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Diss Factsheets

Administrative data

Description of key information

Skin irritation: Negative.
Eye irritation: Negative.

Key value for chemical safety assessment

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Two studies were conducted to assess the potential toxicity to skin and eyes of rabbits following guideline and GLP principles.

The primary skin irritation potential of FAT 41'029/A was investigated by topical application of 0.5 g to 6 cm2 intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The test article did not elicit any skin reactions at the application site at any of the observation times (all scores 0). The mean values from 24 to 72 hours were therefore 0 for erythema and for oedema. Light red staining produced by the test article of the treated skin was seen in all animals one hour after treatment. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Thus, FAT 41'029/A is considered to be "not irritating" to rabbit skin.

The primary irritation potential of FAT41'029/A was investigated by instillation of 0.1 g into the left eye of each of three young adult New Zealand White rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary irritation score was 0.11 (max. 13).The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris,grade 0.11 redness of the conjunctivae and grade 0.00 chemosis of the conjunctivae. A slight corneal opacity was seen in one animal at the 1- hour examination. Slight to moderate conjunctival redness was observed in all animals at the first hour and persisted in only one animal 24 hours later. Slight conjunctival swelling was noted in one animal at the 1-hour examination. A slightly reddened sclera was observed in two animals at the first hour, persisted in one animal at the 24 hours, disappeared in the second one and appeared in the third animal. All eye reactions were clear within 48 hours after treatment.Red-brown remnants of the test article in eye or conjunctival sac were observed in the female animals one hour after treatment.No corrosion was observed at any of the measuring intervals.Thus, FAT41'029/A is considered to be not irritating to the rabbit eye.

Justification for classification or non-classification

The test substance shall not be classified according to the CLP regulation (Regulation EC No. 1272/2008) or DSD (Directive 67/548/EEC) for skin or eye irritation/corrosion. Data on respiratory irritation are not available.