NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	110-16-7
Chemical Name	maleic acid
Substance ID	m-nite-110-16-7_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 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 a chemical group associated with self-reactive properties. However, since there is no other data available, classification is not possible.	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	- -	-	-	No data 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	- -	-	-	Test methods applicable to solid substances are not 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)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Since its LD50 = 708 mg/kg for rats (PATTY (5th, 2001)), the substance was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Since its LD50 = 1560 mg/kg for rabbits (PATTY (5th, 2001)), the substance was classified into Category 4.	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	- -	-	-	The solely available datum is that rat LC50 > 0.72 g/m3/1h (converted value: 0.18 mg/L/4h) (PATTY (5th, 2001)). Thus, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Based on descriptions that mild irritation to skin was shown in a rabbit test (PATTY (5th, 2001)), moderate irritation was shown in a 24-hour application test using guinea pigs (PATTY (5th, 2001)), and marked irritation was shown in humans (PATTY (5th, 2001)), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	Based on the description that application of 1% or 5% solution of the substance to the eyes of rabbits for two minutes, was assessed to cause moderate to severe irritation (PATTY (5th, 2001)), and the solution caused severe irritation in humans (PATTY (5th, 2001)), the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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), since the EC3 was estimated to be 2% or less, it was classified in Category 1A. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in a Local Lymph Node Assay (LLNA) (OECD TG 429, GLP) with mice (n=5), the stimulation index (SI values) were 11.2 (1%), 22.0 (2.5%), and 31.5 (5%) (REACH registration dossier (Accessed Nov. 2021)). [Reference Data, etc.] (2) It was reported that, in a maximization test (OECD TG 406, GLP, intradermal injection: 1% solution) with guinea pigs (n=10), the positive rate was 100% (10/10 animals) at both 24 hours and 48 hours after the first challenge exposure with a 25% solution. Since positive reactions were also observed in all control group animals, they were judged to be irritative reactions, and a rechallenge exposure was performed with a 1% solution. It was reported that the positive rate was 30% (3/10 animals) at both 24 hours and 48 hours after the rechallenge exposure (REACH registration dossier (Accessed Nov. 2021)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Since there is no in vivo test data available, classification is not possible. As relevant information, as for in vitro tests, most Ames tests resulted negative (NTP DB (accessed August 2008), IUCLID (2000)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	In a test in which rats were fed a diet containing the substance for two years, no tumorigenesis was reported (PATTY (5th, 2001)). However, classification is not possible based only on this result.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Classification not possible	- -	-	-	From the results of a two-generation reproductive toxicity test in which maleic anhydride was orally administered to rats and a test using pregnant rats, reproductive toxicity and the developmental toxicity of maleic acid were estimated to be negative (SIDS (J) (accessed October 2008)). However, in these tests, the subjective substance (maleic acid) itself was not used, and details of tests were not described. Thus, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 1 (kidney)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	Immediately after oral administration of 200 or 400 mg/kg to rats (males), damage to the kidneys (damage and necrosis of the proximal tubules) occurred, and it advanced to extensive necrosis within 24 hours (PATTY (5th, 2001)). Also in a case in which 9 mg/kg or more was orally administered to dogs, necrosis of the proximal tubules was observed (HSDB (2003)). Since rats and dogs showed renal toxicity at doses equivalent to guidance values of Category 1, the substance was classified into Category 1 (kidney).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a feeding administration test using rats, no effects were detected, except for the case of 28-day exposure, which was associated with decreased weight gain in the high-dose group (162.5 mg/kg/day; conversion, 50.5 mg/kg) and changes in weights of the adrenal glands in all dose groups (PATTY (5th, 2001)). In addition, in the case of two-year exposure, retardation of the growth rate in the moderate-dose group and high-dose group, and increase of mortality rate in all dose groups were observed, but its oncogenicity and toxicological effects were not different from the control group, and specific pathological findings are not reported (PATTY (5th, 2001)). Although it is described that exposure of maleic anhydride at 100 mg/kg/day or more to rats for 90 days caused damage to the kidneys and that some effects were induced by the maleic acid that was produced because maleic anhydride was hydrolyzed in the body (SIDS (J) (accessed October 2008)), these effects were not observed in the repeated exposure tests for 28 days and for two years, in which the subjective substance (maleic acid) itself was used, and the findings were not adopted for classification. However, taking into account the results from single exposure, the dose that causes toxicity is doubtful. For classification, data indicating differences in exposure methods (gavage and diet feeding) also need to be clarified. Thus, classification is not possible at present.	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 3	- -	H402	P273 P501	Since its 96h-LC50 = 75 mg/L for fish (trout, bluegill) (SIDS, 2004), the substance was classified into Category 3.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Although its preexisting classification for acute toxicity is Category 3, it is rapidly degradable (BOD degradability for 28 days = 87% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1994)) and it is estimated to have low potential for bioconcentration (LogPow = -2.61 (SIDS, 2004)), thus the substance was classified into "Not classified".	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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