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Diss Factsheets
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EC number: 248-962-2 | CAS number: 28319-77-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.