Registration Dossier

Administrative data

Description of key information

The Primary skin irritation study in rabbits (4-Hour Semi-occlusive application) was conducted under GLP in accordance with OECD no.404 and EC Guideline B.4 ".
Study no. 842958 performed on July 22, 2002.
The Primary eye irritation study in rabbits was conducted under GLP in accordance with OECD no.405 and EC Guideline B.5 ".
Study no. 842959 performed on July 22, 2002.
Testing facility: RCC Ltd, Switzerland

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The skin irritation potential was investigated by topical semi-occlusive application of 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was 4 hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hrs, as well as 7 days after removal of the dressing.

The application of FEBA1 did not elicit any skin reactions at the application site of any animal at any of the observation times. The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0. A light yellow staining was, however, noted at the test site of all animals during the observation period for all animals. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals.

The primary eye irritation potential was investigated by instillation of 0.1 g into one eye of each of 3 young adult New Zealand White rabbits. Scoring of irritation effects was performed app.1, 24, 48 and 72 hrs after test item application. The scores of each animal at the following reading times (24, 48, 72 hrs) were used in calculating the respective mean values for each type of lesion.

The primary irritation score was calculated by totaling the mean cumulative scores at 24, 48, 72 hrs and then dividing the resulting total by the number of data points. The primary eye irritations core was 0.78 (max 13).

The eye reactions consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.78 redness of the conjunctivae and grade 0.00 chemosis of the conjunctivae. The instillation of FEBA1 resulted in mild, early-onset and transient ocular changes. Reddening of the conjunctivae and sclerae was observed in all animals. These effects were reversible and were no longer evident 72 hrs after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal. No corrosion was oserved. No stining of the treated eyes by the test item was observed.

Justification for selection of skin irritation / corrosion endpoint:
One available study

Justification for selection of eye irritation endpoint:
One available study

Justification for classification or non-classification

The test item did not induce significant or irreversible damage to the skin and to the eye and it's considered not irritating to rabbit skin and eye.