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
Fumaric acid was a slight or mild skin irritant and a moderate eye irritant. Read across has been made to malic acid.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Malic acid and fumaric acid have similar dissociation constant and are conisdered moderately strong organic acids. Local skin and eye irritation is expected, but dilution will quickly reduce effects.
Effects on skin irritation/corrosion: slightly irritating
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
Fumaric acid is listed on Annex I of Directive 67/548/EEC as an irritant to eyes (Xi; R36).
The mild skin irritation observed was insufficient to justify classification of fumaric acid. Moderate, reversible eye irritation seen in the study discussed above shows that fumaric acid should remain classified for ocular irritation according to current EU criteria.
Fumaric acid is classified as an eye irritant. It is assigned the symbol Xi and the risk-phrase R36 - irritating to the eyes according to Directive 67/548/EEC. It is assigned the pictogram GHS07 with the signal word warning and the hazard statement H319 "causes serious eye irritation". It is proposed to classify malic acid the same.
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