GHS Classification Result

Chemical Name:fumaric acid
CAS:110-17-8

Result:
ID: 20A2170
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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.
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Not classified - - - - Its autoignition point is 740degC, which is above 70degC.
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 contains 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 - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Not classified - - - - The classification is based on the description that its rat LD50 is 10700 mg/kg (PATTY (5th, 2001)).
1 Acute toxicity (Dermal) Not classified - - - - The classification is based on the description that its rabbit LD50 is > 20000 mg/kg (IUCLID (2000)).
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 - - - - Since 12-hour exposure tests using rabbits found that the substance causes mild irritation (PATTY (5th, 2001)), it was classified into the "Not classified" category using the JIS classification criteria (Category 3 in the United Nations classification).
3 Serious eye damage/eye irritation Category 2A Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
Since rabbit tests found that the substance has severe effect (PATTY (5th, 2001)), and it is rated as R36 in the EU classification.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - Guinea pig maximization tests found that the substance is not sensitizing (IUCLID (2000)), which indicates that the substance falls under the "Not classified" category. However, since these are List 2 studies, classification is not possible.
5 Germ cell mutagenicity Classification not possible - - - - Regarding in vitro tests, both Ames tests (NTP DB (accessed in October 2008)) and chromosomal aberration tests yielded negative results (IUCLID (2000)). However, since no in vivo test results are available, classification is not possible.
6 Carcinogenicity Classification not possible - - - - In 2-year mixed diet administration tests using rats (IUCLID (2001)), no increase in incidences of tumorigenesis was noted. However, due to insufficient data available, classification is not possible.
7 Reproductive toxicity Classification not possible - - - - In reproduction toxicity tests using guinea pigs that underwent mixed diet administration, no adverse effects were noted on growth of the first generation animals and on fertility or lactation of the second generation animals (JECFA SERIES 6 (1975)). However, since sufficient test details are not provided, classification is not possible based on this study.
8 Specific target organ toxicity - Single exposure Classification not possible - - - - No data available.
9 Specific target organ toxicity - Repeated exposure Classification not possible - - - - In 2-year mixed diet administration tests using dogs, no abnormalities were noted in terms of blood biochemical examinations, organ weights, and histopathological examinations (JECFA SERIES 6 (1975)) at the dose of 1250 mg/kg, which is higher than Category 2 guidance values. In 1 to 2 year mixed diet administration tests using rats, no adverse effects were noted in histopathological examinations on bones, the liver, kidney, spleen, and stomach in 0.1-1% dose groups (JECFA SERIES 6 (1975)). In addition, 75 people received 500 mg of this substance daily for one year without any toxic symptoms or abnormalities in terms of red blood cells, white blood cells, proteins, creatinine level, liver functions, or kidney functions measured in blood biochemical examinations (JECFA SERIES 6 (1975)). These reports indicate that the substance falls under the "Not classified" category for oral route, however, no test results through other administration routes are available. Thus, classification is not possible due to insufficient data available.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Since its 72-hour EC50 = 41mg/L for algae (Scenedesmus subspicatus) (IUCLID, 2000), the substance was classified into Category 3.
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Its classification for acute toxicity is Category 3, it is rapidly degradable (14-day BOD degradability = 70% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1993)), and its potential for bioaccumulation is presumably low (logPow = 0.46 (PHYSPROP Database, 2008)). Based on this information, the substance was classified into the "Not classified" category.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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