Registration Dossier

Administrative data

Description of key information

28 day oral toxicity study performed, with top dose level of 500 mg/kg resulting in slight changes in blood chemistry, urine effects and liver response.  Limited data provided by ECHA as a result of the Article 26 Inquiry.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
50 mg/kg bw/day

Additional information

28 day oral toxicity study performed, with top dose level of 500 mg/kg resulting in slight changes in blood chemistry, urine effects and liver response. Limited data provided by ECHA as a result of the Article 26 Inquiry so difficult to assess the results fully. It is possible that the findings were 'adaptive', but insufficient information is available. There is no information on the rationale for selecting dose levels; for example, it is unclear why 1000 mg/kg was not selected for top dose or why the 150 mg/kg/day dose level was not selected as an intermediate dose level to aid classification.


Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver

Justification for classification or non-classification

The effects seen at 500 mg/kg/day were possibly adaptive changes and no effects were reported at 50 mg/kg/day. The original notification was reviewed and the responsible CA did not consider that classification was required on the basis of this testing.