Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute toxicity testing by oral, dermal and inhalation exposure demonstrated no evidence of toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
5 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
14 000 mg/kg bw

Additional information

An acute oral toxicity test with dioctyl maleate resulted in a LD50 greater than 2000 mg/kg bw/day. Other studies less reliable also support a very low oral toxicity. The dermal LD50 identified in literature was 15 mL/kg (14000 mg/kg).

Based on the physico-chemical characteristics and structural properties, and the general lack of significant effects seen with this product in the workplace, the acute inhalation LC50 value of dibutyl maleate (>= 5000 mg/m³) was used as surrogate for the purpose of this risk assessment.

In conclusion, dioctyl maleate is practically non toxic via acute oral, inhalation or dermal exposure.

Justification for classification or non-classification

According to criteria in Regulation (EC) No 1272/2008, the substance does not have to be classified for acute oral, inhalation or dermal toxicity.