Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 306-549-5 | CAS number: 97281-48-6
- 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
One study exists on the substance for skin irritation. The local skin tolerance of the test item was investigated after a single application on the skin on the back under occluded patch during 48 hours, on health adult volunteers.
Average irritant score ofter the application was 0.0. According to the experimental conditions of the study the test item can be considered as non irritant regarding its primary skin tolerance.
No study is available for eye irritation and a weight of evidence assessment was therefore perfomed. Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are only mild indications for eye irritation potential for the tested compounds. Raw data from the tests are not available. Based on an overall weight of evidence approach it is concluded, that the compound phosphatidylcholines, soya, hydrogenated is of low to moderate concern for eye irritation. No classification as eye irritating should apply for the substance.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Remarks:
- patch test method in humans
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010.04.27- 2010.04.29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for the assessment of skin tolerance of potentially irritant cosmetic ingredients
- Principles of method if other than guideline:
- 24 adult voluntiers
Single application on the back (for 48hours)
Product applied already diluted 10% under occuled patch
Quantity of product 0.02 ml
A dermatologist performs the clinical observation after the removal of the patches.Quantification of the skin irritation is given through a numerical scale (erythema, oedema, dryness, desquamation, vescicles) The average irritant score of the product to be tested is calculated from the average of the quotations obtained for each volunteer, allowing to rang the product from "non irritant to very irritant". Assessment is made by comparison with the "negative" control. - GLP compliance:
- not specified
- Remarks:
- The study follows good clinical practices (GCP)
- Specific details on test material used for the study:
- Phospholipon® 90H
014569 Batch 294008-01/ 096 - Species:
- other: human
- Details on test animals or test system and environmental conditions:
- healthy adults
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Already diluted
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 0.02 ml (10% diluted)
- Duration of treatment / exposure:
- 48 hours
- Observation period:
- na
- Number of animals:
- 24 human volunteers
- Irritation parameter:
- erythema score
- Basis:
- other: All volunteers
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- According to the experimental conditions of the study the product can be considered as non irritant regarding its primary skin tolerance.
- Irritation parameter:
- edema score
- Basis:
- other: All volunteers
- Time point:
- 24/48/72 h
- Score:
- >= 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- According to the experimental conditions of the study the product can be considered as non irritant regarding its primary skin tolerance.
- Irritant / corrosive response data:
- average irritant score of the product is 0.0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Average irritant score of the test item is 0.0. The test item is not considered an irritant
- Executive summary:
The local skin tolerance of the test item was investigated after a single application on the skin on the back under occluded patch during 48 hours, on health adult volunteers.
Average irritant score ofter the application was 0.0. According to the experimental conditions of the study the test item can be considered as non irritant regarding its primary skin tolerance.
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Principles of method if other than guideline:
- occlusive plastic test chambers (Imtradex Germany)
48 hours of exposure and expection emidiatly after removal and again at 72 hours
20 human voluntiers (11 female/9 male, age 16-60 years) - GLP compliance:
- no
- Species:
- other: human volunteers
- Details on test animals or test system and environmental conditions:
- age: 16-60 years
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Amount / concentration applied:
- 0.5, 1.0 and 3 .0 mg/cm2 skin
- Duration of treatment / exposure:
- 48h
- Observation period:
- from time 48h to 72h
- Number of animals:
- 20 human volunteers
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Max. score:
- 0.2
- Reversibility:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, it can be said, that under the chosen circumstances the 3 different concentrations of liposomes (0.5; 1.0 and 3.0 mg phospholipid/cm2 skin) were tolerated well.
- Executive summary:
The irritant potential of different solutions of liposomes was investigated in 20 dermatologically healthy volunteers by means of occlusive patch testing.
The group of subjects consisted of 11 women and 9 men between the age of 16 and 60 years.
In conclusion, it can be said, that under the chosen circumstances the 3 different concentrations of liposomes (0.5; 1.0 and 3.0 mg phospholipid/cm2 skin) were tolerated well.
Referenceopen allclose all
Score of irritance ± SD
0.5 mg phospholipid/cm2 skin 0.1 0.30
1.0 mg phospholipid/cm2 skin 0.05 0.22
3.0 mg phospholipid/cm2 skin 0.2 0.52
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: Weight of evidence analysis based on expert evaluated data on the group of lecithins
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: based on expert group reviews and published data
- Justification for type of information:
- Data on this endpoint are not available for Phosphatidylcholines, soya, hydrogenated.
In order to assess the eye irritation of hydrogenated phosphatidylcholines, the potential eye irritation of the hydrogenated lecithins in general as well as non-hydrogenated phosphatidylcholines (lecithins) can be considered. In order to combine data on several similar substances an overall weight of evidence approach is used for the assessment. - Principles of method if other than guideline:
- Collection of data based on scientifically acceptable methods.
- Specific details on test material used for the study:
- For more details, please see attached weight of evidence document.
- Species:
- rabbit
- Strain:
- not specified
- Controls:
- other: contralateral eye
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritant / corrosive response data:
- Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are only mild indications for eye irritation potential for the tested compounds.
- Other effects:
- In one test, a positively charged liposome preparation significantly increased the number of blinks after application. Please see attached document for details.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are indications for mild eye irritation potential for these tested compounds. Raw data from the tests are not available. Based on an overall weight of evidence approach it is concluded, that the compound phosphatidylcholines, soya, hydrogenated is of low to moderate concern for eye irritation. No classification as eye irritating should apply for the substance.
- Executive summary:
The ocular irritation potential of hydrogenated lecithin is reported in final report on the safety assessment of lecithin and hydrogenated lecithin reviewed by the Cosmetic Ingredient Review Expert Panel. Hydrogenated lecithin produced minimal conjunctival irritation. All signs of irritation were cleared by day 2. The study concludes that hydrogenated lecithin is not a primary ocular irritant.
The European Lecithin Manufacturers association (ELMA) has also provided a statement that neither hydrogenated lecithin, nor lecithin should carry a hazard warning for this endpoint.
A number of studies on ocular irritation of lecithin and lecithin-containing cosmetic products have been tested in Draize tests using rabbits. The content of lecithin in the tested products was 2.25 to 3 % of Lecithin 65%. Lecithin 65% was also tested alone. The results ranged from non-irritating to moderate irritation, with the majority of the tests resulting in minimal irritation.
Two other tests of ocular irritating potential of neutral and positively charged lecithin from egg liposome preparations are also described in Fiume (2001). In one test the responses did not exceed “practically non-irritating” and immediately decreased to non-irritating. No lesions were found at microscopic examination. In the other test, the positively charged liposome preparation significantly increased the number of blinks.
Based on the studies described above on both hydrogenated lecithin and lecithin, the CIR panel concluded that lecithins and hydrogenated lecithins are not primary ocular irritants, and further the panel evaluated the substances to be safe for use in rinse off products and leave on products at concentrations ≤ 15%.
Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are only mild indications for eye irritation potential for the tested compounds. Raw data from the tests are not available. Based on an overall weight of evidence approach it is concluded, that the compound phosphatidylcholines, soya, hydrogenated is of low to moderate concern for eye irritation. No classification as eye irritating should apply for the substance.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
One study exists on the substance for skin irritation. The local skin tolerance of the test item was investigated after a single application on the skin on the back under occluded patch during 48 hours, on health adult volunteers.
Average irritant score ofter the application was 0.0. According to the experimental conditions of the study the test item can be considered as non irritant regarding its primary skin tolerance.
No study is available on eye irritation. A weight of evidence analysis was therefore performed. Based on the available studies on hydrogenated lecithin and lecithin, it can be concluded that there are only mild indications for eye irritation potential for the tested compounds. Raw data from the tests are not available. Based on an overall weight of evidence approach it is concluded, that the compound phosphatidylcholines, soya, hydrogenated is of low to moderate concern for eye irritation.
No classification as skin or eye irritating should apply for the substance.
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.