Registration Dossier

Administrative data

Description of key information

Repeat dose oral toxicity data is not available for EC 283-392-8, but an OECD 422 study is available for an analogous substance and suitable for read across. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
160 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

The oral repeat dose toxicity of an analog substance was evaluated with rats at doses as high as 160 mg/kg/day for up to 52 consecutive days in accordance with OECD 422. Substance-related toxicity was limited to morbundity, adverse clinical signs, and epithelial hyperplasia, hyperkeratosis, and inflammation of the stomach. The NOAEL for systemic toxicity was 160 mg/kg/day. The NOEL for portal of entry irritation and related secondary effects parental toxicity was 40 mg/kg/day. 

 

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and the EU CLP (Regulation (EC) No. 1272/2008) classification of this substance is not required for prolonged exposure.