Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is not carried out according to EU or OECD guideline.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eleven panellists, male and female, between the ages of 28 and 49 years, who met the inclusion criteria were selected for participation in this study.
- Test site: The lower back between the scapulae and the belt line, lateral to the midline served as the treatment site. The area was free of sunburn, suntan, scars, active dermal lesions, and uneven skin tones.
- Light source: A solar UV Simular for with a 150 watt xenon arc lamp was used in this evaluation. The instrument produces a continuous emission spectrum in the UVA and UVB region (290 - 400 nanometers), which was partially, blacked out by a filter. The UV-A irradiation was 5-8 minutes (total dose 10.5 - 16.8 joules) depending on a subjects MED (= determination of minimal erythemal dose).
A MED is defined as the time interval or dosage of UVA light irradiation suffient to produce minimal, perceptile erythema on untreated skin.
Prior to the testing phase, the MED for each subject was determined by irradiating each subject with a sequence of timed UVA exposures to adjacent sites on the lower back. Twenty-four hours after irradiation, the sites were evaluated for erythema according to the following grading system:
0 negative; no visible reaction
+/- minimal erythema
1 + defined erythema
2 + moderate erythema
3+ severe erythema
- Treatment Phase: On the first day of the study, three test sites were outlined on the back with a skin marker. Two sites were treated with the test product as described below and the third site remained untreated.
Approximately 0.2 ml of the test material was applied to the 3/4" x 3/4" gauze portion of an occlusive adhesive patch dressing, and the patch was adhered to the appropriate test site.
Twenty-four hours later, the patches were removed and the appropriate sites were irradiated with timed UVA exposures to achieve a minimal erythemal response Time of exposure for each subject was based upon results of the pre-study MED determination.
All test and control sites were examined at fifteen minutes, twenty-four hours, and forty eight hours following irradiation. The test sites were grated according to the above grading system.
The criteria for a positive (phototoxic) reaction is based upon interpretation of erythemyl responses as follows:
If the degree of erythema noted on the treated, irradiated site is significantly greater than the erythema observed on the non-treated, irradiated control site, the test material is judged to be phototoxic.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
NA

Results and discussion

Any other information on results incl. tables

All eleven panelists, 2 male and 9 female, successfully completed the study.

Applicant's summary and conclusion

Conclusions:
The test item did not induce a response indicative of phototoxic reaction.
Executive summary:

The test item did not induce a response indicative of phototoxic reaction.