Registration Dossier

Administrative data

Description of key information

This study was conducted in compliance with the United States Environmental Protection Agency (EPA) TSCA Good Laboratory Practice Standards (40 CFR Part 792), 18 September 1989; the Organisation for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice [C (97) 186/Final]. The protocol was designed to be in general accordance with the OECD Guidelines for Testing Chemicals, Health Effects Test Guidelines, Section 408, September 1998, and the European Chemicals Bureau test method B.26

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
619 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

ISODECYL BENZOATE was administered ad libitum via the basal diet for a minimum of 91 consecutive days to 3 groups (Groups 2-4) of Crl:CD(SD) rats. Dosage levels were 1000, 3000 and 10,000 ppm administered as 0.1%, 0.3% and 1.0% w/w of ISODECYL BENZOATE in the basal diet, respectively. A concurrent control group (Group 1) received the basal diet on a comparable regimen. Each group consisted of 10 animals/sex.

Based on the results of this study, orally (diet) administered ISODECYL BENZOATE for 91 or 92 days was well tolerated in Crl:CD(SD) rats at dosage levels of 0.1%, 0.3% and 1.0% w/w ISODECYL BENZOATE (1000, 3000 and 10,000 ppm, respectively). There were no test substance-related effects on clinical observations, body weights, food consumption, functional observational battery parameters, locomotor activity, clinical pathology parameters (hematology, coagulation, serum chemistry or urinalysis), ophthalmic examinations, organ weights, and macroscopic or microscopic examinations.Therefore, the no-observed-effect level (NOEL) for oral (diet) administration of ISODECYL BENZOATE to Crl:CD(SD) rats for 91 or 92 consecutive days was the highest dose-level of 1.0% w/w which was approximately equivalent to 619 mg/kg/day for males and 736 mg/kg/day for females.

Justification for classification or non-classification

No treatment related effects on clinical observations, body weights, food consumption, functional observational battery parameters, locomotor activity, clinical pathology parameters (hematology, coagulation, serum chemistry or urinalysis), ophthalmic examinations, organ weights, and macroscopic or microscopic examinations.

No classification for repeated-dose toxicity is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.