Latest GHS Classification Results by the Japanese Government (edited by NITE)

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 151-21-3
Chemical Name Sodium dodecyl sulfate
Substance ID m-nite-151-21-3_v1
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) To Guidance List
UN GHS document (External link) To UN GHS document
FAQ(GHS classification results by the Japanese Government) To FAQ
List of Information Sources (Excel file) List of Information Sources
List of Definitions/Abbreviations Definitions/Abbreviations
Sample Label by MHLW (External link) To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link) To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link) To OECD/eChemPortal (External link)

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Flammable solids Classification not possible
-
-
- - No data available. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Self-reactive substances and mixtures Not classified (Not applicable)
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Self-heating substances and mixtures Classification not possible
-
-
- - No data available. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17 Desensitized explosives -
-
-
- - - - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
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. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Vapours) Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.
FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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." FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.
FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.
FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).
FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.
FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.
FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
11 Hazardous to the aquatic environment Short term (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. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Hazardous to the aquatic environment Long term (Chronic) 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. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available. FY2015 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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