Online mixture classification calculator

Germ cell mutagenicity

Non-additivity approach

The additivity approach is not applicable for calculation of Germ cell mutagenicity.

If a single ingredient classified as germ cell mutagen 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 mutagen if at least one ingredient is classified as a Category 1A, Category 1B or Category 2 mutagen and is present at or above the appropriate generic concentration limit as shown in Table 3.5.2 of Annex I to CLP for Category 1A, Category 1B and Category 2 respectively.

Component classified as

Generic concentration limits triggering classification of a mixture as

Component classified as	Muta. 1A	Muta. 1B	Muta. 2
Muta. 1A	≥ 0.1 %
Muta. 1B		≥ 0.1 %
Muta. 2			≥ 1.0 %

Note.

The concentration limits in the table above apply to solids and liquids (w/w units) as well as gases (v/v units).

Hierarchy of hazard categories

Hazard

➔

−	Germ cell mutagenicity, category 1A (Muta. 1A: H340)
−	Germ cell mutagenicity, category 1B (Muta. 1B: H340)
−	Germ cell mutagenicity, category 2 (Muta. 2: H341)

A more severe classification for a mixture overrides a less severe classification. For example, if ingredients of a mixture lead to classification both as germ cell mutagenicity sub-category 1A (Muta. 1A) and germ cell mutagenicity sub-category 1B (Muta. 1B) the sub-category 'Muta. 1A' must be selected.

To select pictogram, signal word and precautionary statements please refer to Annex I, part 3, Table 3.5.3 of Regulation (EC) no 1272/2008 (CLP).

Additional labelling provisions

There are provisions resulted from point 29 of Annex XVII to Regulation (EC) no. 1907/2006 (REACH). Mixture containing substance classified as Mutagen and listed in Appendix 3 or 4 of Annex XVII to REACH, when the individual concentration of such a substance equals to or greater than specific or generic concentration limit:

−	mixture is prohibited for supply to the general public and
−	packaging of such mixture 'must be marked visibly, legibly and indelibly as follows: "Restricted to professional users".'. Derogations from this obligation are outlined in the same provision and are related to the use in: medicinal or veterinary products, cosmetic products, some types of fuels and oil products, artists' paints, etc.

See also answer of European Chemical Agency in section Q&As, ID: 0156 .

Example 1

Example 2

Example 3

There is a mixture:

Ingredient	Conc. % (w/w)	Classification
Substance A	0.08	Muta. 1A: H340
Substance B	2.3	Muta. 1B: H340
Substance C	1.5	Muta. 2: H341
Water	96.12	−

Cut-off limits

−	There is no generic cut-off limit for Germ cell mutagenicity (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 any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits.

Calculation of 'Muta. 1A'

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

Calculation of 'Muta. 1B'

−	Concentration of substance B is above the generic concentration limit 0.1 %. This leads to classification Muta. 1B .

Calculation of 'Muta. 2'

−	Concentration of substance C is above the generic concentration limit 1.0 %. This leads to classification Muta. 2 .

Selection of hazard category

−	Classification sub-category 'Muta. 1B' is more severe than 'Muta. 2', therefore, mixture is classified as 'Muta. 1B'.

Selection of hazard statements

−	H340 corresponds to 'Muta. 1B'.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Danger' correspond to 'Muta. 1B'.

Selection of precautionary statements

−	For H340 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Muta. 1B
Hazard statements:	H340
Pictogram:
	GHS08
Signal word:	Danger
Precautionary statements:	P201, P202, P280, P308+P313, P405, P501

There is a mixture:

Ingredient	Conc. % (w/w)	Classification
Substance A	0.08	Muta. 1A: H340
Substance D	0.06	Muta. 1A: H340
Substance E	0.07	Muta. 1A: H340
Substance C	1.5	Muta. 2: H341
Water	98.29	−

Cut-off limits

−	There is no generic cut-off limit for Germ cell mutagenicity (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 any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits.

Calculation of 'Muta. 1A'

−	Concentration of substances A, D and E are below the generic concentration limit 0.1 %. Because non-additivity approach is applied their concentrations are not summed. This does not lead to classification 'Muta. 1A'.

Calculation of 'Muta. 2'

−	Concentration of substance C is above the generic concentration limit 1.0 %. This leads to classification Muta. 2 .

Selection of hazard category

−	The mixture is classified as 'Muta. 2'.

Selection of hazard statements

−	H341 corresponds to 'Muta. 2'.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Warning' correspond to 'Muta. 2'.

Selection of precautionary statements

−	For H341 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Muta. 2
Hazard statements:	H341
Pictogram:
	GHS08
Signal word:	Warning
Precautionary statements:	P201, P202, P280, P308+P313, P405, P501

There is a mixture:

Ingredient	Conc. % (w/w)	Classification	Specific Conc. Limits
Substance A	0.08	Muta. 1A: H340	−
Substance P	0.07	Muta. 1B: H340	−
Substance M	0.02	Muta. 2: H341	Muta. 2: H341: C ≥ 0.01 %
Water	99.83	−	−

Cut-off limits

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

Specific and Generic concentration limits

−	Substance M has a specific concentration limit (SCL). Because SCL has a precedence over generic concentration limit, concentration of M 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 'Muta. 1A'

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

Calculation of 'Muta. 1B'

−	Concentration of substance P is below the generic concentration limit 0.1 %. This does not lead to classification 'Muta. 1B'.

Calculation of 'Muta. 2'

−	Concentration of substance M is above specific concentration limit (0.01 %). This leads to classification Muta. 2 .

Selection of hazard category

−	The mixture is classified as 'Muta. 2'.

Selection of hazard statements

−	H341 corresponds to 'Muta. 2'.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Warning' correspond to 'Muta. 2'.

Selection of precautionary statements

−	For H341 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Muta. 2
Hazard statements:	H341
Pictogram:
	GHS08
Signal word:	Warning
Precautionary statements:	P201, P202, P280, P308+P313, P405, P501