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
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A repeated-dose toxicity combined with a reproductive/developmental toxicity screen conducted on an analogue of the substance according to OECD Test Guideline No 422 found no adverse effects on oestrous cycle, copulation, fertility, delivery or lactation and no changes related to gestation index, gestation length, numbers of corpora lutea, implantation sites or implantation index. There were no changes in sex ratio, body weight, viability or morphology of pups. The No Observed Adverse Effect Level (NOAEL) for reproductive and developmental toxicity was considered to be 1000 mg/kg/day for both parent animals and offspring, this being the highest dose level investigated.

 

A two-generation reproductive toxicity study is required in accordance with Section 8.7.3 of Column 1, Annex IX. It is proposed to waive the need to conduct this study on the basis of the fact that a well-conducted OECD 422 combined repeat-dose and reproductive/developmental toxicity screening study is available on the substance. This study shows that the substance has no functional effect on the reproductive performance of both male and female rats. It provides adequate data to demonstrate the potential toxicity to reproduction of the substance to humans and to derive relevant DNELs for oral exposure.

Short description of key information:

Fertility - Rat: NO(A)EL - 1000 mg/kg/day

Justification for selection of Effect on fertility via oral route:

Single study available for evaluation

Effects on developmental toxicity

Description of key information

Developmental toxicity - rat: NO(A)EL 1000 mg/kg/day

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Species:
rat
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

A repeated-dose toxicity combined with a reproductive/developmental toxicity screen conducted according to OECD Test Guideline No 422 has been conducted on the substance itself. No adverse effects on oestrous cycle, copulation, fertility, delivery or lactation and no changes related to gestation index, gestation length, numbers of corpora lutea, implantation sites or implantation index were found. There were no changes in sex ratio, body weight, viability or morphology of pups. The No Observed Adverse Effect Level (NOEL) for reproductive and developmental toxicity was considered to be 1000 mg/kg/day for both parent animals and offspring, this being the highest dose level investigated.

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

Single study available for evaluation

Justification for classification or non-classification

An OECD screening study of reproductive toxicity revealed no functional changes in fertility or reproductive performance.

In accordance with the criteria laid down in Regulation (EC) No. 1272/2008 no toxicologically significant effects are evident sufficient to warrant classification.