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Diss Factsheets
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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
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- 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.
Test material
- Reference substance name:
- D-Gluconamide, N-(3-hydroxypropyl)-
- Cas Number:
- 190445-18-2
- Molecular formula:
- C9H19NO7
- IUPAC Name:
- D-Gluconamide, N-(3-hydroxypropyl)-
- Reference substance name:
- gluconic acid, aminopropanol salt
- Molecular formula:
- C9 H21 N1 O8
- IUPAC Name:
- gluconic acid, aminopropanol salt
- Test material form:
- liquid
- Remarks:
- 50% solution in water
- Details on test material:
- % solids in water: 48.0 - 52.0
Constituent 1
Constituent 2
- 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
In vitro test system
- 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
Results and discussion
In vitro
Results
- 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%
Applicant's summary and conclusion
- 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.
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.
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