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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The original study is not available, however this study was peer reviewed and included in two reference books.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000
Report Date:
2000
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Charles River CD

Administration / exposure

Route of administration:
oral: gavage
Duration of treatment / exposure:
Days 6-15 of gestation
Frequency of treatment:
once per day
No. of animals per sex per dose:
25
Control animals:
yes, concurrent vehicle
Details on study design:
Sex: female
Duration of test: 10-days

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Remarks on result:
other: No data

Results (fetuses)

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
>= 1 500 mg/kg bw/day
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

 There were signs of maternal toxicity in the rats dosed at 1500 mg/kg/day including reduced grooming, ataxia, reduced body weight gain and lethargy, and one death was recorded. Treatment with TBEP in corn oil had no effect at any dose level on foetal resorption, foetal viability, post-implantation loss, total implantations or the incidence of foetal malformations.

Applicant's summary and conclusion

Conclusions:
NOEL (maternal): 500 mg/kg bw/day
NOEL (development): 1500 mg/kg bw/day
Exposure of pregnant rats to TBEP during organogenesis did not affect embryofoetal development.
Executive summary:

In a developmental toxicity study, TBEP was administered by gavage in corn oil to three groups of 25 mated Charles River CD female rats at dose levels of 250, 500 and 1500 mg/kg bw/day on days 6 to 15 of gestation. A fourth group served as a vehicle control. Maternal weight gain was depressed only in the high-dose group. The treatment had no effect at any dose level on foetal resorption, foetal viability, post-implantation loss, total implantations or incidence of foetal malformations.

The original study report was not available, however the principal data are summarised in two peer-reviewed publications. The published report is considered adequate to cover the requirements for this endpoint.