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Description of key information

Acute Oral Toxicity

-LD50 > 2000 mg/kg bodyweight to female Wistar strain rats

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Quality of whole database:
The key study was conducted under GLP conditions in accordance with the standardised guidelines OECD 420. It was asigned a reliability score of1 in accordance with the criteria detailed by klimisch (1997)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 420, EU Method B1 bis under GLP conditions.

Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female rats were given a single oral dose of the test item at a dose level of 2000 mg/kg bodyweight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no mortalities during the course of the study. Signs of systemic toxicity noted six and seven days after dosing were hunched posture, dehydration, pilo-erection and distended abdomen. There were no signs of systemic toxicity noted in the initial treated animal. Three animlas showed body weight loss during the first week with expected gain in body weight during the second week. The remaining two animals showed expected gains in bodyweight.

No abnormalities were noted at necropsy.

The acute oral lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight

Justification for classification or non-classification

In accordance with the critreia for classification as defined in Annex 1, REgulation (EC) No. 1272/2008, the test material does not require classification for acute toxicity.

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