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Description of key information

LD50(oral) > 2000 mg/kg (RCC, 2002)
LD50(dermal) > 2000 mg/kg (RCC, 2002)

Key value for chemical safety assessment

Additional information

Acute oral toxicity:

Three male and three female HanBrI: WIST (SPF) rats were treated with the test substance by oral gavage administration at a dosage of 2000 mg/kg body weight (RCC, 2002). The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a volume dosage of 10 ml/kg. The study was conducted according to OECD 423 guideline and GLP. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The LD50(oral) is greater than 2000 mg/kg bw.

Acute dermal toxicity:

Five male and five female HanBrI: WIST (SPF) rats were treated with the test substance at 2000 mg/kg by dermal application (RCC, 2002). The test item was diluted in vehicle (PEG 300) at a concentration of 0.5 g/ml and administered at a volume dosage of 4 ml/kg. The application period was 24 hours. The study was conducted according to OECD 402 guideline and GLP. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Morality/viability was recorded twice daily during test days 1-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. No systemic signs of toxicity were observed during the study period. A slight green-yellow staining was present at the test site of all animals from day 2 to 7. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The LD50(dermal) is greater than 2000 mg/kg bw.

Justification for classification or non-classification

No classification and labeling is required according to DSD-DPD and CLP, as both the oral and dermal LD50 was greater than 2000 mg/kg with no mortality observed in both studies.