Registration Dossier

Administrative data

Description of key information

A 28-day repeated dose toxicity study was carried out according to a method similar or equivalent to OECD guideline 407. 10 rats [BOR:WISW (SPF Cpb)] per sex and dose received 0, 50, 200 or 800 (after 3 days 600) mg/kg bw/day. Test item was prepared in water to give a constant volume of 5 ml/kg over a period of 4 weeks by stomach tube. 
At the high dose level sedation and narcosis, hypothermia, retarded body weight gain in connection with lower feed consumption and increased mortality were found to occur. Changes in the haematology and clinical chemistry parameters were seen at doses of 200 mg/kg body weight and above (increased neutrophil count, polychromasia) and particularly at the high dose level (decreased leukocyte count and haemoglobin concentration, anisocytosis, elevated alanine aminotransferase activity, elevated cholesterol level as well as bilirubin and total protein concentration). Macroscopic examination and histopathology did not reveal any changes. The no observed effect level (NOAEL) is 50 mg/kg body weight.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
50 mg/kg bw/day
Study duration:

Additional information

Justification for classification or non-classification