A mixture of: (9-cis,12-cis)-2-hydroxy-3-(octadeca-9,12-dienoylamino)propyl hexadecanoate; (9-cis)-2-hydroxy-3-(octadeca-9-enoylamino)propylhexadecanoate ethyl hexadecanoate;

Skin irritation / corrosion

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.