The purpose of this example is to show calculation of Skin corrosion / 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 | 3.0 |
Acute Tox. 2: H330 Acute Tox. 2: H300 Skin Corr. 1A: H314 |
− |
Substance B | 1.8 |
Acute Tox. 4: H312 Acute Tox. 4: H302 Skin Corr. 1A: H314 |
− |
Substance C | 0.9 | Skin Corr. 1A: H314 |
Skin Corr. 1A: H314: C ≥ 5 % Skin Corr. 1B: H314: 2 % ≤ C < 5 % Skin Irrit. 2: H315: 0.5 % ≤ C < 2 % Eye Irrit. 2: H319: 0.5 % ≤ C < 2 % |
Substance D | 2.5 |
Acute Tox. 4: H302 Skin Corr. 1B: H314 Skin Sens. 1: H317 Aquatic Acute 1: H400 Aquatic Chronic 1: H410 |
− |
Substance E | 12.0 | Skin Corr. 1B: H314 |
Skin Corr. 1B: H314: C ≥ 25 % Skin Irrit. 2: H315: 10 % ≤ C < 25 % Eye Irrit. 2: H319: 10 % ≤ C < 25 % |
Substance G | 20.0 |
Skin Corr. 1C: H314 Aquatic Chronic 3: H412 |
− |
Substance H | 4.1 |
Repr. 1B: H360D Acute Tox. 4: H302 Skin Corr. 1C: H314 |
− |
Water | 55.7 | − | − |
Calculation of mixture classification.
Following ingredients are classified as acute toxicants:
− | Substance A: Acute Tox. 2: H330 (inhalation) / Acute Tox. 2: H300 (oral). |
− | Substance B: Acute Tox. 4: H312 (dermal) / Acute Tox. 4: H302 (oral). |
− | Substance D: Acute Tox. 4: H302 (oral). |
− | Substance H: Acute Tox. 4: H302 (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 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). Concentrations of substances B, D and H 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. 2: H300 -> ATE = 5 |
− | Substance B: Acute Tox. 4: H302 -> ATE = 500 |
− | Substance D: Acute Tox. 4: H302 -> ATE = 500 |
− | Substance H: Acute Tox. 4: H302 -> ATE = 500 |
100 / ATE mix = conc. A / ATE A + conc. B / ATE B + conc. D / ATE D + conc. H / ATE H
100 / ATE mix = 3.0 / 5 + 1.8 / 500 + 2.5 / 500 + 4.1 / 500
ATE mix = 162.127
The value 162.127 is between 50 and 300 (CLP, Annex I, Table 3.1.2). This leads to oral Acute Tox. 3 .
Calculation of dermal Acute Toxicity
ATE values converted from dermal acute toxicity categories:
− | Ingredient B: Acute Tox. 4: H312 -> ATE = 1 100 |
100 / ATE mix = conc. B / ATE B
100 / ATE mix = 1.8 / 1 100
ATE mix = 61111.111
The value 61111.111 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 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:
− | Ingredient A: Acute Tox. 2: H330 -> ATE = 0.5 |
100 / ATE mix = conc. A / ATE A
100 / ATE mix = 3.0 / 0.5
ATE mix = 16.667
The value 16.667 is between 10.0 and 20.0 (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 4 .
ATE values converted from inhalation (mists) acute toxicity categories:
− | Ingredient A: Acute Tox. 2: H330 -> ATE = 0.05 |
100 / ATE mix = conc. A / ATE A
100 / ATE mix = 3.0 / 0.05
ATE mix = 1.667
The value 1.667 is between 1.0 and 5.0 (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 4 .
Selection of hazard category
− | Both oral 'Acute Tox. 3' and inhalation 'Acute Tox. 4' are applied. Category 3 is more severe than 4, therefore, mixture is classified as 'Acute Tox. 3'. |
Selection of hazard statements
− | H301 corresponds to oral 'Acute Tox. 3'. |
− | H332 corresponds to inhalation 'Acute Tox. 4'. |
− | Hazard statements H301 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 GHS06 and signal word 'Danger' correspond to 'Acute Tox. 3'. |
Selection of precautionary statements
− | For H301 following precautionary statements are applied: P264, P270, P301+P310, P321, P330, P405, P501. |
− | For H332 following precautionary statements are applied: P261, P271, P304+P340, P312. |
− | For both H301 and H332 following precautionary statements are applied: P261, P264, P270, P271, P301+P310, P304+P340, P312, P321, P330, P405, P501. |
Following ingredients are classified as corrosive / irritant to skin:
− | Substance A: Skin Corr. 1A: H314. |
− | Substance B: Skin Corr. 1A: H314. |
− | Substance C: Skin Corr. 1A: H314. |
− | Substance D: Skin Corr. 1B: H314. |
− | Substance E: Skin Corr. 1B: H314. |
− | Substance G: Skin Corr. 1C: H314. |
− | Substance H: Skin Corr. 1C: 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 C is below this value therefore, it is not taken into account for calculation 'Skin Corr. 1A' and 'Skin Corr. 1B'. Other hand, concentration of C is above the lower border of SCLs for 'Skin Irrit. 2', therefore, C is taken into account when calculating this category. |
Calculation of 'Skin Corr. 1A'
− | Because substance C is not taken into account and other ingredients (A and B) have no specific concentration limits for 'Skin Corr. 1A', their concentrations must be summed.
conc. A + conc. B = 3.0 + 1.8 = 4.8 % The obtained value 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 Corr. 1B'
− | Concentration of substance E is below its specific concentration limit 25 %. This does not lead to classification 'Skin Corr. 1B' |
− | According to the Note to Table 3.2.2 of Annex I to CLP, to classify a mixture as 'Skin Corr. 1B' concentrations of ingredients classified as 'Skin Corr. 1A' and 'Skin Corr. 1B' are added. Because substance E has specific concentration limit for 'Skin Corr. 1B', 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.
− Substances A, B and D have no SCLs, therefore, generic concentration limit 5 % is applied (GCL). − Substance E has SCL 25 % for 'Skin Corr. 1B', therefore, this value should be used (SCL-1B). conc. A / GCL + conc. B / GCL + conc. D / GCL + conc. E / SCL-1B = 3.0 / 5 + 1.8 / 5 + 2.5 / 5 + 12.0 / 25 = 1.94 The obtained value is above 1. This leads to classification Skin Corr. 1B . |
Calculation of 'Skin Corr. 1C'
− | According to the Note to Table 3.2.2 of Annex I to CLP, to classify a mixture as 'Skin Corr. 1C' concentrations of ingredients classified as 'Skin Corr. 1A', 'Skin Corr. 1B' and 'Skin Corr. 1C' are added. Because substance E has specific concentration limit for 'Skin Corr. 1B', 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.
− Substances A, B, D and G have no SCLs, therefore, generic concentration limit 5 % is applied (GCL). − Substance E has SCL 25 % for 'Skin Corr. 1B', therefore, this value should be used (SCL-1B). conc. A / GCL + conc. B / GCL + conc. D / GCL + conc. E / SCL-1B + conc. B / GCL = 3.0 / 5 + 1.8 / 5 + 2.5 / 5 + 12.0 / 25 + 20.0 / 5 = 5.940 The obtained value is above 1. This leads to classification Skin Corr. 1C . |
Calculation of 'Skin Corr. 1'
− | Because mixture does not contain ingredient with 'Skin Corr. 1' such classification is not calculated. |
Calculation of 'Skin Irrit. 2'
− | Concentration of substance C is inside the specific concentration limit range (0.5 ≤ C < 2 %). This leads to classification Skin Irrit. 2 . |
− | Concentration of substance E is inside the specific concentration limit range (10 ≤ C < 25 %). This leads to classification Skin Irrit. 2 . |
Selection of hazard category
− | Classification category 'Skin Corr. 1B' is more severe than 'Skin Corr. 1C' and 'Skin Irrit. 2', therefore, mixture is classified as 'Skin Corr. 1B'. |
Selection of hazard statements
− | H314 corresponds to 'Skin Corr. 1B'. |
Selection of pictogram and signal word
− | Pictogram GHS05 and signal word 'Danger' correspond to 'Skin Corr. 1B'. |
Selection of precautionary statements
− | For H314 following precautionary statements are applied: P260, P264, P280, P301+P330+P331, P303+P361+P353, P363, P304+P340, P310, P321, P305+P351+P338, P405, P501. |
Mixture have no ingredients classified as serious damage to eyes / eye irritation, but following ingredients have influence on that classification:
− | Substance A: Skin Corr. 1A: H314. |
− | Substance B: Skin Corr. 1A: H314. |
− | Substance C: Skin Corr. 1A: H314. |
− | Substance D: Skin Corr. 1B: H314. |
− | Substance E: Skin Corr. 1B: H314. |
− | Substance G: Skin Corr. 1C: H314. |
− | Substance H: Skin Corr. 1C: 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
− | Mixture does not contain ingredients classified as 'Eye Dam. 1' or 'Eye Irrit. 2'. |
Relevant ingredients
All ingredients in the mixture have influence on classification of serious eye damage / eye irritation.
− | Concentrations of substances A, B, D, E, G and H are above 1 % (CLP, Annex I, 3.2.3.3.1), therefore, they are 'relevant ingredients' and are taken into account. |
− | Concentration of substance C is below 1 % (CLP, Annex I, 3.2.3.3.1), therefore, it is not 'relevant ingredient' and is not taken into account. |
Calculation of 'Eye Dam. 1'
− | Because no ingredient has specific concentration limit for 'Eye Dam. 1', concentrations of relevant ingredients A, B, D, E, G and H must be summed.
conc. A + conc. B + conc. D + conc. E + conc. G + conc. H = 3.0 + 1.8 + 2.5 + 12.0 + 20.0 + 4.1 = 43.4 % The obtained value is above the generic concentration limit 3 % (CLP, Annex I, Table 3.3.3). This leads to classification Eye Dam. 1 . |
Calculation of 'Eye Irrit. 2'
− | Concentration of substance C is inside the specific concentration limit range (0.5 ≤ C < 2 %). This leads to classification Eye Irrit. 2 . |
− | Concentration of substance E is inside the specific concentration limit range (10 ≤ C < 25 %). 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 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 substance D and only D is classified as 'Skin Sens. 1' only its concentration should be compared to generic concentration limits. |
Calculation of '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 reproductive toxicants:
− | Substance H: Repr. 1B: H360D. |
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 H, its concentration should be compared to generic concentration limit. |
Calculation of 'Repr. 1B'
− | Concentration of substance H is above the generic concentration limit 0.3 % (CLP, Annex I, Table 3.7.2). This leads to classification Repr. 1B . |
Selection of hazard category
− | The mixture is classified as 'Repr. 1B'. |
Selection of hazard statements
− | H360D is selected for category 'Repr. 1B' because of the substance H. |
Selection of pictogram and signal word
− | Pictogram GHS08 and signal word 'Danger' correspond to 'Repr. 1B'. |
Selection of precautionary statements
− | For H360D following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501. |
Following ingredients are classified as hazardous to the aquatic environment:
− | Substance D: Aquatic Acute 1: H400 / Aquatic Chronic 1: H410. |
− | Substance G: Aquatic Chronic 3: H412. |
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), where M is M-factor.
− | 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, it 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 G is above 1 %, therefore, it is taken into account for calculation of 'Aquatic Chronic 3'. |
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.
conc. D × M = 2.5 × 1 = 2.5 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.
conc. D × M = 2.5 × 1 = 2.5 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 3'
− | Concentration of substance D must be multiplied by its M-factor and multiplied by 100. To this value concentration of substance G must be added.
(M × 100 × conc. D) + conc. G = (1 × 100 × 2.5) + 20.0 = 270 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 |
Acute Toxicity | Acute Tox. 3 | H301 H332 |
![]() GHS07 |
Warning | P261, P264, P270, P271, P301+P310, P304+P340, P312, P321, P330, P405, P501 |
Skin corrosion / Irritation | Skin Corr. 1B | H314 | ![]() GHS05 |
Danger | P260, P264, P280, P301+P330+P331, P303+P361+P353, P363, P304+P340, P310, P321, P305+P351+P338, P405, P501 |
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 |
Reproductive toxicity | Repr. 1B | H360D | ![]() GHS08 |
Danger | P201, P202, P280, P308+P313, P405, 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. According to Part 1 of Annex III to CLP if H314 is assigned then H318 does not need to be indicated in hazard communication.
Classification and labelling of the mixture
Classification: | Acute Tox. 3, Skin Corr. 1B, Eye Dam. 1, Skin Sens. 1, Repr. 1B, Aquatic Chronic 3 |
Hazard statements: | H301, H314, H317, H332, H360D, H412 |
Pictograms: | ![]() |
GHS05 | |
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|
GHS07 | |
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|
GHS08 | |
Signal word: | Danger |
Precautionary statements: | P201, P202, P260, P261, P264, P270, P271, P272, P273, P280, P301+P310, P301+P330+P331, P302+P352, P303+P361+P353, P304+P340, P305+P351+P338, P308+P313, P310, P312, P321, P330, P333+P313, P362+P364, P363, 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.