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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Based on investigations on sex organs and sperm staging in a subacute repeated dose study performed according to current guidleines and GLP
Additional information

In a 28 -day oral gavage study in rats receiving up to 1000 mg/kg bw of the test item per day for 28 consecutive days, no effects on male and female sex organs was observed. The study included an an extended histopatholgy of the male sex organs including sperm staging .No test substance related effects on the sex organs up to the highest dose tested were observed. This indicates that on a screening level there is no immediate concern for possible effects on fertility.


Short description of key information:
In a 28 -day oral gavage study in rats receiving up to 1000 mg/kg bw of the test item per day for 28 consecutive days, no effects on male and female sex organs was observed. The study included an an extended histopatholgy of the male sex organs including sperm staging .No test substance related effects on the sex organs up to the highest dose tested were observed. This indicates that on a screening level there is no immediate concern for possible effects on fertility.

Justification for selection of Effect on fertility via oral route:
In a 28 -day oral gavage study in rats receiving up to 1000 mg/kg bw of the test item per day for 28 consecutive days, no effects on male and female sex organs was observed. The study included an an extended histopatholgy of the male sex organs including sperm staging .No test substance related effects on the sex organs up to the highest dose tested were observed. This indicates that on a screening level there is no immediate concern for possible effects on fertility.

Effects on developmental toxicity

Description of key information
No effects on prenatal embryo-fetal development were observed at the maximum recommended dose of 1000 mg/kg bw day administered to female Spraque-Dawley rats between day 5 and day 19 of gestation. No maternal toxicity was observed at this dose level as well.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Oral guideline conform developmental toxicity study in rats according to recent guidelines and under GLP. No effects were observed at the recommended upper limit dose of 1000 mg/kg bw/day.
Additional information

Based on the absence of developmental effects in a pre-natal study for developmental toxicity in Spraque Dawley rats receiving the test substance up to the maximum recommended dose level of 1000 mg/kg bw/day by oral gavage the substance is not considered to have any effects on the developing embryo or fetus and it is consequently not classified for developmental toxicity.

Justification for classification or non-classification

Based on the available data that did not show any effect of the test substance on male and female sex organs in a 28 -day oral gavage study in rats up to a dose level of 1000 mg/kg bw/day and the absence of effects on developmental toxicity in a prenatal developmental toxicity study in rats up to dose levels of 1000 mg/kg bw/day a classification for reproductive endpoints is not warranted.