The purpose of this example is to show calculation of Carcinogenicity 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 | 2.0 |
Carc. 1A: H350i STOT RE 1: H372 Skin Sens. 1: H317 Aquatic Chronic 4: H413 |
− |
Substance B | 0.08 |
Carc. 1A: H350 Acute Tox. 3: H331 Acute Tox. 3: H301 Aquatic Acute 1: H400 Aquatic Chronic 1: H410 |
− |
Substance C | 0.005 |
Carc. 1B: H350 Acute Tox. 3: H331 Acute Tox. 4: H302 Eye Irrit. 2: H319 STOT SE 3: H335 Skin Irrit. 2: H315 |
Carc. 1B: H350: C ≥ 0.001 % |
Substance D | 2.3 |
Carc. 1B: H350i Skin Sens. 1: H317 Aquatic Acute 1: H400 Aquatic Chronic 1: H410 |
− |
Substance E | 1.2 |
Acute Tox. 2: H300 Carc. 2: H351 |
− |
Substance H | 1.5 |
Carc. 2: H351 Eye Dam. 1: H318 |
− |
Water | 92.915 | − | − |
Calculation of mixture classification.
Following ingredients are classified as acute toxicants:
− | Substance B: Acute Tox. 3: H331 (inhalation) / Acute Tox. 3: H301 (oral). |
− | Substance C: Acute Tox. 3: H331 (inhalation) / Acute Tox. 4: H302 (oral). |
− | Substance E: Acute Tox. 2: H300 (oral). |
Because there are no data on LD50 (oral, dermal) / 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). Concentrations of substances B and C are below this value, therefore, they are not taken into account. Concentration of substance E 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 E: Acute Tox. 2: H300 -> ATE = 5 |
100 / ATE mix = conc. E / ATE E
100 / ATE mix = 1.2 / 5
ATE mix = 416.667
The value 416.667 is between 300 and 2 000 (CLP, Annex I, Table 3.1.2). This leads to oral Acute Tox. 4 .
Selection of hazard category
− | The mixture is classified as 'Acute Tox. 4'. |
Selection of hazard statements
− | H302 corresponds to oral '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 H302 following precautionary statements are applied: P264, P270, P301+P312, P330, P501. |
Following ingredients are classified as corrosive / irritant to skin:
− | Substance C: Skin Irrit. 2: H315. |
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 C is below this value, therefore, it is not taken into account. |
Because only substance C is classified as irritant to skin and its concentration is below the cut-off limit, there is no need to calculate classification corrosive / irritant to skin.
Classification of the mixture
The mixture is not classified in category corrosive / irritant to skin.
Following ingredients are classified as serious damage to eyes / eye irritation:
− | Substance C: Eye Irrit 2: H319. |
− | Substance H: Eye Dam. 1: H318. |
The mixture's pH is between 2 and 11.5, this does not lead to classification 'Eye Dam. 1'. Mixture contains no ingredients leading to the application of non-additivity approach, therefore, Additivity approach is applied.
Cut-off limits
− | For serious damage to eyes / eye irritation 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. Concentration of substance H is above this value, therefore, it is taken into account. |
Specific and Generic concentration limits
− | Because no specific concentration limits is applied for substance H, its concentration must be compared to generic concentration limits. |
Calculation of 'Eye Dam. 1'
− | Concentration of substance H is below the generic concentration limit 3 % (CLP, Annex I, Table 3.3.3). This does not lead to classification 'Eye Dam. 1'. |
Calculation of 'Eye Irrit. 2'
− | Concentration of substance H must be multiplied by 10.
10 × conc. H = 10 × 1.5 = 15 % The obtained value is above the generic concentration limit 10 % (CLP, Annex I, Table 3.3.3). This leads to classification Eye Irrit. 2 . |
Selection of hazard category
− | The mixture is classified as 'Eye Irrit. 2'. |
Selection of hazard statements
− | H319 corresponds to 'Eye Irrit. 2'. |
Selection of pictogram and signal word
− | Pictogram GHS07 and signal word 'Warning' correspond to 'Eye Irrit. 2'. |
Selection of precautionary statements
− | For H319 following precautionary statements are applied: P264, P280, P305+P351+P338, P337+P313. |
Following ingredients are classified as respiratory / skin sensitisers:
− | Substance A: Skin Sens. 1: H317. |
− | Substance D: 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 D 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 D 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 carcinogens:
− | Substance A: Carc. 1A: H350i. |
− | Substance B: Carc. 1A: H350. |
− | Substance C: Carc. 1B: H350. |
− | Substance D: Carc. 1B: H350i. |
− | Substance E: Carc. 2: H351. |
− | Substance H: 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 C has specific concentration limit (SCL). Because SCL has a precedence over generic concentration limit, concentration of C must be compared to its SCL. |
− | Because no specific concentration limits are applied for substances A, B, D, E and H, their concentrations must be compared to generic concentration limits. |
Calculation of 'Carc. 1A'
− | Concentration of substance A is above the generic concentration limit 0.1 % (CLP, Annex I, Table 3.6.2). This leads to classification Carc. 1A . |
− | Concentration of substance B is below the generic concentration limit 0.1 % (CLP, Annex I, Table 3.6.2). This does not lead to classification 'Carc. 1A'. |
Calculation of 'Carc. 1B'
− | Concentration of substance C is above its specific concentration limit 0.001 %. 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 . |
− | Concentration of substance H 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. 1A' is more severe than 'Carc. 1B' and 'Carc. 2', therefore, mixture is classified as 'Carc. 1A'. |
Selection of hazard statements
− | Both statements H350i (substances A and D) and H350 (substance C) are applied, therefore, a choice between them should be made. Because H350 indicates that inhalation is not the only route of exposure, the statement H350 must be selected. |
Selection of pictogram and signal word
− | Pictogram GHS08 and signal word 'Danger' correspond to 'Carc. 1A'. |
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 C: STOT SE 3: H335. |
Cut-off limits
− | For 'STOT SE 3' 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. |
Classification of the mixture
The mixture is not classified in category specific target organ toxicity – single exposure.
Following ingredients are classified as specific target organ toxicity – repeated exposure (STOT RE):
− | Substance A: STOT RE 1: H372. |
Cut-off limits
− | There is no generic cut-off limit for STOT RE (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 limit is applied to substance A, its concentration should be compared to generic concentration limit. |
Calculation of 'STOT RE 1'
− | Concentration of substance A is below the generic concentration limit 10 % (CLP, Annex I, Table 3.9.4). This does not lead to classification 'STOT RE 1'. |
Calculation of 'STOT RE 2'
− | Concentration of substance A is between 1 % and 10 % of the generic concentration limit (CLP, Annex I, Table 3.9.4). This leads to classification STOT RE 2 . |
Selection of hazard category
− | The mixture is classified as 'STOT RE 2'. |
Selection of hazard statements
− | H373 corresponds to 'STOT RE 2'. |
Selection of pictogram and signal word
− | Pictogram GHS08 and signal word 'Warning' correspond to 'STOT RE 2'. |
Selection of precautionary statements
− | For H373 following precautionary statements are applied: P260, P314, P501. |
Following ingredients are classified as hazardous to the aquatic environment:
− | Substance A: Aquatic Chronic 4: H413. |
− | Substance B: Aquatic Acute 1: H400 / Aquatic Chronic 1: H410. |
− | Substance D: Aquatic Acute 1: H400 / Aquatic Chronic 1: H410. |
Cut-off limits
For 'Aquatic Acute 1' and 'Aquatic Chronic 1' cut-off limit is calculated according to formula 0.1/M (CLP, Annex I, 4.1.3.1):
− | There is no M-factor in Table 3 of Annex VI to CLP established for substance B. Person responsible for classification decided to use M = 1 for both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. Concentration of substance B is below 0.1 % (0.1/1), therefore, B is not taken into account for calculation of 'Aquatic Acute 1' and 'Aquatic Chronic 1'. |
− | There is no M-factor in Table 3 of Annex VI to CLP established for substance D. Person responsible for classification decided to use M = 1 for both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. Concentration of substance D is above 0.1 % (0.1/1), therefore, D is taken into account for calculation of both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. |
For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):
− | Concentration of substance A is above 1 %, therefore, it is taken into account. |
Specific and Generic concentration limits
Neither specific nor generic concentration limits are applied for acute toxicity.
Calculation of 'Aquatic Acute 1'
− | Concentration of substance D must be multiplied by its M-factor.
M × conc. D = 1 × 2.3 = 2.3 The obtained value is below 25 % (CLP, Annex I, 4.1.3.5.5.3.1 and Table 4.1.1). This does not lead to classification 'Aquatic Acute 1'. |
Calculation of 'Aquatic Chronic 1'
− | Concentration of substance D must be multiplied by its M-factor.
M × conc. D = 1 × 2.3 = 2.3 The obtained value is below 25 % (CLP, Annex I, 4.1.3.5.5.4.1 and Table 4.1.2). This does not lead to classification 'Aquatic Chronic 1'. |
Calculation of 'Aquatic Chronic 2'
− | Concentration of substance D must be multiplied by its M-factor and multiplied by 10.
M × 10 × conc. D = 1 × 10 × 2.3 = 23 The obtained value is below 25 % (CLP, Annex I, 4.1.3.5.5.4.2 and Table 4.1.2). This does not lead to classification 'Aquatic Chronic 2'. |
Calculation of 'Aquatic Chronic 3'
− | Concentration of substance D must be multiplied by its M-factor and multiplied by 100.
M × 100 × conc. D = 1 × 100 × 2.3 = 230 The obtained value is above 25 % (CLP, Annex I, 4.1.3.5.5.4.3 and Table 4.1.2). This leads to classification Aquatic Chronic 3. |
Calculation of 'Aquatic Chronic 4'
− | Concentrations of substances A and D must be summed.
conc. A + conc. D = 2.0 + 2.3 = 4.3 The obtained value is below 25 % (CLP, Annex I, 4.1.3.5.5.4.4 and Table 4.1.2). This does not lead to classification 'Aquatic Chronic 4'. |
Selection of hazard category
− | The mixture is classified as 'Aquatic Chronic 3'. |
Selection of hazard statements
− | H412 corresponds to 'Aquatic Chronic 3'. |
Selection of pictogram and signal word
− | Neither pictogram nor signal word are required for 'Aquatic Chronic 3'. |
Selection of precautionary statements
− | For H412 following precautionary statements are applied: P273, P501. |
Classification categories | Classification | H statements | Pictograms | Signal words | P statements |
Acute Toxicity | Acute Tox. 4 | H302 | GHS07 |
Warning | P264, P270, P301+P312, P330, P501 |
Serious damage to eyes / Eye irritation | Eye Irrit. 2 | H319 | GHS07 |
Warning | P264, P280, P305+P351+P338, P337+P313 |
Respiratory / Skin sensitisation | Skin Sens. 1 | H317 | GHS07 |
Warning | P261, P272, P280, P302+P352, P333+P313, P321, P362+P364, P501 |
Carcinogenicity | Carc. 1A | H350 | GHS08 |
Danger | P201, P202, P280, P308+P313, P405, P501 |
Specific target organ toxicity - repeated exposure | STOT RE 2 | H373 | GHS08 |
Warning | P260, P314, P501 |
Hazardous to the aquatic environment | Aquatic Chronic 3 | H412 | − | − | P273, 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, Eye Irrit. 2, Skin Sens. 1, Carc. 1A, STOT RE 2, Aquatic Chronic 3 |
Hazard statements: | H302, H317, H319, H350, H373, H412 |
Pictograms: | |
GHS07 | |
GHS08 | |
Signal word: | Danger |
Precautionary statements: | P201, P202, P260, P261, P264, P270, P272, P273, P280, P301+P312, P302+P352, P305+P351+P338, P308+P313, P314, P321, P330, P333+P313, P337+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.