Registration Dossier
Registration Dossier
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EC number: 295-458-3 | CAS number: 92045-76-6 A complex combination of hydrocarbons obtained from residual oils by solvent crystallisation and treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C25.
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions. The study is an acceptable, well-documented study report that followed sound scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
- Reference Type:
- publication
- Title:
- Final report on the safety assessment of fossil and synthetic waxes
- Author:
- Elder, R.L.
- Year:
- 1 984
- Bibliographic source:
- Journal of the American College of Toxicology 3(3):43-99
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- skin sensitisation
- Principles of method if other than guideline:
- The method did not strictly follow the guideline but is deemed appropriate as utilized in this report.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 5% paraffin wax
- IUPAC Name:
- 5% paraffin wax
- Reference substance name:
- 8002-74-2
- Cas Number:
- 8002-74-2
- IUPAC Name:
- 8002-74-2
- Test material form:
- liquid: viscous
- Details on test material:
- -Test Substance: 5% paraffin wax, eye-shadow formulation
Constituent 1
Constituent 2
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 25/dose
- Ethical approval:
- not specified
- Route of exposure:
- dermal
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- Route of induction and challenge exposure: epicutaneous, occlusive.
The material was applied under occlusion to the same site on the volar forearm of all subjects for five 48-hour periods. The patch sites were pre-treated for 24 hours with 2.5% aqueous sodium lauryl sulphate under occlusion. A challenge patch was applied after a 14-day rest, and the sites were read on removal of the patch and 24 hours thereafter.
Results and discussion
- Outcome of incidence:
- No irritation or sensitisation were observed.
Applicant's summary and conclusion
- Conclusions:
- No irritation or sensitisation was observed subsequent to dermal exposure to an eye shadow formulation containing 5% paraffin wax.
- Executive summary:
The material was applied under occlusion to the same site on the volar forearm of 25 subjects for five 48-hour periods. The patch sites were pre-treated for 24 hours with 2.5% aqueous sodium lauryl sulphate under occlusion. A challenge patch was applied after a 14-day rest, and the sites were read on removal of the patch and 24 hours thereafter. No irritation and no sensitisation were observed.
This study received a Klimisch score of 2 and is classified as reliable with restrictions. The study is an acceptable, well-documented study report that followed sound scientific principles.
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