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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	101-90-6
Chemical Name	1,3-Bis[(2,3-epoxypropyl)oxy]benzene
Substance ID	R01-B-097
Classification year (FY)	FY2019
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
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)." Besides, this substance has a melting point of 32-33 deg C (HSDB (Access on October 2019)). From information on a flash point of 113 deg C (closed cup) (ICSC (2005)), even if it becomes liquid at high temperatures, it would be classified as "Not classified."
7	Flammable solids	*	- -	-	-	There is information that it is combustible (GESTIS (Access on Sep. 2019)), but the classification is not possible due to no data.
8	Self-reactive substances and mixtures	*	- -	-	-	There are chemical groups associated with self-reactive properties (epoxides) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	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	*	- -	-	-	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 (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	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	*	- -	-	-	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)	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 2,570 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), DFGOT vol.7 (1996)), 2.57 g/kg (2,570 mg/kg) (PATTY (6th, 2012), HSDB (Access on October 2019)) (2) LD50 for rats: 2,200-3,000 mg/kg (NTP TR257 (1986))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Since the exposure time in (1) was unknown and the purity was low (purity 60%), it was used as reference data. [Reference Data, etc.] (1) LD50 for rabbits: 0.64 mL/kg (774.4 mg/kg) (PATTY (6th, 2012))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	[Rationale for the Classification] Based on (1)-(5), it was classified in Category 2. [Evidence Data] (1) In a skin irritation test (Draize method) with rabbits, the skin irritation score was 5 (maximum 8), indicating moderate irritation (PATTY (6th, 2012)). (2) This substance is irritating to the skin and mucous membranes (DFGOT vol.7 (1996)). (3) Contact with this substance causes severe skin irritation in humans (DFGOT vol.7 (1996)). (4) This substance is moderately to highly irritating to the skin (HSDB (Access on October 2019)). (5) This substance is highly irritating to the skin and mucous membranes (GESTIS (Access on October 2019)). [Reference Data, etc.] (6) It was classified in "Skin Irrit. 2 (H315)" in the EU-CLP classification (EU CLP classification (Access on October 2019)).
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2. [Evidence Data] (1) This substance is irritating to the skin and mucous membranes (DFGOT vol.7 (1996)). (2) In an eye irritation test (Draize method) with rabbits, the irritation score was 45 (maximum 110), indicating severe irritation (PATTY (6th, 2012), REACH registration dossier (Access on November 2019)). [Reference Data, etc.] (3) It was classified in "Eye Irrit. 2 (H319)" in the EU-CLP classification (EU CLP classification (Access on October 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1)-(3), it was classified in Category 1A. [Evidence Data] (1) In a mouse local lymph node assay (LLNA) according to OECD TG 429, it was judged as positive, and the value of EC3 was estimated to be less than 2% (REACH registration dossier (Access on November 2019)). (2) In humans, contact with this substance causes severe skin irritation and some sensitization (DFGOT vol.7 (1996)). (3) This substance is sensitizing to the skin (GESTIS (Access on October 2019)). [Reference Data, etc.] (4) It was classified as "Skin Sens. 1B (H317)" in the EU-CLP classification (EU CLP classification (Access on October 2019)).
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), according to the weight of evidence, it was classified in Category 2. [Evidence Data] (1) As for in vivo, negative and positive results were reported in micronucleus tests with mice, but it was judged as positive overall based on the weight of evidence (DFGOT vol.7 (1996), IARC 71 (1999), PATTY (6th, 2012), NTP DB (Access on October 2019)). (2) As for in vitro, there were positive reports in bacterial reverse mutation tests, and a chromosome aberration test and a mouse lymphoma test with cultured mammalian cells, and a negative report in an unscheduled DNA synthesis test with cultured mammalian cells (DFGOT vol.7 (1996), IARC 71 (1999), PATTY (6th, 2012), NTP DB (Access on October 2019)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on classification results by other organizations in (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in 2B by IARC (IARC 71 (1999)), in 2B by Japan Society For Occupational Health (JSOH) (Recommendation of Occupational Exposure Limits (proposed in 1991)), as R by NTP (NTP RoC (14th, 2016)), in Carc.2 in EU CLP (EU CLP classification (Access on October 2019)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] There are no reports on single exposure to this substance in humans. Based on (1) and (2), since in the case of inhalation exposure, it was considered to show respiratory tract irritation, it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) It was described that the mist of this substance may be irritating to the eyes and respiratory tract (HSDB (Access on October 2019)). (2) There was a description that this substance showed strong irritation to the skin and eyes of rabbits (DFGOT vol.7 (1996)). [Reference Data, etc.] (3) In a single oral administration test with rats, dyspnea and central nervous system depression were observed. There is no description of the minimum dose where effects were observed. However, if they were observed at around 2,570 mg/kg, the LD50 value, this would correspond to exceeding the range of Category 2 (DFGOT vol.7 (1996)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), as a result of testing in the oral route in experimental animals, only lesions of the forestomach considered to be due to irritation were observed within the range for Category 1 and Category 2. Therefore, it was judged as "Not classified." As for other routes, classification was not possible due to lack of data. [Evidence Data] (1) In a 13-week repeated-dose toxicity test with rats dosed by gavage, lesions of the forestomach were observed. Also a reduced body weight gain was observed in males at or above 100 mg/kg/day (converted guidance value: 72 mg/kg/day, within the range of Category 2), and at 200 mg/kg/day (converted guidance value: 144 mg/kg/day, exceeding the range of Category 2), death (1/10 animals) and minimal to mild centrilobular fatty metamorphosis (only control and high-dose groups were tested) were observed in males, and a reduced body weight gain was observed in females (NTP TR257 (1986), DFGOT vol.7 (1996)). (2) In a 13-week repeated-dose toxicity test with mice dosed by gavage, lesions of the forestomach were observed. Deaths (male: 9/10, female: 7/10), focal necrosis and fatty metamorphosis in the liver (only control and high-dose groups were tested) were also observed in males and females at 400 mg/kg/day (converted guidance value: 289 mg/kg/day, exceeding the range of Category 2) (NTP TR257 (1986), DFGOT vol.7 (1996)).
10	Aspiration hazard	*	- -	-	-	[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)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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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