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Example 3

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.

Acute Toxicity

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.

Serious damage to eyes / Eye irritation

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, Version 5.0 July 2017, 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, Version 5.0 July 2017, 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.
Respiratory / Skin sensitisation

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.
Specific target organ toxicity – repeated exposure

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.

Hazardous to the aquatic environment

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.


Selection of classification, H statements, pictograms,
signal word and P statements
Classification categories Classification H statements Pictograms Signal words P statements
Serious damage to eyes / Eye irritation Eye Dam. 1 H318 pictogram ghs 05
GHS05
Danger P280, P305+P351+P338, P310
Respiratory / Skin sensitisation Skin Sens. 1 H317 pictogram ghs 07
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: pictogram ghs 05
   GHS05
pictogram ghs 07
   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.