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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
human, primary irritation and sensitisation study
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Please see attached full test report.
GLP compliance:
no
Remarks:
Study in human volunteers

Test material

1
Reference substance name:
Fatty acids, C16-18 (even numbered) and C18 (unsaturated) (9Z)-octadec-9-enyl esters.
EC Number:
701-212-2
Cas Number:
869110-10-1
Molecular formula:
R1, R2, R3: C15-, C17- saturated, C17- unsaturated alkyl chains
IUPAC Name:
Fatty acids, C16-18 (even numbered) and C18 (unsaturated) (9Z)-octadec-9-enyl esters.
Specific details on test material used for the study:
Lipex Shea WM, sample No. 20580 Date:2010-08-05 Batch#10-19-002

Test animals

Species:
other: human
Strain:
not specified
Details on test animals or test system and environmental conditions:
See the attached test report.

Test system

Type of coverage:
other: human patch test
Preparation of test site:
other: bath or wash
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.02-0.05 ml in case of liquids and/or 0.02 g in case of solids.
Duration of treatment / exposure:
48 h (first application), 24 hours thereafter for the remainder of the study. 9 consecutive 24-hours exposures.
Observation period:
In re-test 10-14 days after last exposure, a retest/challenge test was performed and the test site was evaluated my trained personnel 48 and 96 h post exposure. Subjects was instructed to report delayed reactions
Number of animals:
52 (50 completed)
Details on study design:
Please see the attached study report.

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
No adverse effects reported
Irritant / corrosive response data:
No effects reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under conditions of the study, there were no identifiable sign or symptoms of primary irritation or sensitization (contact allergy) noted for Lipex Shea WM (the registered substance).
Executive summary:

Under conditions of the study, there were no identifiable sign or symptoms of primary irritation or sensitization (contact allergy) noted for Lipex Shea WM (the registered substance).