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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

A No Observed Effect-Level (NOEL) of 450 mg/kg bw/day was considered due to the results of the present subchronic repeated dose oral study.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
450 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

The oral toxicity of the test item when given by daily administration to rats at dosages of 50, 150, and 450 mg/kg bw/day has been investigated over a period of 13 weeks and possible recovery from treatment-related changes over a 4 week recovery period.

No signs of toxicity were observed during the "in-life" phase of the study. Slight variations were observed in body weight, clinical chemistry and urine parameters at the end of treatment, all within the range of historical control data. All these changes were no longer evident at the end of recovery. No treatment related changes were seen at histopathological examination.

On the basis of these results, no significant signs of apossible effect of the test item were seen at any of the dose levels investigated. Therefore, the high-dose of 450 mg/kg bw/day may be considered the No Observed Effect Level (NOEL) in this study.

Justification for classification or non-classification

No classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.