3-chloroaniline

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: scientifically acceptable and sufficient documented

Data source

Reference

Reference Type:

publication

Title:

The detection of carcinogen-induced sperm head abnormalities in mice

Author:

Topham JC

Year:

1980

Bibliographic source:

Mutat Res 69, 149-155 (1980)

Materials and methods

Principles of method if other than guideline:

Groups of 5 (male CBA x female BALB/c) F1 male mice; 10-12 weeks old; received 5 daily i.p. injections of the test substance (25, 50, 100 or 200 mg/kg bw) or vehicle alone (5 ml/kg bw/day). Positive controls (20 mg/kg/day cyclophosphamide monohydrate) are included in the study. 5 weeks after the last dose the mice are killed and sprem from the cauda epididymidis are suspended in saline. Smears of sperm from each animal are dried and stained with Eosin Y. Sperm heads are classified as of normal or abnormal morphology. differences in the incidence of abnormal sprem between the groups are compared using the Wilcoxson Rank Sum Test.

GLP compliance:

no

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

3-chloroaniline

EC Number:

203-581-0

EC Name:

3-chloroaniline

Cas Number:

108-42-9

Molecular formula:

C6H6ClN

IUPAC Name:

3-chloroaniline

Test material form:

other: liquid

Details on test material:

m-chloroaniline was obtained from Aldrich Chemical Co. (Gillingham, England)

Test animals

Species:

mouse

Strain:

other: (male CBA x female BALB/c) F1 male mice

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

5 days

Frequency of treatment:

daily

Duration of test:

5 days treatment and 5 weeks post exposure period

Doses / concentrations

Remarks:

Doses / Concentrations:
25, 50, 100 or 200 mg/kg bw
Basis:

No. of animals per sex per dose:

5 animals per dose

Control animals:

yes, concurrent vehicle

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

200 mg/kg bw/day

Based on:

test mat.

Sex:

male

Basis for effect level:

other: sperm head abnormalities

Any other information on results incl. tables

m-chloroaniline did not significantly increase the incidence of abnormal sperm heads.

Applicant's summary and conclusion

Executive summary:

Groups of 5 (male CBA x female BALB/c) F1 male mice; 10-12 weeks old; received 5 daily i.p. injections of the test substance (25, 50, 100 or 200 mg/kg bw) or vehicle alone (5 ml/kg bw/day). Positive controls (20 mg/kg/day cyclophosphamide monohydrate) are included in the study. 5 weeks after the last dose the mice are killed and sprem from the cauda epididymidis are suspended in saline. Smears of sperm from each animal are dried and stained with Eosin Y. Sperm heads are classified as of normal or abnormal morphology. Differences in the incidence of abnormal sprem between the groups are compared using the Wilcoxson Rank Sum Test.

As a result, m-chloroaniline did not significantly increase the incidence of abnormal sperm heads in the highest applied dose of 200 mg/kg bw (1/2 LD50).