Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Currently viewing:

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only short abstract available

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Final report on safety assessment of phenoxyethanol
Author:
Anonymous
Year:
1990
Bibliographic source:
J. Am. Coll. Toxicol. 9(2): 259-277
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Type of study / information:
Phototoxicity study after patch test with phenoxyethanol
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
Phenoxyethanol was patch tested in human subjects. After removal of the patch, sites were exposed to UVA light and evaluated at different time points.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Phenoxyethanol
- Analytical purity: no data

Method

Ethical approval:
not specified
Details on study design:
Phenoxyethanol (0.3 ml) was applied undiluted to patches, which were then applied in duplicate to the volar surface of the forearm of each of 28 panelists (male and female, aged 18-50). One patch was removed after 24 hours. The site was rinsed and dried, and was then exposed for 10 minutes to 16-20 J/cm of UVA light. The second patch was removed, and the site was rinsed and dried. All sites were evaluated 1, 24, 48 and 72 hours after irradiation.
Exposure assessment:
not specified

Results and discussion

Results:
Twelve panelists had reactions of varying duration following irradiation. Five had readily visible but mild reactions (a score of 1) at 1 hour, three panelists had scores of 1 at 24 hours, and one had a score of 1 at both 1 and 72 hour. All of these reactions had subsided by the next evaluation. The final two panelists had reactions at 1, 24 and 48 hours, and at 1, 48 and 72 hours, respectively. All of these reactions were readily visible but mild. One panelist also had a mild reaction at 72 hours at the unexposed patch site. This panelist had no reactions at the irradiated site. It was concluded that phenoxyethanol was not phototoxic under the conditions of the study. Occasional incidence of slight erythema were observed at the irradiation site, but these were not considered significant since erythema was occasionally observed at both non irradiated sites and blank control patch sites.

Applicant's summary and conclusion