GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 2426-08-6
Chemical Name n-Butyl 2,3-epoxypropyl ether
Substance ID R03-C-013-MHLW
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)
New/Revised Revised
Classification result in other fiscal year FY2016   FY2006  
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 -
-
-
- - -
2 Flammable gases -
-
-
- - -
3 Aerosols -
-
-
- - -
4 Oxidizing gases -
-
-
- - -
5 Gases under pressure -
-
-
- - -
6 Flammable liquids -
-
-
- - -
7 Flammable solids -
-
-
- - -
8 Self-reactive substances and mixtures -
-
-
- - -
9 Pyrophoric liquids -
-
-
- - -
10 Pyrophoric solids -
-
-
- - -
11 Self-heating substances and mixtures -
-
-
- - -
12 Substances and mixtures which, in contact with water, emit flammable gases -
-
-
- - -
13 Oxidizing liquids -
-
-
- - -
14 Oxidizing solids -
-
-
- - -
15 Organic peroxides -
-
-
- - -
16 Corrosive to metals -
-
-
- - -
17 Desensitized explosives -
-
-
- - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word 		Hazard statement
(code) 		Precautionary statement
(code) 		Rationale for the classification
1 Acute toxicity (Oral) -
-
-
- - -
1 Acute toxicity (Dermal) -
-
-
- - -
1 Acute toxicity (Inhalation: Gases) -
-
-
- - -
1 Acute toxicity (Inhalation: Vapours) -
-
-
- - -
1 Acute toxicity (Inhalation: Dusts and mists) -
-
-
- - -
2 Skin corrosion/irritation -
-
-
- - -
3 Serious eye damage/eye irritation -
-
-
- - -
4 Respiratory sensitization -
-
-
- - -
4 Skin sensitization -
-
-
- - -
5 Germ cell mutagenicity -
-
-
- - -
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501 		[Rationale for the Classification]
Based on (1), clear evidence of carcinogenicity of malignant tumors was observed even though it was in only one species of animals, and based on (4) emphasizing that this substance is a target substance in the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act. Therefore, it was classified in Category 1B. Besides, evidence of carcinogenicity was also observed in (2) and (3).

[Evidence Data]
(1) In a carcinogenicity study with rats exposed by inhalation to this substance for two years (6 hours/day, 5 days/week) (OECD TG451, GLP), increased incidences of tumors of the nasal cavity (adenomas/squamous cell carcinomas) were observed in both males and females. In addition, squamous cell papilloma and esthesioneuroepithelioma in males, and adenosquamous carcinoma, esthesioneuroepithelioma, and sarcoma of the nasal cavity in females were also observed. The increased incidence of nasal cavity squamous carcinoma was observed in both females and males and it was regarded as clear evidence of carcinogenicity in rats (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2005), IARC 125 (2020)).
(2) In a carcinogenicity study with mice exposed by inhalation for two years (6 hours/day, 5 days/week) (OECD TG451, GLP), an increase in the incidence of nasal cavity hemangioma was observed in both males and females. The incidence of nasal cavity hemangioma in both males and females was regarded as a clear evidence of carcinogenicity in mice (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2005), IARC 125 (2020)).
(3) This substance induced malignant neoplasms in two species of experimental animals. In addition, there was also strong mechanistic evidence that it exhibited key characteristics of carcinogens (enhanced cell proliferation/cell death, genotoxicity (suggestive evidence)) (IARC 125 (2020)).
(4) This substance is a target substance in the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act (guidelines in order to prevent the impairment of worker's health, announcement No. 27 on February 7, 2020).
(5) As for the classification results by domestic and international organizations, the IARC classified this substance in Group 2B (IARC 125 (2020)), the Japan Society For Occupational Health (JSOH) classified it in Group 2B (Recommendation of Occupational Exposure Limits (2016)), the EU classified it in Carc. 2 (EU-CLP Classification Results (Accessed Sep. 2021)), the DFG classified it in Category 3 (List of MAK and BAT values 2020 (Accessed Sep. 2021)).

[Reference Data, etc.]
(6) As for the assessment of carcinogenicity of this substance, no human data were available (IARC 125 (2020)).
7 Reproductive toxicity -
-
-
- - -
8 Specific target organ toxicity - Single exposure -
-
-
- - -
9 Specific target organ toxicity - Repeated exposure -
-
-
- - -
10 Aspiration hazard -
-
-
- - -

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) -
-
-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
-
-
- - -
12 Hazardous to the ozone layer -
-
-
- - -


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