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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
04.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
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

Test material

Constituent 1
Chemical structure
Reference substance name:
Choline glycerophosphate
EC Number:
248-962-2
EC Name:
Choline glycerophosphate
Cas Number:
28319-77-9
Molecular formula:
C8H20NO6P
IUPAC Name:
bis(2-hydroxy-N,N,N-trimethylethanaminium) 2,3-dihydroxypropyl phosphate
Test material form:
liquid

Test animals

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.