Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
3 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
The study was conducted in accordance with OECD422 test guidelines and to GLP. Therefore the study was considered reliable without restrictions.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The qualitative sperm staging revealed no test item-related spermatogenic changes. At 10 mg Potassium dicyanoaurate/kg b.w./day, a slight reduction was noted for the birth index (pups born alive and dead) and accordingly a slight increase was noted for the post-implantation loss. No influence was noted on the fertility and the reproductive parameters of the parental generation (FO-Generation) with respect to fertility, pre-coital time, gestation length, number of stillbirths, the gestation index, the fertility index and the preimplantation loss for any of the examined dose levels.


Short description of key information:
A repeat-dose oral toxicity and reproductive toxicity screening study in rats conducted in accordance with OECD422 study design.

Justification for selection of Effect on fertility via oral route:
A single guideline study (OECD422) conducted in accordance with GLP.

Effects on developmental toxicity

Description of key information
A repeat-dose oral toxicity and reproductive toxicity screening study in rats conducted in accordance with OECD422 study design.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
10 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Measurement of survival index, body weight and gross abnormalities in F1 generation pups from the OECD422 test guideline study conducted to GLP.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No adverse effects were noted on the development of the pups (F1-Generation) with respect to survival index, body weight, gross abnormalities.

Justification for classification or non-classification

Observations of general toxicity for Potassium dicyanoaurate, such as local irritation of the forestomach and in the gastroinstestinal tract, were detected at lower concentrations than those that may influence reproductive performance or F1 development. The results suggest that the NOAEL for systemic toxicity (3 mg Potassium dicyanoaurate/kg b.w/day) is protective for reproductive and developmental toxicity.