GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 97-65-4
Chemical Name Itaconic acid
Substance ID 24A6078
Classification year (FY) FY2012
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/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) Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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 solids Classification not possible
-
-
- - No data available.
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is a chemical group associated with self-reactive properties (unsaturated bond) in the molecule, but the classification is not possible due to no data.
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 430 deg C (MSDS (Merck) (2010)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - No data available.
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.
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - It was classified as "Not classified" in the Classification JIS (corresponding to Category 5 in UN GHS classification) based on an LD50 value of 2,969 mg/kg for rats (Directive EEC 84/449-B1; GLP) (SIDS (Access on Aug. 2012)).
1 Acute toxicity (Dermal) Not classified
-
-
- - It was classified as "Not classified" based on an LD0 value of > 2,000 mg/kg for rats (Directive EEC 84/449-B3; GLP) (SIDS (Access on Aug. 2012)).
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - No data available.
2 Skin corrosion/irritation Not classified
-
-
- - It was classified as "Not classified" because it was not irritating in a test in which 0.5 mL of this substance was applied to rabbits for 24 hours (Directive 84/449/EEC, B.4; GLP) (PATTY (5th, 2001), IUCLID (2000)).
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
In an eye irritation test with rabbits, the average assessment score at 24, 48, 72 hours after the application was 4 for corneal opacity, corneal damage was visually confirmed in about 25% (lower part) of the eye, and epithelial damage (corneal fluorescein staining, a maximum of 50%) was found. Therefore, it was classified in Category 1. Besides, this substance is designated as deleterious substances (Cabinet Order Article 2) (published documents for the Committee on Poisonous and Deleterious Substances).
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
4 Skin sensitization Not classified
-
-
- - It was classified as "Not classified" because it was not sensitizing in a maximization test with guinea pigs (Directive 84/449/EEC, B.6; GLP) (PATTY (5th, 2001), IUCLID (2000)).
5 Germ cell mutagenicity Not classified
-
-
- - It was classified as "Not classified" based on a negative result in a micronucleus test by oral administration to mice (in vivo mutagenicity test) (Directive 84/449/EEC, B.12 GLP) (IUCLID (2000)). Besides, as for in vitro tests, there is a report on a negative result in all of an Ames test (Directive 84/449/EEC, B.14; GLP), a chromosomal aberration test with CHO cells (OECD TG 473; GLP), and an HGPRT test with V79 cells derived from Chinese hamster lung (OECD TG 476, GLP) (IUCLID (2000)).
6 Carcinogenicity Classification not possible
-
-
- - No data available.
7 Reproductive toxicity Classification not possible
-
-
- - It is reported that the NOEL was 1,000 mg/kg/day for both males and females in a developmental toxicity/teratogenicity test with rats (OECD TG415: GLP) (SIDS (Access on Aug. 2012)), but there are no further descriptions, and the details are unknown. Therefore, it was classified as "Classification not possible."
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Oral administration of 500 mg/kg to cats caused vomiting and diarrhea probably due to irritation of the gastrointestinal tract, but no systemic toxicity was observed at up to 1,000 mg/kg, and 5,000 mg/kg above the guidance value range was a fatal dose, where severe gastrointestinal disturbances, convulsions, and prostration were found (PATTY (5th, 2001)). The above results alone gave insufficient data for classification. Therefore, it was classified as "Classification not possible."
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - There are reports on the NOAEL of 14,000 ppm (1,001-1,088 mg/kg/day) in a 13-week diet administration test with rats (PATTY (5th, 2001)), the NOAEL of 500 mg/kg/day (converted guidance value: 154 mg/kg/day) in a 4-week oral administration test with rats (SIDS (Access on Aug. 2012)), the NOAEL of 2.0% (1,748-2,158 mg/kg/day) in a 90-day diet administration test with rats (Existing Food Additives (2000)), and no effects at 100 mg/kg/day (the NOAEL, 100 mg/kg/day or above) in a 14-week oral administration test with cats (PATTY (5th, 2001)), and because the NOAEL in multiple repeated-dose tests exceeded the upper limit of the guidance value range, it corresponds to "Not classified" in the oral route. However, because effects in the other routes are unknown due to no data, it was classified as "Classification not possible" for specific target organ toxicity (repeated exposure).
10 Aspiration hazard Classification not possible
-
-
- - No data available.

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 72-hour EC50 = 47 mg/L for algae (Desmodesmus subspicatus) (SIDS, 2001).
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - Reliable chronic toxicity data were not obtained. It was classified in Category 3 in acute toxicity. However, it is rapidly degradable (readily biodegradable, BOD 82% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1997)), and low bioaccumulation is estimated (LogKow = -0.34 (PHYSPROP Database, 2009)). Therefore, it was classified as "Not classified."
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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