Registration Dossier

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998

Materials and methods

Principles of method if other than guideline:
Groups of 10 male and 10 female F344/N rats were administered 0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight in dilute hydrochloric acid by gavage 5 days a week for 13 weeks. Animals were evaluated for hematology, clinical chemistry, histopathology, and reproductive system effects. Histopathological evaluations were performed on all animals in the vehicle control and 160 mg/kg groups. The following reproductive tissues/organs were examined: testes (with epididymis), prostate gland, seminal vesicle, uterus, vagina, clitoral glands, ovaries and mammary gland. additionally sperm motility and vaginal cytology were examined.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
m-chloroaniline, a pale yellow liquid, was identified by infrared spectroscopy; each spectrum was consistent with a literature reference (Aldrich Library of FT-IR Spectra, 1985) and with that expected for the chemical structure. Gas chromatography indicated a purity greater than 99%.
Boiling Point: 230.5°C
Density at 22°C: 1.210
Vapor pressure: <0.1 mmg Hg at 30°C
Solubility: practically insoluble in water, soluble in organic solvents

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1 M hydrochloric acid
Details on mating procedure:
not applicable - subchronic study
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
5 days a week for 13 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight
Basis:
nominal conc.
No. of animals per sex per dose:
10 male and 10 female rats/dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
160 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No relevant adverse effects on reproductive tissues/organs and sperm motility or vaginal cytology were detected at the highest applied dose (160 mg/kg bw/d).

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

No relevant adverse effects on reproductive tissues/organs and sperm motility or vaginal cytology were detected at the highest applied dose (160 mg/kg bw/d).

Applicant's summary and conclusion

Executive summary:

Groups of 10 male and 10 female F344/N rats were administered 0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight in dilute hydrochloric acid by gavage 5 days a week for 13 weeks. Animals were evaluated for hematology, clinical chemistry, histopathology, and reproductive system effects. Histopathological evaluations were performed on all animals in the vehicle control and 160 mg/kg groups. The following reproductive tissues/organs were examined: testes (with epididymis), prostate gland, seminal vesicle, uterus, vagina, clitoral glands, ovaries and mammary gland. additionally sperm motility and vaginal cytology were examined.

No adverse effects on reproductive tissues/organs and sperm motility or vaginal cytology evaluations were detected at the highest applied dose (160 mg/kg bw/d)