Registration Dossier
Registration Dossier
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EC number: 700-725-9 | CAS number: -
Sensitisation data (human)
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:
- 1 984
- 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 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
Constituent 1
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
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