Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: One reliable study is available. In this study, the LD50 (rat) was > 5000 mg/kg bw.
Acute dermal toxicity: No data are available for the dermal route.
Acute inhalation toxicity: No data are available for the inhalation route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
1 - Reliable Guideline study available

Additional information

Acute oral toxicity:

One reliable study is available. In this study the acute oral toxicity was investigated using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations [1993]. A group of ten (5 male and 5 female) albino rats (Wistar) were dosed with 5000 mg/kg of the test material by oral gavage. The animals were observed for 14 days after test material administration for signs of toxicity and mortalities. Gross autopsies were performed on all animals that either died within the 14 day observation period or on surviving animals. There were no mortalities or signs of clinical toxicity. The acute oral LD50 in male and female rats is > 5000 mg/kg bw.

Justification for classification or non-classification

Acute oral toxicity:

An acute oral toxicity study performed using a similar method to that given in 16 CFR 1500.3 of the Federal Hazardous Substances Act Regulations resulted in a LD50 > 5000 mg/kg bw [Costello, 1982]. On the basis of this study classification for acute oral toxicity is not required.