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EC number: 839-734-9 | CAS number: 2290526-77-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 18 June, 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- anhydro-D-glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- EC Number:
- 839-734-9
- Cas Number:
- 2290526-77-9
- Molecular formula:
- C15H29NO5 C17H33NO5
- IUPAC Name:
- anhydro-D-glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- Test material form:
- liquid: viscous
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN SM™
- Source species:
- human
- Details on animal used as source of test system:
- The EPISKIN-SMTM tissues are provided as kits (SkinEthic), consisting of the following components relevant for this study:
1x EPISKIN-SM™ plate containing 12 reconstructed epidermis units (area: 0.38 cm2); each reconstructed epidermis is attached to the base of a tissue culture insert with an O-ring set and maintained on nutritive agar for transport (Lot: 19-EKIN-046 for main experiment, 19-EKIN-041 for killed tissue controls)
1x 12-well assay plate
1x flask of sterile maintenance medium (basic medium for incubations, Lot: 19MAIN3052)
1x flask of sterile assay medium (basic medium for use in MTT assays, Lot: 19ESSC048)
Validity controls as provided by the supplier (SkinEthic): - Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 3min, 60min, 4h
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3min
- Value:
- 81.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60min
- Value:
- 75.4
- Negative controls validity:
- other: not relevant
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 4h
- Value:
- 30.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- The test item showed non-specific MTT-reducing potential. Therefore, additional killed tissue controls were treated with the test item to determine the non-specific reduction of MTT (NSMTT) and the results were corrected to the true MTT metabolic conversion (TODTT). The test item showed no water-colouring potential.
The controls confirmed the validity of the study. The mean OD570 of the two negative control tissues was between 0.6 and 1.5 for each exposure period, excepted for the 60 minute time point (1,651). This do not influence the outcome of the test because the corrosivity was shown with the 4 hours’ time point and the outcome of the test would not change. The mean relative tissue viability (% negative control) of the positive control was 20% (3.2%) after 4 h treatment. The maximum inter tissue viability difference of replicate tissues of all dose groups was 30% (0.1% - 25.3%).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed corrosive effects. The relative mean tissue viability after 4 h treatment was decreased below 35%. Additionally, the relative mean tissue viability was decreased to not more than 35% after 60 min treatment. The test item is therefore classified as “corrosive“ in accordance with a combination of optional sub-categories 1B and 1C.
- Executive summary:
In the present study the skin corrosivity potential of cyclic Glucamide C8-C10 was analysed. Since corrosive chemicals are cytotoxic after a short time exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EPISKIN-SM™, a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min, 60 minand 4 hexposure period and compared to those of the concurrent negative controls.
The test item showed non-specific MTT-reducing potential. Therefore, additional killed tissue controls were treated with the test item to determine the non-specific reduction of MTT (NSMTT) and the results were corrected to the true MTT metabolic conversion (TODTT). The test item showed no water-colouring potential.
The test item showed corrosive effects. The mean relative tissue viability (% negative control) was reduced below 35% (30.6%, NSMTT-corrected) after 4 h treatment and to not more than 35% (75.4%, NSMTT-corrected) after 60 min treatment. Relative mean tissue viability was reduced to 81.2%, NSMTT-correctedafter 3 min treatment.
The controls confirmed the validity of the study. The mean OD570of the two negative control tissues was between 0.6 and 1.5 for each exposure period, excepted for the 60 minute time point (1,651). This do not influence the outcome of the test because the corrosivity was shown with the 4 hours’ time point and the outcome of the test would not change. The mean relative tissue viability (% negative control) of the positive control was£ 20% (3.2%) after 4 h treatment. The maximum inter tissue viability difference of replicate tissues of all dose groups was£ 30% (0.1% - 25.3%).
In this study under the given conditions the test item showed corrosive effects. The relative mean tissue viability after 4 h treatment was decreased below 35%. Additionally, the relative mean tissue viability was decreased to not more than35%after 60 min treatment. The test item is therefore classified as “corrosive“ in accordance witha combination of optional sub-categories 1B and 1C.
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