Registration Dossier

Administrative data

Description of key information

Oral:
Relevant NOAEL (equivalent to OECD 407, gavage, rat): 1000 mg/kg bw/d
A 28 -day repeated oral dose toxicity study of the test item followed by a 14 -day recovery study was performed in groups of five male and five female Crl:CD (SD) rats at 5 weeks of age. The high dose was set at 1000 mg/kg/day, and altogether 3 doses including 150 and 25 mg/kg/day were employed. Recovery groups were also set for the 1000 mg/kg and vehicle control groups.
No death occurred and no abnormalities were noted in all examinations.
No abnormalities were noted in the recovery test.
Based on these results, the NOEL and NOAEL of the test item in rats under the present study conditions were estimated to be 1000 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
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
reliable without restrictions

Additional information

see above


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Guideline conform GLP study

Justification for classification or non-classification

Due to the NOAEL of 1000 mg/kg bw/day in a 28 day oral toxicity study (OECD 407) in rats the test substance does not have to be classified regarding systemic and target organ toxicity after repeated exposure according to the criteria laid down in in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).