The purpose of this example is to show calculation of Germ cell mutagenicity 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 | 2.2 |
Carc. 1B: H350 Muta. 2: H341 Acute Tox. 2: H330 Acute Tox. 3: H301 Skin Corr. 1B: H314 Skin Sens. 1: H317 |
Carc. 1B: H350: C ≥ 0.01 % Muta. 2: H341: C ≥ 0.01 % STOT SE 3: H335: C ≥ 5 % |
Substance B | 2.5 |
Carc. 1B: H350 Muta. 1B: H340 Skin Sens. 1: H317 |
− |
Substance C | 0.9 |
Carc. 1B: H350 Muta. 2: H341 Acute Tox. 4: H302 |
− |
Substance D | 0.3 |
Carc. 1B: H350 Muta. 2: H341 |
− |
Substance E | 1.4 |
Carc. 2: H351 Muta. 2: H341 |
− |
Substance G | 0.8 | Muta. 2: H341 | − |
Substance H | 0.7 | Muta. 1B: H340 | − |
Water | 91.2 | − | − |
Calculation of mixture classification.
Following ingredients are classified as acute toxicants:
− | Substance A: Acute Tox. 2: H330 (inhalation) / Acute Tox. 3: H301 (oral). |
− | Substance C: Acute Tox. 4: H302 (oral). |
Because there are no data on LD50 (oral) / LC50 (inhalation) the acute toxicity category for appropriate route (oral, 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 A 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). Concentration of substance C is below this value, therefore, it is not 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 A: Acute Tox. 3: H301 -> ATE = 100 |
100 / ATE mix = conc. A / ATE A
100 / ATE mix = 2.2 / 100
ATE mix = 4545.455
The value 4545.455 is above 2 000 (CLP, Annex I, Table 3.1.2). This does not lead to oral acute toxicity.
Calculation of inhalation Acute Toxicity
There is one ingredient (A) classified as acute toxicant via inhalation route and no mixture's physical forms of inhalation routes of exposure are known, therefore, all possible routes should be calculated separately. Inhalation exposure may be calculated for three physical forms: (1) gases, (2) vapours and (3) dust/mist. Because mixture is a liquid the gaseous form may be omitted. During the usage of the mixture it can not be excluded that mixture may forms vapours and/or mists, therefore, inhalation exposure should be calculated for 2nd and 3rd forms.
ATE values converted from inhalation (vapours) acute toxicity categories:
− | Substance A: Acute Tox. 2: H330 -> ATE = 0.5 |
100 / ATE mix = conc. A / ATE A
100 / ATE mix = 2.2 / 0.5
ATE mix = 22.727
The value 22.727 is above 20.0 for vapours (CLP, Annex I, Table 3.1.2). This does not lead to acute toxicity via inhalation route.
ATE values converted from inhalation (mists) acute toxicity categories:
− | Substance A: Acute Tox. 2: H330 -> ATE = 0.05 |
100 / ATE mix = conc. A / ATE A
100 / ATE mix = 2.2 / 0.05
ATE mix = 2.273
The value 2.273 is between 1.0 and 5.0 for dust/mist (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 4 .
Selection of hazard category
− | The mixture is classified as 'Acute Tox. 4'. |
Selection of hazard statements
− | H332 corresponds to inhalation 'Acute Tox. 4'. |
Selection of pictogram and signal word
− | Pictogram GHS07 and signal word 'Warning' correspond to 'Acute Tox. 4'. |
Selection of precautionary statements
− | For H332 following precautionary statements are applied: P261, P271, P304+P340, P312. |
Following ingredients are classified as corrosive / irritant to skin:
− | Substance A: Skin Corr. 1B: H314. |
The mixture's pH is between 2 and 11.5, this does not lead to classification 'Skin Corr. 1'. Mixture contains no ingredients leading to the application of non-additivity approach, therefore, Additivity approach is applied.
Cut-off limits
− | For skin corrosion / irritation the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Concentration of substance A is above this value, therefore, it is taken into account. |
Specific and Generic concentration limits
− | Because no specific concentration limits are applied for substance A and only A is classified as 'Skin Corr. 1B' only its concentration should be compared to generic concentration limits. |
Calculation of 'Skin Corr. 1B'
− | Concentration of substance A is below the generic concentration limit 5 % (CLP, Annex I, Table 3.2.3). This does not lead to classification 'Skin Corr. 1B'. |
Calculation of 'Skin Irrit. 2'
− | Concentration of substance A is between 1 % and 5 %, generic concentration limits for 'Skin Irrit. 2' (CLP, Annex I, Table 3.2.3). This leads to classification Skin Irrit. 2 . |
− | Concentration of substance A should be multiplied by 10.
10 × conc. A = 10 × 2.2 = 22 % The obtained value is above the generic concentration limit 10 % (CLP, Annex I, Table 3.2.3). This leads to classification Skin Irrit. 2 . |
Selection of hazard category
− | The mixture is classified as 'Skin Irrit. 2'. |
Selection of hazard statements
− | H315 corresponds to 'Skin Irrit. 2'. |
Selection of pictogram and signal word
− | Pictogram GHS07 and signal word 'Warning' correspond to 'Skin Irrit. 2'. |
Selection of precautionary statements
− | For H315 following precautionary statements are applied: P264, P280, P302+P352, P321, P332+P313, P362+P364. |
Following ingredients are classified as respiratory / skin sensitisers:
− | Substance A: Skin Sens. 1: H317. |
− | Substance B: Skin Sens. 1: H317. |
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 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 should be compared to generic concentration limits. |
Calculation of 'Skin Sens. 1'
− | Concentration of substance A is above the generic concentration limit 1.0 % (CLP, Annex I, Table 3.4.5). Because no sub-categorisation is required this leads to classification Skin Sens. 1 . |
− | Concentration of substance B is above the generic concentration limit 1.0 % (CLP, Annex I, Table 3.4.5). Because no sub-categorisation is required this leads 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. |
Following ingredients are classified as germ cell mutagens:
− | Substance A: Muta. 2: H341. |
− | Substance C: Muta. 2: H341. |
− | Substance D: Muta. 2: H341. |
− | Substance E: Muta. 2: H341. |
− | Substance G: Muta. 2: H341. |
− | Substance B: Muta. 1B: H340. |
− | Substance H: Muta. 1B: H340. |
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 A has specific concentration limit (SCL). Because SCL has a precedence over generic concentration limit, concentration of A 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. 1B'
− | Concentration of substance B is above the generic concentration limit 0.1 % (CLP, Annex I, Table 3.5.2). This leads to classification Muta. 1B . |
− | Concentration of substance H is above the generic concentration limit 0.1 % (CLP, Annex I, Table 3.5.2). This leads to classification Muta. 1B . |
Calculation of 'Muta. 2'
− | Concentration of substance A is above its specific concentration limit 0.01 %. This leads to classification Muta. 2 . |
− | Concentration of substance C is below the generic concentration limit 1.0 % (CLP, Annex I, Table 3.5.2). This does not lead to classification 'Muta. 2'. |
− | Concentration of substance D is below the generic concentration limit 1.0 % (CLP, Annex I, Table 3.5.2). This does not lead to classification 'Muta. 2'. |
− | Concentration of substance E is above its generic concentration limit 1.0 % (CLP, Annex I, Table 3.5.2). This leads to classification Muta. 2 . |
− | Concentration of substance G is below the generic concentration limit 1.0 % (CLP, Annex I, Table 3.5.2). This does not lead 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. |
Following ingredients are classified as carcinogens:
− | Substance A: Carc. 1B: H350. |
− | Substance B: Carc. 1B: H350. |
− | Substance C: Carc. 1B: H350. |
− | Substance D: Carc. 1B: H350. |
− | Substance E: 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
− | Substance A has specific concentration limit (SCL). Because SCL has a precedence over generic concentration limit, concentration of A must be compared to its SCL. |
− | Because no specific concentration limits are applied for substances B, C, D and E, their concentrations must be compared to generic concentration limits. |
Calculation of 'Carc. 1B'
− | Concentration of substance A is above its specific concentration limit 0.01 %. This leads to classification Carc. 1B . |
− | Concentration of substance B is above the generic concentration limit 0.1 % (CLP, Annex I, Table 3.6.2). This leads to classification Carc. 1B . |
− | Concentration of substance C is above the generic concentration limit 0.1 % (CLP, Annex I, Table 3.6.2). This leads to classification Carc. 1B . |
− | Concentration of substance D is above the generic concentration limit 0.1 % (CLP, Annex I, Table 3.6.2). This leads to classification Carc. 1B . |
Calculation of 'Carc. 2'
− | Concentration of substance E 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
− | Classification sub-category 'Carc. 1B' is more severe than 'Carc. 2', therefore, mixture is classified as 'Carc. 1B'. |
Selection of hazard statements
− | H350 corresponds to 'Carc. 1B'. |
Selection of pictogram and signal word
− | Pictogram GHS08 and signal word 'Danger' correspond to 'Carc. 1B'. |
Selection of precautionary statements
− | For H350 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501. |
Following ingredients are classified as specific target organ toxicity – single exposure (STOT SE):
− | Substance A: is not classified as STOT SE, but it has a specific concentration limit for STOT SE 3: H335. |
Cut-off limits
− | Because substance A is not classified as STOT SE the cut-off limit for 'STOT SE 3' is not applied for A. |
Specific and Generic concentration limits
− | Substance A has specific concentration limit (SCL) for 'STOT SE 3', therefore, concentration of A must be compared to its SCL. |
Calculation of 'STOT SE 3: H335'
− | Concentration of substance A is below its specific concentration limit 5 %. This does not lead to classification 'STOT SE 3: H335'. |
Classification of the mixture
The mixture is not classified in category specific target organ toxicity – single exposure.
Classification categories | Classification | H statements | Pictograms | Signal words | P statements |
Acute Toxicity | Acute Tox. 4 | H332 | ![]() GHS07 |
Warning | P261, P271, P304+P340, P312 |
Skin corrosion / Irritation | Skin Irrit. 2 | H315 | ![]() GHS07 |
Warning | P264, P280, P302+P352, P321, P332+P313, P362+P364 |
Respiratory / Skin sensitisation | Skin Sens. 1 | H317 | ![]() GHS07 |
Warning | P261, P272, P280, P302+P352, P333+P313, P321, P362+P364, P501 |
Germ cell mutagenicity | Muta. 1B | H340 | ![]() GHS08 |
Danger | P201, P202, P280, P308+P313, P405, P501 |
Carcinogenicity | Carc. 1B | H350 | ![]() GHS08 |
Danger | P201, P202, P280, P308+P313, P405, P501 |
According to Article 20(3) of CLP if both signal words are applied, 'Danger' is used.
Classification and labelling of the mixture
Classification: | Acute Tox. 4, Skin Irrit. 2, Skin Sens. 1, Muta. 1B, Carc. 1B |
Hazard statements: | H315, H317, H332, H340, H350 |
Pictograms: | ![]() |
GHS07 | |
![]() |
|
GHS08 | |
Signal word: | Danger |
Precautionary statements: | P201, P202, P261, P264, P271, P272, P280, P302+P352, P304+P340, P308+P313, P312, P321, P332+P313, P333+P313, P362+P364, 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.