Online mixture classification calculator

Reproductive toxicity

Non-additivity approach

The additivity approach is not applicable for calculation of Reproductive toxicity.

If a single ingredient classified as reproductive toxicant 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 reproductive toxicant if at least one ingredient is classified as a Category 1A, Category 1B or Category 2 reproductive toxicant and is present at or above the appropriate generic concentration limit as shown in Table 3.7.2 of Annex I to CLP for Category 1A, Category 1B and Category 2 respectively.

The mixture is classified for effects on or via lactation if at least one ingredient is classified for effects on or via lactation and is present at or above the appropriate generic concentration limit as shown in Table 3.7.2 of Annex I to CLP for the additional category for effects on or via lactation.

Component classified as

Generic concentration limits triggering classification of a mixture as

Component classified as	Repr. 1A	Repr. 1B	Repr. 2	Lact.
Repr. 1A	≥ 0.3 % (note 1)
Repr. 1B		≥ 0.3 % (note 1)
Repr. 2			≥ 3.0 % (note 1)
Lact.				≥ 0.3 % (note 1)

Note.

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

Note 1.

If a Category 1 or Category 2 reproductive toxicant or a substance classified for effects on or via lactation is present in the mixture as an ingredient at a concentration ≥ 0.1 %, a safety data sheet shall be available for the mixture upon request.

Hierarchy of hazard categories

Hazard

➔

−	Reproductive toxicity, category 1A (Repr. 1A: H360 *)
−	Reproductive toxicity, category 1B (Repr. 1B: H360 *)
−	Reproductive toxicity, category 2 (Repr. 2: H361 **)

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

Category for effects on or via lactation (Lact.) is not replaced by Reproductive toxicity 1A, 1B or 2.

For example, if ingredients of a mixture lead to classification both as reproductive toxicity sub-category 1A (Repr. 1A) and category for effects on or via lactation (Lact.) such a mixture will be classified both as 'Repr. 1A' and 'Lact.'.

* To Reproductive toxicity category 1A and 1B one of the following statement is applied:

−	H360: May damage fertility or the unborn child (state specific effect if known)(state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
−	H360F: May damage fertility.
−	H360Fd: May damage fertility. Suspected of damaging the unborn child.
−	H360FD: May damage fertility. May damage the unborn child.
−	H360D: May damage the unborn child.
−	H360Df: May damage the unborn child. Suspected of damaging fertility.

** To Reproductive toxicity category 2 one of the following statement is applied:

−	H361: Suspected of damaging fertility or the unborn child (state specific effect if known) (state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard).
−	H361f: Suspected of damaging fertility.
−	H361fd: Suspected of damaging fertility. Suspected of damaging the unborn child.
−	H361d: Suspected of damaging the unborn child.

For description of statements H360F, H360Fd, H360FD, H360D, H360Df and H361f, H361fd, H361d see CLP, Annex I, 1.1.2.1.2.

In hazard statement H360 the lowercase letters 'f' and 'd' means 'Suspected of damaging ...' while uppercase letters 'F' and 'D' means 'May damage ...'. Because 'May' is more severe than 'Suspected'' uppercase letter has precedence over lowercase letter. Between 'F' and 'f' the letter 'F' must be selected. The same way the letter 'D' is selected instead of 'd'. For example, in case if mixture has two ingredients with H360Fd and H360Df the statement H360FD is selected.

Selection of hazard statement(s) depends on letters. For example:

−	if H360D and H361d are applied the statement H360D is selected, because 'd' from H361d is covered by 'D' in H360D. The same approach is applied for 'F' and 'f'.
−	if H360Fd and H361d are applied the statement H360Fd is selected, because 'd' from H361d is covered by 'd' in H360Fd. Between H360Df and H361f the statement H360Df is selected.
−	if H360FD and H360Df are applied the statement H360FD is selected, because 'Df' from H360Df is covered by 'FD' in H360FD. Between H360FD and H360Fd the statement H360FD is selected.
−	if H360F and H361d are applied both statements are selected - H360F and H361d.

To select pictogram, signal word and precautionary statements please refer to Annex I, part 3, Table 3.7.3 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 Repr. 1A or Repr. 1B or Repr. 2 or Lact. the label on the packaging must bear the statement EUH210 - 'Safety data sheet available on request' (CLP, Annex II, 2.10).

Additional labelling provisions

There are provisions resulted from point 30 of Annex XVII to Regulation (EC) no. 1907/2006 (REACH). Mixture containing substance classified as Reproductive toxicant and listed in Appendix 5 or 6 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

Example 4

There is a mixture:

Ingredient	Conc. % (w/w)	Classification
Substance A	2.0	Repr. 1A: H360F
Substance B	0.1	Repr. 1A: H360FD
Substance C	1.5	Repr. 1B: H360Fd
Water	96.4	−

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 for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits.

Calculation of 'Repr. 1A'

−	Concentration of substance A is above the generic concentration limit 0.3 %. This leads to classification Repr. 1A .
−	Concentration of substance B is below the generic concentration limit 0.3 %. This does not lead to classification 'Repr. 1A'.

Calculation of 'Repr. 1B'

−	Concentration of substance C is above the generic concentration limit 0.3 %. This leads to classification Repr. 1B .

Selection of hazard category

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

Selection of hazard statements

−	Because substances A and C have influence on classification, hazard statements H360F and H360Fd are taken into account. Both statements have 'F', one of them has 'd', therefore, 'F' and 'd' must be indicated. This leads to the use H360Fd.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Danger' correspond to 'Repr. 1A'.

Selection of precautionary statements

−	For H360Fd following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Repr. 1A
Hazard statements:	H360Fd
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	0.25	Repr. 1A: H360F
Substance D	1.5	Repr. 1B: H360D
Substance E	0.25	Repr. 1B: H360FD
Substance H	4.5	Repr. 2: H361d
Substance L	4.5	Repr. 2: H361f
Substance M	7.0	Lact.: H362
Water	82.0	−

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 for any ingredient, concentrations of mixture's ingredients must be compared to generic concentration limits.

Calculation of 'Repr. 1A'

−	Concentration of substance A is below the generic concentration limit 0.3 %. This does not lead to classification 'Repr. 1A'.

Calculation of 'Repr. 1B'

−	Concentration of substance D is above the generic concentration limit 0.3 %. This leads to classification Repr. 1B .
−	Concentration of substance E is below the generic concentration limit 0.3 %. This does not lead to classification 'Repr. 1B'.

Calculation of 'Repr. 2'

−	Concentration of substance H is above the generic concentration limit 3.0 %. This leads to classification Repr. 2 .
−	Concentration of substance L is above the generic concentration limit 3.0 %. This leads to classification Repr. 2 .

Calculation of 'Lact.'

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

Selection of hazard category

−	Classification sub-category 'Repr. 1B' is more severe than 'Repr. 2', therefore, mixture is classified as 'Repr. 1B'. Mixture is also classified as 'Lact'.

Selection of hazard statements

−	Because substances D, H, L and M have influence on classification, hazard statements H360D, H361d, H361f and H362 are taken into account.
−	The uppercase letter 'D' has precedence over lowercase letter 'd', letter 'f' is covered by H361f, therefore, 'D' and 'f' must be indicated. H360 is resulted from 'Repr. 1B' and is used instead of H361, which is resulted from less severe 'Repr. 2'. Following elements should be combined: H360, D and f. This leads to the use H360Df .
−	H362 is resulted from 'Lact.' and must also be indicated.

Selection of pictogram and signal word

−	Pictogram GHS08 and signal word 'Danger' correspond to 'Repr. 1B'.
−	No pictogram and signal word are applied for 'Lact.'.

Selection of precautionary statements

−	For H360Df following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.
−	For H362 following precautionary statements are applied: P201, P260, P263, P264, P270, P308+P313.

Classification and labelling of the mixture

Classification:	Repr. 1B, Lact.
Hazard statements:	H360Df, H362
Pictogram:
	GHS08
Signal word:	Danger
Precautionary statements:	P201, P202, P260, P263, P264, P270, P280, P308+P313, P405, 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.

There is a mixture:

Ingredient	Conc. % (w/w)	Classification	Specific Conc. Limits
Substance P	7.0	Repr. 1B: H360FD	Repr. 1B: H360FD: C ≥ 8.5 %
Substance S	7.0	Repr. 1B: H360Df	Repr. 1B: H360Df: C ≥ 9 % Repr. 1B: H360D: 6.5 % ≤ C < 9 %
Substance L	4.5	Repr. 2: H361f	−
Water	81.5	−	−

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

−	Substances P and S have specific concentration limits (SCLs). Because SCL has a precedence over generic concentration limit, concentrations of P and S must be compared to their SCLs.
−	Because no specific concentration limits are applied for substance L, its concentration must be compared to generic concentration limit.

Calculation of 'Repr. 1B'

−	Concentration of substance P is below specific concentration limit (8.5 %). This does not lead to classification 'Repr. 1B'.
−	Concentration of substance S is inside the specific concentration limit range (6.5 ≤ C < 9 %). This leads to classification Repr. 1B .

Calculation of 'Repr. 2'

−	Concentration of substance L is above the generic concentration limit 3.0 %. This leads to classification Repr. 2 .

Selection of hazard category

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

Selection of hazard statements

−

Substance S leads to the use of hazard statement H360D because its concentration is inside the specific concentration limit range (6.5 ≤ C < 9 %). Substance L is also influence on mixture's classification with H361f. Because 'D' is covered by H360D and 'f' is covered by H361f both letters must be indicated. H360 is resulted from 'Repr. 1B' and is used instead of H361, which is resulted from less severe 'Repr. 2'. Following elements should be combined: H360, D and f. This leads to the use H360Df .

Selection of pictogram and signal word

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

Selection of precautionary statements

−	For H360Df following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Repr. 1B
Hazard statements:	H360Df
Pictogram:
	GHS08
Signal word:	Danger
Precautionary statements:	P201, P202, P280, P308+P313, P405, P501

There is a mixture:

Ingredient	Conc. % (w/w)	Classification	Specific Conc. Limits
Substance P	7.0	Repr. 1B: H360FD	Repr. 1B: H360FD: C ≥ 8.5 %
Substance T	1.5	Repr. 2: H361fd	Repr. 2: H361fd: C ≥ 1 %
Substance W	5.5	Repr. 2: H361f	−
Water	86.0	−	−

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

−	Substances P and T have specific concentration limits (SCLs). Because SCL has a precedence over generic concentration limit, concentrations of P and T must be compared to their SCLs.
−	Because no specific concentration limits are applied for substance W, its concentration must be compared to generic concentration limit.

Calculation of 'Repr. 1B'

−	Concentration of substance P is below specific concentration limit (8.5 %). This does not lead to classification 'Repr. 1B'.

Calculation of 'Repr. 2'

−	Concentration of substance T is above specific concentration limit (1 %). This leads to classification Repr. 2 .
−	Concentration of substance W is above the generic concentration limit 3.0 %. This leads to classification Repr. 2 .

Selection of hazard category

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

Selection of hazard statements

−	Because substances T and W have influence on classification, hazard statements H361fd and H361f are taken into account. The letter 'f' from H361f is covered by H361fd, therefore, the statement H361fd is selected.

Selection of pictogram and signal word

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

Selection of precautionary statements

−	For H361fd following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.

Classification and labelling of the mixture

Classification:	Repr. 2
Hazard statements:	H361fd
Pictogram:
	GHS08
Signal word:	Warning
Precautionary statements:	P201, P202, P280, P308+P313, P405, P501