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Description of key information

The submission substance was found to be non-toxic by the oral and dermal routes of exposure during OECD Guideline studies. A study to determine the inhalation toxicity of the submission substance was not conducted due to it being deemed inappropriate with regard to the lack of exposure by this route.

Key value for chemical safety assessment

Additional information

A study was performed to assess the acute oral toxicity of the test material in the Wistar 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” (2001)

§        Method B1 bis Acute Toxicity (Oral) of CommissionRegulation (EC) No. 440/2008

Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test material, as a solutionin 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.

The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (Globally Harmonised Classification System-Unclassified).

A study was performed to assess the acute dermal toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:

§        OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)

§        Method B3 Acute Toxicity (Dermal) of CommissionRegulation (EC) No. 440/2008

Initially, two animals (one male and one female) were given a single, 24-hour, semi-occluded dermal application of the undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Based on the results of the initial test, a further group of eight animals (four males and four females) was similarly treated. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.

The above studies have been ranked Reliability 1 according to the scoring system of Klimisch et al. This ranking was deemed appropriate because the studies were conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies which do not affect the quality of relevant results.

A study to assess the toxicity of the submission substance by the inhalation route of exposure was deemed inappropriate due to the lack of exposure by this route.

Justification for classification or non-classification

The submission substance did not meet the criteria for classification as toxic or harmful by the oral and dermal routes of exposure according to the EU labelling regulations. Data is lacking as regards the submission substance's classification as regarding the inhalation route of exposure.