Registration Dossier

Administrative data

Description of key information

A GLP-compliant study acute oral toxicity study in the rat has been conducted to a method similar to OECD Guideline 401.The acute oral LD50 of the substance has been determined to be approximately 2900 mg/kg.
A GLP compliant study acute dermal toxicity study in the rat has been conducted in accordance with OECD Guideline 402. The acute dermal LD50 of the substance has been determined to be greater than 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 900 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Value:
mg/kg bw

Additional information

Inhalation exposure is considered unlikely based on the physico-chemical properties of the substance and the form in which it is manufactured and used and hence an acute toxicity study by the inhalation route is not considered necessary.

A DNEL for acute toxicity needs only to be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures. In the absence of these criteria being met a DNEL has not been derived.

Justification for classification or non-classification

A GLP-compliant study acute oral toxicty study in the rat has been conducted to a method similar to OECD Guideline 401.The acute oral LD50 of the substance has been determined to be approximately 2900 mg/kg.

A GLP compliant study acute dermal toxicity study in the rat has been conducted in accordance with OECD Guideline 402. The acute dermal LD50 of the substance has been determined to be greater than 2000 mg/kg.

In both studies the LD50 is greater than the cut-off for C&L (2000 mg/kg). In the absence of any other relevant data the substance is not classified for acute toxicity.