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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: patch test
Deviations:
not specified
Principles of method if other than guideline:
The day of the assay, recruited volonteers were informed about the assay design and signed the consent form. The test product was applied onto the scapular part of the back of the volonteers. Patch-test without product was performed in parallel as control. After a forty-eight hours exposure time, patch-tests were delicately removed and their location was surrounded with a special pen for skin use. The assessment of potential skin reactions was performed by the dermatologist 30 minutes after removal of the tests. In case of reaction at t30min, a second observation was made 24 hours after this first one.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: whitish scales

Test animals

Species:
other: human

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Remarks:
nothing
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
20µl
Duration of treatment / exposure:
48 hours
Observation period:
30 minutes after removal
Number of animals:
26 volonteers

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
0
Time point:
48 h
Score:
ca. 0.15
Reversibility:
not specified
Remarks on result:
probability of weak irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The product "omega 6 ceramide" did not provoke any cutaneous reaction. The product tested in pure form, can be considered as very slightly irritant.
Executive summary:

The assessment of potential skin reactions was performed on 24 volunteers.

The product "omega 6 ceramide" did not provoke any cutaneous reaction.

In the study conditions, the product tested in pure form, can be considered as non irritant for a proportion of the human population.