3-Pyridinecarbonitrile, 4-methyl-2,6-bis[(4-methylphenyl)amino]-5-[2-[2-(trifluoromethyl)phenyl]diazenyl]-

Endpoint summary

Description of key information

No mortality was observed in acute oral and dermal toxicity studies in rats after with 2000 mg/kg bw. The studies were performed according to OECD testing guidelines 423 and 402 and under GLP (RCC 2003).

Additional information

Acute oral toxicity:

Three male and three female HanBrl: WIST (SPF) rats were treated with test item by oral gavage administration at a dosage of 2000 mg/kg body weight according to EU method B.1 tris and OECD guideline 423. The test item was diluted in vehicle (PEG 300) at a concentration of 0.1 g/mL and administered at a dose volume of 20 mL/kg bw. 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 median lethal dose of the test item after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight.

Acute dermal toxicity:

Five male and five female HanBrl: WIST (SPF) rats were treated with test item at a dose of 2000 mg/kg by dermal application according to EU method B.3 and OECD guideline 402. The test item was diluted in vehicle (PEG 300) at a concentration of 0.3333 g/mL and administered at a dose volume of 6 mL/kg bw. The application period was 24 hours. 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. No deaths occurred during the study. No clinical signs were observed during the course of the study. Orange discoloration produced by the test item on the test site was observed in all animals immediately after removal of the dressing on test day 2 and persisted up to test day 11 (two animals), test day 13 (seven animals) and test day 15 (one animal). 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 median lethal dose of test item after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight.

Experimental data on acute inhalation toxicity is not available.

Justification for classification or non-classification

Based on available data, the test item does not need to be classified or labelled for acute oral and dermal toxicity according to Directive 67/548/EEC (DSD) and Regulation 1272/2008 EC (CLP).