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Key value for chemical safety assessment

Effects on fertility

Description of key information
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.
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
160 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Guideline studies according OECD 408
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

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


Short description of key information:
Groups of 10 male and 10 female F344/N rats and B6C3F1 mice 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.

Justification for selection of Effect on fertility via oral route:
Valid subchronic toxicity studies with a detailed histopatological investigation of the reproductive organs in rats and mice are available.

Effects on developmental toxicity

Description of key information
no data
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No data

Toxicity to reproduction: other studies

Additional information

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).

Justification for classification or non-classification