GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 151-21-3 |
| Chemical Name | Sodium dodecyl sulfate |
| Substance ID | H27-B-10-METI/M-017B_P |
| Classification year (FY) | FY2015 |
| Ministry who conducted the classification | Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE) |
| New/Revised | Revised |
| Classification result in other fiscal year | FY2008 |
| Download of Excel format | Excel file |
REFERENCE INFORMATION
| Item | Information |
|---|---|
| Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1)) |
| 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 |
- |
- | - | No data available. |
| 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 autoignition temperature data of 310.5 deg C (Sigma-Aldrich, 2015). |
| 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 |
- |
- | - | It is estimated that it does not react vigorously with water because water solubility was measured. Water solubility: 1 g/10 mL (Merck, 2013). |
| 13 | Oxidizing liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (S). However, the classification is not possible due to no data. |
| 15 | Organic peroxides | Not applicable |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule |
| 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) | Category 4 |
 Warning |
H302 | P301+P312 P264 P270 P330 P501 |
There are two reports of LD50 values for rats of 1,200 mg/kg (OECD TG 401) (SIDS (2009)) and 2,730 mg/kg (EHC 169 (1996)). One case corresponds to Category 4, and the other one corresponds to "Not classified" (Category 5 in UN GHS classification). However, it was classified in Category 4 to which the lower LD50 value from the OECD TG 401 compliant test corresponds. |
| 1 | Acute toxicity (Dermal) | Category 2 |
 Danger |
H310 | P302+P352 P361+P364 P262 P264 P270 P280 P310 P321 P405 P501 |
Based on an LD50 value of approximately 200 mg/kg for rabbits (SIDS (2009), EHC 169 (1996)), it was classified in Category 2. Since the data used in the previous classification was the data on the diluted substance, the LD value of the pure substance was adopted, and the category was changed. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | Solid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 | P302+P352 P332+P313 P362+P364 P264 P280 P321 |
As for skin irritation tests with rabbits (OECD TG 404), there are reports that erythema and edema were observed as a result of application of 0.5 mL of this substance (50%), and these persisted during the observation period (for 3 days) (ECETOC TR 66 (1995)), and that moderate irritation was observed (BUA 189 (1996)). In another report, it is reported that as a result of a semi-occlusive application of this substance for 4 hours, moderate to severe irritation was observed, but there was no description of reversibility (SIDS (2009)). From the above, it was classified in Category 2. |
| 3 | Serious eye damage/eye irritation | Category 1 |
 Danger |
H318 | P305+P351+P338 P280 P310 |
There is a report that in an eye irritation test with rabbits (OECD TG 405), irreversible effects were observed in an application of this substance (25% aqueous solution) (SIDS (2009)). In addition, in a report on another eye irritation test, it was reported that corneal opacity, conjunctival redness, conjunctival edema, etc. were observed by an application of this substance (3%), but this resolved by the 7th day (ECETOC TR 48 (1992)). Since irreversible symptoms were observed in the test of an application of a 25% aqueous solution, it was classified in Category 1. The information was added, and the category was revised. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Not classified |
- |
- | - | There is a negative report in a maximization test with guinea pigs (ECETOC TR 77 (1999), BUA 189 (1996)). In addition, as for LLNA tests with mice, two positive and one negative results by application of this substance are reported (SIDS (2009)). There is no report that it showed sensitization in humans, and it was concluded in SIDS (2009) and ECETOC TR 77 (1999) that there was no concern for sensitization by this substance (SIDS (2009), ECETOC TR 77 (1999)). From the above, it was classified as "Not classified." |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a dominant lethal test with mice, a micronucleus test and a chromosomal aberration test with rat bone marrow cells (SIDS (2009), HSDB (Access on November 2015)). As for in vitro, it was negative in a bacterial reverse mutation test, in a mouse lymphoma test, a chromosomal aberration test and a sister chromatid exchange test with mammalian cultured cells (SIDS (2009), NTP DB (Access on November 2015)). The information from EHC described in the previous classification could not be confirmed. |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | There is no carcinogenicity test report on this substance itself. However, EPA gave its view that there was no evidence of carcinogenic potential even if this substance was administered at a concentration of 1.5% (15,000 ppm) in the feed, based on two test results of C12-C15 alkyl sulfates (EPA Final Registration (2010)). In addition, it was stated in SIDS that 2-year tests with rats dosed by feeding with sodium C12-15-alkyl sulfate (CAS RN 68890-70-0) as a test substance were conducted twice under the same conditions, and in both of the two tests, at the high dose of 15,000 ppm (approximately 1,125 mg/kg/day), non-neoplastic lesions and hematotoxicity were observed in the liver, kidney, etc. in addition to decreased body weight gain, decreases in food/water consumption in both sexes, but there was no increase in tumor incidence (SIDS (2009)). From the above, it is considered that this substance also corresponds to "Not classified" from the carcinogenicity test results on similar substances in the oral route, but there is no carcinogenicity information related to this substance in other routes, and there are also no classification results by other organizations. Therefore, classification was not possible due to lack of data for this hazard class. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | There is no information on human reproductive effects. As for experimental animals, there is a description that in a study in which this substance was administered by feeding to male mice at 10,000 ppm for 2 weeks or at 1,000 ppm for 6 weeks and thereafter mated with untreated females, there was no adverse effect on fertility index, and the authors reported that even when it was administered at up to the dose at which it caused a significantly decreased body weight gain in parental animals, no adverse effects on fertility were shown (SIDS (2009)). In two developmental toxicity studies in which the substance was administered by gavage to pregnant rats on gestational day 6-15, there were no adverse effects on fetuses in either at 500 mg/kg/day (Wistar rats) or at 600 mg/kg/day (SD rats) where deaths occurred in the maternal animals (SIDS (2009)). Also, in a test where pregnant mice or pregnant rabbits were dosed by gavage at up to 600 mg/kg/day on gestational day 6-15 or 6-18, respectively, increased incidence of total embryo resorption/litter loss was observed at 600 mg/kg/day where there were deaths in maternal animals, but at 300 mg/kg/day, maternal animals died (1/20 in mice and 1/13 in rabbits), and decreased body weight, diarrhea, etc. were seen in rabbits, however, no adverse effects on the fetuses was observed (SIDS (2009)). From the above, regarding effects on the fertility by the oral route in mice, there was no effect by the administration to male mice, however, effects on the fertility by administration to female mice was unknown because there are no reports. Therefore, classification was not possible due to lack of data for this hazard class. Besides, as for reproductive toxicity of this substance, EPA filled the data gaps, by stating that dose-related effects of reproductive toxicity and systemic toxicity did not occur at up to the maximum dose of 285 mg/kg/day in a 2-generation reproductive toxicity test in which alpha-alkylolefin sulfate as a similar substance was administered orally to rats (EPA Final Registration (2010)). |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system) |
 Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
There is no data on humans. As for experimental animals, diarrhea, decreased locomotor activity, labored breathing, decreased respiratory rate, and coma were found by oral administration to rats (1,200 mg/kg bw, equivalent to Category 2), and tremors, tonic-clonic convulsions, and dyspnea were observed by dermal application to rabbits (LD50 = 200 mg/kg, equivalent to Category 1) (SIDS (2009)). From the above, this substance affects the central nervous system, therefore, it was classified in Category 1 (central nervous system). The data on the respiratory tract irritation described in the previous classification could not be identified. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (liver) |
Warning |
H373 | P260 P314 P501 |
No information on humans is available. As for experimental animals, in a 4-week toxicity test with rats dosed by feeding, in females in the administration groups at or above 0.5% (converted guidance value: 76.2 mg/kg/day), which corresponds to Category 2, increased activity of ALT and alkaline phosphatase, and increases in the liver and left kidney weight were observed, and slight swelling of hepatocytes and an increase in dividing cells were observed in the liver. In addition, in the administration groups at or above 1% (152.4 mg/kg/day), which exceeded the range for Category 2, urinary casts, vacuolar degeneration of the epithelial cells of the renal tubules, PAS stain-positive substances in the renal tubules, and atrophy of the renal glomeruli were observed (EHC 169 (1996)). From the above, effects on the liver were observed in the range for Category 2. Therefore, it was classified in Category 2 (liver). Besides, in the previous classification, the classification was conducted by regarding that the findings in the kidney were observed at a dose within the range for Category 2, but the dose turned out to be outside the range for Category 2 as a result of confirmation. Therefore, the classification result was changed. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 1 |
 Warning |
H400 | P273 P391 P501 |
From 96-hour EC50/LC50 = 0.12 mg/L for crustacea (Acartia tonsa) (SIDS, 2009), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 | P273 P501 |
Due to being rapidly degradable (a degradation rate by 14-day BOD = 85.0%, a degradation rate by TOC = 99.3% (J-CHECK, 2016)), and 7-day NOEC (reproduction) = 0.88 mg/L for crustacea (Ceriodaphnia dubia) (SIDS, 2009), it was classified in Category 3. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
NOTE:
| * A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted. * Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement. Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file. * Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users. * This is a provisional English translation of classification results and is subject to revision without notice. * The responsibility for any resulting GHS labelling and SDS referenced from this site is with users. * Codes assigned to each of the hazard statements and codes for each of the precautionary statement are based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations. |