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Administrative data

Description of key information

Sanders, 2007: The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute Oral Toxicity (Sanders 2007)

Introduction.The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:

• OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 17 December 2001)

• Method B1 bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC

Method.Following a sighting test in which there was no mortality at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in arachis oil BP at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality.There were no deaths.

Clinical Observations.There were no signs of systemic toxicity.

Bodyweight.All animals showed expected gains in bodyweight.

Necropsy.No abnormalities were noted at necropsy.

Conclusion.The discriminatory dose was identified as 2000 mg/kg bodyweight.

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight. The test material was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification according to Commission Directive 200l/59/EC for classification and labelling of dangerous substances.

Justification for classification or non-classification

An acute oral toxicity study concluded that the acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.

Furthermore studies were not performed to assess toxicity via the dermal and inhalation routes as based on the physical-chemical properties of the material and the use of the substance, these routes are not considered to be significant routes of exposure.

Based on the above information, the test material is not considered to be classified for acute toxicity.