The purpose of this example is to show calculation of Specific target organ toxicity - single exposure (STOT SE) 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 |
STOT SE 1: H370 Aquatic Chronic 2: H411 |
STOT SE 1: H370: C ≥ 1 % STOT SE 2: H371: 0.2 % ≤ C < 1 % |
Substance B | 0.9 |
Acute Tox. 3: H301 STOT SE 1: H370 Acute Tox. 4: H312 Aquatic Acute 1: H400 Aquatic Chronic 1: H410 |
− |
Substance C | 5.2 |
Acute Tox. 2: H330 Acute Tox. 2: H300 STOT SE 3: H336 STOT SE 1: H370 (eye) STOT RE 1: H372 Aquatic Acute 1: H400 Aquatic Chronic 1: H410 |
M = 1 M = 100 |
Substance D | 11.0 |
Acute Tox. 4: H302 STOT SE 2: H371 (nervous system) Aquatic Acute 1: H400 Aquatic Chronic 1: H410 |
M = 100 M = 100 |
Substance E | 2.4 |
Acute Tox. 3: H301 STOT SE 2: H371 STOT RE 2: H373 Eye Dam. 1: H318 Skin Sens. 1: H317 Aquatic Chronic 2: H411 |
− |
Substance H | 12.0 |
STOT SE 3: H335 Skin Sens. 1: H317 |
− |
Substance K | 11.0 |
Eye Irrit. 2: H319 STOT SE 3: H335 Skin Irrit. 2: H315 |
− |
Substance L | 1.8 |
Carc. 1B: H350 Muta. 2: H341 Eye Irrit. 2: H319 Skin Irrit. 2: H315 STOT SE 3: H336 Aquatic Chronic 3: H412 |
− |
Substance N | 9.6 |
Acute Tox. 4: H332 Acute Tox. 3: H301 STOT SE 3: H336 Aquatic Acute 1: H400 Aquatic Chronic 1: H410 |
M = 10 M = 10 |
Substance P | 9.8 |
Acute Tox. 4: H302 STOT SE 3: H336 Aquatic Chronic 2: H411 |
− |
Water | 34.8 | − | − |
Calculation of mixture classification.
Following ingredients are classified as acute toxicants:
− | Substance B: Acute Tox. 3: H301 (oral) / Acute Tox. 4: H312 (dermal). |
− | Substance C: Acute Tox. 2: H330 (inhalation) / Acute Tox. 2: H300 (oral). |
− | Substance D: Acute Tox. 4: H302 (oral). |
− | Substance E: Acute Tox. 3: H301 (oral). |
− | Substance N: Acute Tox. 4: H332 (inhalation) / Acute Tox. 3: H301 (oral). |
− | Substance P: 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). Concentrations of substances B, C, E and N 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 B is below this value, therefore, it is not taken into account for calculation 'Acute Tox. 4' for dermal. Concentrations of substances D, N and P 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 B: Acute Tox. 3: H301 -> ATE = 100 |
− | Substance C: Acute Tox. 2: H300 -> ATE = 5 |
− | Substance D: Acute Tox. 4: H302 -> ATE = 500 |
− | Substance E: Acute Tox. 3: H301 -> ATE = 100 |
− | Substance N: Acute Tox. 3: H301 -> ATE = 100 |
− | Substance P: Acute Tox. 4: H302 -> ATE = 500 |
100 / ATE mix = conc. B / ATE B + conc. C / ATE C + conc. D / ATE D + conc. E / ATE E + conc. N / ATE N + conc. P / ATE P
100 / ATE mix = 0.9 / 100 + 5.2 / 5 + 11.0 / 500 + 2.4 / 100 + 9.6 / 100 + 9.8 / 500
ATE mix = 82.604
The value 82.604 is between 50 and 300 (CLP, Annex I, Table 3.1.2). This leads to oral Acute Tox. 3 .
Calculation of dermal Acute Toxicity
Dermal acute toxicity is not calculated, because only substance B is classified as 'Acute Tox. 4' for dermal, but its cocncentration is below the cut-off limit 1 %.
Calculation of inhalation Acute Toxicity
There are two ingredients (C and N) 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 C: Acute Tox. 2: H330 -> ATE = 0.5 |
− | Substance N: Acute Tox. 4: H332 -> ATE = 11 |
100 / ATE mix = conc. C / ATE C + conc. N / ATE N
100 / ATE mix = 5.2 / 0.5 + 9.6 / 11
ATE mix = 8.871
The value 8.871 is between 2.0 and 10.0 for vapours (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 3 .
ATE values converted from inhalation (mists) acute toxicity categories:
− | Substance C: Acute Tox. 2: H330 -> ATE = 0.05 |
− | Substance N: Acute Tox. 4: H332 -> ATE = 1.5 |
100 / ATE mix = conc. C / ATE C + conc. N / ATE N
100 / ATE mix = 5.2 / 0.05 + 9.6 / 1.5
ATE mix = 0.906
The value 0.906 is between 0.5 and 1.0 for dust/mist (CLP, Annex I, Table 3.1.2). This leads to inhalation Acute Tox. 3 .
Selection of hazard category
− | Both oral 'Acute Tox. 3' and inhalation 'Acute Tox. 3' are applied, therefore, the mixture is classified as 'Acute Tox. 3'. |
Selection of hazard statements
− | H301 corresponds to oral 'Acute Tox. 3'. |
− | H331 corresponds to inhalation 'Acute Tox. 3'. |
− | Hazard statements H301 and H331 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 H331 following precautionary statements are applied: P261, P271, P304+P340, P311, P321, P403+P233, P405, P501. |
− | For both H301 and H331 following precautionary statements are applied: P261, P264, P270, P271, P301+P310, P304+P340, P311, P321, P330, P403+P233, P405, P501. |
Following ingredients are classified as corrosive / irritant to skin:
− | Substance K: Skin Irrit. 2: H315. |
− | Substance L: Skin Irrit. 2: H315. |
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). Concentrations of substances K and L are above this value, therefore, they are taken into account. |
Specific and Generic concentration limits
− | Because no specific concentration limits are applied for substances K and L, their concentrations must be compared to generic concentration limit. |
Calculation of 'Skin Irrit. 2'
− | Concentrations of substances K and L must be summed.
conc. K + conc. L = 11.0 + 1.8 = 12.8 % The obtained value is above the generic concentration limit 10 %. 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. |
Following ingredients are classified as serious damage to eyes / eye irritation:
− | Substance E: Eye Dam. 1: H318. |
− | Substance K: Eye Irrit. 2: H319. |
− | Substance L: Eye Irrit. 2: H319. |
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). Concentrations of substances E, K and L are above this value, therefore, they are taken into account. |
Specific and Generic concentration limits
− | Because no specific concentration limits is applied for substances E, K and L, their concentrations must be compared to generic concentration limits. |
Calculation of '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 E is inside the generic concentration limit range (1 ≤ C < 3 % for 'Eye Irrit. 2'). This leads to classification Eye Irrit. 2 . |
− | Concentration of substance E must multiplied by 10. To this value concentrations of substances K and L must be added (without multiplication).
(10 × conc. E) + conc. K + conc. L = (10 × 2.4) + 11.0 + 1.8 = 36.8 % The obtained value is above the generic concentration limit 10 %. 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. |
Following ingredients are classified as respiratory / skin sensitisers:
− | Substance E: Skin Sens. 1: H317. |
− | Substance H: 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 E and H their concentrations should be compared to generic concentration limits. |
Calculation of '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 . |
− | Concentration of substance H 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 germ cell mutagens:
− | Substance L: Muta. 2: H341. |
Cut-off limits
− | There is no generic cut-off limit for germ cell mutagenicity (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 limit is applied for substance L its concentration must be compared to generic concentration limit. |
Calculation of 'Muta. 2'
− | Concentration of substance L is above the generic concentration limit 1.0 % (CLP, Annex I, Table 3.5.2). This leads to classification Muta. 2 . |
Selection of hazard category
− | The mixture is classified as 'Muta. 2'. |
Selection of hazard statements
− | H341 corresponds to 'Muta. 2'. |
Selection of pictogram and signal word
− | Pictogram GHS08 and signal word 'Warning' correspond to 'Muta. 2'. |
Selection of precautionary statements
− | For H341 following precautionary statements are applied: P201, P202, P280, P308+P313, P405, P501. |
Following ingredients are classified as carcinogens:
− | Substance L: 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
− | Because no specific concentration limits are applied for substance L its concentration must be compared to generic concentration limit. |
Calculation of 'Carc. 1B'
− | Concentration of substance L is above the generic concentration limit 0.1 % (CLP, Annex I, Table 3.6.2). This leads to classification Carc. 1B . |
Selection of hazard category
− | The 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. |
Following ingredients are classified as specific target organ toxicity – single exposure (STOT SE):
− | Substance A: STOT SE 1: H370. |
− | Substance B: STOT SE 1: H370. |
− | Substance C: STOT SE 3: H336 / STOT SE 1: H370 (eye). |
− | Substance D: STOT SE 2: H371 (nervous system). |
− | Substance E: STOT SE 2: H371. |
− | Substance H: STOT SE 3: H335. |
− | Substance K: STOT SE 3: H335. |
− | Substance L: STOT SE 3: H336. |
− | Substance N: STOT SE 3: H336. |
− | Substance P: STOT SE 3: H336. |
Cut-off limits
− | There is no generic cut-off limit for STOT SE categories 1 and 2 (CLP, Annex I, Table 1.1), therefore, any concentration of substances A, B, C, D and E are taken into account. |
− | There is generic cut-off limit for STOT SE category 3 (CLP, Annex I, Table 1.1). Concentrations of substances C, H, K, L, N and P are above the generic cut-off limit 1 %, therefore, their concentrations are taken into account. |
Specific and Generic concentration limits
− | Substance A has two specific concentration limits (SCLs). Because SCL has a precedence over generic concentration limit, concentration of A must be compared to its SCLs. |
− | Because no specific concentration limits are applied for other ingredients, their concentrations must be compared to generic concentration limits. |
Calculation of 'STOT SE 1'
− | Concentration of substance A is above its specific concentration limit 1 % for 'STOT SE 1'. This leads to classification STOT SE 1 . |
− | Concentration of substance B is below the generic concentration limit 10 %. This does not lead to classification 'STOT SE 1'. |
− | Concentration of substance C is below the generic concentration limit 10 %. This does not lead to classification 'STOT SE 1'. |
Calculation of 'STOT SE 2'
− | Concentration of substance A is above the upper border of its specific concentration limit 1 % for 'STOT SE 2'. This does not lead to classification 'STOT SE 2'. |
− | Concentration of substance B is below the lower border of generic concentration limit 1 %. This does not lead to classification 'STOT SE 2'. |
− | Concentration of substance C is between 1 % and 10 % of the generic concentration limit. This leads to classification STOT SE 2 . |
− | Concentration of substance D is above the generic concentration limit 10 %. This leads to classification STOT SE 2 . |
− | Concentration of substance E is below the generic concentration limit 10 %. This does not lead to classification 'STOT SE 2'. |
Calculation of 'STOT SE 3: H335'
− | Concentrations of substances H and K must be summed.
conc. H + conc. K = 12.0 + 11.0 = 23.0 % The obtained value is above the generic concentration limit 20 % (CLP, Annex I, 3.8.3.4.5). This leads to classification STOT SE 3: H335 . |
Calculation of 'STOT SE 3: H336'
− | Concentrations of substances C, L, N and P must be summed.
conc. C + conc. L + conc. N + conc. P = 5.2 + 1.8 + 9.6 + 9.8 = 26.4 % The obtained value is above the generic concentration limit 20 % (CLP, Annex I, 3.8.3.4.5). This leads to classification STOT SE 3: H336 . |
Selection of hazard category
− | Classification category 'STOT SE 1' is more severe than 'STOT SE 2' and 'STOT SE 3', therefore, mixture is classified as 'STOT SE 1'. |
Selection of hazard statements
− | H370 corresponds to 'STOT SE 1'. |
− | Because classification criteria of 'STOT SE 3: H335' are fulfilled the hazard statement H335 also must be indicated. |
− | Because classification criteria of 'STOT SE 3: H336' are fulfilled the hazard statement H336 also must be indicated. |
− | 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 SE 1'. |
Selection of precautionary statements
− | For H370 following precautionary statements are applied: P260, P264, P270, P308+P311, P321, P405, P501. |
− | For both H335 and H336 the same following precautionary statements are applied: P261, P271, P304+P340, P312, P403+P233, P405, P501. |
− | For H370, H335 and H336 following precautionary statements are applied: P260, P261, P264, P270, P271, P304+P340, P308+P311, P312, P321, P403+P233, P405, P501. |
Following ingredients are classified as specific target organ toxicity – repeated exposure (STOT RE):
− | Substance C: STOT RE 1: H372. |
− | Substance E: 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 substances C and E, their concentrations should be compared to generic concentration limits. |
Calculation of 'STOT RE 1'
− | 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 1'. |
Calculation of 'STOT RE 2'
− | Concentration of substance C 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 E is below the generic concentration limit 10 % (CLP, Annex I, Table 3.9.4). This does not lead to classification 'STOT RE 2'. |
Selection of hazard category
− | The mixture is classified as 'STOT RE 2'. |
Selection of hazard statements
− | H373 corresponds to 'STOT RE 2'. |
Selection of pictogram and signal word
− | Pictogram GHS08 and signal word 'Warning' correspond to 'STOT RE 2'. |
Selection of precautionary statements
− | For H373 following precautionary statements are applied: P260, P314, P501. |
Following ingredients are classified as hazardous to the aquatic environment:
− | Substance A: Aquatic Chronic 2: H411. |
− | Substance B: Aquatic Acute 1: H400 / Aquatic Chronic 1: H410. |
− | Substance C: Aquatic Acute 1: H400 / Aquatic Chronic 1: H410. |
− | Substance D: Aquatic Acute 1: H400 / Aquatic Chronic 1: H410. |
− | Substance E: Aquatic Chronic 2: H411. |
− | Substance L: Aquatic Chronic 3: H412. |
− | Substance N: Aquatic Acute 1: H400 / Aquatic Chronic 1: H410. |
− | Substance P: Aquatic Chronic 2: H411. |
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):
− | There is no M-factor in Table 3 of Annex VI to CLP established for substance B. Person responsible for classification decided to use M = 1 for both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. Concentration of substance B is above 0.1 % (0.1/1), therefore, B is taken into account for calculation of both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. |
− | Substance C has established two different M-factors: M = 1 applies to 'Aquatic Acute 1' and M = 100 applies to 'Aquatic Chronic 1'.
− concentration of substance C is above 0.1 % (0.1/1), therefore, C is taken into account for calculation of 'Aquatic Acute 1', − concentration of substance C is above 0.001 % (0.1/100), therefore, C is taken into account for calculation of 'Aquatic Chronic 1'. |
− | Concentration of substance D is above 0.001 % (0.1/100), therefore, D is taken into account for calculation of both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. |
− | Concentration of substance N is above 0.01 % (0.1/10), therefore, N 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):
− | Concentrations of substances A, E, L and P 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 Acute 1'
− | Concentrations of substances B, C, D and N must be multiplied by their corresponding M-factors and obtained values must be summed.
(conc. B × M) + (conc. C × M) + (conc. D × M) + (conc. N × M) = (0.9 × 1) + (5.2 × 1) + (11.0 × 100) + (9.6 × 10) = 1202.1 The obtained value is above 25 % (CLP, Annex I, 4.1.3.5.5.3.1 and Table 4.1.1). This leads to classification Aquatic Acute 1 . |
Calculation of 'Aquatic Chronic 1'
− | Concentrations of substances B, C, D and N must be multiplied by their corresponding M-factors and obtained values must be summed.
(conc. B × M) + (conc. C × M) + (conc. D × M) + (conc. N × M) = (0.9 × 1) + (5.2 × 100) + (11.0 × 100) + (9.6 × 10)= 1630.5 The obtained value is above 25 % (CLP, Annex I, 4.1.3.5.5.4.1 and Table 4.1.2). This leads to classification Aquatic Chronic 1 . |
Calculation of 'Aquatic Chronic 2'
− | Concentrations of substances B, C, D and N must be multiplied by their corresponding M-factors for 'Aquatic Chronic 1' and multiplied by 10. Obtained values must later be summed with concentrations of substances A, E and P. Please take into account that for substance C the M = 100 is used as for 'Aquatic Chronic 1'.
(M × 10 × conc. B) + (M × 10 × conc. C) + (M × 10 × conc. D) + (M × 10 × conc. N) + conc. A + conc. E + conc. P = (1 × 10 × 0.9) + (100 × 10 × 5.2) + (100 × 10 × 11.0) + (10 × 10 × 9.6) + 1.5 + 2.4 + 9.8 = 17182.7 The obtained value is above 25 % (CLP, Annex I, 4.1.3.5.5.4.2 and Table 4.1.2). This leads to classification Aquatic Chronic 2 . |
Calculation of 'Aquatic Chronic 3'
− | Concentrations of substances B, C, D and N must be multiplied by their corresponding M-factors for 'Aquatic Chronic 1' and multiplied by 100. Concentrations of substances A, E and P must be multiplied by 10. Obtained values must later be summed with concentration of substance L. Please take into account that for substance C the M = 100 is used as for 'Aquatic Chronic 1'.
(M × 100 × conc. B) + (M × 100 × conc. C) + (M × 100 × conc. D) + (M × 100 × conc. N) + (10 × conc. A) + (10 × conc. E) + (10 × conc. P) + conc. L = (1 × 100 × 0.9) + (100 × 100 × 5.2) + (100 × 100 × 11.0) + (10 × 100 × 9.6) + (10 × 1.5) + (10 × 2.4) + (10 × 9.8) + 1.8 = 171829 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 . |
Calculation of 'Aquatic Chronic 4'
− | Concentrations of all ingredients summed.
conc. A + conc. B + conc. C + conc. D + conc. E + conc. L + conc. N + conc. P = 1.5 + 0.9 + 5.2 + 11.0 + 2.4 + 1.8 + 9.6 + 9.8 = 42.2 The obtained value is above 25 % (CLP, Annex I, 4.1.3.5.5.4.4 and Table 4.1.2). This leads to classification Aquatic Chronic 4 . |
Selection of hazard category
− | The mixture is classified as 'Aquatic Acute 1'. |
− | Classification category 'Aquatic Chronic 1' is more severe than 'Aquatic Chronic 2', 'Aquatic Chronic 3' and 'Aquatic Chronic 4', therefore, mixture is classified as 'Aquatic Chronic 1'. |
Selection of hazard statements
− | H400 corresponds to 'Aquatic Acute 1'. |
− | H410 corresponds to 'Aquatic Chronic 1'. Because H410 is applied, the statement H400 don't have to be used (Article 27 and Part 1 of Annex III to CLP). |
Selection of pictogram and signal word
− | Pictogram GHS09 and signal word 'Warning' correspond to both 'Aquatic Acute 1' and 'Aquatic Chronic 1'. |
Selection of precautionary statements
− | For H410 following precautionary statements are applied: P273, P391, P501. |
Classification categories | Classification | H statements | Pictograms | Signal words | P statements |
Acute Toxicity | Acute Tox. 3 | H301 H331 |
![]() GHS06 |
Danger | P261, P264, P270, P271, P301+P310, P304+P340, P311, P321, P330, P403+P233, P405, 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 |
Respiratory / Skin sensitisation | Skin Sens. 1 | H317 | ![]() GHS07 |
Warning | P261, P272, P280, P302+P352, P333+P313, P321, P362+P364, P501 |
Germ cell mutagenicity | Muta. 2 | H341 | ![]() GHS08 |
Warning | P201, P202, P280, P308+P313, P405, P501 |
Carcinogenicity | Carc. 1B | H350 | ![]() GHS08 |
Danger | P201, P202, P280, P308+P313, P405, P501 |
Specific target organ toxicity - single exposure (STOT SE) | STOT SE 1 | H370 H335 H336 |
![]() GHS08 |
Danger | P260, P261, P264, P270, P271, P304+P340, P308+P311, P312, P321, P403+P233, P405, P501 |
Specific target organ toxicity - repeated exposure (STOT RE) | STOT RE 2 | H373 | ![]() GHS08 |
Warning | P260, P314, P501 |
Hazardous to the aquatic environment | Aquatic Acute 1 Aquatic Chronic 1 |
H410 | ![]() GHS09 |
Warning | P273, P391, P501 |
According to Article 20(3) of CLP if both signal words are applied, 'Danger' is used.
According to Article 26(b) if the hazard pictogram 'GHS06' applies, the 'GHS07' is not used.
Classification and labelling of the mixture
Classification: | Acute Tox. 3, Skin Irrit. 2, Eye Irrit. 2, Skin Sens. 1, Muta. 2, Carc. 1B, STOT SE 1, STOT RE 2, Aquatic Acute 1, Aquatic Chronic 1 |
Hazard statements: | H301 + H331, H315, H317, H319, H335, H336, H341, H350, H370, H373, H410 |
Pictograms: | ![]() |
GHS06 | |
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GHS08 | |
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GHS09 | |
Signal word: | Danger |
Precautionary statements: | P201, P202, P260, P261, P264, P270, P271, P272, P273, P280, P301+P310, P302+P352, P304+P340, P305+P351+P338, P308+P311, P308+P313, P311, P312, P314, P321, P330, P332+P313, P333+P313, P337+P313, P362+P364, P391, P403+P233, 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.