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Key value for chemical safety assessment

Toxic effect type:
dose-dependent

Effects on fertility

Description of key information

Under the conditions of the test (OECD TG 422, GLP), the systemic NOAEL was determined to be 150 and mg/kg bw based on the increase of liver weights effect. The fertility NOAEL is >= 500 mg/kg bw based on the absence of an adverse effect. The developmental NOAEL is >= 500 mg/kg bw based on the absence of an adverse effect.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Additional information

This executive summary is the same as presented in the repeated doses toxicity section.


In a combined 28-days repeated dose toxicity study with reproduction/developmental screening performed in accordance with OECD TG 422 and GLP, the substance was administrated via oral gavage to Sprague-Dawley rats (10 per dose per sex) at dosages of 50, 150 and 500 mg test item/kg bw/day. Control animals received the vehicle, corn oil, alone. All parameters measured from the OECD TG 422 have been recorded.


Clinical signs: No adverse effects considered to be associated with treatment were observed for mortality, clinical signs, neurobehavior, bodyweight and food consumption.


Haematology: No adverse effects considered to be associated with treatment were observed.


Biochemical parameters: No adverse effects considered to be associated with treatment were observed.


Organ effects weight: Absolute and body weight adjusted liver weights were increased in all groups of treated males with a dose response apparent and statistical significance attained at 500 and 150 mg/kg/day for the adjusted values. Compared to Control, absolute and adjusted kidney weights were also increased in all groups of treated males with statistical significance attained for the adjusted values at 500 mg/kg/day, but there was no dose response apparent. On Day 13 of lactation, absolute and body weight adjusted liver weights for females that received 500 or 150 mg/kg/day were higher with statistical significance attained at 500 mg/kg/day for adjusted weights. Absolute and body weight adjusted spleen weights were lower in all treated females statistical significance was attained for all treated groups for the adjusted weights.


Macroscopy and histopathology: No adverse effects considered to be associated with treatment were observed.


Fertility: No adverse effects considered to be associated with treatment were observed.


Development: No adverse effects considered to be associated with treatment were observed.


Under the conditions of this study, the NOAEL for repeated dose toxicity was established to be 150 mg/kg bw/day for males and females, based on the increase in liver weights effect. The fertility NOAEL is >= 500 mg/kg bw based on absence of reproductive toxicity up to the highest dose level tested. The developmental NOAEL is >= 500mg/kg bw based on absence of developmental toxicity up to the highest dose level tested. Based on the results of the available repeated dose studies the substance does not have to be classified for reproductive toxicity (fertility and developmental toxicity) according to EU CLP (EC 1272/2008 and its amendments).

Effects on developmental toxicity

Description of key information

See "toxicity to reproduction part" for more information.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed

Justification for classification or non-classification

Based on the results of the available Repeated dose study and Reproductive / Developmental toxicity screening the substance does not have to be classified for reproductive toxicity (fertility and developmental toxicity) according to EU CLP (EC 1272/2008 and its amendments).

Additional information