Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1987
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Only a single dosage level was studied. Only general results of the assay were provided.

Data source

Reference
Reference Type:
publication
Title:
A summary of the results of 55 chemicals screened for developmental toxicity in mice
Author:
Seidenberg JM and Becker RA
Year:
1987
Bibliographic source:
Teratogenisis, Carcinogenesis, and Mutagenesis 7: 17-28

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
The Chernoff/Kavlock developmental toxicity screening assay was used. Mice were gavaged from day 8 to day 12 of gestation and teratologic effects, such as number of litters and pups alive, were assessed. The major limitation of this study was the absence of description of results.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance (as cited in the test report) : 1,1,2-trichloroethane.

Test animals

Species:
mouse
Strain:
other: ICR/SIM
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on exposure:
no data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
no data
Details on mating procedure:
The animals ICR/ SIM mice (a substrain of the CD-1 mouse) were purchased time-Pregnant from Simonsen Laboratory, Gilroy, CA.
Duration of treatment / exposure:
From day 8 to day 12 of gestation
Frequency of treatment:
daily
Duration of test:
5 days
Doses / concentrations
Remarks:
Doses / Concentrations:
350 mg/kg bw/day
Basis:
nominal conc.
gestation day 7 bodyweight
No. of animals per sex per dose:
26-30
Control animals:
yes, concurrent vehicle
Details on study design:
no data

Examinations

Maternal examinations:
Weighing on days 7 and 13 of gestation and at day 1 postpartum
Ovaries and uterine content:
Dams that had not given birth by gestation day 21 or 22 were necropsied, and their uteri content was examined.
Fetal examinations:
No data
Statistics:
see the remarks below
Indices:
No data
Historical control data:
no data

Results and discussion

Results: maternal animals

Maternal developmental toxicity

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

Details on maternal toxic effects:
no

Results (fetuses)

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

Details on embryotoxic / teratogenic effects:
no

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
350 mg/kg bw/day (nominal)
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

no data

Applicant's summary and conclusion

Conclusions:
1,1,2-trichloroethane induced a negative response in mice using the Chernoff/Kavlock developmental toxicity screening assay. Detailed results were not provided in this literature article.
Executive summary:

1,1,2-trichloroethane was administered by gavage to female ICR/SIM mice on days 8 through 12 of gestation at a dose of 350 mg/kg bw/day (Chernoff/Kavlock developmental toxicity screening test conducted for fifty five chemicals). Dams were allowed to deliver, and the litter size and weight of pups on the day of birth and 2 days postpartum were recorded. There were no changes on any parameters such as teratogenic activity and embryo/foetal viability, and or postanatal growth viability.

The NOAEL was considered to be 350 mg/kg/day for developmental toxicity.