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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	142-16-5
Chemical Name	Bis(2-ethylhexan-1-yl) maleate
Substance ID	R02-A-003-METI, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/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)	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)
Model SDS by MHLW (External link)
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 classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Not classified	- -	-	-	A flash point was 185 deg C (closed-cup) (GESTIS (Accessed June 2020)).
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (ethylenes) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 260 deg C (GESTIS (Accessed June 2020)).
10	Pyrophoric solids	Not classified (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 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).
13	Oxidizing liquids	Not classified (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 classified (Not applicable)	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats (OECD TG410, GLP): > 2,000 mg/kg (REACH registration dossier (Accessed May 2020))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Liquid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" (Category 3 in UN GHS classification) from (1). [Evidence Data] (1) It is reported that in a skin irritation test with rabbits (n = 3) (OECD TG 404, GLP, semi-occlusive, 4-hour application, 13-day observation), erythema and edema completely disappeared within 10 days, and slight irritation was seen (erythema/eschar score: 2/2/2, edema score: 1.3/1.3/1.3) (REACH registration dossier (Accessed May 2020)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 3) (OECD TG 405, GLP, 72-hour observation), all symptoms of corneal opacity, iritis, conjunctival redness, and chemosis completely disappeared within 72 hours (corneal opacity score: 0/0/0.3, iritis score: 0/0/0, conjunctival redness score: 0.7/0.3/0.7, chemosis score: 0.3/0.3/0.3) (REACH registration dossier (Accessed May 2020)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1B from (1), (2). [Evidence Data] (1) It is reported that in a maximization test with guinea pigs (n = 20) (OECD TG 406, GLP, intradermal administration: 3% solution), a positive rate was 100% (20/20) for both 24 hours and 48 hours after challenge (first), and a positive rate was 100% (20/20) for both 24 hours and 48 hours after challenge (second) (REACH registration dossier (Accessed May 2020)). (2) It is reported that in a maximization test with guinea pigs (n = 20) (OECD TG 406, intradermal administration: 10% solution), a positive rate was 50% (10/20) and 10% (2/20) 24 hours and 48 hours after challenge, respectively (REACH registration dossier (Accessed May 2020)). [Reference Data, etc.] (3) It is reported that in a Buehler test with guinea pigs (n = 20) (OECD TG 406, GLP, topical administration: 2.5, 25, 50, 100% solutions), no positive reactions were seen (REACH registration dossier (Accessed May 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on the data of (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a bacterial reverse mutation assay, negative results were reported (REACH registration dossier (Accessed May 2020)). (2) In a mammalian cell gene mutation assay (mouse lymphoma cells), negative results were reported (REACH registration dossier (Accessed May 2020)). (3) In an in vitro chromosome aberration test (CHL cells), negative results were reported (REACH registration dossier (Accessed May 2020)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. In (1), no reproductive toxicity was observed, but no data on developmental toxicity was available. [Evidence Data] (1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG422, GLP, for 29 days (males), 43 to 56 days (females)), no reproductive toxicity was observed at 1,000 mg/kg/day (REACH registration dossier (Accessed May 2020)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified" in the oral route. However, there was not sufficient information available for classification in the other route. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in an acute oral toxicity test (OECD TG401, GLP) with rats, no effects were observed at 2,000 mg/kg (REACH registration dossier (Accessed May 2020)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified" in the oral route. However, there was not sufficient information available for classification in the other route. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG422, GLP) with rats dosed by gavage (for 29 days (males), 43 to 56 days (females)), higher total protein and albumin levels and higher absolute and relative liver weights in males were observed at 300 mg/kg/day (converted guidance value: 96.7 mg/kg/day (males), within the range for Category 2); and higher liver weights and hypertrophy of the hepatocytes in the centrilobular area of the liver, diffuse hyperplasia/hypertrophy of the follicular epithelium in the thyroid glands, and hypertrophy of the adenohypophyseal cells (multifocal) in the pituitary gland were observed at 1000 mg/kg/day (converted guidance value: 322 to 622 mg/kg/day, in the range corresponding to "Not classified") (REACH registration dossier (Accessed May 2020)).
10	Aspiration hazard	Classification not possible	- -	-	-	[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)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 59.5 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Sufficient data on rapid degradability were not obtained. If chronic toxicity data are used, then it is classified in Category 1 from 72-hour NOErC = 0.052 mg/L for algae (Raphidocelis subcapitata) (REACH registration dossier, 2021). 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 from 48-hour EC50 = 59.5 mg/L for crustacea (Daphnia magna) (REACH registration dossier, 2021). By drawing a comparison between the above results, it was classified in Category 1.
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.
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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