Registration Dossier

Administrative data

Description of key information

The substance is of low acute toxicity by the oral and dermal routes, with acute LD0s higher than 2000 mg/kg kw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

Oral toxicity

The acute oral toxicity of the test item was evaluated in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008) guidelines (Gerbeix, 2009). The test item was prepared in purified water and was administered by oral route (gavage), under a volume of 10 mL/kg, to groups of three fasted female Sprague-Dawley rats. Treatment was first performed at the dose-level of 300 mg/kg. As no death occurred, a second group was treated at the dose-level of 2000 mg/kg. A third group was also treated at the same dose‑level to confirm the absence of mortality at this dose-level. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test item. All animals were subjected to necropsy. Neither mortality nor clinical signs were observed during the study. When compared to CIT historical control animals, the body weight gain of the animals was not affected by treatment with the test item. At necropsy, no apparent abnormalities were observed in any animal. The oral LD0of the test item was higher than 2000 mg/kg in rats.

Dermal toxicity

The acute dermal toxicity of the test item was evaluated in rats according to OECD (No. 402, 24th February 1987) and Commission Regulation (EC) (No. 440/2008, Part B.3, 30 May 2008) guidelines (Gerbeix, 2010). The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. The test item was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females). The application was performed with the test item in its original form at the dose-level of 2000 mg/kg. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test item. All animals were subjected to necropsy. Neither mortality nor systemic clinical signs were observed during the study. A brown coloration of the skin was noted in all animals on day 2. When compared to CIT historical control animals, a slightly lower body weight gain was noted in 1/5 males between day 8 and day 15. The body weight gain of the other animals was not affected by treatment with the test item. No apparent abnormalities were observed at necropsy in any animal. Under the experimental conditions of this study, the dermal LD0of the test item was higher than 2000 mg/kg in rats.

Justification for classification or non-classification

No classification is warranted for oral and dermal acute toxicity under EU Dangerous Substances Directive 67/548/EEC or CLP EU Regulation 1272/2008.