Registration Dossier
Registration Dossier
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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.
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EC number: 265-163-4 | CAS number: 64742-60-5 A complex combination of hydrocarbons obtained by treating a petroleum microcrystalline wax with hydrogen in the presence of a catalyst. It consists predominantly of long, branched chain hydrocarbons having carbon numbers predominantly in the range of C25 through C50.
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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