Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Not published report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
yes
Remarks:
treatment from day 6 to 15 of the gestation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

Exposure of pregnant rats to Halon 1301 vapors from day six through fifteen of gestation at levels of 1000, 10,000 and 50,000 ppm had no effect on their body weight gains. No compound-related clinical signs of toxicity or changes in behavior were noted.

The outcome of pregnancy measured by the number of implantation sites, resorptions and live fetuses, was not adversely affected by the exposure. Exposure did not affect embryonal development as measured by weight and crown-rump length of the fetuses. Only three fetuses, each one from different litter, were found with malformations. All three were from dams exposed to the intermediate level (10,000 ppm) of Halon 1301. These defects were not treatment-related. They are considered as spontaneous, congenital malformations of genetic origin seen in this strain of rats at about the same frequency as in this study.

Under the conditions of this test, Halon 1301 was not embryo-toxic or teratogenic when inhaled by pregnant ChR-CD rats.