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Example 9

The purpose of this example is to show calculation of Specific target organ toxicity - repeated exposure (STOT RE) 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 3.4 Carc. 2: H351
STOT RE 1: H372
Skin Sens. 1: H317
Substance B 11.2 Repr. 1B: H360F
Carc. 1B: H350
STOT RE 1: H372 (respiratory
and haematopoietic systems)
Substance C 5.7 Carc. 2: H351
STOT RE 2: H373
Aquatic Chronic 2: H411
Substance D 0.08 Carc. 1B: H350
Repr. 2: H361f
STOT RE 1: H372 (lung)
STOT RE 1: H372: C ≥ 0.1 %
Carc. 1B: H350: C ≥ 0.01 %
STOT RE 2: H373: 0.01 % ≤ C < 0.1 %
Substance E 11.5 STOT RE 2: H373 (kidneys)
Skin Sens. 1: H317
Aquatic Acute 1: H400
Aquatic Chronic 1: H410
M = 1
M = 1
Water 68.12

Calculation of mixture classification.

Respiratory / Skin sensitisation

Following ingredients are classified as respiratory / skin sensitisers:

Substance A:   Skin Sens. 1: H317.
Substance E:   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 E 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 E 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.
Carcinogenicity

Following ingredients are classified as carcinogens:

Substance A:   Carc. 2: H351.
Substance B:   Carc. 1B: H350.
Substance C:   Carc. 2: H351.
Substance D:   Carc. 1B: H350.

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 D has specific concentration limit (SCL). Because SCL has a precedence over generic concentration limit, concentration of D must be compared to its SCL.
Because no specific concentration limits are applied for substances A, B and C, their concentrations must be compared to generic concentration limits.

Calculation of 'Carc. 1B'

Concentration of substance D is above its specific concentration limit 0.01 %. This leads to classification Carc. 1B .
Concentration of substance B 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 A is above the generic concentration limit 1.0 % (CLP, Annex I, Table 3.6.2). This leads to classification Carc. 2 .
Concentration of substance C 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. 1B' is more severe than 'Carc. 2', therefore, mixture is classified as 'Carc. 1B'.

Selection of hazard statements

H350 corresponds to 'Carc. 1B'.

Selection of pictogram and signal word

Pictogram GHS08 and signal word 'Danger' correspond to 'Carc. 1B'.

Selection of precautionary statements

For H350 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.
Reproductive toxicity

Following ingredients are classified as reproductive toxicants:

Substance B:   Repr. 1B: H360F.
Substance D:   Repr. 2: H361f.

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 substances B and D their concentrations should be compared to generic concentration limits.

Calculation of 'Repr. 1B'

Concentration of substance B is above the generic concentration limit 0.3 % (CLP, Annex I, Table 3.7.2). This leads to classification Repr. 1B .

Calculation of 'Repr. 2'

Concentration of substance D is below the generic concentration limit 3.0 % (CLP, Annex I, Table 3.7.2). This does not lead to classification 'Repr. 2'.

Selection of hazard category

The mixture is classified as 'Repr. 1B'.

Selection of hazard statements

H360F is selected for category 'Repr. 1B' because of the substance B.

Selection of pictogram and signal word

Pictogram GHS08 and signal word 'Danger' correspond to 'Repr. 1B'.

Selection of precautionary statements

For H360F following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501.
Specific target organ toxicity – repeated exposure

Following ingredients are classified as specific target organ toxicity – repeated exposure (STOT RE):

Substance A:   STOT RE 1: H372.
Substance B:   STOT RE 1: H372 (respiratory and haematopoietic systems).
Substance C:   STOT RE 2: H373.
Substance D:   STOT RE 1: H372 (lung).
Substance E:   STOT RE 2: H373 (kidneys).

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 for substances A, B, C and E, their concentrations must be compared to generic concentration limits.
Substance D has two specific concentration limits (SCLs). Because SCL has a precedence over generic concentration limit, concentration of D must be compared to its SCLs.

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'.
Concentration of substance B is above the generic concentration limit 10 % (CLP, Annex I, Table 3.9.4). This leads to classification STOT RE 1 .
Concentration of substance D is below its specific concentration limit 0.1 % for 'STOT RE 1'. 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 .
Concentration of substance C is below the generic concentration limit 10 % (CLP, Annex I, Table 3.9.4). This does not lead to classification 'STOT RE 2'.
Concentration of substance D is between 0.01 % and 0.1 % of its specific concentration limit for 'STOT RE 2'. This leads to classification STOT RE 2 .
Concentration of substance E is above the generic concentration limit 10 % (CLP, Annex I, Table 3.9.4). This leads to classification STOT RE 2 .

Selection of hazard category

Classification category 'STOT RE 1' is more severe than 'STOT RE 2', therefore, mixture is classified as 'STOT RE 1'.

Selection of hazard statements

H372 corresponds to 'STOT RE 1'.
For mixtures there is no need to identify the target organs and routes of exposure on the label.

Selection of pictogram and signal word

Pictogram GHS08 and signal word 'Danger' correspond to 'STOT RE 1'.

Selection of precautionary statements

For H372 following precautionary statements are applied: P260, P264, P270, P314, P501.
Hazardous to the aquatic environment

Following ingredients are classified as hazardous to the aquatic environment:

Substance C:   Aquatic Chronic 2: H411.
Substance E:   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), where M is M-factor.

There is no M-factor in Table 3 of Annex VI to CLP established for substance E. Person responsible for classification decided to use M = 1 for both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. Concentration of substance E 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 C is above 1 %, therefore, it is taken into account for calculation of 'Aquatic Chronic 2'.

Specific and Generic concentration limits

Neither specific nor generic concentration limits are applied for acute toxicity.

Calculation of 'Aquatic Acute 1'

Concentration of substance E must be multiplied by its M-factor.

conc. E × M = 11.5 × 1 = 11.5

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 E must be multiplied by its M-factor.

conc. E × M = 11.5 × 1 = 11.5

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 Chronic 1'.

Calculation of 'Aquatic Chronic 2'

Concentration of substance E must be multiplied by its M-factor and multiplied by 10. Obtained value must later be summed with concentration of substance C.

(M × 10 × conc. E) + conc. C = (1 × 10 × 11.5) + 5.7 = 120.7

The obtained value is above 25 %. This leads to classification Aquatic Chronic 2 .

Selection of hazard category

The mixture is classified as 'Aquatic Chronic 2'.

Selection of hazard statements

H411 corresponds to 'Aquatic Chronic 2'.

Selection of pictogram and signal word

Pictogram GHS09 corresponds to 'Aquatic Chronic 2'. No signal word applies.

Selection of precautionary statements

For H411 following precautionary statements are applied: P273, P391, P501.


Selection of classification, H statements, pictograms,
signal word and P statements
Classification categories Classification H statements Pictograms Signal words P statements
Respiratory / Skin sensitisation Skin Sens. 1 H317 pictogram ghs 07
GHS07
Warning P261, P272, P280, P302+P352, P333+P313, P321, P362+P364, P501
Carcinogenicity Carc. 1B H350 pictogram ghs 08
GHS08
Danger P201, P202, P280, P308+P313, P405, P501
Reproductive toxicity Repr. 1B H360F pictogram ghs 08
GHS08
Danger P201, P202, P280, P308+P313, P405, P501
Specific target organ toxicity - repeated exposure STOT RE 1 H372 pictogram ghs 08
GHS08
Danger P260, P264, P270, P314, P501
Hazardous to the aquatic environment Aquatic Chronic 2 H411 pictogram ghs 09
GHS09
P273, P391, P501

According to Article 20(3) of CLP if both signal words are applied, 'Danger' is used.



Classification and labelling of the mixture

Classification: Skin Sens. 1, Carc. 1B, Repr. 1B, STOT RE 1, Aquatic Chronic 2
Hazard statements: H317, H350, H360F, H372, H411
Pictograms: pictogram ghs 07
   GHS07
pictogram ghs 08
   GHS08
pictogram ghs 09
   GHS09
Signal word: Danger
Precautionary statements: P201, P202, P260, P261, P264, P270, P272, P273, P280, P302+P352, P308+P313, P314, P321, P333+P313, P362+P364, P391, 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.