Registration Dossier

Administrative data

Description of key information

LD50 (rat) oral > 5000 mg/kg
LD50 (rat) dermal > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via inhalation route

Endpoint conclusion

Acute toxicity: via dermal route

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

Additional information

Acute oral toxicity:

The test item was administered by oral route to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. No mortality occurred during the study. No clinical signs related to the administration of the test item were observed.The body weight evolution ofthe animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50of the test item is higher than 5000 mg/kg body weight by oral route in the rat.

Acute dermal toxicity:

The test item was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight.

No mortality occurred during the study. Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.

The body weight evolution of the animals remained normal throughout the study, similar between treated and control animals. The macroscopical examination of the animals at the end of the study did not reveal treatmentrelated changes.

In conclusion, the LD50of the test item is higher than 2000 mg/kg body weight by dermal route in the rat.

Justification for classification or non-classification

Not to be classified according to Regulation (EC) No 1272/2008