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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study.

Data source

Reference Type:
other: inquiry result from ECHA

Materials and methods

Test guideline
according to guideline
other: OECD Guideline No. 414, 1981
GLP compliance:
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:

Test animals

other: Rat, Crl:CD BR

Administration / exposure

Route of administration:
other: Not applicable
Details on exposure:
Method of administration or exposure: Whole body exposure
Frequency of treatment:
Duration of exposure per day: 6 hours
Dosing regime: 7 days/week
No. of animals per sex per dose:
Number of dams and doses
25 at 0 mg/kg or mg/l
25 at 5000 mg/kg or mg/l
25 at 20000 mg/kg or mg/l
25 at 50000 mg/kg or mg/l

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Details on maternal toxic effects:
At the 20000 and 50000 ppm there were significant dose-related decreases in maternal body weight gain over the first two days of inhalation exposures. At 50000 ppm this reduction in weight gain was accompagnied by a significant reduction in maternal food consumption and occasional instances of diminished alerting responses during the inhalation exposures. No evidence of maternal toxicity was detected at 5000 ppm. There was no evidence of developmental toxicity at any level tested.

Effect levels (maternal animals)

Dose descriptor:
Effect level:
5 000 mg/kg bw/day (nominal)
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Details on embryotoxic / teratogenic effects:
Effects on fetus - Gross:
No compound-related effects on the incidence of early, late or total resorptions were detected. There were no dead fetuses.

No compound-related effects on mean fetal weight were detected. The values for mean fetal weight were comparable across the control and exposure group.

Effects on fetus - Soft tissue:
No compound-related effect on the incidence of fetal malformations and on the incidence of fetal variations was detected.

Effects on fetus - Skeletal:
No compound-related effect on the incidence of fetal malformations and on the incidence of fetal variations was detected.

Effect levels (fetuses)

Dose descriptor:
Effect level:
50 000 mg/kg bw/day (nominal)
Based on:
not specified
Basis for effect level:
other: fetal mortality, weight, malformation and variations.
Remarks on result:
other: NOAEL=50000 ppm (310000 mg/m3)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion