NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	67-68-5
Chemical Name	Dimethyl sulfoxide
Substance ID	R01-A-023
Classification year (FY)	FY2019
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

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)
Model SDS by MHLW (External link)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	It was classified in Category 4 based on a flash point of 87 deg C (closed cup) (ICSC (2000)).
7	Flammable solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information on an autoignition temperature of 215 deg C (ICSC (2000)).
10	Pyrophoric solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
11	Self-heating substances and mixtures	*	- -	-	-	Classification is not possible because test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	No data available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 14,500 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015), HSDB (Access on September 2019)) (2) LD50 for rats: 17,400 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)) (3) LD50 for rats: >20,000 mg/kg (SIDS (2008))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 40 g/kg (40,000 mg/kg) (DFGOT vol.3 (1992)) (2) LD50 for rats: >40,000 mg/kg (SIDS (2008)) (3) LD50 for rats: 40,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LC50 for rats (4 hours, mixture of the vapor and aerosol): >5,330 mg/m3 (5.33 mg/L) (SIDS (2008))
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In a skin irritation test with rabbits according to OECD TG 404, a very slight or well-defined erythema was observed, but all these disappeared within 72 hours (SIDS (2008), GESTIS (Access on September 2019), REACH registration dossier (Access on November 2019)). [Reference Data, etc.] (2) Skin irritation can develop at the site where this substance is applied topically (HSDB (Access on September 2019)).
3	Serious eye damage/eye irritation	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In an eye irritation test according to OECD TG 405 with rabbits, a slight to moderate conjunctival irritation was observed, which cleared in 72 hours (SIDS (2008), GESTIS (Access on September 2019), REACH registration dossier (Access on November 2019)). (2) This substance was applied as a topical anti-inflammatory agent or as a solvent for ophthalmologic drugs. When applied as eye droplets, 10 to 30% solutions had no effect, but 50 to 90% solutions were perceived as irritant (GESTIS (Access on September 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) A skin sensitization test with guinea pigs according to OECD TG 406 was negative, and a skin sensitization test with humans was also negative (SIDS (2008), GESTIS (Access on September 2019)). (2) In a mouse local lymph node assay (LLNA) equivalent to OECD TG 429, the SI values were less than 3, and the test was judged to be negative (REACH registration dossier (Access on November 2019)). (3) The intracutaneous skin sensitization test of this substance with guinea pigs yielded negative results (DFGOT vol.3 (1992)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, negative results were reported in a micronucleus test, a dominant lethal test and a sister chromatid exchange test with rodents (including the bone marrow of pregnant mice and fetal liver) following intraperitoneal administration (DFGOT vol.3 (1992), SIDS (2008), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). Positive results were reported in a chromosomal aberration test with the bone marrow of rats, but it was pointed out that this may be due to cytotoxicity (DFGOT vol.3 (1992), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). (2) As for in vitro, negative results were reported in bacterial reverse mutation tests, a mammalian cell chromosome aberration test, a mouse lymphoma test, a gene mutation test and an unscheduled DNA synthesis test with cultured mammalian cells (NTP DB (Access on September 2019), DFGOT vol.3 (1992), SIDS (2008), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] There are no classification results by domestic and international organizations. There are no human studies available. Therefore, based on (1), it was classified as "Classification not possible." [Evidence Data] (1) There was no evidence of carcinogenicity in long-term oral administration tests with rats, dogs or monkeys (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). [Reference Data, etc.] (2) It was reported that a promoter action was suggested in a two-stage oral or dermal carcinogenicity study with rats or mice (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] No reproductive effects were observed in (1), and no developmental effects were observed in (2) and (3). However, since (1) is a screening test, it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) In a reproductive toxicity screening test (OECD TG 421) with rats by gavage, no effects on fertility or pups were observed at up to the highest dose level at which reduced body weight gain in maternal animals and increased absolute and relative liver weights in paternal animals were observed (SIDS (2008)). (2) In a developmental toxicity test (OECD TG 414) with female rats administered by gavage on Days 6 to 15 of gestation, reductions in body weight gain and food consumption in dams were observed at the very high dose of 5,000 mg/kg/day, and at the same dose, fetuses showed decreased body weight, which was thought to be associated with reduced maternal body weight gain, as well as an increased incidence of ureter dilation and reduced ossification of ribs. There was also non-dose-related renal pelvis dilatation observed in the fetuses, but no teratogenic effect was observed (SIDS (2008), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). (3) In a developmental toxicity test (OECD TG 414) with female rabbits administered by gavage on Days 7 to 28 of gestation, lower body weight gain was observed in maternal animals, but no effects were observed in fetuses (SIDS (2008)). [Reference Data, etc.] (4) In a developmental toxicity test with female rats administered by gavage on Days 6 to 15 of gestation, decreased food consumption and reduced body weight gain in dams, increased incidences of early resorptions and post-implantation loss in embryos/fetuses, decreased proportion of live fetuses and a slight to moderate decrease in fetal body weights were observed at an extremely high dose of 5,000 mg/kg/day, but no teratogenicity was observed. In this test, no effects were observed in dams or embryos/fetuses at a dose of 1,000 mg/kg/day (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)).
8	Specific target organ toxicity - Single exposure	Category 2 (respiratory organs)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] There is no report of single exposure to this substance in humans. As for experimental animals, based on the information in (1), it was classified in Category 2 (respiratory organs). [Evidence Data] (1) In a single inhalation exposure to the aerosol (Note: described as an aerosol in SIDS Dossier (2008)) of this substance at 1,600 mg/m3 (1.6 mg/L, corresponding to Category 2) for 4 hours with rats, although neither dead animals nor signs of toxicity were observed, necropsy revealed areas of pulmonary edema (SIDS (2008)). Similar findings were observed at higher concentrations (2,000 to 2,900 mg/m3) or longer exposure periods (24, 40 hours), conducted by the original authors (SIDS (2008)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1) to (4), since no effects were reported up to the range of Category 2 by inhalation, oral or dermal exposure to experimental animals, it was classified as "Not classified." [Evidence Data] (1) As a result of a 13-week inhalation exposure test (6 hours/day, 7 days/week) with rats, no treatment-related effects were observed at 2.783 mg/L (exceeding Category 2) in females, except for pseudogland formation in the respiratory epithelium, hyperplasia of the squamous epithelium and increased eosinophilic inclusions in the olfactory epithelium in the nasal passages (SIDS (2008), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). (2) As a result of an oral administration of a 50% aqueous solution of this substance at concentrations of 1 to 9 mL/kg (1,100-9,900 mg/kg/day) for 78 weeks (5 days/week) to rats, depression of weight gain was observed at or above 1 mL/kg (1,100 mg/kg/day, exceeding Category 2), and a slight reduction of hemoglobin and hematocrit, and some degree of change in the refractive index of the eye lens were observed at 9 mL/kg (9,900 mg/kg/day, over Category 2), but no other effects were observed (SIDS (2008), Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)). (3) In dermal application tests with rats, rabbits, dogs and pigs, changes in the lenses of the eyes and skin reactions, etc. were observed at doses exceeding Category 2 (SIDS (2008)). (4) Primates appear to be much less sensitive to ocular toxicity by this substance. Therefore, it is assumed that the ocular effects observed in rats, rabbits, dogs and pigs are not considered relevant to humans (SIDS (2008)). [Reference Data, etc.] (5) As a result of dermal application at 1,000 mg/kg/day for 90 days to 54 subjects, the incidence of eosinophilia was higher, and sedation, and sporadic insomnia and nausea were observed as side effects in the treated group other than expected skin reactions and offensive odor of exhaled breath. No effects in the eyes, liver or lung function were observed (Environmental Risk Assessment for Chemical Substances Vol.13 (Ministry of the Environment, 2015)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Not classified	- -	-	-	It was classified as "Not classified" from 24-hour EC50 = 6,830 mg/L for crustacea (Artemia salina) (Environmental Risk Assessment for Chemical Substances Vol. 13 (Ministry of the Environment, 2015)).
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Reliable chronic toxicity data were not obtained. It was classified as "Not classified" because it is not water-insoluble (water solubility = 1,000 g/L (WATERNT)), and it was classified as "Not classified" in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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.

To GHS Information