Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

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

In an oral reproduction/developmental toxicity screening study, performed according to OECD and EPA test guidelines, rats were exposed to 0, 100, 300 and 1000 mg/kg bw/d Radia 7838 by gavage. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 44-47 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation. Accuracy and homogeneity of formulations were demonstrated by analyses. No treatment related changes were noted in any reproductive parameters investigated in this study (i.e. mating, fertility and conception indices, precoital time, and numbers of corpora lutea and implantation sites). Therefore, the reproduction NOAEL was determined to be >= 1000 mg/kg bw/d.


Short description of key information:
An oral reproduction/developmental screening study was perfomed according to OECD 421 and GLP principles. No effects were observed at the highest dose tested, 1000 mg/kg bw/d.

Effects on developmental toxicity

Description of key information
An oral reproduction/developmental screening study was perfomed according to OECD 421 and GLP principles. No effects were observed at the highest dose tested, 1000 mg/kg bw/d
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

In an oral reproduction/developmental toxicity screening study, performed according to OECD and EPA test guidelines, rats were exposed to 0, 100. 300 and 1000 mg/kg bw/d Radia 7838 by gavage. Males were exposed for 29 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 44-47 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation. Accuracy and homogeneity of formulations were demonstrated by analyses. No toxicologically significant changes were noted in any of the developmental parameters investigated in this study (i.e. gestation index and duration, parturition, maternal care and early postnatal pup development consisting of mortality, clinical signs, body weight and macroscopy). Therefore, the developmental NOAEL was determined to be >= 1000 mg/kg bw/d.

Justification for classification or non-classification

Based on the results of the performed studies, the substance is currently not classified for reproduction and developmental toxicity according to CLP Regulation (EC) No. 1272/2008.