NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	1675-54-3
Chemical Name	bis-[4-(2,3-epoxipropoxi)phenyl]propane
Substance ID	m-nite-1675-54-3_v1
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 molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	The molecule contains chemical groups (epoxide) associated with self-reactive properties. Classification is not possible due to lack of data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140degC) substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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	- -	-	-	Since the rat LD50 = 22736mg/kg (IARC 47 (1999)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rabbit LD50 of > 23200mg/kg (IARC 47 (1999)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	The rabbit tests resulted in that the substance was not irritating (Hazard Assessment Report (CERI, NITE) (2006)). In addition, administration of the substance, 20% solution or undiluted, caused slight or no irritation (DFGOT vol.19 (2003)). Based on these results, the substance was classified into "Not classified". As relevant notes, in primary skin irritation tests following the Draize test procedure with occlusive application of the substance to the skin of rabbits for 24 hours, the substance was moderately irritating (Hazard Assessment Report (CERI, NITE) (2006)). In addition, some commercial products containing the substance may cause irritation.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	The tests, in which the substance was administrated into the eyes of rabbits, resulted in marked irritation (DFGOT vol.19 (2003)). In addition, the substance has been classified into R36 in the EU classification (EU-Annex1 (accessed July 2008)). Thus, the substance was classified into Category 2A.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	Two patients with allergic contact dermatitis and respiratory symptoms such as rhinitis and asthma tested positive by prick tests (DFGOT vol.19 (2003). In addition, cement workers, who repeatedly exhibited contact dermatitis by exposure to this substance, were suspected to have occupational asthma, which turned out to be mild bronchial hyperreactivity. However, there was not sufficient data to support that respiratory allergies were caused by this substance (DFGOT vol.19 (2003)). Since both cases were not concluded to be positive reactions due to the substance, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Two kinds of skin sensitization tests using guinea pigs (maximization test and Buehler test) were conducted and both tests yielded positive results (DFGOT vol.19 (2003)). Furthermore, according to epidemiological studies, many people who were exposed to epoxy resin that contains this substance developed allergic contact dermatitis (CERI / NITE hazard assessment reports (2006), DFGOT vol.19 (2003)). Some of these studies concluded that this substance caused skin sensitization (CERI / NITE hazard assessment reports (2006)). In addition to these positive results documented, the substance has been categorized into R43 in the EU classification, and Sh in the DFG classification, both of which indicate it is skin sensitizing. Thus, the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	The substance was classified into "Not classified" based on negative results obtained from the following tests: dominant lethal tests (heritable mutagenicity tests) using mice that underwent oral or dermal administration, chromosomal aberration tests using testicular germinal epithelium from mice that underwent oral administration (in vivo mutagenicity tests using somatic cells), micronucleus tests using the bone marrow cells from mice or Chinese hamsters that underwent oral administration, and chromosomal aberration tests using the bone marrow cells of Chinese hamsters that underwent oral administration (in vivo mutagenicity tests using somatic cells) (DFGOT vol.19 (2003)). Based on these results, the substance was classified into "Not classified". Among in vitro tests, positive results have been documented from reverse mutation tests using bacteria, mutation tests using mouse lymphoma cells, and chromosomal aberration tests (DFGOT vol.19 (2003)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Not classified	- -	-	-	Since the substance has been classified by the IARC into Group 3 (IARC (vol.47 1999)), it was classified into "Not classified". Although several tests have been conducted in which rats or mice underwent dermal route exposure for 2 years, there was no difference in the frequencies of tumorigenesis between treated and control groups (DFGOT vol.19 (2003), IARC 47 (1999)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Not classified	- -	-	-	In reproductive tests using rats that underwent oral route exposure for one or two generations, decreased body weight gain of parental animals was indicated, but no effects of the substance were observed on reproductive functions, fertility, the development of offspring, and survival of offspring after birth (DFGOT vol.19 (2003)). Furthermore, in developmental toxicity tests using rats or rabbits that underwent oral route exposure during the organogenetic period, mild toxicity was detected in maternal animals at high administration doses, but no adverse effects on the development of offspring and teratogenicity were observed (DFGOT vol.19 (2003)). Since no adverse effects of the substance on reproductive functions and fertility have been detected in reproductive and developmental toxicity tests, the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the oral administration tests using rats that were applied with the substance at 1000mg/kg/day for 28 days (90-day conversion: 311mg/kg/day) or at 1500mg/kg/day for 90 days, no toxic effects were observed other than reduced body weight (DFGOT vol.19 (2003)). Similarly, the tests in which rats underwent oral administration (diet containing the substance) for 26 weeks did not yield significant toxicological changes, and the NOAEL was determined to be 100mg/kg/day (Hazard Assessment Report (CERI, NITE) (2006)). In addition, in the dermal route exposure tests using mice that were applied with doses up to 1000mg/kg/day for 13 weeks, no changes in skin were observed other than localized effects (Hazard Assessment Report (CERI, NITE) (2006)). In the tests using rats, no toxic effects of the substance were detected other than suppressed amounts of food intake and decreased body weight gain (Hazard Assessment Report (CERI, NITE) (2006)). In the tests in which test animals were dermally exposed to the substance up to 1000mg/kg/day for 103 weeks, there were no significant changes observed compared with control groups other than effects due to skin irritation (Hazard Assessment Report (CERI, NITE) (2006)). From these results, no systemic toxicity was observed at the doses higher than the upper limit of Category 2 guidance values (100-1000mg/kg/day) in all of the oral and dermal administration tests using rats or mice with different exposure periods. Although these results indicated that the substance was to be classified into "Not classified" (oral and dermal routes), in conclusion, the substance was classified into "Classification not possible" due to lack of information on inhalation route exposure.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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	Since its 48-hour EC50 = 1.7mg/L for crustaceans (Daphnia magna) (Initial Risk Assessment Report (NITE, CERI, NEDO), 2008), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Since its classification for acute toxicity is Category 2, and it is not rapidly degradable (non-biodegradable, BOD degradability: 0% (Initial Risk Assessment Report (NITE, CERI, NEDO), 2008)), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.

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