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Example 1
The purpose of this example is to show calculation of Acute Toxicity 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 | 0.8 |
Repr. 2: H361d Acute Tox. 4: H302 Eye Dam. 1: H318 |
− |
| Substance B | 2.5 | Acute Tox. 3: H301 | − |
| Substance C | 1.2 |
Repr. 1B: H360Df STOT SE 3: H335 Eye Dam. 1: H318 |
Repr. 1B: H360Df: C ≥ 14 % Repr. 1B: H360D: 10 % ≤ C < 14 % Eye Dam. 1: H318: C ≥ 36 % Eye Irrit. 2: H319: 22 % ≤ C < 36 |
| Substance D | 4.4 |
Acute Tox. 3: H331 Acute Tox. 3: H311 Acute Tox. 3: H301 |
− |
| Substance E | 1.3 |
Acute Tox. 2: H330 Acute Tox. 2: H300 Skin Corr. 1A: H314 |
− |
| Water | 89.8 | − | − |
Calculation of mixture classification.
Acute Toxicity
Following ingredients are classified as acute toxicants:
| − | Substance A: Acute Tox. 4: H302 (oral). |
| − | Substance B: Acute Tox. 3: H301 (oral). |
| − | Substance D: Acute Tox. 3: H331 (inhalation) / Acute Tox. 3: H311 (dermal) / Acute Tox. 3: H301 (oral). |
| − | Substance E: Acute Tox. 2: H330 (inhalation) / Acute Tox. 2: H300 (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). Concentrations of substances B, D and E are above this value, therefore, they are taken into account. |
| − | For 'Acute Tox. 4' the cut-off limit 1 % is applied (CLP, Annex I, Table 1.1). Concentration of substance A 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 B: Acute Tox. 3: H301 -> ATE = 100 |
| − | Substance D: Acute Tox. 3: H301 -> ATE = 100 |
| − | Substance E: Acute Tox. 2: H300 -> ATE = 5 |
100 / ATE mix = conc. B / ATE B + conc. D / ATE D + conc. E / ATE E
100 / ATE mix = 2.5 / 100 + 4.4 / 100 + 1.3 / 5
ATE mix = 303.951
The value 303.951 is between 300 and 2 000 (CLP, Annex I, Table 3.1.2). This leads to oral Acute Tox. 4 .
Calculation of dermal Acute Toxicity
ATE values converted from dermal acute toxicity categories:
| − | Substance D: Acute Tox. 3: H311 -> ATE = 300 |
100 / ATE mix = conc. D / ATE D
100 / ATE mix = 4.4 / 300
ATE mix = 6818.18
The value 6818.18 is above 2 000 (CLP, Annex I, Table 3.1.2). This does not lead to dermal acute toxicity.
Calculation of inhalation Acute Toxicity
There are two ingredients (D and E) classified as acute toxicants via inhalation route. Because no mixture's physical forms of inhalation routes of exposure are known, 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 D: Acute Tox. 3: H331 -> ATE = 3 |
| − | Substance E: Acute Tox. 2: H330 -> ATE = 0.5 |
100 / ATE mix = conc. D / ATE D + conc. E / ATE E
100 / ATE mix = 4.4 / 3 + 1.3 / 0.5
ATE mix = 24.590
The value 24.590 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 D: Acute Tox. 3: H331 -> ATE = 0.5 |
| − | Substance E: Acute Tox. 2: H330 -> ATE = 0.05 |
100 / ATE mix = conc. D / ATE D + conc. E / ATE E
100 / ATE mix = 4.4 / 0.5 + 1.3 / 0.05
ATE mix = 2.874
The value 2.874 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
| − | Both oral 'Acute Tox. 4' and inhalation 'Acute Tox. 4' are applied, therefore, the mixture is classified as 'Acute Tox. 4'. |
Selection of hazard statements
| − | H302 corresponds to oral 'Acute Tox. 4'. |
| − | H332 corresponds to inhalation 'Acute Tox. 4'. |
| − | Hazard statements H302 and H332 belong to different routes of exposure (oral and inhalation), therefore, they both must be indicated on the label and in section 2.2 of safety data sheet. |
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. |
| − | For H332 following precautionary statements are applied: P261, P271, P304+P340, P312. |
| − | For both H302 and H332 following precautionary statements are applied: P261, P264, P270, P271, P301+P312, P304+P340, P312, P330, P501. |
Skin corrosion / Irritation
Following ingredients are classified as corrosive / irritant to skin:
| − | Substance E: Skin Corr. 1A: 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 E is above this value, therefore, it is taken into account. |
Specific and Generic concentration limits
| − | Because no specific concentration limits are applied for substance E and only E is classified as 'Skin Corr. 1A' only its concentration should be compared to generic concentration limits. |
Calculation of 'Skin Corr. 1A'
| − | Concentration of substance E is below the generic concentration limit 5 % (CLP, Annex I, Table 3.2.3). This does not lead to classification 'Skin Corr. 1A'. |
Calculation of 'Skin Irrit. 2'
| − | Concentration of substance E 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 E should be multiplied by 10.
10 × conc. E = 10 × 1.3 = 13 % 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. |
Serious damage to eyes / Eye irritation
Following ingredients are classified as serious damage to eyes / eye irritation:
| − | Substance A: Eye Dam. 1: H318. |
| − | Substance C: Eye Dam. 1: H318. |
Ingredients that also have influence on serious damage to eyes / eye irritation classification:
| − | Substance E: Skin Corr. 1A: H314. |
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 A is below this value, therefore, it is not taken into account. Concentration of substance C is above this value, therefore, it is taken into account. |
Relevant ingredients
| − | Concentration of substance E is above 1 % (CLP, Annex I, 3.2.3.3.1), therefore, it is 'relevant ingredient' and E is taken into account. |
Calculation of 'Eye Dam. 1'
| − | Concentration of substance C is below its specific concentration limit 36 %. 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, Version 5.0 July 2017, section 1.6.3.3.3 is applied.
conc. C / SCL + conc. E / GCL = 1.2 / 36 + 1.3 / 3 = 0.467 - For substance C its specific concentration limit 36 % for 'Eye Dam. 1' is applied, - Because classifications 'Skin Corr. 1A', 'Skin Corr. 1B', 'Skin Corr. 1C', 'Skin Corr. 1' have influence on 'Eye Dam. 1' for substance E generic concentration limit 3 % (CLP, Annex I, Table 3.3.3) is applied. The obtained value is below 1. This does not lead to classification 'Eye Dam. 1'. |
| − | Concentration of substance E 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 C is below its specific concentration limit 22 % (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, Version 5.0 July 2017, section 1.6.3.3.3 is applied.
conc. C / SCL + conc. E / GCL = 1.2 / 22 + 1.3 / 1 = 1.355 - For substance C the lower border 22 % 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 substance E is classified as 'Skin Corr. 1A' generic concentration limit equals to 1. The obtained value is above 1. 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. |
Reproductive toxicity
Following ingredients are classified as reproductive toxicants:
| − | Substance A: Repr. 2: H361d. |
| − | Substance C: Repr. 1B: H360Df. |
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 to substance A, its concentration should be compared to generic concentration limit. |
| − | Substance C has specific concentration limits. Because specific concentration limit has a precedence over generic concentration limit, concentration of substance C should be compared to its specific concentration limits. |
Calculation of 'Repr. 1B'
| − | Concentration of substance C is below its specific concentration limit 14 % for 'Repr. 1B' with hazard statement H360Df. This does not lead to classification 'Repr. 1B'. |
| − | Concentration of substance C is below its specific concentration limit 10 % a lower border for 'Repr. 1B' with hazard statement H360D. This does not lead to classification 'Repr. 1B'. |
Calculation of 'Repr. 2'
| − | Concentration of substance A is below the generic concentration limit 3.0 % (CLP, Annex I, Table 3.7.2). This does not lead to classification 'Repr. 2'. |
Classification of the mixture
The mixture is not classified in category reproductive toxicity.
Specific target organ toxicity – single exposure
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 above this value, therefore, it is taken into account. |
Specific and Generic concentration limits
| − | Because no specific concentration limits are applied to substance C, its concentration should be compared to generic concentration limit. |
Calculation of 'STOT SE 3: H335'
| − | Concentration of substance C is below the generic concentration limit 20 % (CLP, Annex I, 3.8.3.4.5). 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.
Selection of classification, H statements, pictograms,
signal word and P statements
signal word and P statements
| Classification categories | Classification | H statements | Pictograms | Signal words | P statements |
| Acute Toxicity | Acute Tox. 4 | H302 H332 |
 GHS07 |
Warning | P261, P264, P270, P271, P301+P312, P304+P340, P312, P330, P501 |
| Skin corrosion / Irritation | Skin Irrit. 2 | H315 | GHS07 |
Warning | P264, P280, P302+P352, P321, P332+P313, P362+P364 |
| Serious damage to eyes / Eye irritation | Eye Irrit. 2 | H319 | GHS07 |
Warning | P264, P280, P305+P351+P338, P337+P313 |
Classification and labelling of the mixture
| Classification: | Acute Tox. 4, Skin Irrit. 2, Eye Irrit. 2 |
| Hazard statements: | H302 + H332, H315, H319 |
| Pictograms: | |
| GHS07 | |
| Signal word: | Warning |
| Precautionary statements: | P261, P264, P270, P271, P280, P301+P312, P302+P352, P304+P340, P305+P351+P338, P312, P321, P330, P332+P313, P337+P313, 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.