Registration Dossier

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Combined repeat dose and reproductive/developmental toxicity screening test of 1-chloro-2 (chloromethyl)benzene in rats.
Author:
Ministry of Health, Labour and Welfare
Year:
1999
Bibliographic source:
Japan Toxicity Testing Reports of Environmental Chemicals, 7, 492-502.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
α,2-dichlorotoluene
EC Number:
210-258-8
EC Name:
α,2-dichlorotoluene
Cas Number:
611-19-8
Molecular formula:
C7H6Cl2
IUPAC Name:
1-chloro-2-(chloromethyl)benzene
Constituent 2
Reference substance name:
alpha,2-dichlorotoluene
IUPAC Name:
alpha,2-dichlorotoluene
Details on test material:
Source: Ihara Chemical Industry Co., Ltd.-Lot
No.T7030-Purity: 99.65%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.1% Tween 80 solution
Duration of treatment / exposure:
Exposure period: male: 14 days before mating and thereafter 31 days,
female: 14 days before mating to day 3 of lactation
Premating exposure period (males): 14 days
Premating exposure period (females): 14 days
Duration of test: male: to day 45 female: to day 3 of lactation
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
2, 10, 50 mg/kg/day
Basis:

Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
> 50 mg/kg bw/day

Results: F1 generation

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 50 mg/kg bw/day

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

Test substance had no effects in reproductive parameters
such as the mating index, the fertility index, number of
corpora lutea or implantations, the implantation index, the
delivery index, the gestation index, gestation length,
parturition or maternal behavior. On examination of
neonates, there were no significant differences in number of
offspring or live offspring, the sex ratio, the live birth
index, the viability index or body weight. No abnormal
findings related to the test substance were found for
external features, clinical signs or necropsy of the
offspring.

Applicant's summary and conclusion

Executive summary:

The study was conducted as a combined repeat dose and reproductive/developmental toxicity screening test according to OECD 422 in compliance with GLP.Test substance was administrated by gavage to rats (12 animals/sex/group) at doses of 0 (vehicle control, 0.1% Tween 80 solution), 2, 10 and 50 mg/kg bw/day. Males were dosed from 14 days before mating to the day before scheduled sacrifice through the mating period (total 45 days). Females were dosed from 14 days before mating to 4 days after delivery through the mating and gestation periods (total 41-48 days). O-Chlorobenzylchloride showed no effect on the following parental reproductive parameters; mating index, fertility index, numbers of corpora lutea and implantations, implantation index, delivery index, gestation index, gestation length, and parturition and maternal behavior. Regarding the examination of neonates, there was no effect of o-Chlorobenzylchloride on the numbers of total offspring and live offspring, sex ratio, live birth index, viability index, or body weight. Also, no compound-related abnormality was found in external features, clinical signs, or autopsy findings of offspring. Based on these observations, the NOAEL for reproductive/developmental toxicity was considered to be 50 mg/kg bw/day in rats.