Registration Dossier

Administrative data

Description of key information

The 28-day repeated oral dose toxicity study was performed according to OECD Guideline 407 and GLP principles. In addition, an oral reproduction/developmental screening study was perfomed according to OECD 421 and GLP principles.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

In an oral repeated dose 28 -day toxicity study, performed according to OECD, EC an EPA test guidelines, rats were exposed to 0, 50, 150 and 1000 mg/kg bw/d Radiagreen RA by daily gavage. Formulation analysis confirmed accuracy, homogeneity and stability of formulations. No toxicologically significant changes were noted in any of the parameters investigated, i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, organ weights and macro- and microscopic examinations. Therefore, the NOAEL was determined to be >= 1000 mg/kg bw/d.

In an oral reproduction/developmental 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 parental parameters investigated, i.e. clinical appearance, body weight, food consumption, macroscopic examination, organ weights and microscopic examination. Therefore, the parental 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 not classified for repeated dose toxicity according to CLP Regulation (EC) No. 1272/2008.