Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

Extended One Generation Reproductive Toxicity Study: on-going


 

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
Study duration:
chronic
Experimental exposure time per week (hours/week):
168
Species:
rat
Quality of whole database:
GLP and OECD guideline compliant study
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

OECD 414 study in rats (Klimisch 1, Key study); maternal NOAEL = 60 mg/kg bw/day; embryo-fetal NOAEL = 110 mg/kg bw/day


OECD 414 study in rabbits (Klimisch 1, Key study); maternal NOAEL = 300 mg/kg bw/day; embryo-fetal NOAEL = 300 mg/kg bw/day

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
60 mg/kg bw/day
Study duration:
subacute
Experimental exposure time per week (hours/week):
168
Species:
rat
Quality of whole database:
GLP and OECD guideline compliant studies
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

No adverse effects on reproductive function and on pre-natal development have been identified in the preliminary study and in the on-going extended one generation toxicity study as well as in two pre-natal developmental toxicity studies in rats and rabbits. Therefore, the registered substance does not need to be currently classified for reproductive toxicity according to CLP regulation.

Additional information