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Administrative data

Description of key information

A subacute toxicity study on rats  (OECD 407, GLP) was performed to evaluate the repeated dose toxicity of the substance. The test item did not induce any mortalities, abnormalities or clinical symptoms. Based on the results of these studies, the NOEL and the NOAEL of the test substance is 1462.9 for male and 1552.1 mg/kg bw /d for female rats.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 462.9 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Procedure and observations

The test item was administered to male and female Wistar rats at dietary concentrations of 0, 1,500, 5,000 and 15,000 ppm (BASF AG 2002a). Control and high dose group consisted of each 10 animals per sex whereas low and mid dose group consisted of each 5 animals per sex. After 4 weeks of treatment 5 animals per sex of all dose groups were sacrificed (main groups). The remaining 5 animals per sex of control and high dose group were maintained for another 14-days without administration of the test substance. All animals were examined for clinical signs, body weight changes and food consumption, effects on biochemical parameters and hematology. Urinalysis as well as a functional observation battery were also performed.

No substance related effects were observed after treatment and after recovery period. The test substance did not cause mortalities or sings of toxicity and gross necropsy as well as histopathology was without findings. The only substance related effect was a yellow discoloration of the faeces.

Discussion

The test substance did not induce any mortalities, abnormalities or clinical symptoms. The only remarkable finding in the pre-study was a yellow discoloration of faeces. This incidental finding was considered to be due to the presence of the test substance in the faeces and not a manifestation oif toxicity. Thus, the no-observed-adverse-effect level (NOAEL) under the conditions of the present study was 15,000 ppm for both sexes or 1462.9 mg/kg bw for male and 1552.1 mg/kg bw for female rats, respectively.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for repeated dose toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EU) 2018/1480.