Registration Dossier

Administrative data

Description of key information

The toxicity of the test item was evaluated when administered daily to rats by the oral route for 13 consecutive weeks and to investigate possible recovery from any treatment-related effects during a 4 week recovery period in accordance with OECD guideline 408. No changes of toxicological importance were seen at any of the dose Ievels investigated and, therefore, the No Observed Effect Level (NOEL) in this study is considered to be 1000 mg/kg/day/bw.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 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 75, 250 and 1000 mg/kg/day has been investigated in accordance with OECD guideline 408 over a period of 13 weeks and possible recovery from any treatment-related changes over a 4 week additional period. No biologically relevant treatment-related changes were observed. Statistically significant variations in food consumption and clinical chemistry parameters, as well as those in organs weights, were slight, in many cases not consistent between sexes and always within historical control values. No treatment related changes were observed at histopathological examination. No treatment-related local changes were observed at the site oftreatment (i.e. the mucose of the gastro-intestinal tract). Furthermore, no adverse systemic effects were observed. No changes of toxicological importance were seen at any of the dose Ievels investigated and, therefore, the No Observed Effect Level (NOEL) in this study is considered to be 1000 mg/kg/day/bw.

Justification for classification or non-classification

Based on the results obtained from the repeated dose testing, the test item was not classified and labelled for specific target organ toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).