Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
yes
Remarks:
Administration comprised only period of organogenesis.
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
68891-38-3 (purity 70.1 %)
IUPAC Name:
68891-38-3 (purity 70.1 %)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Details on test animals or test system and environmental conditions:
According to Guideline.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Analytical verification of doses or concentrations:
no
Details on mating procedure:
According to Guideline.
Duration of treatment / exposure:
Day 6-15 (incl.) post coitum
Frequency of treatment:
Daily
Duration of test:
Until Day 20 p.c.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day
Basis:
nominal conc.
No. of animals per sex per dose:
24 females
Control animals:
yes, concurrent vehicle

Examinations

Maternal examinations:
According to Guideline.
Ovaries and uterine content:
The ovaries and uterine content was examined after termination: Yes

Examinations included: Gravid uterus weight, number of corpora lutea, implantations and early/late resorptions
Fetal examinations:
- External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: No
Statistics:
Yes

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Remarks:
maternal toxicity
Effect level:
> 1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: NOAEL is highest dose tested

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Dose descriptor:
NOAEL
Remarks:
developmental toxicity
Effect level:
> 1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: NOAEL is highest dose tested

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The results of this study showed that repeated oral administration (Day 6-15 post coitum) of the test substance to pregnant rats caused no symptoms of cumulative toxicity and does not reveal any embryotoxic or teratogenic potential up to a dose level of 1000 mg/kg body weight/day.