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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Study period:
march 25 - April 3rd, 2008
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No analytical certificate, no inclusion of phototype I skin, no explanation on final grading method for skin compatibility (in the conclusion)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Type of study / information:
Patch test in human volunteers
Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Draize JH, Appraisal of the safety of chemicals in food, drugs and cosmetics. FDA (ed), USA, 1959, pp 46-48
Frosch PJ & Kligman AM, The Duhring Chamber: an improved technique for epicutaneous testing of irritant and allergic reactions, Contact Dermatitis, 1979, 5, pp 73-81
Matthies W, Test startegies for development of cosmetic products using dermatological test models, Seifen-Öle-Fette-Wachse, 1991, 117, pp 42-43
Mikulowska A, Reactive changes in human epidermius following simple occlusion with water, Contact dermatitis, 1992, 26, pp 224-227
GLP compliance:
no
Remarks:
GLP: not applicable / GCP: no certificate of analysis of test item: purity and stability unknown

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CAE
- Physical state: brown-orange semi-liquid, oily
- Purity test date: not indicated
- Lot/batch No.: 1456
- Expiration date of the lot/batch: not indicated
- Stability under test conditions: not indicated
- Storage condition of test material: not indicated

Method

Ethical approval:
not specified
Details on study design:
Monocentric study in open, in 20 volunteers (final number after 2 exclusions). Inclusion and exclusion criteria were defined. Subject used as its own control.
Exposure assessment:
measured
Details on exposure:
EXPOSURE:
- Patch test on the back
- 160 µL of test item/person (exposure measured using micropipette)
- Negative control site: patch with distilled water
- skin contact for 48h

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:
- Skin phototypes II to IV included
- 17 women, 3 men

Results and discussion

Results:
Very slight erythema in 1/20 volunteer, Slight erythema in 1/20 volunteer : 10% of volunteers are reactive
Mdis = 0.075
The interpretation method enables to grade as "very good / good / quite good / moderate / bad skin compatibility", but the thresholds values (Mdis) for these classes are not indicated.

Applicant's summary and conclusion

Conclusions:
Under the experimental conditions adopted, the test item has a good skin compatibility.
Executive summary:

Identical to "Results". NB: the substance being an intermediate in strictly controlled conditions, it is not used as a cosmetic raw material