The purpose of this example is to show calculation of Serious damage to eyes / Eye irritation 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 | 1.5 |
Acute Tox. 4: H302 Eye Dam. 1: H318 Skin Sens. 1: H317 Aquatic Chronic 3: H412 |
− |
Substance B | 9.7 |
Acute Tox. 4: H302 STOT RE 2: H373 Eye Dam. 1: H318 Skin Sens. 1: H317 |
− |
Substance C | 10.0 | Eye Dam. 1: H318 |
Eye Dam. 1: H318: C ≥ 30 % Eye Irrit. 2: H319: 20 % ≤ C < 30 % |
Substance D | 2.1 |
Acute Tox. 3: H301 Eye Irrit. 2: H319 Skin Irrit. 2: H315 |
− |
Substance E | 3.3 |
Skin Irrit. 2: H315 Eye Dam. 1: H318 Aquatic Chronic 3: H412 |
− |
Substance H | 19.0 |
Eye Irrit. 2: H319 Aquatic Chronic 2: H411 |
− |
Water | 54.4 | − | − |
Calculation of mixture classification.
Following ingredients are classified as acute toxicants:
− | Substance A: Acute Tox. 4: H302 (oral). |
− | Substance B: Acute Tox. 4: H302 (oral). |
− | Substance D: Acute Tox. 3: H301 (oral). |
Because there are no data on LD50 (oral, dermal) / LC50 (inhalation) the acute toxicity category for appropriate route (oral, dermal, 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 D 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). Concentrations of substances A and B are above this value, therefore, they are 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. 4: H302 -> ATE = 500 |
− | Substance B: Acute Tox. 4: H302 -> ATE = 500 |
− | Substance D: Acute Tox. 3: H301 -> ATE = 100 |
100 / ATE mix = conc. A / ATE A + conc. B / ATE B + conc. D / ATE D
100 / ATE mix = 1.5 / 500 + 9.7 / 500 + 2.1 / 100
ATE mix = 2304.147
The value 2304.147 is above 2 000 (CLP, Annex I, Table 3.1.2). This does not lead to oral acute toxicity.
Classification of the mixture
The mixture is not classified in category acute toxicity.
Following ingredients are classified as serious damage to eyes / eye irritation:
− | Substance A: Eye Dam. 1: H318. |
− | Substance B: Eye Dam. 1: H318. |
− | Substance C: Eye Dam. 1: H318. |
− | Substance E: Eye Dam. 1: H318. |
− | Substance D: Eye Irrit. 2: H319. |
− | Substance H: Eye Irrit. 2: H319. |
Mixture's pH is > 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). Concentrations of all ingredients are above this value, therefore, they are taken into account. |
Calculation of 'Eye Dam. 1'
− | Concentration of substance C is below its specific concentration limit 30 %. This does not lead to classification 'Eye Dam. 1'. |
− | Because substance C has specific concentration limit for 'Eye Dam. 1', the formula from Guidance on the Application of the CLP Criteria, Part 1: General Principles for Classification and Labelling, Version 5.0, Nov 2024, section 1.6.3.3.3 is applied.
conc. A / GCL + conc. B / GCL + conc. C / SCL + conc. E / GCL = 1.5 / 3 + 9.7 / 3 + 10.0 / 30 + 3.3 / 3 = 5.167 - For substance C its specific concentration limit 30 % for 'Eye Dam. 1' is applied, - For classification 'Eye Dam. 1' generic concentration limit 3 % (CLP, Annex I, Table 3.3.3) is applied. The obtained value is above 1. This leads to classification Eye Dam. 1 . |
Calculation of 'Eye Irrit. 2'
− | Concentration of substance C is below its specific concentration limit 20 % (lower border for 'Eye Irrit. 2'). This does not lead to classification 'Eye Irrit. 2'. |
− | Because substance C has specific concentration limit for 'Eye Irrit. 2', the formula from Guidance on the Application of the CLP Criteria, Part 1: General Principles for Classification and Labelling, Version 5.0, Nov 2024, section 1.6.3.3.3 is applied.
conc. A / GCL + conc. B / GCL + conc. C / SCL + conc. D / GCL + conc. E / GCL + conc. H / GCL 1.5 / 1 + 9.7 / 1 + 10.0 / 20 + 2.1 / 10 + 3.3 / 1 + 19 / 10 = 17.110 - For substance C the lower border 20 % of its specific concentration limit for 'Eye Irrit. 2' is applied. For 'Eye Irrit. 2' two generic concentration limits are applied (CLP, Annex I, Table 3.3.3): - 1 % (as lower border of 1 % ≤ C < 3 %) if calculation is based on 'Skin Corr. 1A', 'Skin Corr. 1B', 'Skin Corr. 1C', 'Skin Corr. 1' and 'Eye Dam. 1', - 10 % if calculation is based on 'Eye Irrit. 2'. Because substances A, B, C and E are classified as 'Eye Dam. 1' generic concentration limit equals to 1. Substances D and H are classified as 'Eye Irrit. 2', therefore, for them generic concentration limit 10 is applied. The obtained value is above 1. This leads to classification Eye Irrit. 2 . |
Selection of hazard category
− | Classification category 'Eye Dam. 1' is more severe than 'Eye Irrit. 2', therefore, mixture is classified as 'Eye Dam. 1'. |
Selection of hazard statements
− | H318 corresponds to 'Eye Dam. 1'. |
Selection of pictogram and signal word
− | Pictogram GHS05 and signal word 'Danger' correspond to 'Eye Dam. 1'. |
Selection of precautionary statements
− | For H318 following precautionary statements are applied: P280, P305+P351+P338, P310. |
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 specific target organ toxicity – repeated exposure (STOT RE):
− | Substance B: STOT RE 2: H373. |
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 limits are applied to substance B, its concentration should be compared to generic concentration limit. |
Calculation of 'STOT RE 2'
− | Concentration of substance B is below the generic concentration limit 10 % (CLP, Annex I, Table 3.9.4). This does not lead to classification 'STOT RE 2'. |
Classification of the mixture
The mixture is not classified in category specific target organ toxicity – repeated exposure.
Following ingredients are classified as hazardous to the aquatic environment:
− | Substance A: Aquatic Chronic 3: H412. |
− | Substance E: Aquatic Chronic 3: H412. |
− | Substance H: Aquatic Chronic 2: H411. |
Cut-off limits
For Aquatic Chronic categories 2-4 the generic cut-off limit 1 % is applied (CLP, Annex I, Table 1.1):
− | Concentrations of substances A, E and H are above 1 %, therefore, they are taken into account. |
Specific and Generic concentration limits
Neither specific nor generic concentration limits are applied for acute toxicity.
Calculation of 'Aquatic Chronic 2'
− | Concentration of substance H 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 H must be multiplied by 10. To this value concentrations of substances A and E must be added.
(conc. H × 10) + conc. A + conc. E = (19.0 × 10) + 1.5 + 3.3 = 194.8 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 . |
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 |
Serious damage to eyes / Eye irritation | Eye Dam. 1 | H318 | ![]() GHS05 |
Danger | P280, P305+P351+P338, P310 |
Respiratory / Skin sensitisation | Skin Sens. 1 | H317 | ![]() GHS07 |
Warning | P261, P272, P280, P302+P352, P333+P313, P321, P362+P364, 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: | Eye Dam. 1, Skin Sens. 1, Aquatic Chronic 3 |
Hazard statements: | H317, H318, H412 |
Pictograms: | ![]() |
GHS05 | |
![]() |
|
GHS07 | |
Signal word: | Danger |
Precautionary statements: | P261, P272, P273, P280, P302+P352, P305+P351+P338, P310, P333+P313, P321, P362+P364, 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.