Registration Dossier

Administrative data

Description of key information

OECD 422: NOAEL 150 mg/kg for females, 500 mg/kg for males

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
150 mg/kg bw/day
Study duration:
Quality of whole database:
well documented test

Mode of Action Analysis / Human Relevance Framework

Additional information

Under the conditions of this Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, the oral administration by gavage of octadecanoic acid, sulfo-, potassium salt to Wistar rats revealed no signs of general systemic toxicity in male parental animals up to 500 mg/kg bw/d. Signs of systemic toxicity were observed in female parental animals at 500 mg/kg bw/d. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 500 mg/kg bw/d in male

parental animals and 150 mg/kg bw/d in female parental animals.

Justification for classification or non-classification