Hydrocarbon waxes (petroleum), hydrotreated microcryst.

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

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

Test material information

Constituent 1

Reference substance name:

5% paraffin wax

IUPAC Name:

5% paraffin wax

Constituent 2

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

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.