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Diss Factsheets

Administrative data

Description of key information

Oral by gavage, subacute (4 weeks) (Rat-Wistar, GLP, OECD TG 407, EU Method B. 7): NOAEL = 40 mg/kg body weight
[Bayer AG, Report No. PH-34876, 2007-04-20]

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

Additional information

Anilinomorpholinon was administered orally by gavage to 10 male and female Wistar rats per dose group, in doses of 0, 0.1, 2 and 40 mg/kg body weight for a period of 28 (males)/29 (females) days. The animals were regularly observed and weighed. Food and water intakes were determined. Clinical laboratory investigations of blood samples were performed. Organs and tissues were subjected to gross and histopathological investigation. Selected organs were weighed. No treatment-related adverse effects were observed up to and including the highest dose administered and therefore, the NOAEL for Anilinomorpholinon given orally by gavage was established at 40 mg/kg in male and female rats.

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.