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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: Guidelines for the Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients
Version / remarks:
COLIPA, 1997
GLP compliance:
not specified
Remarks:
According to good clinical practices
Species:
other: humans
Details on test animals or test system and environmental conditions:
- Age: 18-70 years old
- Sex: female and/or male
- Volunteers must have social insurance number
- Free from dermatological lesions on the area studied
- Volunteers with a proof of home address
- Able to understand study requirements
- Answer the specific criteria of the study
Type of coverage:
other: patch of a 68 mm2 polyethylene plastic moss chamber with a filter paper incorporated
Preparation of test site:
other: cleaned up with demineralised water and dried with cellulose cotton wool tissue
Vehicle:
not specified
Amount / concentration applied:
0.02 ml
Product was put pure (already diluted at 10%) under occluded patch. The equipment used is the IQ ULTRA patch test, made of a 68 mm2 polyethylene plastc moss chamber with a filter paper incorporated.
Duration of treatment / exposure:
Single application during 48 hours
Observation period:
The patches are left in contact 48 hours, then the withdrawal of the patches and the reading are made by the dermatologist
Number of animals:
24 volunteers
Details on study design:
The patches are put on the back of the volunteer. A specific examination of the contact zone is carried out just before starting the study in order to apply the product on a surface free from macroscopic irritation marks, scars or any abnormalities which could interfere with the reading of the results.
In parallel to the application of products to be studied, an empty patch "negative" control is applied.
Irritation parameter:
erythema score
Basis:
other:
Remarks:
All the volunteers
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
other:
Remarks:
All the volunteers
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
other: Dryness / desquamation
Basis:
other:
Remarks:
All the volunteers
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
other: Vesicle
Basis:
other:
Remarks:
All the volunteers
Time point:
48 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
In the experimental conditions, choline glycerophosphate can be considered as non irritant regarding its primary skin tolerance.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: Test Guidelines for Assessment of Skin Compatibility of Cosmetic Finished Products in Man. Food and Chemical Toxicology
Version / remarks:
COLIPA, 1996
Principles of method if other than guideline:
According to good clinical practice (CPMP Working Party on Efficacy of Medicinal Products Note for Guidance: Good Clinical Practice for Trials on Medicinal Products in the European Community -1990-CB-55-89-706-EN-c)
GLP compliance:
not specified
Species:
other: Humans
Details on test animals or test system and environmental conditions:
Age >= 18 years
No pregnant or lactating women
No blemishes or marks which interfere with scoring
No skin desease that may interfere with the aim of the study
Type of coverage:
other: Product was applied 5% in water in square test-chambers (Haye's Test Chambers; HAL Allergie GmbH, Düsseldorf)
Vehicle:
not specified
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
Test concentration : 5% in water
Duration of treatment / exposure:
48 hours
Observation period:
At 48 h (30 min after patch removal) and 72 h after patch application.
Number of animals:
50 volunteers
Details on study design:
The product was applied to the back of the volunteers.
Irritation parameter:
erythema score
Time point:
other: 48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
other: Fissure
Time point:
other: 48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
other: Scaling
Time point:
other: 48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
On the basis of the test results and under the test conditions, the product is classified as 'harmless' as regards the possibÍlity of skin irritation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification