NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	126-33-0
Chemical Name	tetrahydrothiophene-1,1-dioxide; sulpholane
Substance ID	m-nite-126-33-0_v2
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 molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Its autoignition point is 528degC (Chemical Risk Information Platform (CHRIP) (accessed in November 2008)), which is above 70degC.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	The substance is stable in contact with water.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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	- -	-	-	Its rat LD50 values were 2489 mg/kg for male and 2324 mg/kg for female in one study (SIDS (accessed in November 2008)), and they were 2006 mg/kg for male and 2130 mg/kg for female in other study (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council), accessed in November 2008). All these LD50 values fall under the "Not classified" category using the JIS classification criteria (Category 5 in the United Nations classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Its rat LD50 of > 2000 mg/kg and rabbit LD50 values of 12600 mg/kg (SIDS (accessed in November 2008)) and 4897 mg/kg (SIDS (accessed in November 2008)) all fall under the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Its rat LC50 values obtained in inhalation tests: 12 mg/L/4h and 3.6 mg/kg/17.5h (15.75 mg/kg/4h) (SIDS (accessed in November 2008)), fall under the "Not classified" category	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	Rabbit and guinea pig studies found the substance not irritating (SIDS (accessed in November 2008)). Similarly, other rabbit tests found the substance mildly irritating, or according to the EC classification, not irritating as it was graded 2 on a scale of 1 to 10 (IUCLID, 2000). Based on these results, the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	A rabbit test (US Federal Register 29 FR 13009 (1964)) found the substance not irritating (mild conjunctivitis was noted but healed in several hours). A rabbit Draize test found the substance slightly irritating (corneal opacity, and iridial and conjunctival irritation were noted but were healed quickly; all treated animals showed complete recovery 7 days after application) (SIDS (accessed in November 2008)). A different rabbit test found the substance moderately irritating (SIDS (accessed in November 2008)). Overall, since the Draize test found the substance slightly irritating, it was classified into Category 2B.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Not classified	- -	-	-	Since guinea pig maximization tests found the substance not sensitizing (SIDS (accessed in November 2008), IUCLID (2000)), it was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification is not possible due to lack of in vivo mutagenicity test results as well as positive results in in vitro mutagenicity tests using several indices. Regarding in vitro mutagenicity tests, Ames tests and chromosomal aberration tests gave negative results while mouse lymphoma assays gave positive results (SIDS (accessed in November 2008)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a preliminary reproduction toxicity screening test using rats that underwent oral administration, decreased number of estrous cases before mating, decreased birth index, decreased live birth index, and death of neonates were noted at doses that caused body weight loss and decreased amount of food consumption (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council), accessed in November 2008). Thus, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In 27-day inhalation exposure tests using rats, guinea pigs, dogs, or monkeys (dose: 0.495 mg/L, 8 hour/day and 5 days/week), liver and lung inflammation in rats, lung inflammation in guinea pigs, dogs, and monkeys were noted at 0.495 mg/L, which is above Category 2 guidance values (SIDS (accessed in November 2008)). In 90 to 110-day inhalation exposure tests (23 hours/day) using rats, NOAEL was 0.02 mg/L (equivalent to Category 2 guidance values) and LOAEL was not obtained. In 85 to 110 day inhalation exposure tests (23 hours/day) using guinea pigs, NOAEL was 0.159 mg/L, which is above Category 2 guidance values, and fatty vacuolization in the liver was detected at 0.2 mg/L (given that the saturated vapour pressure concentration is 0.04 mg/L, the study was presumably carried out in a mist state) (SIDS (accessed in November 2008)). In 90 to 110-day inhalation exposure tests (23 hours/day) using dogs, NOAEL was 0.02 mg/L and chronic pulmonary inflammation was detected at 0.2 mg/L. In 90 to 110-day inhalation exposure tests (23 hours/day) using monkeys, NOAEL was 0.02 mg/L and chronic pleuritis was found at 0.2 mg/L (SIDS (accessed in November 2008)). Since all NOAELs obtained in different animal tests are above Category 2 guidance values, the substance presumably has no effects at doses that are within the range of guidance values. These results indicate that the substance falls under the "Not classified" category (inhalation); however, since its effects through other administration routes are unclear, the substance was classified into the "Classification not possible" category. As additional background information, in a 28-day oral exposure test using rats that received 60, 200, or 700 mg/kg (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council), accessed in November 2008), increased hyaline droplets and acidophilic bodies in the proximal renal tubular epithelium were found in male rats at 200 mg/kg (the 90-day conversion value falls under Category 2 guidance values). However, these changes were considered to be specific to male rats, so we did not evaluate this study.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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)	Not classified	- -	-	-	It was classified as "Not classified" from 72-hour ErC50 > 1000 mg/L for algae (Raphidocelis subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998)), 48-hour EC50 = 850 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998)), and 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998), SIAR, 2004).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (a degradation rate by BOD: 10.1% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1975)), 72-hour NOErC= 310 mg/L for algae (Raphidocelis subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998)), and 21-day NOEC = 25 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998), SIAR, 2004). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (fish), then it is classified as "Not classified" due to being not rapidly degradable and 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1998), SIAR, 2004). From the above results, it was classified as "Not classified."	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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