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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	2425-79-8
Chemical Name	1,4-Butanediol diglycidyl ether
Substance ID	24A6129
Classification year (FY)	FY2012
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)	Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point of 110 deg C [closed-cup] (MSDS (Sigma-Aldrich, 2012)) is above 93 deg C.
7	Flammable solids	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (epoxides) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	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).
13	Oxidizing liquids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	It was classified in Category 4 based on an LD50 value of 1,120-1,880 mg/kg for rats (PATTY (6th, 2012)).
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification or "Not classified") based on an LD50 value of > 2,150 mg/kg for rats (PATTY (6th, 2012)).
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.
2	Skin corrosion/irritation	Not classified	- -	-	-	It was classified as "Not classified" because it was not an irritant in a test by a 4-hour semi-occlusive application to the rabbit skin (OECD TG404) (PATTY (6th, 2012)). Besides, it is also reported that it was a moderate to severe irritant in another test with rabbits by a 24-hour occlusive application (PATTY (6th, 2012)), but the data of the test according to the OECD guideline were adopted. And it was classified in Xi: R38 in EU classification (EC-JRC (ESIS) (Access on Oct. 2012)).
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It was classified in Category 2A because it was a severe irritant in an eye irritation test with rabbits (PATTY (6th, 2012)). Besides, there are List 3 data that it was moderately irritating after an application of 100 mg to the rabbit eye (RTECS (2006): the original article, Archives of Industrial Health: 20, 390, 1959). And it was classified in Xi: R36 in EU classification (EC-JRC (ESIS) (Access on Oct. 2012)).
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	It was classified in Category 1 because it is described that it was sensitizing in multiple sensitization tests, including a maximization test, with guinea pigs (PATTY (6th, 2012), HSDB (2012)), and it was listed as a contact allergen in Contact Dermatitis (Frosch) (5th, 2011) (corresponding to List 1). Besides, this substance has been shown to cause skin sensitization in exposed workers (PATTY (6th, 2012)). It was classified in Xi: R43 by the EU (EC-JRC (ESIS) (Access on Oct. 2012)).
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a micronucleus test with peripheral erythrocytes after oral administration to mice (in vivo somatic cell mutagenicity test) (PATTY (6th, 2012)). Furthermore, as for in vivo tests, it was reported to be negative in a sister chromatid exchange test with bone marrow cells after oral administration to Chinese hamsters (in vivo somatic cell genotoxicity test). On the other hand, as for in vitro tests, positive results were reported in all of an Ames test (NTP DB (1982)), a mouse lymphoma test (PATTY (6th, 2012)), and a chromosomal aberration test with Chinese hamster lung fibroblasts (PATTY (6th, 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	Data are lacking. Besides, it is reported that a significant increase in the incidence of skin and systemic tumors was not observed in a carcinogenicity test by 2-year dermal administration to mice (dose concentrations: 0.05 and 0.2%) (PATTY (6th, 2012)).
7	Reproductive toxicity	Classification not possible	- -	-	-	No data available.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 28-day repeated oral administration test with rats (doses: 25, 100, 200, 400 mg/kg/day), lower body weights, changes in blood and blood biochemistry parameters, and higher liver weights were shown at 400 mg/kg/day (converted guidance value: 124 mg/kg/day), and at the doses lower than that, hyperplasia of the stratified squamous epithelium in the forestomach was observed as a lesion in the stomach. It is described that the finding in the stomach was considered to be a local effect by the irritation of the test substance and not applicable to humans because there are differences in the stomach epithelium between rodents and humans (PATTY (6th, 2012)). No toxicity effects to be the rationale for classification were found in the 28-day oral administration test with rats, and there are no data in the other exposure routes (inhalation, dermal). Therefore, it was classified as "Classification not possible" due to lack of data.
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 13 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, 2006)).
11	Hazardous to the aquatic environment (Long-term)	Category 3	- -	H412	P273 P501	If chronic toxicity data are used, then it is classified as "Not classified" due to 72-hour NOEC = 29 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2006)), although it is not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)). 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 due to being not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 2002)), and 96-hour LC50 = 13 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, 2006)). By drawing a comparison between the above results, it was classified in Category 3.
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.

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