Registration Dossier

Administrative data

Description of key information

Please refer to section 7.3 for the description of the irritation effects and to 7.4 for the description of the sensitisation effects. 

Additional information

Sensitisation

Human patch tests

T. Fujii, S. Furukawa and S. Suzuki, 1972 (Yukugaku 21 (12) pg 904 -908).

In a closed human patch study the skin sensitizing potential of the test item was tested. The test was conducted with 7703 subjects suffering from dermatoses. The test item item was applicated to the upper inside of the arm. Ethanol 99% and a non-irritative cream base were used as vehicle. A concentration of 0.05 -0.5 % were applicated. Only in one subject erythema reactions were found. According to this result the test item can be considered as not sensitizing.

Skin irritation

Human patch study of T. Fujii, S. Furukawa and S. Suzuki, 1972 (Yukugaku 21 (12) pg 904 -908).

In a closed human patch study the skin irritation potential of the test item was tested. 1763 healthy male and female subjects were tested in condition 1 and 1830 subjects in condition 2. The following application way was chosen: In condition 1 the site of application was the small of back in condition 2 the upper inside of arm. Vaselinum Aldum, Unguentum Hydrophilicum were used as vehicle in condition 1 and Unguentum Simplex, Unguentum Hydrophlicum were used as vehicle in condition 2. The test item was applied in a concentration of 3 -20 % and in a concentration of 0.2 -2 %. No irritation reactions were observed in 30 subjects.

Human patch study of A.E. Katz, 1946 (The Spice Mill 69 pg 46-47)

A 24 hour closed patch test was conducted on male and female volunteers. Test material was applied undiluted to an area on the inner arm of the subjects measuring 1 cm in diameter. Immediately following application, the area was covered with an adhesive bandage for 24 hours. Reactions were read daily for 5 days. No effects, no positive irritating reactions were observed in 23 tests.