Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No effects on clinical signs, body weight changes, food consumption or necropsy findings in either sex were detected.

Testicular and epididymal weights were similar among all four groups (No histopathological changes in these reproductive organs of the male rats.)

Parental animals exhibited no effects on reproductive parameters including the copulation index, fertility index, gestation index, delivery index, parturition or maternal behavior.

There were no significant differences in the number of offspring or live offspring, sex ratio, live birth index, viability index, or body weight. No abnormal findings attributable to the test substance were noted in external examination, clinical signs or necropsy of the offspring.


Short description of key information:
The substance is not considered to be toxic to reproduction.

Effects on developmental toxicity

Description of key information
The substance is not considered to be toxic to reproduction. 
Additional information

No effects on clinical signs, body weight changes, food consumption or necropsy findings in either sex were detected.

Testicular and epididymal weights were similar among all four groups (No histopathological changes in these reproductive organs of the male rats.)

Parental animals exhibited no effects on reproductive parameters including the copulation index, fertility index, gestation index, delivery index, parturition or maternal behavior.

There were no significant differences in the number of offspring or live offspring, sex ratio, live birth index, viability index, or body weight. No abnormal findings attributable to the test substance were noted in external examination, clinical signs or necropsy of the offspring.

Justification for classification or non-classification

There are conclusive but not sufficient data for classification of the substance with regard to reproduction toxicity.

The substance is not classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008.