A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6

Specific investigations: other studies

Administrative data

Endpoint:

specific investigations: other studies

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

31.01. - 23.02.2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study, with acceptable restrictions, performed under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guidelines for Testing of Chemicals. Draft proposal for a New Guideline: "Acute Dermal Photoirritation Dose-Response Test", February 1995.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: CTFA Safety Testing Guidelines, The Cosmetic, Toiletry and Fragrance Association, Inc. Washington, D.C. 20036; "Guidelines for Evaluating Photodermatitis:, 1991.

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6

EC Number:

401-680-5

EC Name:

A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6

Cas Number:

125304-04-3

Molecular formula:

C25 H35 N3 O and C37 H59 N3 O

IUPAC Name:

Reaction mass of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol, branched and 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol, branched

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals in Boyertown, Pennsylvania
- Age at study initiation: 4 - 6 weeks
- Weight at study initiation: appr. 300 - 450 grams
- Housing: in stainless steel cages
- Diet: Lab Diet Certified Guinea Pig Diet #5026 ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 29
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

dermal

Vehicle:

petrolatum

Remarks:

for challenge; unchanged during induction

Frequency of treatment:

5 dermal induction treatments, days 1, 3,6, 8 and 10
1 challenge treatment on day 21

No. of animals per sex per dose:

20 test group animals, 10 control animals
Positive control: 10 test and 5 control animals.

Control animals:

yes

Examinations

Examinations:

Skin reactions were evaluated 24, 48 and 2 hours after challegenge.

Positive control:

Positive control was performed with 3,3',4',5-Tetrachlorosalicylanilid.
Concentrations: 7.5% during induction, 7.5, 5 & 2.5% during challenge. Vehicle = ethanol

Results and discussion

Details on results:

This test item was not a photoallergen in guinea pigs, under the conditions of this test.

Any other information on results incl. tables

The positive conrol substance resulted in sensitization and is therefore a photoallergen in guinea pigs, under the conditions of this test.

Applicant's summary and conclusion

Executive summary:

Twenty Hartley-strain guinea pigs, male, 388 - 472 g, were used as a test group. Each test group animal received injections of an adjuvant and then five induction treatments over a period of two consecutive weeks. Each induction treatment consisted of a dosage of the test item followed by an exposure of the animals to UVB irradiation and UV-A irradiation. Eleven days after the last induction application, the animals were challenged. Three concentrations of the test item and/or the vehicle were applied to each animal so that each concentration was applied to one site on each side of each animal. One site dosed with each concentration was then exposed to approximately 10 joules/cm² of UV-A irradiation. The remaining site dosed with each concentration was not exposed to the UV-A. Ten similar animals, 418 - 468 g, were utilized as a control group. They were treated with the adjuvant but received no exposure to the test article or UV irradiation until the challenge phase, when they received the same challenge treatment as the test group animals. Induction sites were evaluated prior to each treatment. Challenge sites were evaluated 24, 48 and 72 hours following irradiation.The test item was used as received for the induction dosages and in petrolatum suspensions at challenge.