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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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP status unknown. Study sufficiently described and based on generally well accepted scientific principles. Klimisch 2.e study.

Data source

Reference
Reference Type:
publication
Title:
Teratogenicity of benzyl chloride in the rat
Author:
Skowronski G. and Abdel-Rahman S.
Year:
1986
Bibliographic source:
J. Toxicol. Environm. Health, 17, 51-56.

Materials and methods

Principles of method if other than guideline:
Oral teratogenic study was performed in female SD(Crj:CD) rats at doses of 0 (vehicle: corn oil), 50, 100 mg/kg/day from day 6 through day 15 of gestation
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):
No further information

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
- Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1 male to 3 females
- Length of cohabitation: overnight
- Proof of pregnancy: sperm in vaginal smear as ay 0 of pregnancy
No further information
Duration of treatment / exposure:
Oral administration of benzyl chloride from day 6 to day 15 to pregnant rats.
Frequency of treatment:
Daily
Duration of test:
Twenty days
Doses / concentrations
Remarks:
Doses / Concentrations:
50 and 100 mg/kg/day in corn oil
Basis:
nominal conc.
No. of animals per sex per dose:
8 pregnant females per dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results (fetuses)

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

Effect levels (fetuses)

open allclose all
Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day (nominal)
Basis for effect level:
other: fetotoxicity
Dose descriptor:
NOEL
Effect level:
100 mg/kg bw/day (nominal)
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:
In the test conditions, a NOEL for fetal toxicity of benzyl chloride was considered to be 50 mg/kg and NOEL for teratogenicity was considered to be 100 mg/kg.
Executive summary:

The authors tested the teratogenicity of benzyl chloride (CAS n° 100 -44 -7) by exposing female Sprague-Dawley rats at doses of 0 (vehicle: corn oil), 50, 100 mg/kg/day from day 6 through day 15 of gestation. The postion and number of implantations, resorptions, and live fetuses and the mean fetal weight were recorded. External and visceral abnormalities and skeletal defects were also checked in the sampled fetuses.

No signs of toxicity was observed in the dams. The number of implantations, resorptions, and live fetuses and the mean fetal weight were not affected at both dosage groups. The only significant change was the reduction of fetal length at 100 mg/kg. All live fetuses were normal in the external appearance. No major skeletal or visceral abnormalities resulting from treatment with benzyl chloride were noted. No significant increase was detected in the number of skeletal and visceral variations.

In the test conditions, based on the reduction of fetal length, a NOEL for fetal toxicity was considered to be 50 mg/kg/day and a NOEL for teratogenicity was considered to be 100 mg/kg/day because no teratogenic changes were observed.

The GLP status of the study is not known but is well described. Besides, the study is based on generally well accepted scientific principles. Therefore , this study should be considered as reliable with restrictions, a Klimisch 2.e study.