Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
916 mg/kg bw/day
Additional information

A two-generation study reproduction study was conducted to determine the potential adverse effects of MRD-08-293 (CasRN 131298-44-7) on reproduction. Based on the lack of effects on F0and F1reproductive performance (mating, fertility, copulation, and conception indices, estrous cyclicity, and spermatogenic endpoints), the no-observed-adverse-effect level (NOAEL) for reproductive toxicity when offered in the diet to Crl:CD(SD) rats was considered to be 10,000 ppm, the highest exposure level tested. When expressed on a body weight basis (average of F0and F1animals), this concentration corresponded approximately 676 mg/kg/day for males over the entire generation and 916, 641, and 1469 mg/kg/day for females during pre-mating, gestation, and lactation, respectively.  Additionally, there were no effects on the following parameters: no effects on anogenital distance, no cryptorchidism, no hypospadias, no effects with regard to testes histopathology and no effects on spermatogenic endpoints. Based on this study, isodecyl benzoate does not have any endocrine disrupting properties. 

Short description of key information:
No adverse effects on reproductive parameters.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Dose descriptor:
300 mg/kg bw/day
Additional information

The potential maternal toxicity and developmental toxicity of Isodecyl Benzoate were evaluated. Isodecyl Benzoate in corn oil was administered orally by gavage to three groups of 25 bred Sprague-Dawley Crl:CJYBR female rats once daily from gestation days 6 through 15. Dosage levels were 30, 300 and 1000 mg/kg/day administered at a dose volume of 5 ml/kg. All maternal animals survived to the scheduled necropsy; no clinical signs related to compound administration were noted in the treated groups. A mean body weight loss occurred in the 1000 mg/kg/day group during gestation days 6-9. Food consumption was unaffected by treatment throughout the study period in all dose groups. No treatment-related internal findings were observed at necropsy. The only adverse effects of treatment on the developing fetus were a decrease in the mean fetal body weight and a reduction in the incidence of cervical centrum no. 1 ossified (both of which are indications of developmental retardation in the fetuses) in the 1000 mg/kg/day group in the presence of slight maternal toxicity. Based on the results of this study, the dose level of 300 mg/kg/day was considered to be the NOAEL (no observable adverse effect level) for maternal toxicity and developmental toxicity.

Justification for classification or non-classification

No classification for reproductive or developmental 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.