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EC number: 940-284-1 | CAS number: 1591782-62-5
- 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 / corrosion
- Remarks:
- other: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.46 (Skin Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
Test material
- Reference substance name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- EC Number:
- 940-284-1
- Cas Number:
- 1591782-62-5
- Molecular formula:
- C15H31NO6 C17H35NO6
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- Test material form:
- other: solid
- Details on test material:
- Chemical Name: D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs.
CAS No.: 85316-98-9 and 85261-20-7 (related to main C-chain lengths of the active material)
Physical State: solid, powder
Colour: colourless
Molecular Weight: 321.42 – 349.47 g/mol
pH: 8-10 (20°C, 10 g/l)
Storage Conditions: room temperature
Constituent 1
Test system
- Amount / concentration applied:
- Solids: 10 mg + 5 µL aqua dest.
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- 42 +/- 1 h
- Details on study design:
- The test was performed on EpiSkin, an organotypic reconstructed three-dimensional model of the human epidermis. 3 replicate tissues are dosed with the test item, the negative control (10µL PBS) and the positive control (10µL 5% SDS), respectively. After 15 minutes treatment period at room temperature the test item and the controls are rinsed off with PBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours. Isopropanol extracts are measured photometrically at 550 nm.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Tissue viability
- Time point:
- other: 42 hours p.a.
- Remarks on result:
- other: According to Article 13 of the REACH Regulation (EC) 1907/2006, information on the endpoint `skin irritation` has been generated using OECD TG 439 `In vitro skin irritation: Reconstructed human epidermis test methode`. Thus no standard scores are given.
- Other effects:
- The test item showed no direct MTT reducing capability and no colouring potential.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item is classified as "non-irritant" (No Category).
- Executive summary:
In the in vitro skin irritation test using the EpiSkin human epidermis model [10 mg test item + 5 µL A. dest.] were applied topically for 15 minutes. After 42 h post-incubation cytotoxic effects were determined via MTT reduction assay.
The mean relative tissue viability (% negative control) was > 50%.
The test item is therefore classified as "non-irritant" (UN GHS: No Category).
This study is classified as acceptable:
OD550 of the blank is < 0.1.
Mean OD550 of the three negative control tissues is >= 0.6 and <= 1.5.
Mean relative tissue viability of the three positive contol tissues is <= 40%.
Standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is < 18%.
This study satisfies the requirement for Test Guideline OECD 439 for in vitro skin irritation and is relevant for classification and labeling. Based on the results, Glucamide 810 is not subject for classification and labelling requirements with regard to skin irritation according UN GHS and EU CLP ("No Category").
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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