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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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.

Diss Factsheets

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. It is an acceptable, well-documented study report that followed sound scientific principles.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981
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 irritation / corrosion
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:
Formulation-foot cream 15% paraffin wax
IUPAC Name:
Formulation-foot cream 15% 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: Foot cream formulation of 15% paraffin was tested in a single 24-hour patch test.

Method

Type of population:
general
Subjects:
-19 human volunteers
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional
Exposure assessment:
measured
Details on exposure:
Foot cream formulation of 15% paraffin was tested in a single 24-hour patch test.

Results and discussion

Clinical signs:
No observations of clinical toxicity were reported
Outcome of incidence:
The foot cream formulation of 15% paraffin did not produce skin irritation in 19 human subjects

Applicant's summary and conclusion

Conclusions:
The foot cream formulation of 15% paraffin did not produce skin irritation in 19 human subjects
Executive summary:

In a single 24 -hour patch test, a foot cream formulation of 15% paraffin wax was applied under occlusion for 24 hours to the forearm or the upper back of 19 human subjects. Readings were taken immediately after patch removal. The test material did not produce irritation.

This study received a Klimisch score of 2 and is classified as reliable with restrictions. It is an acceptable, well-documented study report that followed sound scientific principles.