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Description of key information

The LD50 value derived from the acute oral toxicity study with FeNaEDDHA is > 2000 mg/kg bw. The dermal LD50 is > 2000 mg/kg bw. The inhalation (4h) LC50 is > 4200 mg/m³ air.

Key value for chemical safety assessment

Additional information

Oral route

In two acute oral toxicity studies according to OECD Guideline 401 and GLP, the LD50 in albino rats and Sprague-Dawley CD strain rats was determined to be greater than 2000 mg/kg bw. Body weight development was not impaired. No deaths occurred in both studies.

Inhalation route

An acute inhalation toxicity study, according to OECD Guideline 403 was performed in albino rats. Upon a four-hour acute inhalation exposure and a 14-days post-treatment observation period, no mortalities were elicited by the test item at a concentration of 4202 ± 188 mg/m³. From the absence of mortalities it can be assumed that the LC50 to both sexes is greater than 4200 mg/m³ air. The animals of both sexes exposed to the test article experienced the symptoms piloerection and dyspnoea to a similar extent. They recovered within 5 days. At autopsy, no deviations from normal morphology could be detected in all animals.

Dermal route

Two acute dermal toxicity studies (limit test), according to OECD Guideline 402 were performed with the test substance in albino rats and Sprague-Dawley CD strain rat.

All animals survived the 2000 mg/kg bw dermal application. No mortalities occured in both studies and body weight development was not impaired.

The acute dermal LD50 -values of FeNaEDDHA were considered to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result, the substance is not considered to be classified for acute oral, inhalation and dermal toxicity under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.