NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	68955-20-4
Chemical Name	Sodium alkyl sulfate (alkyl C=16-18)
Substance ID	m-nite-68955-20-4_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)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available. Besides, there is the autoignition temperature information of > 400 deg C (SIDS Dossier (2009)) although it is rated as reliability 4 (reliability not assignable).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2016	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 (Not applicable)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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), but the classification is not possible due to no data.	FY2016	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	FY2016	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.	FY2016	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)	Not classified	- -	-	-	There are 2 reports of LD50 values for rats, > 1,886 mg/kg (OECD TG 401) (SIDS (2009)) and > 1,100 mg/kg (Directive 79/831/EEC, Annex V, part B) (SIDS (2009)). Although, in these 2 reports, decreased motility and salivation were observed, no death cases were observed. In addition, also in the results of necropsy, no toxicological findings attributed to this substance were observed (SIDS (2009)). 　Moreover, based on these data, the LD50 value of the oral administration of this substance was set to be "greater than 2,000 mg/kg" in SIDS (2009) 　From the above, this substance was classified as "Not classified" (Category 5 in UN GHS classification) based on expert judgment.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	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)	FY2016	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)	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　There are 2 reports of skin irritation studies (OECD TG 404) using rabbits. It is reported that as a result of applying 25% of this substance for 4 hours, edema and erythema were observed, but that the recovery was within 7 days (SIDS (2009), BUA 189 (1996)). It is also reported that as a result of applying 55% of this substance, slight irritation was observed (BUA 189 (1996)). Moreover, in other study using rabbits, it is reported that as a result of 4-hour semi-occlusive application of 31.5% of this substance, slight irritation was observed (SIDS (2009)). 　All studies were conducted at low concentrations, so it is thought that they would indicate more reactivity at higher concentrations. However, they were judged to be insufficient data for use in classification. IUCLID information in the previous classification could not be confirmed because it was not available. The classification was revised because the information was updated.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There are 2 reports of eye irritation studies (OECD TG 405) using rabbits. It is reported that as a result of applying 25% of this substance, corneal opacity, erythema, conjunctival edema and exudation were observed, but that the recovery was within 10 days (SIDS (2009)). 　It is also reported that as a result of applying 55% of this substance, it was irritating since moderate to strong corneal and conjunctival reactions were found (BUA 189 (1996)). Moreover, in 2 other reports on eye irritation tests using rabbits, it is reported that as a result of applying 5% of this substance, slight to moderate irritation was observed, but the recovery was within 12 days. Therefore, it was reported as this was moderate to irritation (SIDS (2009)). 　As both studies were conducted at low concentrations, it is thought that this indicates more reactivity at higher concentrations. Therefore, this substance was classified in Category 2A. IUCLID information in the previous classification could not be confirmed because it was not available. The classification was revised because the information was updated.	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	It is reported that in a skin sensitization test (Directive 79/831/EWG, Annex V, Part B) using 20 guinea pigs, sensitization by this substance was not observed (SIDS (2009)). Also, it is reported that in another skin sensitization test using 20 guinea pigs, sensitization by this substance was not observed (SIDS (2009)). It is reported that as a result of patch tests in 97 volunteers, sensitization by this substance was not observed (SIDS (2009)). 　From the above, it was determined that this substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo data, micronucleus tests using mice were negative (SIDS (2009), BUA (1996)). As for in vitro, bacterial reverse mutation tests were also negative (SIDS (2009), BUA (1996)). Therefore, this substance was classified as "Classification not possible" according to the GHS classification guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, for sodium C12-15 alkyl sulfate (CAS 68890-70-0), it is described that in a 2-year carcinogenicity study using rats administered by feeding, no evidence of carcinogenicity was observed (SIDS (2009)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a developmental toxicity study in pregnant rats administered by gavage during the period of organogenesis, no developmental toxicity was observed in fetuses at up to 675 mg/kg/day, where suppression in body weight gain and diarrhoea were observed in maternal animals (SIDS (2009)). 　However, because there is no information on the effects on fertility and sexual function, the classification was not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　There is no single exposure data on this substance in humans. 　As for experimental animals, it is reported that in a single oral dose study using rats, decreased motility and salivation were observed at 2,000 mg/kg (SIDS Dossier (2009)). However, it was insufficient to identify target organs. Therefore, this substance was classified as "Classification not possible."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is no information on humans. 　As for experimental animals, in a 13-week repeated dose toxicity study using rats administered by feeding, at a dose of 230 mg/kg/day which is above Category 2, an increase in liver weights and hypertrophy of hepatocytes were observed. Moreover, in a 13-week repeated dose toxicity study using rats administered by gavage, at a dose of 165 mg/kg/day (converted guidance value: 119 mg/kg/day) which is above Category 2, an increase in liver weights, increase in ALT activity and mild irritation changes in the stomach were observed (SIDS (2009)). On the other hand, in a 3-week repeated dose toxicity study using rats administered by feeding, at a dose of 417 mg/kg/day (converted guidance value: 97.3 mg/kg/day) which is equivalent to Category 2, hypertrophy of hepatocytes and increase in ALT and LDH activity were observed (SIDS (2009)). 　As described above, it is thought that the liver is the target organ, but in the 13-week studies, effects were observed only at doses above Category 2, and in the 3-week study, it was observed at a dose near the upper limit of Category 2. 　Therefore, this substance was classified as "Classification not possible" based on the 13-week test results which are more suitable for using for GHS classification.	FY2016	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.	FY2016	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 2	- -	H401	P273 P501	From 96-hour LC50 = 5.2 mg/L for fish (Danio rerio) (SIDS, 2007), it was classified in Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Reliable chronic toxicity data were not obtained. Because rapid degradability data were not obtained, and it was classified in Category 2 for acute toxicity, it was classified in Category 2.	FY2016	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.	FY2016	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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