Registration Dossier

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

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: Scientifically acceptable method; limited documentation; limit dose not reached.

Data source

Reference
Reference Type:
publication
Title:
A teratological evaluation following oral administration of trichloro- and dichlorobenzene isomers to the rat
Author:
Ruddick JA, Black WD, Villeneuve DC, Valli VE
Year:
1983
Bibliographic source:
Teratology 27, 73A-74A, 1983

Materials and methods

Principles of method if other than guideline:
A teratological evaluation following oral administration of trichloro- and dichlorobenzene isomers to the rat.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-dichlorobenzene
EC Number:
208-792-1
EC Name:
1,3-dichlorobenzene
Cas Number:
541-73-1
Molecular formula:
C6H4Cl2
IUPAC Name:
1,3-dichlorobenzene
Details on test material:
no data

Test animals

Species:
rat
Strain:
Sprague-Dawley

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on mating procedure:
no data
Duration of treatment / exposure:
6th - 15th day of gestation
Frequency of treatment:
daily
Duration of test:
15 days
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
Sex: female

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
other: maternal toxicity
Effect level:
200 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: Maternal toxicity was not reported at 200 mg/kg bw (highest applied dose)

Results (fetuses)

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

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
200 mg/kg bw/day
Based on:
test mat.
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

1,3-dichlorobenzene revealed no teratological effects.

Applicant's summary and conclusion

Executive summary:

1,3-dichlorobenzene was administered by gavage to pregnant Sprague-Dawley rats on their 6th - 15th day of gestation. Dosages were 50, 100 or 200 mg/kg bw/day.

Maternal weight gain, changes in microscopic examination and 15 biochemical parameters were used to evaluate maternal toxicity. Fetal changes were measured by litter size, fetal weight, deciduoma, skeleton and visceral examination, residue analysis and microscopy.

1,3-dichlorobenzene revealed no teratological effects.