If a single ingredient with classification STOT SE category 1 or 2 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 specific target organ toxicant with single exposure if at least one ingredient is classified as a Category 1 or Category 2 specific target organ toxicant and is present at or above the appropriate generic concentration limit as shown in Table 3.8.3 of Annex I to CLP for Category 1 and 2 respectively.
If a Category 2 specific target organ toxicant is present in the mixture as an ingredient at a concentration ≥ 1.0 % a safety data sheet shall be available for the mixture upon request.
The generic cut-off value for Specific target organ toxicity - single exposure category 3 is 1 % (CLP, Annex I, Table 1.1). This means that if mixture consists of substances classified as STOT SE category 3 each present at a concentration below 1 % and even if the sum of their concentrations is above 1 % the mixture will not be classified for STOT SE category 3.
A mixture may be classified either as STOT SE 3: H335 or STOT SE 3: H336 or both.
A more severe classification for a mixture overrides a less severe classification. For example, if ingredients of a mixture lead to classification both as specific target organ toxicity - single exposure category 1 (STOT SE 1) and specific target organ toxicity - single exposure category 2 (STOT SE 2) the category 'STOT SE 1' must be selected.
If a mixture is classified as 'STOT SE 1' or 'STOT SE 2' and classification criteria of 'STOT SE 3: H335' or 'STOT SE 3: H336' are also fulfilled, only the hazard statement (H335 and/or H336) will be added in hazard communication.
When a mixture is classified as 'STOT SE 1' or 'STOT SE 2' on the basis of ingredients the hazard statement H370 (category 1) or H371 (category 2) may be used without specifying the target organs and without specifying the routes of exposure.
To select pictogram, signal word and precautionary statements please refer to Annex I, part 3, Table 3.8.4 of Regulation (EC) no 1272/2008 (CLP).
Mixtures are classified for either or both STOT SE (single exposure) and STOT RE (repeated exposure) independently.
There is a mixture:
| Ingredient |
Conc. % (w/w) |
Classification |
| Substance A |
12 |
STOT SE 1: H370 |
| Substance B |
3 |
STOT SE 1: H370 |
| Substance C |
8 |
STOT SE 2: H371 |
| Water |
77 |
− |
Cut-off limits
| − |
There is no generic cut-off limit for STOT SE categories 1 and 2 (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 'STOT SE 1' (non-additivity approach)
| − |
Concentration of substance A is above the generic concentration limit 10 %. This leads to classification STOT SE 1 . |
| − |
Concentration of substance B is below the generic concentration limit 10 %. This does not lead to classification 'STOT SE 1'. |
Calculation of 'STOT SE 2' (non-additivity approach)
| − |
Concentration of substance A is above the upper border of generic concentration limit 10 %. This does not lead to classification 'STOT SE 2'. |
| − |
Concentration of substance B is between 1 % and 10 % of the generic concentration limit. This leads to classification STOT SE 2 . |
| − |
Concentration of substance C is below the generic concentration limit 10 %. This does not lead to classification 'STOT SE 2'. |
Selection of hazard category
| − |
Classification category 'STOT SE 1' is more severe than 'STOT SE 2', therefore, mixture is classified as 'STOT SE 1'. |
Selection of hazard statements
| − |
H370 corresponds to 'STOT SE 1'. |
Selection of pictogram and signal word
| − |
Pictogram GHS08 and signal word 'Danger' correspond to 'STOT SE 1'. |
Selection of precautionary statements
| − |
For H370 following precautionary statements are applied: P260, P264, P270, P308+P311, P321, P405, P501. |
Classification and labelling of the mixture
| Classification: |
STOT SE 1 |
| Hazard statements: |
H370 |
| Pictogram: |
 |
|
GHS08 |
| Signal word: |
Danger |
| Precautionary statements: |
P260, P264, P270, P308+P311, P321, 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 |
| Substance A |
0.9 |
STOT SE 1: H370 |
| Substance B |
2.0 |
STOT SE 1: H370 (lung) (inhalation) |
| Substance C |
15.0 |
STOT SE 2: H371 |
| Substance D |
11.0 |
STOT SE 3: H335 |
| Substance E |
11.0 |
STOT SE 3: H335 |
| Water |
60.1 |
− |
Cut-off limits
| − |
There is no generic cut-off limit for STOT SE categories 1 and 2 (CLP, Annex I, Table 1.1), therefore, any concentration of substances A, B and C are taken into account. |
| − |
There is generic cut-off limit for STOT SE category 3 (CLP, Annex I, Table 1.1). Concentrations of substances D and E are above the generic cut-off limit 1 %, therefore, their concentrations are 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 'STOT SE 1' (non-additivity approach)
| − |
Concentration of substance A is below the generic concentration limit 10 %. This does not lead to classification 'STOT SE 1'. |
| − |
Concentration of substance B is below the generic concentration limit 10 %. This does not lead to classification 'STOT SE 1'. |
Calculation of 'STOT SE 2' (non-additivity approach)
| − |
Concentration of substance A is below the lower border of generic concentration limit 1 %. This does not lead to classification 'STOT SE 2'. |
| − |
Concentration of substance B is between 1 % and 10 % of the generic concentration limit. This leads to classification STOT SE 2 . |
| − |
Concentration of substance C is above the generic concentration limit 10 %. This leads to classification STOT SE 2 . |
Calculation of 'STOT SE 3: H335' (additivity approach)
| − |
Concentrations of substances D and E must be summed.
conc. D + conc. E = 11 + 11 = 22 %
The obtained value is above the generic concentration limit 20 %. This leads to classification STOT SE 3: H335 . |
Selection of hazard category
| − |
Classification category 'STOT SE 2' is more severe than 'STOT SE 3', therefore, mixture is classified as 'STOT SE 2'. |
Selection of hazard statements
| − |
H371 corresponds to 'STOT SE 2'. |
| − |
Because classification criteria of 'STOT SE 3: H335' are also fulfilled the hazard statement H335 also must be indicated. |
| − |
For mixtures there is no need to identify the target organs and routes of exposure on the label. |
Selection of pictogram and signal word
| − |
Pictogram GHS08 and signal word 'Warning' correspond to 'STOT SE 2'. |
Selection of precautionary statements
| − |
For H371 following precautionary statements are applied: P260, P264, P270, P308+P311, P405, P501. |
| − |
For H335 following precautionary statements are applied: P261, P271, P304+P340, P312, P403+P233, P405, P501. |
Classification and labelling of the mixture
| Classification: |
STOT SE 2 |
| Hazard statements: |
H371, H335 |
| Pictogram: |
|
|
GHS08 |
| Signal word: |
Warning |
| Precautionary statements: |
P260, P261, P264, P270, P271, P304+P340, P308+P311, P312, P403+P233, 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 |
| Substance A |
12 |
STOT SE 1: H370 (eye)
STOT SE 3: H336 |
| Substance D |
11 |
STOT SE 3: H335 |
| Substance E |
11 |
STOT SE 3: H335 |
| Substance G |
7 |
STOT SE 3: H336 |
| Substance H |
7 |
STOT SE 3: H336 |
| Substance L |
7 |
STOT SE 3: H336 |
| Water |
45 |
− |
Cut-off limits
| − |
There is no generic cut-off limit for STOT SE categories 1 and 2 (CLP, Annex I, Table 1.1), therefore, any concentration of substance A is taken into account. |
| − |
There is generic cut-off limit for STOT SE category 3 (CLP, Annex I, Table 1.1). Concentrations of all substances are above the generic cut-off limit 1 %, therefore, their concentrations are 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 'STOT SE 1' (non-additivity approach)
| − |
Concentration of substance A is above the generic concentration limit 10 %. This leads to classification STOT SE 1 . |
Calculation of 'STOT SE 3: H335' (additivity approach)
| − |
Concentrations of substances D and E must be summed.
conc. D + conc. E = 11 + 11 = 22 %
The obtained value is above the generic concentration limit 20 %. This leads to classification STOT SE 3: H335 . |
Calculation of 'STOT SE 3: H336' (additivity approach)
| − |
Concentrations of substances A, G, H and L must be summed.
conc. A + conc. G + conc. H + conc. L = 12 + 7 + 7 + 7 = 33 %
The obtained value is above the generic concentration limit 20 %. This leads to classification STOT SE 3: H336 . |
Selection of hazard category
| − |
Classification category 'STOT SE 1' is more severe than 'STOT SE 3', therefore, mixture is classified as 'STOT SE 1'. |
Selection of hazard statements
| − |
H370 corresponds to 'STOT SE 1'. |
| − |
Because classification criteria of 'STOT SE 3: H335' are fulfilled the hazard statement H335 also must be indicated. |
| − |
Because classification criteria of 'STOT SE 3: H336' are fulfilled the hazard statement H336 also must be indicated. |
| − |
For mixtures there is no need to identify the target organs and routes of exposure on the label. |
Selection of pictogram and signal word
| − |
Pictogram GHS08 and signal word 'Danger' correspond to 'STOT SE 1'. |
Selection of precautionary statements
| − |
For H370 following precautionary statements are applied: P260, P264, P270, P308+P311, P321, P405, P501. |
| − |
For both H335 and H336 the same following precautionary statements are applied: P261, P271, P304+P340, P312, P403+P233, P405, P501. |
Classification and labelling of the mixture
| Classification: |
STOT SE 1 |
| Hazard statements: |
H370, H335, H336 |
| Pictogram: |
|
|
GHS08 |
| Signal word: |
Danger |
| Precautionary statements: |
P260, P261, P264, P270, P271, P304+P340, P308+P311, P312, P321, P403+P233, 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 M |
0.7 |
STOT SE 1: H370 |
STOT SE 1: H370: C ≥ 1 %
STOT SE 2: H371: 0.2 % ≤ C < 1 % |
| Substance D |
11.0 |
STOT SE 3: H335 |
− |
| Substance E |
2.0 |
STOT SE 3: H335 |
− |
| Substance G |
12.0 |
STOT SE 3: H336 |
− |
| Substance H |
9.5 |
STOT SE 3: H336 |
− |
| Substance R |
0.5 |
STOT SE 3: H336 |
− |
| Water |
64.3 |
− |
− |
Cut-off limits
| − |
There is no generic cut-off limit for STOT SE categories 1 and 2 (CLP, Annex I, Table 1.1), therefore, any concentration of substance M is taken into account. |
| − |
There is generic cut-off limit for STOT SE category 3 (CLP, Annex I, Table 1.1). Concentrations of substances D, E, G and H are above the generic cut-off limit 1 %, therefore, their concentrations are taken into account. In turn, concentration of substance R is below the generic cut-off limit 1 %, therefore, its concentrations is not taken into account |
Specific and Generic concentration limits
| − |
Substance M has specific concentration limits (SCLs). Because SCL has a precedence over generic concentration limit, concentration of M must be compared to its SCLs. |
| − |
Because no specific concentration limits are applied for other ingredients, their concentrations must be compared to generic concentration limits. |
Calculation of 'STOT SE 1' (non-additivity approach)
| − |
Concentration of substance M is below the specific concentration limit of 1 %. This does not lead to classification 'STOT SE 1'. |
Calculation of 'STOT SE 2' (non-additivity approach)
| − |
Concentration of substance M is inside the specific concentration limit range (0.2 % ≤ C < 1 %). This leads to classification STOT SE 2 . |
Calculation of 'STOT SE 3: H335' (additivity approach)
| − |
Concentrations of substances D and E must be summed.
conc. D + conc. E = 11.0 + 2.0 = 13 %
The obtained value is below the generic concentration limit 20 %. This does not lead to classification 'STOT SE 3: H335'. |
Calculation of 'STOT SE 3: H336' (additivity approach)
| − |
Concentrations of substances G and H must be summed.
conc. G + conc. H = 12.0 + 9.5 = 21.5 %
The obtained value is above the generic concentration limit 20 %. This leads to classification STOT SE 3: H336 . |
Selection of hazard category
| − |
Classification category 'STOT SE 2' is more severe than 'STOT SE 3', therefore, mixture is classified as 'STOT SE 2'. |
Selection of hazard statements
| − |
H371 corresponds to 'STOT SE 2'. |
| − |
Because classification criteria of 'STOT SE 3: H336' are fulfilled the hazard statement H336 also must be indicated. |
Selection of pictogram and signal word
| − |
Pictogram GHS08 and signal word 'Warning' correspond to 'STOT SE 2'. |
Selection of precautionary statements
| − |
For H371 following precautionary statements are applied: P260, P264, P270, P308+P311, P405, P501. |
| − |
For H336 following precautionary statements are applied: P261, P271, P304+P340, P312, P403+P233, P405, P501. |
Classification and labelling of the mixture
| Classification: |
STOT SE 2 |
| Hazard statements: |
H371, H336 |
| Pictogram: |
|
|
GHS08 |
| Signal word: |
Warning |
| Precautionary statements: |
P260, P261, P264, P270, P271, P304+P340, P308+P311, P312, P403+P233, 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 M |
0.7 |
STOT SE 1: H370 |
STOT SE 1: H370: C ≥ 1 %
STOT SE 2: H371: 0.2 % ≤ C < 1 % |
| Substance S |
9.7 |
STOT SE 1: H370 |
STOT SE 1: H370: C ≥ 10 %
STOT SE 2: H371: 3 % ≤ C < 10 % |
| Substance D |
6.8 |
STOT SE 3: H335 |
− |
| Substance T |
2.3 |
not classified * |
STOT SE 3: H335: C ≥ 5 % |
| Substance U |
5.5 |
STOT SE 3: H335 |
STOT SE 3: H335: C ≥ 25 % |
| Substance G |
12.0 |
STOT SE 3: H336 |
− |
| Water |
73.8 |
− |
− |
* - There are substances in Table 3 of Annex VI to CLP which are not classified as 'STOT SE 3: H335', but have specific concentration limit for this category. In such case for precautionary reasons it is better to treat such ingredient as classified in this category. Anyway, such situation should be clarified by authorities.
Cut-off limits
| − |
There is no generic cut-off limit for STOT SE categories 1 and 2 (CLP, Annex I, Table 1.1), therefore, any concentrations of substances M and S are taken into account. |
| − |
There is generic cut-off limit for STOT SE category 3 (CLP, Annex I, Table 1.1). Concentrations of substances D, G, T and U are above the generic cut-off limit 1 %, therefore, their concentrations are taken into account. |
Specific and Generic concentration limits
| − |
Substances M and S have specific concentration limits (SCLs). Because a non-additivity approach is applied for calculation 'STOT SE 1' and 'STOT SE 2' and because SCL has a precedence over generic concentration limit their concentrations must be compared to theirs SCLs. |
| − |
Substances T and U have specific concentration limits (SCLs). Because an additivity approach is applied for calculation 'STOT SE 3' and because SCL has a precedence over generic concentration limit the formula from Guidance on the Application of the CLP Criteria, Version 5.0 July 2017, section 1.6.3.3.3 is applied. |
| − |
Because no specific concentration limit is applied for substance G, its concentration must be compared to generic concentration limit. |
Calculation of 'STOT SE 1' (non-additivity approach)
| − |
Concentration of substance M is below the specific concentration limit of 1 %. This does not lead to classification 'STOT SE 1'. |
| − |
Concentration of substance S is below the specific concentration limit of 10 %. This does not lead to classification 'STOT SE 1'. |
Calculation of 'STOT SE 2' (non-additivity approach)
| − |
Concentration of substance M is inside the specific concentration limit range (0.2 % ≤ C < 1 %). This leads to classification STOT SE 2 . |
| − |
Concentration of substance S is inside the specific concentration limit range (3 % ≤ C < 10 %). This leads to classification STOT SE 2 . |
Calculation of 'STOT SE 3: H335' (additivity approach)
| − |
Because substances T and U have SCLs for 'STOT SE 3: H335', the formula from Guidance on the Application of the CLP Criteria, Version 5.0 July 2017, section 1.6.3.3.3 is applied.
conc. D / GCL + conc. T / SCL + conc. U / SCL = 6.8 / 20 + 2.3 / 5 + 5.5 / 25 = 1.020
GCL for 'STOT SE 3' is 20 % (CLP, Annex I, 3.8.3.4.5). Substance G is not taken into account, because it has 'STOT SE 3: H336' (not H335).
The obtained value is above 1. This leads to classification STOT SE 3: H335 . |
Calculation of 'STOT SE 3: H336' (additivity approach)
| − |
Concentration of substance G is below the generic concentration limit 20 %. This does not leads to 'STOT SE 3: H336'. |
Selection of hazard category
| − |
Classification category 'STOT SE 2' is more severe than 'STOT SE 3', therefore, mixture is classified as 'STOT SE 2'. |
Selection of hazard statements
| − |
H371 corresponds to 'STOT SE 2'. |
| − |
Because classification criteria of 'STOT SE 3: H335' are fulfilled the hazard statement H335 also must be indicated. |
Selection of pictogram and signal word
| − |
Pictogram GHS08 and signal word 'Warning' correspond to 'STOT SE 2'. |
Selection of precautionary statements
| − |
For H371 following precautionary statements are applied: P260, P264, P270, P308+P311, P405, P501. |
| − |
For H335 following precautionary statements are applied: P261, P271, P304+P340, P312, P403+P233, P405, P501. |
Classification and labelling of the mixture
| Classification: |
STOT SE 2 |
| Hazard statements: |
H371, H335 |
| Pictogram: |
|
|
GHS08 |
| Signal word: |
Warning |
| Precautionary statements: |
P260, P261, P264, P270, P271, P304+P340, P308+P311, P312, P403+P233, 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.