GHS Classification Result

Chemical Name:maleic acid
CAS:110-16-7

Result:
ID: 20A2098
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 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.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
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
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) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
Since its LD50 = 708 mg/kg for rats (PATTY (5th, 2001)), the substance was classified into Category 4.
1 Acute toxicity (Dermal) Category 4 Warning H312: Harmful in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment (see ... on this label).
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ...
Since its LD50 = 1560 mg/kg for rabbits (PATTY (5th, 2001)), the substance was classified into Category 4.
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 - - - - 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.
2 Skin corrosion/irritation Category 2 Warning H315: Causes skin irritation P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment (see ... on this label).
P362: Take off contaminated clothing and wash before reuse.
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.
3 Serious eye damage/eye irritation Category 1 Danger H318: Causes serious eye damage P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P310: Immediately call a POISON CENTER or doctor/physician.
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.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
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)).
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.
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.
8 Specific target organ toxicity - Single exposure Category 1 (kidney) Danger H370: Causes damage to organs (kidney) P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
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).
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.
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 96h-LC50 = 75 mg/L for fish (trout, bluegill) (SIDS, 2004), the substance was classified into Category 3.
11 Hazardous to the aquatic environment (Long-term) 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".


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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