1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methylbutane-1-sulphonamide

Endpoint summary

Description of key information

Acute oral and dermal toxicity studies have been conducted on C4 alcohol. The results of the studies were:

Acute oral toxicity is greater than 2000 mg/kg when tested according to OECD 423.

Acute dermal toxicity is greater than 2000 mg/kg when tested according to OECD 402.

Additional information

Acute Oral Toxicity:

An assessment of acute oral toxicity with the test article in female and male Wistar rats was employed using the acute toxic class method. The study was carried out based on OECD 423 and the EC Commission Directive 96/54/EC, Part B.1. The test article was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Lethargy, uncoordinated movements, hunched posture and/or chromodacryorrhoea were noted among the females between days 1 and 3. Lethargy and uncoordinated movements were noted among the males between days 1 and 2. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 values of the test article in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test article does not have to be classified and has no obligatory labelling requirement for oral toxicity.

Acute Dermal Toxicity:

The acute dermal lethality potential of the test article was evaluated in female Wistar Han rats. The study was conducted according to OECD 402 (2017) in compliance with OECD GLP regulations. The test article was homogenized in polyethylene glycol 400 (PEG 400) prior to dosing so as to deliver 2,000 mg/kg body weight to each animal at a dose volume of 10 mL/kg body weight. One day before dosing, an area of approximately 5x7 cm on the back of the animals was clipped. The test item was applied in an area of approximately 10% of the total body surface, i.e. 18 cm² for females. The test item was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages. The application period was 24 hours, after which the dressing was removed and the skin cleaned of residual test item using water. Initially, the test article was administered to a single female Wistar Han rat by a single dermal application at 2000 mg/kg body weight for 24 hours in a range finder study. Based on the results, the main study was performed by dosing two females at 2000 mg/kg. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred. Chromodacryorrhoea (snout) was noted for one animal on Day 1 only. No irritation was noted for any of the animals at any time point. The body weight gain shown by the animals during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. Based on the results of the study, the dermal LD50 of the test article is rats is greater than 2,000 mg/kg body weight.

Justification for classification or non-classification

The test article is not classified for acute oral or dermal toxicity according to GHS classification criteria.