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Description of key information

The NOAEL for systemic toxicity after repeated substance application via oral gavage (28 to 56 days) was reported to be 50 mg/kg body weight/day in rats (i.e. no systemic effects were seen  up to the highest dose tested in this OECD 422 conducted under GLP standards). 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

Additional information

In a guideline study (OECD 422) the test substance was administered by daily oral gavage to male and female Wistar rats at dose levels of 0, 10, 25 or 50 mg/kg body weight/day. The males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 28 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum,and at least 3 days of lactation (for 38 to 56 days).

There were no changes for mortality, clinical signs, body weight, food consumption, functional observations, clinical laboratory investigations, organ weights, or microscopic examination, that were considered to be an effect of treatment. Based on the findings on the stomach observed macroscopically, the parental No Observed Adverse Effect Level (NOAEL) for local effects was established at 25 mg/kg body weight/day. The parental NOAEL for systemic toxicity of 50 mg/kg body weight/day was established for the submission substance (as no effects were seen and this is the highest dose tested).

Justification for classification or non-classification

Based on the available data no classification according to Regulation (EC) No. 1272/2008 on specific target organ toxicity is warranted. Furthermore no classification according to Council Directive 67/548/EEC is needed.

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