Registration Dossier

Administrative data

Description of key information

GLP study utilising registered substance reporting an oral NOAEL of 100 mg/kg/day in the male rat (OECD 408).  In the 
same study, female rats had an NOAEL of 300 mg/kg/day.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
100 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Based on the results of the key study, which tested the registered material, there was a 13% decline in body weights of males at 100 mg/kg/day which did not recover during 28 days of observation. There was no apparent change in any other parameters that could be observed or measured (including histologically), and there were no similar changes in the female rats in the same study. The No Observed Effect Level (NOEL) for oral (gavage) administration of the test material to Crl:CD(SD) rats for 90 consecutive days was 100 mg/kg/day. This is the appropriate value for risk or hazard assessment.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
This OECD 408 90d study is the longest exposure duration and the most reliable source of data from which to derive a NOAEL. Based on the results of this study, oral administration of EXP1503090 to Crl:CD(SD) rats at dosage levels of 30, 100, and 300 mg/kg/day for a minimum of 90 consecutive days resulted in adverse, lower body weights (up to 13.9% lower) with corresponding lower food consumption in the 300 mg/kg/day group males. The lower body weights in the 300 mg/kg/day group males were considered to be the key effect and thus the no observed adverse-effect level (NOAEL) was 100 mg/kg/day for males (and 300 mg/kg/day for females). The value for males was taken forward.

Justification for classification or non-classification

The key study described a reasonable dose/concentration above which a degree of toxic effect was acknowledged. The NOAEL derived was 100mg/kg bw/day, so the substance is not considered to require classification under the terms of Directive 67/548/EEC or GHS as reflected by Regulation (EC) 1272/2008.