3-chloroaniline

Toxicity to reproduction

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

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, 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 generation)

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)