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Administrative data

Description of key information

Oral LD50 in rats for both sexes combined = 4600 mg/kg.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
4 600 mg/kg bw

Additional information

Acute oral toxicity

An acute oral toxicity study was conducted in rats. No formal official test guideline was available at the time of the test, and no formal claim of GLP compliance was made, although the study report contained a quality assurance statement.

A preliminary test was conducted at dose levels 1000 and 5000 mg/kg; two animals per sex per dose level were administered a single oral dose, then observed for clinical signs for five days. On the basis of this preliminary study, dose levels for the main study were determined.

In the main study five rats per sex per dose level were administered a single oral dose by gavage. Dose levels in the main study were 0 (control level), 1600, 2500, 4000, and 5000 mg/kg bodyweight. Following test substance administration, the animals were observed for clinical signs and mortality for 14 days. Surviving animals were sacrificed on day 14 of the observation period and a macroscopic post mortem examination of each animal was conducted.

The acute median lethal oral dose and their 95% confidence limits to rats of the test substance were estimated to be:

Males and females combined: 4600 (4200 to 5000) mg/kg bodyweight..

Males Only: 4700 (4100 to 5400) mg/kg bodyweight.

Females Only: 4500 (3900 to 5100) mg/kg bodyweight.

Justification for classification or non-classification

The determined acute oral toxicity gave an LD50 value greater than 2000 mg/kg for both sexes. On this basis the test substance does not require clasification as acutely toxic according to either the Dangerous Substances Directive (Directive 67/548/EEC) or the CLP Regulation (EC Regulation 1272/2008).