1,4:5,8-Dimethanonaphthalene, 2-ethylidene-1,2,3,4,4a,5,8,8a-octahydro-

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route

Dose descriptor:

NOAEL

50 mg/kg bw/day

Additional information

A screening study (Huntingdon Life Sciences, 2011, study number VHJ0023) was conducted to assess the reproductive and developmental toxicity of ETD in Rats (Wistar). The study was conducted according to OECD test guideline 421, and in compliance with GLP.

Groups of 10 animals per sex per dose level were administered dose levels 0 (vehicle control), 12.5, 50, and 200 mg/kg/day by oral gavage. Males were administered test item for six consecutive weeks; females were administered test item for 15 days before pairing until day 6 after the birth of the F1 generation.

A minor change in the oestrous cycles was seen at 200 mg/kg/day, as well as a significantly low number of implantations and reduced litter size. Minimal effects were seen at 50 mg/kg/day, and on this basis it was concluded that the NOAEL was 50 mg/kg/day for reproductive performance when ETD was administered to the Wistar rat.

Short description of key information:
NOAEL (Screening study in Rats, Oral gavage) = 50 mg/kg/day

Justification for classification or non-classification

Effects on fertility (changes to the oestrous cycle, and a reduced number of implantations) were seen at high doses in the screening study noted above. A full study (for example an OECD 414 Guideline study) is not available for reproductive or developmental toxicity, and so the result is not considered entirely conclusive. On this basis, ETD is classified as a Category 2 reproductive toxin according to the CLP Regulation (Regulation (EC) 1272/2008); the applicable Hazard phrase is therefore "H361: Suspected of damaging fertility or the unborn child".

The corresponding classification according to the Dangerous Substances Directive (67/548/EEC) is "Reproductive Category 3, R62: Possible risk of impaired fertility".