Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

CPC has been well studied after repeated dose exposure in rats and dogs. In both 28 -day and 6 month studies, there is no evidence that the substance causes adverse effects on reproductive organs. Toxicokinetic studies indicate it is rapidly eliminated from the body. From these findings it is concluded that the fertility of males and females in not affected by exposure to CPC.


Short description of key information:
Repeated dose toxicity studies do not indicate that CPC has any effect on reproductive organs.

Effects on developmental toxicity

Description of key information
CPC is not teratogenic or fetotoxic at levels below those associated with maternal toxicity.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Species:
rabbit
Quality of whole database:
adequate
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

CPC was examined in a teratology study in rabbits during gestation days 7-18, at doses of 2.5 to 25 mg/kg.   Maternal lethality was observed at higher doses.  Maternal toxicity, as anorexia, loss of body weight and reduced food consumption, was observed at 25 mg/kg CPC, which also resulted in nonsignificant decreases in the number of live fetuses and fetal weight in female offspring only. The findings in the 25 mg/kg CPC group require further study as only 6/15 dams were appropriately exposed.  There was no evidence of teratogenic effects seen at any of the CPC levels tested. It is clear that CPC is not teratogenic in rabbits at doses ranging up to ones that are embryotoxic and fatal to the dam (12 mg/kg bw).


Justification for selection of Effect on developmental toxicity: via oral route:
experimental result

Justification for classification or non-classification

In a developmental toxicity (teratology) study on CPC, there was no evidence of reproductive or developmental toxicity at doses which are not maternally toxic. The data do not meet the criteria for classification as a reproductive toxicant, according to Regulation EC No. 1272/2008.