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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline/GLP study performed using commercial product at an experienced contract laboratory. Complete documentation available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
gravimetric
Duration of treatment / exposure:
Gestation days 6-15
Frequency of treatment:
once daily
Duration of test:
Through day 20 of gestation
No. of animals per sex per dose:
25 females/group
Control animals:
yes, concurrent vehicle

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:
NOEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity

Results (fetuses)

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

Effect levels (fetuses)

open allclose all
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: embryotoxicity
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
EBTBP was not a maternal or embryo toxicant at oral doses up to and including 1000 mg/kg/d administered from GD6-15. Teratogenic effects were not observed at any dose.
Executive summary:

EBTBP was administered to four groups of 25 mated female Sprague Dawley rats by gavage in corn oil at doses of 0, 100, 500 or 1000 mg/kg/d on gestation days 6-15. The animals were observed daily for clinical signs of toxicity. Body weights were measured on gestation days 0, 6, 9, 12, 16, and 20. Food consumption was measured daily. All females were sacrificed on gestation day 20 and subjected to a cesarean section. Fetuses were individually weighed sexed and examined for external, visceral and skeletal abnormalities. No maternal mortality or clinical signs of toxicity were observed during the study. No treatment-related differences were noted among the groups with respect to maternal body weights, food consumption, necropsy or caesarean section data. No treatment-induced fetal malformations or developmental variations were detected. The maternal and fetal NOEL was 1,000 mg/kg/d.  This study was conducted according to US TSCA Guidelines and Good Laboratory Practices.