Registration Dossier

Administrative data

Description of key information

Repeat dose study by gavage in accordance with OECD Test Guideline 407  is available for this substance 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

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

Additional information

Oral administration of the test substance to rats by gavage in accordance with OECD Test Guideline 407 (1995) produces treatment related microscopic changes in the adrenal glands of the male and female rats and kidneys of the male rats of the 150 and 500 mg/kg/day groups. The adrenal gland changes are accompanied by an increase in adrenal weight only at the high doses level. The male kidney effects are accompanied by an increase in hyaline droplets which is consistent with male rat species specific effect resulting from the excessive accumulation of α2-microglobulin in renal proximal tubular epithelial cells. Microscopic changes also are present in the stomach of the male and female rats of the 500 mg/kg/day group and these changes were possibly treatment related. Landing foot splay was statistically significantly decreased in mid- and high-dose females, and rectal temperature was also statistically significantly decreased in the high-dose females. However, because landing foot splay was not increased and there were no statistically significant differences in mean motor activity data or other functional observational battery parameters, this is not considered to be evidence of serious adverse effects. Therefore, the no observable adverse effect level (NOAEL) for this study is 150 mg/kg/day, and the no observable effect level (NOEL) is 50 mg/kg/day.

Justification for classification or non-classification

In accordance to Directive 67/548/EEC and EU CLP (Regulation (EC) No. 1272/2008), classification of this substance is not required for prolonged exposure.