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EC number: 944-951-8 | CAS number: -
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was performed according to national and/or international guidelines applying a study plan and Standard Operating Procedures. Although the performing laboratory is not GLP certified, test procedures are generally following GLP guidance and rules.
- Specific details on test material used for the study:
- Chemical name: Samson
Code: S18+
CAS number: -
Batch number: -
Purity: not specified
Physical state: Liquid
Storage conditions: Room temperature - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- foreskin from a single donor
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Description: Ashland 0.5 cm2 reconstructed epidermis from normal human keratinocytes. Cells are grown on inert polycarbonate filter on chemically defined medium. airlifted for 17 days.
Batch N°: 1503EPID03
Origin: Foreskin
Quality Controls: Certified by Ashland Tissue Engineering laboratories. April 6, 2015 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 100%
- Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours, duration of MTT incubation: 3 hours
- Number of replicates:
- 9
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Viability (%)
- Value:
- >= 90.3 - <= 95.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Viability 87 to 107%
- Positive controls validity:
- valid
- Remarks:
- Viability < 2%
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the In-Vitro Skin Irritation by the Ashland Epidermis Equivalent (Aee) Test Method reaction mass of hydroxylpropyl gluconamide and hydroxypropyl ammonium gluconate is classified as Non Irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 30 to April 9, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- other: Hens Egg Test on the Chorio-Allantoic Membrane (HET-CAM).
- Version / remarks:
- Journal officiel de la République Française of December 26, 1996 with some modifications described in the Standard Operation Procedure N°TAM-01-v2
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was performed according to national and/or international guidelines applying a study plan and Standard Operating Procedures. Although the performing laboratory is not GLP certified, test procedures are generally following GLP guidance and rules.
- Specific details on test material used for the study:
- ID: Samson 18+
Appearance: liquid
Storage: room temperature - Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- Eggs reception and incubation
- Upon receipt, the cracked or broken eggs are discarded. Before incubation, the eggs are stored in egg boxes (blunt ends upwards). If the incubation didn’t take place in few hours after reception, eggs are stored at 8°C; and kept away from light for a maximum of 7 days, then for 24 h at 20°C before being placed in an incubator.
- Clean and fertile White Leghorn chicken eggs are placed in an incubator for eight days with a rotating tray at 37.8 ± 0.5ºC and 52 ± 2% relative humidity. - Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- S18+ at 100%; 10%; 5% in 300 µL.
- Duration of treatment / exposure:
- 300 seconds
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- Test article groups: 4; Controles: 2
- Details on study design:
- This test is carried out on 9 days’ old, fertilized and embryonated chicken eggs. The eggshell and inner membrane are carefully removed taking care that the CAM is not injured.
- Each test substance (if included, benchmark and solvent/vehicle controls) is applied to 4 eggs. Positive and negative controls are applied to only two eggs.
- 300 μl of test product are then deposited on the membrane. A timer is started immediately after application.
- At 20 seconds, test substance is removed from the membrane by rinsing the CAM with approximately 2x2.5 ml of DPBS 1X.
- The CAM reactions are observed over a period of 300 seconds. The time of the appearance of HAEMORRHAGE, HYPERAEMIA and COAGULATION should be monitored and recorded, in seconds
- Pictures are taken at 0, 30, 120 and 300 seconds and recorded as t=0s, t=30s, t=120s and t=300s for the corresponding tested substance.
- For each egg, the numerical time-dependant scores for HAEMORRHAGE, HYPERAEMIA and COAGULATION are summed to give a single numerical value.
- The Irritation Score (IS) of the tested product is the arithmetic average, rounded to the decimal, of the scores obtained on four eggs (treated with a same test substance). Therefore, the maximal score is 21.
IS < 1 = Practically not irritant
1 ≤ IS < 5 = Slightly irritant
5 ≤ IS < 9 = Moderately irritant
IS ≥ 9 = Irritant - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 100%
- Value:
- 2.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Value = 0
- Positive controls validity:
- valid
- Remarks:
- Values: NaOH 1N = 19; NaOH 0.1N= 10
- Remarks on result:
- other: Slightly irritant
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 10%
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to HET-CAM test, Samson S18+ at 100% is identified as Slightly irritant and Samson S18+ at 10% in H2O is identified as Practically not irritant.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April, 2015
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- - SKINETHIC Eye Irritation Test- Standard Operating Procedure – “SkinEthicTM Human Corneal Epithelial Model (SkinEthicTM HCE) Long exposure-time treatment”, 2010.
- N.Alépée et al., Cosmetics Europe multi-laboratory pre-validation of the SkinEthicTM reconstituted human corneal epithelium test method for the prediction of eye irritation, 2013.
- SKINETHIC website - http://www.skinethic.com/OC_IRRITATION_CHEM.asp OCULAR IRRITATION ASSAY, 2014 - Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- The study was performed according to national and/or international guidelines applying a study plan and Standard Operating Procedures. Although the performing laboratory is not GLP certified, test procedures are generally following GLP guidance and rules.
- Specific details on test material used for the study:
- Chemical name: Samson
Code: S18+
CAS number: -
Batch number: -
Purity: not specified
Physical state: Liquid
Storage conditions: Room temperature - Species:
- human
- Details on test animals or tissues and environmental conditions:
- Ashland Reconstituted Human Corneal Epithelial Model
Description: Human Corneal Epithelium
Batch N°: 1504HCE01
Origin: Immortalized Human Corneal Epithelium cells
Quality Controls: April 13, 2015 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 100%
- Duration of treatment / exposure:
- 1 h
- Duration of post- treatment incubation (in vitro):
- 16 h, MTT incubation: 3 h
- Number of animals or in vitro replicates:
- 9
- Details on study design:
- EXPERIMENTAL PROTOCOL
1. First day: Pre-incubation step
- For a given chemical 3 tissues were be used.
- An appropriate numbers of 6-well plates were filled with 1 ml of maintenance culture medium.
- HCE tissues were transferred into maintenance medium filled wells, using sterile forceps.
- Place the HCE tissues at 37°C, 5% CO2 until test substance application (usually 24 hours).
2 Second day: Application / Rinsing
- 24-well plate was filled with 300μl by well of pre-warmed maintenance culture medium.
- Tissues were transferred.
- 30 μL ± 0.5 μL (or 30 μg) of products and controls were dispensed on the top of cornea.
- Plates containing the treated corneas were kept at room temperature for 1 hour.
- Tissues were rinsed 3 times with 5 mL of DPBS (adjust the distribution to 0.5 mL per push). Remaining DPBS was removed by tapping the inserts on absorbent paper.
- Epitheliums were transferred in a new 24-well plate containing 300 μl of fresh maintenance medium.
- Treated and rinsed corneas were incubated at 37°C, 5% CO2 for 16 hours (± 60 minutes).
3 Third day: Viability measurement
- 24-well plates were filled with 300 μL MTT solution (0.5mg/ml).
- Treated tissues were transferred in the pre-filled MTT 24-well plates and Incubated for 3 hours (± 5 minutes) at 37°C and 5% CO2.
- Treated tissue insert bottom was dried on sterile absorbent paper and transferred in new plate containing 750 μl of isopropanol solution.
- 750 μL isopropanol solutions were added on the top of each tissue.
- Plate was protected from evaporation by stretching 3 parafilm layers over the plate and adding the lid on the plate and incubated for 2 hours (± 5 minutes) at room temperature with gentle agitation (about 150 rpm) for formazan extraction.
- Tissue and polycarbonate filter were pierced with a tip in order to get the whole extraction solution in the corresponding well.
- Extraction solution was homogenized by pipetting 3 times up and down to complete formazan crystals solubilization.
- 2 x 200 μL extraction solution per well (= 2 wells per tissue i.e. 2 replicates per tissue) were transferred into a 96-well plate.
- Optical Densities (OD) was read using a 96-well plate spectrophotometer: The concentration of formazan was measured by determining the OD at 570 nm. - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Viability (percentage)
- Value:
- 98.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100% viability
- Positive controls validity:
- valid
- Remarks:
- 21.9 % viability
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to Ashland Reconstituted Human Corneal Epithelial (RHCE) Long exposure-time treatment test, Samson S18+ displayed no irritation potential.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
According to the In-Vitro Skin Irritation by the Ashland Epidermis Equivalent (Aee) Test Method reaction mass of hydroxylpropyl gluconamide and hydroxypropyl ammonium gluconate is classified as Non Irritant.
Eye irritation:
According to a Reconstituted Human Corneal Epithelial (RHCE) Long exposure-time treatment test, the reaction mass displayed no irritation potential. According to HET-CAM test, the reaction mass is identified as Slightly irritant at 100% and as Practically not irritant at 10% in H2O.
Justification for classification or non-classification
Based on the in-vitro studies performed according to internationally accepted protocols, Reaction mass of 3-hydroxypropan-1-aminium D-gluconate and N-(3-hydroxypropyl)-D-gluconamide does not meet the criteria for classification as irritant for skin or eye.
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