Registration Dossier
Registration Dossier
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EC number: 203-743-0 | CAS number: 110-17-8
Endpoint summary
Administrative data
Description of key information
Fumaric acid was practically nontoxic when tested in guideline-comparable studies of acute oral and acute dermal toxicity. Inhalation testing is not required since a non-toxic response can be predicted based on the absence of inhalation exposure since the granulometry test confirms virtually no particles within the rat respirable range (< 6 % of particles are respirable i.e. < 10 micron). However, since human exposure via inhalation of a larger range of particles may be considered a possibility, an inhalation study was completed in rats at the maximum practical atmosphere concentration. 1.3 mg/L resulted in no adverse effects of inhalation exposure and confirmed the theoretical predictions.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 10 700 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 1 306 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 20 000 mg/kg bw
Additional information
The single dose oral toxicity of fumaric acid in Sprague-Dawley rats was reported as 10700 mg/kg for males and 9300 mg/kg for females. Single dose dermal toxicity of fumaric acid using female New Zealand albino rabbits was reported as 20000 mg/kg.
Since the percent particles within the respirable range is very low (< 6 % are < 10 micron), exposure via inhalation is predicted to be low to none. Under these circumstances a study conducted at the limit dose of 5 mg/L is likely to elicit no adverse response, in the absence of significant levels of respiratory exposure. Since the result can be predicted it is unjustifiable to conduct a mammalian study to determine inhalation toxicity more precisely.
However, data was available from an acute inhalation study in rats, conducted at the maximum achievable atmosphere concentration - 1.306 mg/L or 1306 mg/m³. No adverse effects were observed at the practical limit dose concentration.
Justification for classification or non-classification
It is not proposed to classify fumaric acid for acute oral toxicity or for acute dermal toxicity based on experimental results.
The predicted absence of inhalation exposure would also preclude classification for respiratory effects. The experimental results confirm that no classification is needed in accordance with EU CLP or GHS classification systems.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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