Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Sensitisation data (human)

Currently viewing:

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

Constituent 1
Reference substance name:
Carnauba wax
EC Number:
232-399-4
EC Name:
Carnauba wax
Cas Number:
8015-86-9
IUPAC Name:
Carnauba wax
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