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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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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:
1975
Report Date:
1975
Reference Type:
publication
Title:
Final report on the safety assessment of fossil and synthetic waxes
Author:
Elder, R.L.
Year:
1984
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
-Test Substance: 5% paraffin wax, eye-shadow formulation

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.