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Key value for chemical safety assessment

Toxic effect type:

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
1 000 mg/kg bw/day
Study duration:
Additional information

In a well conducted GLP and guideline B.7 study using Sprague-Dawley (Crl: CD VAF) rats, 60 rats (30 female and 30 male) per group were gavaged with Chiguard

380/Chiguard 380W at dose of 0mg/kg or mg/l,15 mg/kg or mg/l, 150 mg/kg or mg/l, 1000 mg/kg or mg/l for 7 days a week. Administration of the substance to the male and female rats bagan 70 days and 14 days before mating, respectively, and continued to euthanasia. In addition, a satellite group of 10 male rats were added to the high dose group (1000 mg/kg/bw) and the animals were euthanized following 28 days of exposure. The testes from these animals were preserved, proccessed, and evaluated microscopically. Another treatment group (1 mg/kg bw/day) of 30 males was also added to this study and treated as described for the main study groups with exception that males were not mated to females, and all tissues collected were preserved but microscopic examination was not conducted. At weaning, selected male pups were continued exposed on study for 67 days (90 ± 2 days of age). During this time, body weights, food consumption, and daily observations were recorded. Necropsies were conducted at termination of exposure, specified tissues were weighed and collected, and microscopic evaluation from the control and high-dose group (1000 mg/kg/day) animals were conducted. Sperm motility and concentration were evaluated in P1 and F1 males. There were no treatment related-finding. The NOAEL was 1000 mg/kg bw/day.

Short description of key information:

NOAEL(P): 1000mg/kg bw/day (EU method B.7)

Justification for classification or non-classification

Based on the available information in the dossier, the substance Chiguard 380/Chiguard 380W (CAS# 18600-59-4) need not to be classified as reproductive toxicity when considering the criteria outlined in Annex VI of 67/548/EEC and in Annex I of 1272/2008/EC.

Additional information