Registration Dossier

Administrative data

Description of key information

Acute oral toxicity, rat:
Eastman 1969: LD50 = 708 mg per kg body weight
Löser 1978 (maleic anhydride): LD50 = 1030 mg/kg body weight
Mürmann 1984 (maleic anhydride): LD50 = 1090 mg/kg body weight
Acute dermal toxicity, rabbit:
Vernot 1977 (maleic anhydride): LD50 = 2620 mg/kg body weight
Sax 1989: LD50 = 1560 mg/kg body weight
Younger Labs 1976 (maleic anhydride): 298 <LD50<1000 mg/kg body weight
Acute toxicity, inhalation:
Existing data are inadequate to determine the acute toxicity by inhalation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
708 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
1 560 mg/kg bw

Additional information

The data on maleic acid are from secondary sources, which reference the values from unpublished reports. The data on maleic anhydride are sufficiently robust and could also be used for maleic acid given that maleic anhydride is hydrolyzed to maleic acid in the body.

Acute oral toxicity:

LD50 data for maleic acid as well as for maleic anhydride are in the same range: 708, 1030, 1090 mg per kg body weight and result in the same classification. Therefore the data for maleic acid are used for classification (LD50 = 708 mg/kg bw). These data are also flagged "critical study for SIDS endpoint" in the SIDS dossier.

Acute dermal toxicity:

LD50 data for maleic acid are 1560 mg per kg body weight, whereas the LD50 data for maleic anhydride are between (practically) 400 and 100 mg/kg or above 2000 mg/kg (2620 mg/kg). For safety reasons, the data on maleic acid are taken for classification (1560 mg/kg bw). These data are also flagged "critical study for SIDS endpoint in the SIDS dossier.

Acute inhalation toxicity: Inhalation is not relevant, as the size particles are to large to inhale.

The derivation of the relevant toxicity descriptors and the calculation of the DNELs and their justifications was the task of DSM Netherlands. DSM Netherlands requested to use their data and justifications in the IUCLID.

Justification for classification or non-classification

Based on the LD50 of 708 mg per kg body weight for oral toxicity the test substance is classified as "R22 Harmful if swallowed" and as "Acutely toxic Category 4".

Based on the LD50 of 1560 mg per kg body weight for dermal toxicity the test substance is classified as "R21 Harmful in contact with skin" and as "Acutely toxic Category 4".