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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats. An oral trial in rats dosed with 2.0 to 200 mg/kg of the test chemical from the 6th to 15th day of gestation. The dosed rats were observed for pre-natal, post-natal and placental transfer of the test chemical. The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from authoritative database
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats
GLP compliance:
not specified
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
female
Details on test animals or test system and environmental conditions:
no data available
Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on exposure:
no data available
Details on mating procedure:
no data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
day 6 to day 15 of gestation
Frequency of treatment:
daily
Details on study schedule:
no data availabler
Remarks:
2-200 mg/kg
No. of animals per sex per dose:
no data available
Control animals:
not specified
Details on study design:
no data available
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
no effects observed
Description (incidence and severity):
did not result in embryotoxic or fetal effects or congenital malformations.
Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed
Description (incidence and severity):
The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
Dose descriptor:
NOAEL
Effect level:
200 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
Critical effects observed:
no
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Sexual maturation:
not specified
Anogenital distance (AGD):
not specified
Nipple retention in male pups:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified
Other effects:
no effects observed
Description (incidence and severity):
The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
Behaviour (functional findings):
not specified
Developmental immunotoxicity:
not specified
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
200 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: The test chemical did not result in embryotoxic or fetal effects or congenital malformations.
Critical effects observed:
no
Reproductive effects observed:
no
Conclusions:
The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg
Executive summary:

A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats. An oral trial in rats dosed with 2.0 to 200 mg/kg of the test chemical from the 6th to 15th day of gestation. The dosed rats were observed for pre-natal, post-natal and placental transfer of the test chemical. The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subacute
Experimental exposure time per week (hours/week):
168
Species:
rat
Quality of whole database:
Klimisch Rating 2
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Various studies have been reviewed to evaluate the reproductive toxicity potential of the test chemical. The results are mentioned below:

A pre-natal developmental toxicity study was performed to evaluate the possibility of placental transfer of the test chemical in rats. An oral trial in rats dosed with 2.0 to 200 mg/kg of the test chemical from the 6th to 15th day of gestation. The dosed rats were observed for pre-natal, post-natal and placental transfer of the test chemical. The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 200 mg/kg

This is supported by a similar pre-natal developmental toxicity study performed to evaluate the possibility of placental transfer of the test chemical in mice. An oral trial in mice dosed with 1.6 to 160 mg/kg of the test chemical from the 6th to 15th day of gestation. The dosed rats were observed for pre-natal, post-natal and placental transfer of the test chemical. The test chemical did not result in embryotoxic or fetal effects or congenital malformations. Hence, the NOAEL value can be considered to be 160 mg/kg

These results are further strengthened by study performed on guinea pigs to report whether exposure to the test chemical caused effect on reproduction and lactation. Groups of 12 male and female guinea pigs were dosed with 1% test chemical in diet (i.e approx 400 mg/kg/day). The exposure period was not reported.There were no detectable toxic effects on growth, reproduction or lactation of  the test chemical treated guinea pigs. Hence, the NOAEL value can be considered to be 400 mg/kg/day.

Based on the available information, the test chemical can be regarded as safe during maternity and lactation. The NOAEL value can be considered to be 200 mg/kg/day.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information, the test chemical can be regarded as safe during maternity and lactation.

Additional information