Registration Dossier

Administrative data

Description of key information

Repeat dose oral toxicity data is not available for EC 218-679-8-9, but an OECD 422 study is available for an analogous substance EC 270-608-0 and suitable for read across. In this study, the parental NOAEL for systemic toxicity also was determined to be 160 mg/kg/day.  

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 with EU CLP (Regulation (EC) No. 1272/2008) classification of this substance is not required for prolonged exposure.