Registration Dossier

Administrative data

Description of key information

The test material is not acutely toxic. 

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

Acute toxicity: oral (OECD TG 401)

In an acute oral toxicity study, fasted Sprague-Dawley strain Albino rats (five male and five female) were given a single oral dose of undiluted test material at a dose level of   5000  mg/kg bw and observed for 14 days (Costello, 1982).

All animals appeared ruffled up to 3 h after treatment; they appeared oily and dirty after 24h, but appeared normal thereafter. One male rat died on day 2 with the remaining animals exhibited a discharge around the eyes and nose. They appeared essentially recovered after 72 h and continued to appear normal throughout the remainder of the observation period. Gross pathologic examination revealed nothing remarkable.

The oral LD50 value of test material in rats of both sexes has been determined to be greater than 5000 mg/kg and the substance was considered not toxic.

Acute toxicity: dermal (OECD TG 434)

This substance does not show adverse toxicity effects via the dermal route of exposure in rabbits when tested in accordance with OECD 434 (Morris, 1991). The treated skin surface of animals showed irritation after test material removal, but there were no other clinical signs of toxicity or behavioral changes over the 15 day observation period. Macroscopic examination of all animals at the end of the study did not reveal any changes that were considered to have arisen as a result of treatment. The rabbit dermal LD50 is greater than 2000 mg/kg.

Justification for classification or non-classification

In accordance with EU CLP (Regulation (EC) No. 1272/2008), classification of this substance is not required for acute toxicity.