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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 from supporting substance (structural analogue or surrogate)
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:
1980
Report date:
1980
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

Constituent 1
Reference substance name:
63231-60-7
Cas Number:
63231-60-7
IUPAC Name:
63231-60-7
Constituent 2
Reference substance name:
15% microcrystalline wax
IUPAC Name:
15% microcrystalline wax
Test material form:
liquid: viscous
Details on test material:
-Test Substance: A lipstick formulation containing 15% microcrystalline wax was tested.

Method

Type of population:
general
Subjects:
-25 human volunteers
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
A lipstick formulation containing 15% (0.3g) microcrystalline wax was applied under occlusion to the volar forearm of all subjects for five consecutive 48-hour periods.  After a 10-day rest, an adjacent untreated site was pre-treated with 10% sodium lauryl sulfate for 1 hour, and then a patch of the test material was applied to the challenge site for 48 hours under occlusion.

Results and discussion

Clinical signs:
No observations of clinical toxicity were reported
Outcome of incidence:
No irritation or contact sensitisation was observed.

Applicant's summary and conclusion

Conclusions:
Not a dermal sensitiser
Executive summary:

Read across justification

No skin sensitisation studies in humans have been reported for petrolatum (non-carcinogenic feed-stock), but data have been reported for the principal constituents of these petrolatums, as well as paraffin and hydrocarbon waxes which are similar to petrolatum constituents.

A lipstick formulation containing 15% (0.3g) microcrystalline wax was applied under occlusion to the volar forearm of all subjects for five consecutive 48-hour periods.  After a 10-day rest, an adjacent untreated site was pre-treated with 10% sodium lauryl sulfate for 1 hour, and then a patch of the test material was applied to the challenge site for 48 hours under occlusion. The test material did not cause contact sensitisation immediately after patch removal or 24 hours after.

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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