Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 025 mg/kg bw
Quality of whole database:
Study conducted according to internationally accepted testing guidelines.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The solid substance was assessed according to OECD GD 129 (3T3 NRU). Preliminary value of LD50= 1025 mg/kg is confirmed with comparison of similar substances, suggesting a classification for the test item of our interest.

Justification for classification or non-classification

Adopting the WoE approach based on the result of OECD GD 129 on the test item of our interest ( IC50  about 450 μg/ml i.e. LD50= 1025 mg/kg) and considering the data regarding acute oral toxicity available for similar substances, the substance is classified H302 “Harmful if swallowed”” according to the CLP regulation (EC n.1272/2008).