NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	2426-08-6
Chemical Name	n-Butyl 2,3-epoxypropyl ether
Substance ID	m-nite-2426-08-6_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 molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (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)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Based on a flash point of 54 deg C (closed cup) (ICSC(J) (2005)), it was classified in Category 3.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (strained ring (epoxides)) present in the molecule, but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	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 liquid 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)	- -	-	-	It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is not chemically bonded to elements other than carbon or hydrogen.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	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	- -	-	-	No data 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	- -	-	-	Based on the LD50 values of 2,050 mg/kg (HSDB (Access on May 2016)) and 2,260 mg/kg (ACGIH (7th, 2001, 2014), PATTY (6th, 2012), NTP (2004), HSDB (Access on May 2016)) for rats, this substance was classified as "Not classified" (Category 5 of UN GHS classification). 　Along with the revision of the GHS classification guidance for the Japanese Government, the classification was changed.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	There are reports of LD50 values for rabbits of 788 mg/kg (NTP (2004), PATTY (6th, 2012), HSDB (Access on May 2016)) and 4,930 mg/kg (ACGIH (7th, 2001, 2014), NTP (2004), PATTY (6th, 2012)). 　One case is equivalent to Category 3, and one case is equivalent to "Not classified." The category with higher hazard was adopted, and this substance was classified in Category 3.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	Based on reports of LC50 values of 670 ppm (8 hours) (converted 4-hour equivalent value: 948 ppm) (ACGIH (7th, 2001, 2014)) and 1,030 ppm (8 hours) (converted 4-hour equivalent value: 1,457 ppm) (NTP (2004), PATTY (6th, 2012)) for rats, this substance was classified in Category 3. 　Note that it was judged that the mist was not present since these values are lower than 90% of the saturated vapor pressure concentration (4,245 ppm), so the reference value of the gas was applied.	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	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	As for effects on humans, since it is described that it is irritating to the skin (ACGIH (7th, 2001), DFGOT vol.4 (1992), PATTY (6th, 2001)), this substance was classified in Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	As for effects on humans, since it is described that it is irritating to the eyes (ACGIH (7th, 2001), DFGOT vol.4 (1992), PATTY (6th, 2001, 2012)), this substance was classified in Category 2B.	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	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	There are descriptions that sensitization was observed in two skin sensitization tests for humans (DFGOT vol. 4 (1992)) and that skin sensitization has been reported in humans (PATTY (6th, 2012)). In addition, because there are many reports that skin sensitization has been recognized for humans and animals, this substance is classified as Dermal Sensitizer (DSEN) in ACGIH (7th, 2014). 　Therefore, this substance was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo, positive and negative findings are reported in micronucleus tests using mice, and a chromosomal aberration test using rat bone marrow cells is positive (ACGIH (7th, 2014), PATTY (6th, 2012), Health Canada and Environment Canada (2010), NTP (2004)). As for in vitro, a bacterial reverse mutation test and a mouse lymphoma assay in mammalian cells are positive (ACGIH (7th, 2014), PATTY (6th, 2012), NTP (2004), Health Canada and Environment Canada (2010), NTP DB (Access on June 2016)). From the above, this substance was classified in Category 2 based on the GHS classification guidance for the Japanese Government. 　Additionally, there are several reports of dominant lethal assays using mice in vivo (Environment Canada/Health Canada (2010), ACGIH (7th, 2014), NTP (2004)). However, the reproducibility of the data is poor, there are problems and contradictions in the test conditions etc., and highly reliable evaluation results have not been obtained.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	It is described that in a 10-week inhalation study using male rats, atrophy of the testes was observed at 400 mg/m3 (75 ppm) or above (NTP Review of Toxicological Literature (2004), Environment Canada/Health Canada (2010), ACGIH (7th, 2014), OEL Documentations (2016)). 　It is described that in a study in which untreated female mice were mated with male mice dermally exposed to 1500 mg/kg 3 times/week for 3 weeks, decreases in pregnancy rates and in the number of implants and an increase in fetal death rates were observed (Screening Assessment for the Challenge (Environment Canada/Health Canada (2010), ACGIH (7th, 2014), OEL Documentations (2016)). Moreover, it is described that in a study involving pregnant rats dosed by gavage during gestation days 0-19 at doses of up to 250 mg/kg/day, fetal hypoplasia and reductions in fetal number and in the implantation rate were observed (OEL Documentations (2016)), and the Japan Society For Occupational Health classifies this substance as Group 3 in Reproductive Toxicants based on the limited evidence in experimental animals (OEL Documentations (2016)). Therefore, this substance was classified in Category 2 for this hazard class.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	It is reported that inhalation of this substance was found to be irritating to the respiratory tract in humans (DFGOT vol. 4 (1992)). Therefore, this substance was classified in Category 3 (respiratory tract irritation).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs), Category 2 (reproductive organs (male))	Danger Warning	H372 H373	P260 P264 P270 P314 P501	There is no information on humans. 　As for experimental animals, it is reported that in a 28-day repeated inhalation toxicity study using rats, degeneration of the nasal mucosa and hyperplastic-metaplastic lesions in the ciliated epithelium of the respiratory tract were observed at 92.5 ppm (converted guidance value: 0.15 mg/L), which is within the range of Category 1 (DFGOT vol.4 (1992), PATTY (6th, 2012)). 　In addition, it is reported that in a 10-week repeated inhalation toxicity study using rats, atrophy of the testes (slight patchy atrophy) was observed at 75 ppm (converted guidance value: 0.25 mg/L), which is within the range of Category 2 (DFGOT vol.4 (1992), PATTY (6th, 2012), ACGIH (7th, 2014)). 　Therefore, this substance was classified in Category 1 (respiratory organs) and Category 2 (genetic organs (men)).	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 48-hour EC50 = 2 mg/L for crustacea (Acartia tonsa) (AQUIRE, 2016), 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. Due to not rapidly degradable (a degradation rate by BOD: 40% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1986)), and acute toxicity Category 2, 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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