α-chlorotoluene

Developmental toxicity / teratogenicity

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

Test material information

Constituent 1

Reference substance name:

α-chlorotoluene

EC Number:

202-853-6

EC Name:

α-chlorotoluene

Cas Number:

100-44-7

Molecular formula:

C7H7Cl

IUPAC Name:

(chloromethyl)benzene

Constituent 2

Reference substance name:

Chloromethylbenzene

IUPAC Name:

Chloromethylbenzene

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)

1

Dose descriptor:

NOEL

Effect level:

50 mg/kg bw/day (nominal)

Basis for effect level:

other: fetotoxicity

2

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.