NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	108-31-6
Chemical Name	Maleic anhydride
Substance ID	25B0026
Classification year (FY)	FY2013
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 by the Japanese Government (July, 2013)
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	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solid	Classification not possible	- -	-	-	No data available.The classification was revised according to the GHS classification guidance for the Japanese government.
8	Self-reactive substances and mixtures	Type G	- -	-	-	There is a chemical group associated with self-reactive properties (unsaturated bond) in the molecule. However, it is classified in Class 8 (UN2215) in UNRTDG, and it does not correspond to hazards of the highest precedence, self-reactive substances and mixtures.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 477 deg C (ICSC (1997)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available (melting poin 53 deg C (ICSC (1997))).
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	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

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	Among 13 LD50 values for rats, which were targeted [235 mg/kg (females) (DFGOT vol. 4 (1992)), 400 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), DFGOT vol. 4 (1992), CICAD 75 (2009)), 409 mg/kg (males) (DFGOT vol. 4 (1992)), 495 mg/kg, 824 mg/kg, 840 mg/kg, 850 mg/kg, 900 mg/kg (DFGOT vol.4 (1992)), 1.03 g/kg (males), 1.09 g/kg (SIDS (2007)), 1,050 mg/kg (DFGOT vol. 4 (1992)), 1,100 mg/kg (DFGOT vol. 4 (1992)), and about 1 g/kg (ACGIH (7th, 2011), SIDS (2007)) ], one corresponded to Category 3, and 12 corresponded to Category 4. Therefore, it was classified in Category 4 to which most corresponded.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification) based on LD50 = 2,620 mg/kg for rabbits (DFGOT vol. 4 (1992), ACGIH (7th, 2011), CICAD 75 (2009), SIDS (2007)). Besides, the classification was conducted based on the information (ACGIH (7th, 2011), CICAD 75 (2009), SIDS (2007)) obtained in this investigation.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	It is described in DFGOT vol. 4 (1992) that the application of the powder moistened with water caused necrosis in a skin irritation test with rabbits, although it is not a result of a 4-hour application. And it is described in SIDS (2007) that there was severe irritation in a skin irritation test with rabbits by a 4-hour application. Furthermore, this substance is classified in "C; R34" in EU DSD classification and "Skin Corr. 1B H314" in EU CLP classification. SIDS (2007), EU DSD classification, and EU CLP classification were obtained in this investigation and added. The classification was changed to Category 1 because the information on sub-categorization could not be obtained (the information that irritation in a Draize test with rabbits or human findings is mild and disappear within seven days).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	It is described in DFGOT vol. 4 (1992) that severe irritation and sometimes irreversible damage were observed in an eye irritation test with rabbits, and it is described in ACGIH (7th, 2011) that severe and persistent congestion and vascularization of the cornea were found in an eye irritation test with rabbits. And it is described in SIDS (2007) that there was severe irritation in an eye irritation test with rabbits, and it is described in the Initial Risk Assessment Report (NITE, CERI, NEDO, 2008) that in another eye irritation test with rabbits, as a result of an application to the conjunctival sac, corrosion was seen. Furthermore, this substance is corrosive to the skin and is classified in "C; R34" in EU DSD classification and "Skin Corr. 1B H314" in EU CLP classification. It was classified in Category 1 based on the above information.
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	This substance is classified in occupational sensitizers to the airway Group 2 in the Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2012), "Sensitizer (SEN)" in ACGIH (7th, 2011), "Sah" in DFGOT vol. 11 (1998), "R42/43" in EU DSD classification, and "Resp. Sens. 1 H334" in EU CLP classification. Furthermore, the Special Committee of the Japanese Society of Occupational and Environmental Allergy (2004) reported that it was a sensitizer to the respiratory tract, therefore it was classified in Category 1.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	This substance is classified in occupational skin sensitizers Group 2 in the Recommendation of Occupational Exposure Limits (Japan Society For Occupational Health (JSOH), 2012), "Sensitizer (SEN)" in ACGIH (7th, 2011), "Sah" in DFGOT vol. 11 (1998), "R42/43" in EU DSD classification, and "Skin Sens. 1 H317" in EU CLP classification. Furthermore, it is described in Chemical Substance Hazard Data (CERI, 2001) that it was positive in a maximization test with guinea pigs, and the Special Committee of the Japanese Society of Occupational and Environmental Allergy (2004) reported that it was a skin sensitizer, therefore it was classified in Category 1.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. As for in vivo, it was negative in a chromosomal aberration test with rat bone marrow cells (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2007), ACGIH (7th, 2011), DFGOT vol. 4 (1992)). On the other hand, as for in vitro, it was negative in a bacterial reverse mutation test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2007), ACGIH (7th, 2011), DFGOT vol. 4 (1992), NTP DB (Access on July 2013)), but it was positive in a chromosomal aberration test with cultured mammalian cells (SIDS (2007), Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). Besides, the positive result was assessed to be unclear because the details are unknown (SIDS (2007)). The category was changed according to the revised GHS classification guidance for the Japanese government.
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because ACGIH classified it in A4 (ACGIH (7th, 2011)). The category was changed according to the revised GHS classification guidance for the Japanese government.
7	Reproductive toxicity	Not classified	- -	-	-	It was classified as "Not classified" because it is described that in a two-generation reproductive toxicity test with rats by oral administration, no reproductive toxicity in parent animals or developmental effects in offspring were observed at up to the dose where marked toxicity such as death and reduced weight gain occurred in parent animals (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2007), DFGOT vol. 4 (1992)), and it is described that in an oral administration teratogenicity test with rats, no effects were found in fetuses even at the doses where maternal toxicity (reduced weight gain, decreased body weights) occurred (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), SIDS (2007), ACGIH (7th, 2011), DFGOT vol. 4 (1992)).
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory organs, gastrointestinal tract, liver)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	It was classified in Category 1 (respiratory system) because it is described that it is irritating to the nose and throat in humans (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), Environmental Risk Assessment for Chemical Substances vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)), and in serious cases, bronchitis, emphysema (Environmental Risk Assessment for Chemical Substances vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)), and asthma may occur (Environmental Risk Assessment for Chemical Substances vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003), DFGOT vol. 4 (1992)). On the other hand, as for experimental animals, it is described that acute inflammation of the gastrointestinal tract from irritation of the mucosa of the gastrointestinal tract, vomiting of blood, and bloody diarrhea after oral administration to rats or dogs and hemorrhage in the lung and liver after oral administration to rats were observed at the doses (180-256 mg/kg) within the guidance values for Category 1 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008), DFGOT vol. 4 (1992)), therefore it was classified in Category 1 (gastrointestinal tract, liver).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs, haemal system), Category 2 (kidney)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In humans, it is reported that respiratory symptoms (cough, rhinitis, shortness of breath, wheezing) were observed after occupational exposure by inhalation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). And there is a case report on a person who was occupationally exposed by inhalation and developed hemolytic anemia (ACGIH 7th, 2011), and anemia findings were also found in experimental animals (4-week diet administration to rats), although they are findings in one test only (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)), therefore hemolytic anemia in humans was judged to be effects of repeated exposure to this substance. Other than these, in experimental animals, effects on the kidney (enlargement and discoloration of the kidney, diffuse dilatation and degeneration of the renal tubules, etc.) were seen at the dose (100 mg/kg/day), the upper limit of the guidance values for Category 2, in a 90-day oral administration (feeding) test with rats, and effects on the mucosa of the nasal cavity (metaplasia or hyperplasia of the mucosal epithelium, inflammation) were observed at the concentration (converted guidance value concentration: 0.001 mg/L) within the guidance value range for Category 1 in 6-month inhalation exposure tests with rats, hamsters, or monkeys (Initial Risk Assessment Report (NITE, CERI, NEDO, 2008)). From the above, it was classified in Category 1 (respiratory system, blood system), Category 2 (kidney). Besides, information sources in List 2, 3 were mainly used in the previous classification, while the classification was based on information sources in List 1 this time, therefore the classification result was partly changed (Category 2 (liver, spleen) in the previous classification was deleted).
10	Aspiration hazard	Classification not possible	- -	-	-	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 (Acute)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 96-hour LC50 = 75 mg/L for fish (Oncorhynchus mykiss, Lepomis macrochirus) (SIDS, 2007).
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 being not rapidly degradable (a degradation rate by BOD: 54.8% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975)), and 72-hour NOEC = 150 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2007). 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: 54.8% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1975)), and 96-hour LC50 = 75 mg/L for fish (Oncorhynchus mykiss, Lepomis macrochirus) (SIDS, 2007). 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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