Registration Dossier

Administrative data

Description of key information

The test item benzoic acid isononylester is of low acute toxicity as shown by the follwoing results:
Acute toxicity oral (by gavage): LD50 > 2500 mg/kg
Acute toxicity dermal: LD50 > 2000 mg/kg
Acute toxicity inhalation: LC50 > 5.2 mg/L

Key value for chemical safety assessment

Additional information

Acute Toxicity, oral exposure route: A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test material was administered orally undiluted. 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 over the study period Necropsy: No abnormalities were noted at necropsy

Conclusion: The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated from the flow chart given in the respective OECD guideline as being greater than 2500 mg/kg bodyweight. The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC.

Acute Toxicity, dermal exposure route: A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of undiluted test material to intact skin 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. Dermal Irritation: There were no signs of dermal irritation.

Bodyweight: All animals showed expected gains in bodyweight over the study period. Necropsy: No abnorrnalities were noted at necropsy.

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

Acute Toxicity, Inhalation exposure: A study was performed to assess the acute inhalation toxicity of the test material. The method used followed that described in the OECD Guidelines far Testing of Chemieals (1981) No. 403 "Acute Inhalation Toxicity" referenced as Method B2 in Commission Directive 92/69/EEC "Acute Toxicity - Inhalation" (which constitutes Annex V of Council Directive 67/548/EEC).

A group of ten Sprague-Dawley Crl:CD® (SD) IGS BR strain rats (five males and five females) was exposed to an aerosol atmosphere. The animals were exposed far four hours using a no se only exposure system, followed by a fourteen day observation period. No deaths occurred in a group of ten rats exposed to a mean achieved atmosphere concentration of 5.22 mg/L. It was therefore considered that the acute inhalation median lethal concentration (LC50) of Benzoic acid isononylester, in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, was greater than 5.22 mg/L.

Justification for classification or non-classification

EU classification according to Annex VI of Directive 67/548/EEC: no classification required

GHS classification (GHS UN rev.2, 2007): no classification required

The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated from the flow chart given in the respective OECD guideline as being greater than 2500 mg/kg bodyweight. The test material does not meet the criteria for classification according to EU labelling regulations Commission Directive 2001/59/EC.

The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations Commission Directive 2001/59/EC far classification and labelling of dangerous substances and preparations.

The acute inhalation median lethal concentration (LC50) of Benzoic acid isononylester, in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, was greater than 5.22 mg/L.