Registration Dossier

Administrative data

Description of key information

LD50 (Oral, rat) > 5000 mg/kg bw.
LD50 (Dermal, rat) >= 2000 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

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

Additional information

An acute oral toxicity study (Hazleton Laboratories America., 20011) was conducted in rats. Five male and five female rats received a single dose (5000 mg/kg bodyweight), then were observed for mortality and clinical signs. No animals died, and there were no abnormal findings at necropsy.

An acute dermal toxicity study was conducted (Parmakon Europe) in Sprague Dawley Rats according to OECD test guideline 402. Five males and five females were dosed at 2000 mg/kg with the test material in sterile codex liquid paraffin vehicle; the test material was applied and the test site secured with a semiocclusive dressing for 24 hours. No animals died, and no signs of local or systemic toxicity were observed.Only some kidney lesions may be noted, at the highest dose level group.

Justification for classification or non-classification

The LD50 for both oral and dermal exposure were determined to be greater than 2000 mg/kg for acute exposure; on this basis T-1540N does not trigger the criteria for classification as acutely toxic, according to EC Regulation 1272 /2008.