Registration Dossier

Toxicological information

Specific investigations: other studies

Currently viewing:

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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals 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.