Item | Information |
---|---|
CAS RN | 577-11-7 |
Chemical Name | Sodium salt of bis(2-ethylhexyl) sulfosuccinate |
Substance ID | 24A6109 |
Classification year (FY) | FY2012 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
New/Revised | New |
Classification result in other fiscal year | |
Download of Excel format | Excel file |
Item | Information |
---|---|
Guidance used for the classification (External link) | Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition) |
UN GHS document (External link) | UN GHS document |
Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | eChemPortal |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | Not applicable |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. |
2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
3 | Aerosols | Not applicable |
- |
- | - | Not aerosol products. |
4 | Oxidizing gases | Not applicable |
- |
- | - | Solid (GHS definition) |
5 | Gases under pressure | Not applicable |
- |
- | - | Solid (GHS definition) |
6 | Flammable liquids | Not applicable |
- |
- | - | Solid (GHS definition) |
7 | Flammable solids | Classification not possible |
- |
- | - | It is described that it is not flammable (Weiss (2nd, 1986)), but the details are unknown. Therefore, the classification is not possible. |
8 | Self-reactive substances and mixtures | Not applicable |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. |
9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition) |
10 | Pyrophoric solids | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from the information "Ignition Temperature: Not pertinent" (Weiss (2nd, 1986)). Therefore, it was classified as "Not classified." |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data available. |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified |
- |
- | - | There is a metal (Na) present in the molecule, but from data: water solubility 71000 mg/L (HSDB (2001)), it is estimated that it does not react vigorously with water. |
13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition) |
14 | Oxidizing solids | Classification not possible |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (S, Na). However, the classification is not possible due to no data on oxidization. |
15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure. |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Test methods applicable to solid substances are not available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | Among LD50 values for rats of 1.80, 3.08, 3.98, 4.3 g/kg (JECFA 723 (1991)), about 2,000, 4,200 mg/kg (USEPA/HPV (2001), corresponding List 1), two correspond to Category 4, and four correspond to "Not classified." It was classified as "Not classified" (Category 5 in UN GHS classification), to which most corresponded. |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | It was classified as "Not classified" based on an LD50 value of > 10 g/kg for rabbits (USEPA/HPV (2001)). |
1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | No data available. |
2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
It is described that the scores for non-abraded skin were 2.33 (erythema), 2.5 (edema) after 24 hours and 1.66 (erythema), 1.6 (edema) after 72 hours, and no necrosis or irreversible changes were observed in a test by an occlusive application of 0.5 mL to rabbits (IUCLID (2000)). Therefore, it was classified in Category 2. |
3 | Serious eye damage/eye irritation | Category 2 |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
It was classified in Category 2 because it is described that no necrosis or irreversible changes were observed in a test in which 100 mg was applied to rabbits, and it was irritating (IUCLID (2000)), and there was mild irritation in a test in which 250 microg was applied to rabbits (HPVIS (2009)). |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | No data available. |
4 | Skin sensitization | Classification not possible |
- |
- | - | No data available. |
5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | The classification is not possible due to no in vivo test data. Besides, as for in vitro tests, it is reported that it was negative in an Ames test (USEPA/HPV (2001)) and positive and negative in a chromosomal aberration test with CHO cells (USEPA/HPV (2011)). |
6 | Carcinogenicity | Classification not possible |
- |
- | - | No data available. |
7 | Reproductive toxicity | Category 2, Additional category: Effects on or via lactation |
Warning |
H361
H362 |
P308+P313
P201 P202 P280 P405 P501 |
It was classified in Category 2 because it is described that there were an increase in fetal resorptions and a significant increase in externally malformed fetuses at the dose that produced reduced weight gain in maternal animals in a test by diet administration to pregnant rats during the organogenesis period (JECFA 723 (1991)). And it was classified in the Additional category: Effects on or via lactation because it is reported that there were reduced weight gain and the lowering of survival rate, which were attributed to impairment of nutrition because of the substance secreted in the milk, in a diet administration three-generation test with rats (0, 0.5, or 1.0% in the diet) (JECFA 723 (1991)). |
8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | In an acute oral exposure test with rats (doses: 2,820, 3,560, 4,480, 5,040 mg/kg), there were deaths in the groups at or above 3,560 mg/kg, and most deaths occurred within 6-24 hours after exposure. It is described that toxic signs included prostration and lethargy, and yellow fluid was observed in the gastrointestinal tract of the dead animals, but no visible lesions were found in the surviving animals at necropsy (USEPA/HPV (2001)). However, because the above test was conducted at the high doses above the upper limit of the guidance values for Category 2, and effects at doses within the guidance values are unknown, it was classified as "Classification not possible" due to lack of data. |
9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | It is described that in a 90-day diet administration test with rats (1% in the diet (converted value: 500 mg/kg/day)), no deaths or abnormal behavioral reactions were noted, and no treatment-related effects were observed on weight gain, food consumption, hematological tests, urinalyses, or histopathological examination (USEPA HPV (2001)). Therefore, it corresponds to "Not classified" in oral exposure. However, because of no data on toxicity effects in the other routes (inhalation, dermal), it was classified as "Classification not possible." |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. |
Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment (Acute) | Category 3 |
- |
H402 |
P273
P501 |
It was classified in Category 3 from 48-hour EC50 = 19.0 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999)). |
11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 |
P273
P501 |
If chronic toxicity data are used, then it is classified as "Not classified" from 21-day NOEC = 7.03 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999)), although it is not rapidly degradable (not readily degradable, a degradation rate by BOD: 0, 9, 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (not readily degradable, a degradation rate by BOD: 0, 9, 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1991)), and 96-hour LC50 = 68.2 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1999)). By drawing a comparison between the above results, it was classified in Category 3. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | This substance is not listed in the Annexes to the Montreal Protocol. |
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