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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature (review)

Data source

Reference
Reference Type:
publication
Title:
Final report on the safety assessment of candelilla wax, carnauba wax, japan wax and beeswax
Author:
Anonymus
Year:
1984
Bibliographic source:
Journal of the American College of Toxicology, 3 (3), 1-41
Report Date:
1984

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Summarised results from repeated insult patch test and from photosensitisation test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
RIPT: lipstick formulation containing 5.61% carnauba wax
Photosensitisation test: 25% carnauba wax dissolved in heavy mineral oil

Method

Type of population:
general
Subjects:
RIPT: 151 men and women
Photosensitisation test: 23 individuals
Route of administration:
dermal

Results and discussion

Results of examinations:
In RIPT the test item neither showed sensitising nor clinically significant skin irritating properties
The test item was not phototoxic or photosensitising.

Applicant's summary and conclusion