Registration Dossier

Administrative data

Description of key information

Acute toxicity of the test item was evaluated in two assay according GLP and OECD guideline 401 and 402. The substance did not cause any mortalities or treatment related effects after oral or dermal application. LD50 in rats is therefore greater than 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Procedure and observations

The test article was administered to male and female rats (5 each) at a concentration of 2000 mg/kg bw via the oral route (gavage). Thereafter, the animals were observed for a 14d treatment free period and daily checked for mortalitiy and clinical signs or symptoms. All animals survived until scheduled day of necropsy. Gross necropsy did not reveal any findings. Substance releated effects were not observed.

Five male and five female rats were treated with with the test article at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.25 g/ml and administered at a volume dosage of 8 ml/kg. The application period was 24 hours. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. No deaths occurred during the study. No clinical signs were observed during the observation period. Red staining of the treated skin area produced by the test item was noted in all animals immediately after removal of the dressing and persited up to test day 10. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.

Discussion

The substance is not considered to be acute toxic via the oral or dermal route. LD50 oral / dermal > 2000 mg/kg bw

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute toxicity under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.

                               

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

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 acute toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).