GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 1120-71-4
Chemical Name 1,2-Oxathiolane 2,2-dioxide; 1,3-Propane sultone
Substance ID R02-B-085-MHLW, MOE
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006   FY2010  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. It was classified as "Not classified."
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
7 Flammable solids Classification not possible
-
-
- - No data available. Besides, there is information that it is combustible (GESTIS (Access on May 2020)).
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. It was classified as "Not classified."
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
10 Pyrophoric solids Classification not possible
-
-
- - No data available.
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available.
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). It was classified as "Not classified."
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
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). However, the classification is not possible due to no data.
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16 Corrosive to metals Classification not possible
-
-
- - It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
17 Desensitized explosives Not classified (Not applicable)
-
-
- - 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) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
[Rationale for the Classification]
It was classified in Category 3 from (1) - (5).

[Evidence Data]
(1) LD50 for rats: 100-157 mg/kg (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2010))
(2) LD50 for rats: 100-200 mg/kg (AICIS (formerly, NICNAS) IMAP (2015))
(3) LD50 for rats: 157 mg/kg (MAK (DFG) vol.4 (1992))
(4) LD50 for rats: 350 mg/kg (MAK (DFG) vol.4 (1992))
(5) LD50 for rats: 100 mg/kg (GESTIS (Access on May 2020))
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
[Rationale for the Classification]
It was classified in Category 3 from (1).

[Evidence Data]
(1) LD50 for rabbits: 660 mg/kg (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2010), MAK (DFG) vol.4 (1992), AICIS (formerly, NICNAS) IMAP (2015))
1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified."
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) Category 4


Warning
H332 P304+P340
P261
P271
P312
[Rationale for the Classification]
From (1), because LC50 (4 hours) was between 1.95-3.21 mg/L, it was classified in Category 4.
Besides, the classification result was changed from the previous classification by using new information sources.
Because the exposure concentration (2.14 mg/L) where all the animals died was higher than the saturated vapor pressure concentration (1.8 mg/L), a reference value in the unit of mg/L was applied as dust.

[Evidence Data]
(1) LC50 for rats (6 hours): between 1.3-2.14 mg/L (no death at 1.3 mg/L, death of all the animals at 2.14 mg/L) (converted 4-hour equivalent value: 1.95-3.21 mg/L) (AICIS (formerly, NICNAS) IMAP (2015))
(2) Vapor pressure of this substance: 0.27 mmHg (25 deg C) (NTP RoC (14th, 2016)) (converted value for the saturated vapor pressure concentration: 1.8 mg/L)
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
[Rationale for the Classification]
It was classified in Category 2 from (1), (2). The classification result was changed because new data (1), (2) were obtained.

[Evidence Data]
(1) This substance was reported to be irritating to the skin in both humans and animals (MAK (DFG) vol.4 (1992)).
(2) In an in-vitro skin corrosion test according to OECD TG 431 (in vitro membrane barrier test), it was judged as not corrosive (REACH registration dossier (Access on August 2020)).

[Reference Data, etc.]
(3) This substance was reported to be slightly irritating in a skin irritation test with rabbits (Draize test) (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2010)).
(4) In an experiment in which this substance (0.1-20 mL or 10 drops) was applied to the skin of guinea pigs, moderate edema and necrosis over the entire patch and erythema (score = 3) at the perimeter of the patch were observed, and alopecia and scarring were seen two weeks later. In an experiment by open application of this substance (10 drops), erythema (score = 2-3) and edema were found at 24 and 48 hours post application, but the effects were minimal after one to two weeks (AICIS (formerly, NICNAS) IMAP (2015), REACH registration dossier (Access on August 2020)).
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
[Rationale for the Classification]
It was classified in Category 2A from (1). The classification result was changed due to new data obtained.

[Evidence Data]
(1) In an eye irritation test in which this substance (one drop) was applied to the rabbit eye, conjunctivitis and corneal opacity were observed at 24-72 hours after application, and edema reversed, but conjunctival erythema and corneal opacity were not reversed at 14 days after application (AICIS (formerly, NICNAS) IMAP (2015), REACH registration dossier (Access on August 2020)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2). The classification result was changed because new data in (1), (2) were obtained.

[Evidence Data]
(1) In a guinea pig skin sensitization test equivalent to OECD TG 406 (Buehler test, application concentration 1%), no skin reactions were observed, and it was judged as negative for skin sensitization (AICIS (formerly, NICNAS) IMAP (2015)).
(2) In a guinea pig skin sensitization test equivalent to OECD TG 406 (maximization test, intradermal administration 1%), no skin reactions were observed, and it was judged as negative for skin sensitization (REACH registration dossier (Access on August 2020)).

[Reference Data, etc.]
(3) Contact dermatitis was seen in occupational exposure to this substance, and skin sensitization was also possible for the substance (MAK (DFG) vol.4 (1992)).
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
It was classified in Category 2 from (1), (2).

[Evidence Data]
(1) As for in vivo, it was reported to be positive in micronucleus tests with peripheral blood after intraperitoneal or oral administration to mice (IARC 110 (2017), OEL Documentations (Carcinogenicity classification) (Japan Society For Occupational Health (JSOH), 2017), AICIS (formerly, NICNAS) IMAP (2015)). And it is reported that it induced DNA strand breaks in brain cells after intravenous administration to rats (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2010), AICIS (formerly, NICNAS) IMAP (2015)).
(2) As for in vitro, it was reported to be positive in a bacterial reverse mutation test, and a chromosomal aberration test and a sister chromatid exchange test using cultured mammalian cells in the absence of metabolic activation (IARC 110 (2017), OEL Documentations (Carcinogenicity classification) (Japan Society For Occupational Health (JSOH), 2017), AICIS (formerly, NICNAS) IMAP (2015), Risk Assessment Report (Ministry of Health, Labour and Welfare, 2010), MAK (DFG) vol.4 (1992)).
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Among classification results by other organizations in (1), the latest classification by IARC and the Japan Society for Occupational Health (JSOH) was Group 2A based on information in (2) - (4). Therefore, it was classified in Category 1B.

[Evidence Data]
(1) As for classification results by domestic and international organizations, Group 2A by IARC (IARC 110 (2017)), Group 2A by the Japan Society for Occupational Health (JSOH) (OEL Documentations (Carcinogenicity classification) (Japan Society For Occupational Health (JSOH), 2017)), A3 by ACGIH (ACGIH (7th, 2001)), R by NTP (NTP RoC (14th, 2016)), Carc.1B in EU CLP classification (EU CLP classification (Access on May 2020)), and 1 in MAK (DFG) (DFG List of MAK and BAT Values (2019)).
(2) As information in humans, it is reported that 55 male workers who had been exposed in a German chemical plant where this substance was manufactured in the 1950s to 1970s were investigated, and 24 tumors in total in 20 persons were observed by 2010. It is described in this report that among tumors found, 2 cases of glioblastoma and 1 case of malignant schwannoma (peripheral nerve sheath tumor) in the nervous system organs and 1 case of duodenum carcinoma were rarely occurring tumors in humans, and because similar tumors were induced in animal tests, associations with exposure were especially suspected. However, exposure concentrations, confounding factors, etc. were not assessed (OEL Documentations (Carcinogenicity classification) (Japan Society For Occupational Health (JSOH), 2017)).
(3) As for carcinogenicity in animal tests, in tests by skin application to three strains of mice, there were reports on the formation of skin tumors (including malignant ones) after single-dose skin application, and skin tumors (including malignant ones), lymphoreticular tumors, lung tumors, and tumors in the uterus or mammary gland after 56-week application. There was a report on the formation of fibrosarcoma and epithelial tumors at the administration site in a test by 63-week subcutaneous administration to mice, and there was a report on the formation of malignant brain glioma, adenocarcinoma of the mammary gland, leukemia, squamous cell carcinoma of the auditory tubes, and adenocarcinoma of the small intestine in a test by 61-week or 32-week gavage administration to rats (OEL Documentations (Carcinogenicity classification) (Japan Society For Occupational Health (JSOH), 2017), IARC 110 (2017)).
(4) As for genotoxicity of this substance, it was positive in various in-vitro tests, including ones using human cells, and in-vivo tests, and it is reported that this substance directly reacted with DNA and proteins (OEL Documentations (Carcinogenicity classification) (Japan Society For Occupational Health (JSOH), 2017), IARC 110 (2017)).
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.
8 Specific target organ toxicity - Single exposure Category 1 (systemic)


Danger
H370 P308+P311
P260
P264
P270
P321
P405
P501
[Rationale for the Classification]
There was no report on acute exposure to this substance in humans. In experimental animals, based on (1) and (2), the minimum dose at which effects were observed was not described, and it was assumed that effects were observed at least around the LD50 values (oral: 100 to 157 mg/kg, dermal: 157 mg/kg, within the range for Category 1). Therefore, it was classified in Category 1 (systemic toxicity). A new information source was used and the classification results were changed from the previous classification.

[Evidence Data]
(1) Acute intoxication of experimental animals by this substance was characterized by early apathy, progressive dyspnea, bloody diarrhea, tremor and spasms. Depending on the dose, death occurred between 6 hours and several days after treatment with this substance. It was reported that a pathological examination revealed hemorrhagic pulmonary edema, severe intestinal bleeding and cerebral edema. In addition, it was reported that this substance was highly cytotoxic and could cause necrosis (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2010), MAK (DFG) vol.4 (1992)).
(2) In an acute oral toxicity test of this substance with rats, the LD50 values (oral: 100 to 157 mg/kg, dermal: 157 mg/kg) were reported although there was no description of the minimal dose at which effects were observed (Risk Assessment Report (Ministry of Health, Labour and Welfare, 2010)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Classification was not possible due to lack of data.
10 Aspiration hazard Classification not possible
-
-
- - [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) Category 3
-
-
H402 P273
P501
It was classified in Category 3 from 48-hour EC50 = 16 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2020). The classification result was changed from the previous classification by using new information.
11 Hazardous to the aquatic environment Long term (Chronic) Category 3
-
-
H412 P273
P501
If chronic toxicity data are used, then it is classified as "Not classified" because it was rapidly degradable (a 4-week degradation rate by BOD: 95% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2002)) and due to 72-hour EC10 > 320 mg/L for algae (Desmodesmus subspicatus) (REACH registration dossier, 2020).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 because sufficient data on bioaccumulation were not obtained and due to 48-hour EC50 = 16 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2020), although it was rapidly degradable (a 4-week degradation rate by BOD: 95% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2002)).
By drawing a comparison between the above results, it was classified in Category 3. The classification result was changed from the previous classification by using new information.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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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