Registration Dossier
Registration Dossier
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EC number: 210-514-9 | CAS number: 617-48-1
Endpoint summary
Administrative data
Description of key information
Malic acid is conisdered to be of low toxicity and is widely used in food.
A discriminating dose of > 2000 mg is considered a conservative figure (LD 50 fumaric acid > 10 000 mg/kg)
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Some published data found on malic acid that suggests acute oral toxicity at less than 2000 mg/kg in mice (1.6 - 3.2 mg/kg, Kodak 1982) and published rat oral LD50 of 3.2 mg/kg (Kodak 1981). The source data has not been possible to obtain, but are indiacted as supporting studies.
Comments on the toxicity of other caboxylic acids suggest that local irritation / corrosion can occur at high concentration and the oral and systemic dermal toxicity will be highly dependant on the choice of vehicle and concentration tested. Testing on the salts show similar low toxicity (BIBRA review 1987) to that of the acid when administered by Gavage.
Justification for classification or non-classification
There is no evidence of acute toxicity at levels that would require classification.
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