Online mixture classification calculator

Respiratory / Skin sensitisation

Non-additivity approach

The additivity approach is not applicable for calculation of Respiratory sensitisation and Skin sensitisation.

If a single ingredient classified as respiratory or skin sensitiser is present in the mixture above the generic or specific concentration limit the mixture must be classified for that hazard. Other hand, if the mixture contains two or more ingredients each below the generic or specific concentration limit, even if the sum of their concentrations is above generic concentration limit, the mixture will not be classified.

The mixture is classified as a Respiratory or Skin sensitiser if at least one ingredient is classified as a respiratory or skin sensitiser and is present at or above the appropriate generic concentration limit as shown in Table 3.4.5 of Annex I to CLP for solid/liquid and gas respectively.

Component classified as

Generic concentration limits triggering classification of a mixture as

Component classified as

Resp. Sens. 1

Skin Sens. 1

Component classified as	Solid / liquid	Gas	All physical states
Resp. Sens. 1	≥ 1.0 %	≥ 0.2 %
Resp. Sens. 1A	≥ 0.1 %	≥ 0.1 %
Resp. Sens. 1B	≥ 1.0 %	≥ 0.2 %
Skin Sens. 1			≥ 1.0 %
Skin Sens. 1A			≥ 0.1 %
Skin Sens. 1B			≥ 1.0 %

If a mixture is classified as sensitizing based on the presence of a sensitizing ingredient at a concentration at or above the generic or specific concentration limit no sub-categorisation is required.

Some substances that are classified as sensitisers may elicit a response, when present in a mixture in quantities below the concentrations established in Table 3.4.5 of Annex I to CLP, in individuals who are already sensitised to the substance or mixture (see Note to Table 3.4.6 of Annex I to CLP).

Component classified as

Concentration limits for elicitation

Component classified as

Resp. Sens. 1

Skin Sens. 1

Component classified as	Solid / liquid	Gas	All physical states
Resp. Sens. 1	≥ 0.1 % (see note)	≥ 0.1 % (see note)
Resp. Sens. 1A	≥ 0.01 % (see note)	≥ 0.01 % (see note)
Resp. Sens. 1B	≥ 0.1 % (see note)	≥ 0.1 % (see note)
Skin Sens. 1			≥ 0.1 % (see note)
Skin Sens. 1A			≥ 0.01 % (see note)
Skin Sens. 1B			≥ 0.1 % (see note)

Note.

This concentration limit for elicitation is used for the application of the special labelling requirements of section 2.8 of Annex II to protect already sensitised individuals. A Safety data sheet is required for the mixture containing a component at or above this concentration. For sensitising substances with a specific concentration limit, the concentration limit for elicitation shall be set at a tenth of the specific concentration limit.

Mixtures containing at least one sensitising substance (CLP, Annex II, 2.8). If mixture is not classified as sensitising ('Skin Sens. 1: H317', 'Skin Sens. 1A: H317', 'Skin Sens. 1B: H317', 'Resp. Sens. 1: H334', 'Resp. Sens. 1A: H334', 'Resp. Sens. 1B: H334') but containing at least one ingredient classified as sensitising and present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I, the label must include:

EUH208 — 'Contains (name of sensitising substance). May produce an allergic reaction'.

Mixtures classified as sensitising containing other substance(s) classified as sensitising (in addition to the one that leads to the classification of the mixture) and present in a concentration equal to or greater than that specified in Table 3.4.6 of Annex I to CLP should include the name(s) of that/those substance(s) on the label.

Where a mixture is labelled in accordance with Section 2.4 or 2.5 of Annex II to CLP, the statement EUH208 may be omitted from the label for the substance concerned.

For example, if for some ingredient the specific concentration limit of Resp. Sens. 1A is 0.09 % the concentration limits for elicitation of this ingredient equals 0.009 % (0.09 / 10).

−	If mixture contains ingredients (substances A, B and C) classified as sensitising and every at concentration above generic / specific concentration limit that leads to classification of the whole mixture as sensitising, there is no need to indicate names of these substances on the label.
−	If mixture contains at least 1 ingredient (substance A) classified as sensitising at concentration above generic / specific concentration limit that leads to classification of the whole mixture as sensitising, and contains ingredients (substances B and C) classified as sensitising at concentration below generic / specific concentration limit but above elicitation concentration limit, the label must bear names of these ingredients. Because CLP does not precise the wording this may be: 'Contains substance A, substance B and substance C.'.
−	If mixture contains no ingredients classified as sensitising at concentration above generic / specific concentration limit (mixture is not classified as sensitising), and contains ingredients (substances A, B and C) classified as sensitising at concentration below generic / specific concentration limit but above elicitation concentration limit, the label must bear the statement EUH208. For this example it should be: 'Contains substance A. May produce an allergic reaction. Contains substance B. May produce an allergic reaction. Contains substance C. May produce an allergic reaction.'.

Hierarchy of hazard categories

Hazard

➔

−	Respiratory sensitisation, category 1 (Resp. Sens. 1: H334)
−	Respiratory sensitisation, sub-category 1A (Resp. Sens. 1A: H334)
−	Respiratory sensitisation, sub-category 1B (Resp. Sens. 1B: H334)

Hazard

➔

−	Skin sensitisation, category 1 (Skin Sens. 1: H317)
−	Skin sensitisation, sub-category 1A (Skin Sens. 1A: H317)
−	Skin sensitisation, sub-category 1B (Skin Sens. 1B: H317)

A more severe classification for a mixture overrides a less severe classification. For example, if ingredients of a mixture lead to classification both as respiratory sensitisation category 1 (Resp. Sens. 1) and respiratory sensitisation sub-category 1A (Resp. Sens. 1A) the category 'Resp. Sens. 1' must be selected. The same way, between 'Skin Sens. 1' and 'Skin Sens. 1A' the category 'Skin Sens. 1' must be selected.

In case if a mixture is classified as both respiratory and skin sensitiser and because these categories belong to different routes of exposure (inhalation and dermal) both classifications must be indicated in hazard communication (label, section 2.2 of safety data sheet).

To select pictogram, signal word and precautionary statements please refer to Annex I, part 3, Table 3.4.7 of Regulation (EC) no 1272/2008 (CLP).

If mixture is not intended for the general public and is not classified as hazardous but contains:

−	≥ 0.1 % of a substance classified as Skin Sens. 1 or Skin Sens. 1B or Resp. Sens. 1 or Resp. Sens. 1B or
−	≥ 0.01 % of a substance classified as Skin Sens. 1A or Resp. Sens. 1A or
−	≥ one tenth of the specific concentration limit for a substance classified as skin sensitiser or respiratory sensitiser with a specific concentration limit

the label on the packaging must bear the statement EUH210 - 'Safety data sheet available on request' (CLP, Annex II, 2.10).

Example 1

Example 2

Example 3

Example 4

Example 5

There is a solid mixture:

Ingredient	Conc. % (w/w)	Classification
Substance A	2.0	Resp. Sens. 1A: H334
Substance B	0.5	Resp. Sens. 1B: H334
Inert substance	97.5	−

Cut-off limits

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

Specific and Generic concentration limits

−	Because no specific concentration limits are applied for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits.

Calculation of 'Resp. Sens. 1'

−	Concentration of substance A is above the generic concentration limit 0.1 % for solid / liquid mixture. Because no sub-categorisation is required this leads to classification Resp. Sens. 1 .
−	Concentration of substance B is below the generic concentration limit 1.0 % for solid / liquid mixture. This does not lead to classification 'Resp. Sens. 1'.

Selection of hazard category

−	The mixture is classified as 'Resp. Sens. 1'.

Selection of hazard statements

−	H334 corresponds to 'Resp. Sens. 1'.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Danger' correspond to 'Resp. Sens. 1'.

Selection of precautionary statements

−	For H334 following precautionary statements are applied: P261, P284, P304+P340, P342+P311, P501.

Classification and labelling of the mixture

Classification:	Resp. Sens. 1
Hazard statements:	H334
Pictogram:
	GHS08
Signal word:	Danger
Precautionary statements:	P261, P284, P304+P340, P342+P311, P501

Additional information on the label

Because,

−	the mixture is classified as sensitising (due to substance A) and
−	substance B is above concentration limit for elicitation (0.1 %)

according to section 2.8 of Annex II to CLP label must include names of both substances A and B: 'Contains substance A and substance B.'.

There is a gaseous mixture:

Ingredient	Conc. % (v/v)	Classification
Substance C	0.07	Resp. Sens. 1: H334
Substance D	0.15	Resp. Sens. 1B: H334
Substance E	0.6	Skin Sens. 1A: H317
Substance G	0.23	Skin Sens. 1B: H317
Inert gas	98.95	−

Cut-off limits

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

Specific and Generic concentration limits

−	Because no specific concentration limits are applied for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits.

Calculation of 'Resp. Sens. 1'

−	Concentration of substance C is below the generic concentration limit 0.2 % for gas mixture. This does not lead to classification 'Resp. Sens. 1'.
−	Concentration of substance D is below the generic concentration limit 0.2 % for gas mixture. This does not lead to classification 'Resp. Sens. 1'.

Calculation of 'Skin Sens. 1'

−	Concentration of substance E is above the generic concentration limit 0.1 %. Because no sub-categorisation is required this leads to classification Skin Sens. 1 .
−	Concentration of substance G is below the generic concentration limit 1.0 %. This does not lead to classification 'Skin Sens. 1'.

Selection of hazard category

−	The mixture is classified as 'Skin Sens. 1'.

Selection of hazard statements

−	H317 corresponds to 'Skin Sens. 1'.

Selection of pictogram and signal word

−	Pictogram GHS07 and signal word 'Warning' correspond to 'Skin Sens. 1'.

Selection of precautionary statements

−	For H317 following precautionary statements are applied: P261, P272, P280, P302+P352, P333+P313, P321, P362+P364, P501.

Classification and labelling of the mixture

Classification:	Skin Sens. 1
Hazard statements:	H317
Pictogram:
	GHS07
Signal word:	Warning
Precautionary statements:	P261, P272, P280, P302+P352, P333+P313, P321, 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

Because,

−	the mixture is classified as sensitising (due to substance E) and
−	substance C is above concentration limit for elicitation (0.1 %) and
−	substance D is above concentration limit for elicitation (0.1 %) and
−	substance G is above concentration limit for elicitation (0.1 %)

according to section 2.8 of Annex II to CLP label must include names of substances C, D, E and G: 'Contains substance C, substance D, substance E and substance G.'.

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification	Specific Conc. Limits
Substance S	0.3	Resp. Sens. 1: H334	Resp. Sens. 1: H334: C ≥ 0.2 %
Substance B	1.5	Resp. Sens. 1B: H334	−
Substance E	0.6	Skin Sens. 1A: H317	−
Water	97.6	−	−

Cut-off limits

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

Specific and Generic concentration limits

−	Substance S has a specific concentration limit (SCL). Because SCL has a precedence over generic concentration limit, concentration of S must be compared to its SCL.
−	Because no specific concentration limits are applied for other ingredients, their concentrations must be compared to generic concentration limits.

Calculation of 'Resp. Sens. 1'

−	Concentration of substance S is above specific concentration limit (0.2 %). This leads to classification Resp. Sens. 1 .
−	Concentration of substance B is above the generic concentration limit 1.0 % for liquid mixture. Because no sub-categorisation is required this leads to classification Resp. Sens. 1 .

Calculation of 'Skin Sens. 1'

−	Concentration of substance E is above the generic concentration limit 0.1 %. Because no sub-categorisation is required this leads to classification Skin Sens. 1 .

Selection of hazard categories

−	Because classification categories 'Resp. Sens. 1' and 'Skin Sens. 1' belong to different routes of exposure (respiratory and dermal) both of them must be selected.

Selection of hazard statements

−	H334 corresponds to 'Resp. Sens. 1'.
−	H317 corresponds to 'Skin Sens. 1'.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Danger' correspond to 'Resp. Sens. 1'.
−	Pictogram GHS07 and signal word 'Warning' correspond to 'Skin Sens. 1'.
−	According to Article 26(1,d) of CLP the pictogram GHS08 must be selected. According to Article 20(3) of CLP if the signal word 'Danger' is used the 'Warning' is not used.

Selection of precautionary statements

−	For H334 following precautionary statements are applied: P261, P284, P304+P340, P342+P311, P501.
−	For H317 following precautionary statements are applied: P261, P272, P280, P302+P352, P333+P313, P321, P362+P364, P501.

Classification and labelling of the mixture

Classification:	Resp. Sens. 1, Skin Sens. 1
Hazard statements:	H334, H317
Pictogram:
	GHS08
Signal word:	Danger
Precautionary statements:	P261, P272, P280, P284, P302+P352, P304+P340, P321, P333+P313, P342+P311, P362+P364, P501

Additional information on the label

Because,

−	the mixture is classified as sensitising (due to substances S and E) and
−	substance B is above concentration limit for elicitation (0.1 %)

according to section 2.8 of Annex II to CLP label must include names of substances S, B and E: 'Contains substance S, substance B and substance E.'.

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification	Specific Conc. Limits
Substance S	0.15	Resp. Sens. 1: H334	Resp. Sens. 1: H334: C ≥ 0.2 %
Substance B	0.09	Resp. Sens. 1B: H334	−
Substance E	0.08	Skin Sens. 1A: H317	−
Water	99.68	−	−

Cut-off limits

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

Specific and Generic concentration limits

−	Substance S has a specific concentration limit (SCL). Because SCL has a precedence over generic concentration limit, concentration of S must be compared to its SCL.
−	Because no specific concentration limits are applied for other ingredients, their concentrations must be compared to generic concentration limits.

Calculation of 'Resp. Sens. 1'

−	Concentration of S is below specific concentration limit (0.2 %), therefore, this does not lead to classification 'Resp. Sens. 1'.
−	Concentration of substance B is below the generic concentration limit 1.0 % for liquid mixture. This does not lead to classification 'Resp. Sens. 1'.

Calculation of 'Skin Sens. 1'

−	Concentration of substance E is below the generic concentration limit 0.1 %. This does not lead to classification 'Skin Sens. 1'.

Classification of the mixture

The mixture is not classified.

Additional information on the label

Because,

−	the mixture is not classified as sensitising and
−	substance S is above concentration limit for elicitation (0.02 % as SCL / 10 = 0.2 / 10) and
−	substance E is above concentration limit for elicitation (0.01 %)

according to section 2.8 of Annex II to CLP label must include the statement EUH208: 'Contains substance S. May produce an allergic reaction. Contains substance E. May produce an allergic reaction.'.

There is a liquid mixture:

Ingredient	Conc. % (w/w)	Classification	Specific Conc. Limits
Substance A	2.0	Resp. Sens. 1A: H334	−
Substance S	0.3	Resp. Sens. 1: H334	Resp. Sens. 1: H334: C ≥ 0.2 %
Substance G	1.7	Skin Sens. 1B: H317	−
Water	96.0	−	−

Cut-off limits

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

Specific and Generic concentration limits

−	Substance S has a specific concentration limit (SCL). Because SCL has a precedence over generic concentration limit, concentration of S must be compared to its SCL.
−	Because no specific concentration limits are applied for other ingredients, their concentrations must be compared to generic concentration limits.

Calculation of 'Resp. Sens. 1'

−	Concentration of substance A is above the generic concentration limit 0.1 % for liquid mixture. Because no sub-categorisation is required this leads to classification Resp. Sens. 1 .
−	Concentration of S is above specific concentration limit (0.2 %). Because no sub-categorisation is required this leads to classification Resp. Sens. 1 .

Calculation of 'Skin Sens. 1'

−	Concentration of substance G is above the generic concentration limit 1.0 %. Because no sub-categorisation is required this leads to classification Skin Sens. 1 .

Selection of hazard categories

−	Because classification categories 'Resp. Sens. 1' and 'Skin Sens. 1' belong to different routes of exposure (respiratory and dermal) both of them must be selected.

Selection of hazard statements

−	H334 corresponds to 'Resp. Sens. 1'.
−	H317 corresponds to 'Skin Sens. 1'.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Danger' correspond to 'Resp. Sens. 1'.
−	Pictogram GHS07 and signal word 'Warning' correspond to 'Skin Sens. 1'.
−	According to Article 26(1,d) of CLP the pictogram GHS08 must be selected. According to Article 20(3) of CLP if the signal word 'Danger' is used the 'Warning' is not used.

Selection of precautionary statements

−	For H334 following precautionary statements are applied: P261, P284, P304+P340, P342+P311, P501.
−	For H317 following precautionary statements are applied: P261, P272, P280, P302+P352, P333+P313, P321, P362+P364, P501.

Classification and labelling of the mixture

Classification:	Resp. Sens. 1, Skin Sens. 1
Hazard statements:	H334, H317
Pictogram:
	GHS08
Signal word:	Danger
Precautionary statements:	P261, P272, P280, P284, P302+P352, P304+P340, P321, P333+P313, P342+P311, P362+P364, P501

Additional information on the label

Because,

−	the mixture is classified as sensitising (due to substances A, S and G) and
−	there is no ingredient classified as sensitising at concentration above of limit for elicitation

according to section 2.8 of Annex II to CLP indication the names of substances A, S and G on the label is not required.