aquatic Chronic 1: H410.
Substance E:   Aquatic Acute 1: H400 / Aquatic Chronic 1: H410.
Substance H:   Aquatic Acute 1: H400 / Aquatic Chronic 1: H410.
Substance K:   Aquatic Chronic 3: H412.

Cut-off limits

For 'Aquatic Acute 1' and 'Aquatic Chronic 1' cut-off limit is calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):

Substance A has established one M-factor (M = 10), which applies to both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. Concentration of substance A is above 0.01 % (0.1/10), therefore, A is taken into account for calculation of both 'Aquatic Acute 1' and 'Aquatic Chronic 1'.
Substance B has established two different M-factors: M = 1 applies to 'Aquatic Acute 1' and M = 10 000 applies to 'Aquatic Chronic 1'.

− concentration of substance B is above 0.1 % (0.1/1), therefore, B is taken into account for calculation of 'Aquatic Acute 1',

− concentration of substance B is above 0.00001 % (0.1/10 000), therefore, B is taken into account for calculation of 'Aquatic Chronic 1'.

Substance C has established one M-factor (M = 10 000), which applies to both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. Concentration of substance C is above 0.00001 % (0.1/10 000), therefore, C is taken into account for calculation of both 'Aquatic Acute 1' and 'Aquatic Chronic 1'.
Substance D has established two different M-factors: M = 1 applies to 'Aquatic Acute 1' and M = 10 applies to 'Aquatic Chronic 1'.

− concentration of substance D is above 0.1 % (0.1/1), therefore, D is taken into account for calculation of 'Aquatic Acute 1',

− concentration of substance D is above 0.01 % (0.1/10), therefore, D is taken into account for calculation of 'Aquatic Chronic 1'.

Substance E has established two the same M-factors (M = 10), which applies to both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. Concentration of substance E is above 0.01 % (0.1/10), therefore, E is taken into account for calculation of both 'Aquatic Acute 1' and 'Aquatic Chronic 1'.
There is no M-factor in Table 3 of Annex VI to CLP established for substance H. Person responsible for classification decided to use M = 1 for both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. Concentration of substance H is above 0.1 % (0.1/1), therefore, H is taken into account for calculation of both 'Aquatic Acute 1' and 'Aquatic Chronic 1'.

For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):

Concentration of substance K is above 1 %, therefore, it is taken into account.

Specific and Generic concentration limits

Neither specific nor generic concentration limits are applied for acute toxicity.

Calculation of 'Aquatic Acute 1'

Concentrations of substances A, B, C, D, E and H must be multiplied by their corresponding M-factors and obtained values must be summed.

(conc. A × M) + (conc. B × M) + (conc. C × M) + (conc. D × M) + (conc. E × M) + (conc. H × M) = (0.9 × 10) + (1.3 × 1) + (0.7 × 10 000) + (2.5 × 1) + (0.6 × 10) + (0.5 × 1) = 7019.3

The obtained value is above 25 % (CLP, Annex I, 4.1.3.5.5.3.1 and Table 4.1.1). This leads to classification Aquatic Acute 1 .

Calculation of 'Aquatic Chronic 1'

Concentrations of substances A, B, C, D, E and H must be multiplied by their corresponding M-factors and obtained values must be summed.

(conc. A × M) + (conc. B × M) + (conc. C × M) + (conc. D × M) + (conc. E × M) + (conc. H × M) = (0.9 × 10) + (1.3 × 10 000) + (0.7 × 10 000) + (2.5 × 10) + (0.6 × 10) + (0.5 × 1) = 20040.5

The obtained value is above 25 % (CLP, Annex I, 4.1.3.5.5.4.1 and Table 4.1.2). This leads to classification Aquatic Chronic 1 .

Calculation of 'Aquatic Chronic 2'

Concentrations of substances A, B, C, D, E and H must be multiplied by their corresponding M-factors for 'Aquatic Chronic 1' and multiplied by 10.

(M × 10 × conc. A) + (M × 10 × conc. B) + (M × 10 × conc. C) + (M × 10 × conc. D) + (M × 10 × conc. E) + (M × 10 × conc. H) = (10 × 10 × 0.9) + (10 000 × 10 × 1.3) + (10 000 × 10 × 0.7) + (10 × 10 × 2.5) + (10 × 10 × 0.6) + (1 × 10 × 0.5) = 200405

The obtained value is above 25 % (CLP, Annex I, 4.1.3.5.5.4.2 and Table 4.1.2). This leads to classification Aquatic Chronic 2 .

Calculation of 'Aquatic Chronic 3'

Concentrations of substances A, B, C, D, E and H must be multiplied by their corresponding M-factors for 'Aquatic Chronic 1' and multiplied by 100. Obtained values must later be summed with concentration of substance K.

(M × 100 × conc. A) + (M × 100 × conc. B) + (M × 100 × conc. C) + (M × 100 × conc. D) + (M × 100 × conc. E) + (M × 100 × conc. H) + conc. K = (10 × 100 × 0.9) + (10 000 × 100 × 1.3) + (10 000 × 100 × 0.7) + (10 × 100 × 2.5) + (10 × 100 × 0.6) + (1 × 100 × 0.5) + 1.8 = 2004051.8

The obtained value is above 25 % (CLP, Annex I, 4.1.3.5.5.4.3 and Table 4.1.2). This leads to classification Aquatic Chronic 3 .

Calculation of 'Aquatic Chronic 4'

Concentrations of all ingredients summed.

conc. A + conc. B + conc. C + conc. D + conc. E + conc. H + conc. K = 0.9 + 1.3 + 0.7 + 2.5 + 0.6 + 0.5 + 1.8 = 8.3

The obtained value is below 25 % (CLP, Annex I, 4.1.3.5.5.4.4 and Table 4.1.2). This does not lead to classification 'Aquatic Chronic 4'.

Selection of hazard category

The mixture is classified as 'Aquatic Acute 1'.
Classification category 'Aquatic Chronic 1' is more severe than 'Aquatic Chronic 2' and 'Aquatic Chronic 3', therefore, mixture is classified as 'Aquatic Chronic 1'.

Selection of hazard statements

H400 corresponds to 'Aquatic Acute 1'.
H410 corresponds to 'Aquatic Chronic 1'. Because H410 is applied, the statement H400 don't have to be used (Article 27 and Part 1 of Annex III to CLP).

Selection of pictogram and signal word

Pictogram GHS09 and signal word 'Warning' correspond to both 'Aquatic Acute 1' and 'Aquatic Chronic 1'.

Selection of precautionary statements

For H410 following precautionary statements are applied: P273, P391, P501.


Selection of classification, H statements, pictograms,
signal word and P statements
Classification categories Classification H statements Pictograms Signal words P statements
Carcinogenicity Carc. 2 H351 pictogram ghs 08
GHS08
Warning P201, P202, P280, P308+P313, P405, P501
Reproductive toxicity Lact. H362 P201, P260, P263, P264, P270, P308+P313
Hazardous to the aquatic environment Aquatic Acute 1
Aquatic Chronic 1
H410 pictogram ghs 09
GHS09
Warning P273, P391, P501



Classification and labelling of the mixture

Classification: Carc. 2, Lact., Aquatic Acute 1, Aquatic Chronic 1
Hazard statements: H351, H362, H410
Pictograms: pictogram ghs 08
   GHS08
pictogram ghs 09
   GHS09
Signal word: Warning
Precautionary statements: P201, P202, P260, P263, P264, P270, P273, P280, P308+P313, P391, P405, P501

According to Article 28(3) of CLP if mixture has more than 6 precautionary statements, supplier should select among of them the most important 6 statements that should be indicated on the label. The same selected statements should be placed in section 2.2 'Hazards identification' of safety data sheet (SDS). The rest may be placed in section 16 'Other information' of SDS.