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Diss Factsheets
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EC number: - | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 October 2021 to 02 December 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guidline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for the Testing of Chemicals No. 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:
- 18 June 2019
- Qualifier:
- according to guideline
- Guideline:
- other: EURL ECVAM DB-ALM Method Summary No. 164: EpiOcular™ Eye Irritation Test - Summary
- Version / remarks:
- 22 July 2015
- Qualifier:
- according to guideline
- Guideline:
- other: EpiOcular™ Eye Irritation Test (OCL-200-EIT) For the prediction of acute ocular irritation of chemicals For use with MatTek Corporation’s Reconstructed Human EpiOcular™ Model
- Version / remarks:
- 29 June 2015
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
Test material
- Reference substance name:
- D-Glucitol, anhydro-1-deoxy-1-(methylamino)-, N-[C12-14(even numbered) acyl] derivs.
- Molecular formula:
- C19H37NO5 C21H41NO5
- IUPAC Name:
- D-Glucitol, anhydro-1-deoxy-1-(methylamino)-, N-[C12-14(even numbered) acyl] derivs.
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
- Specific details on test material used for the study:
- Batch No.: S148866
Aggregate State at RT: slightly turbid solid mass
Colour: brown
Storage Conditions: room temperature
Expiry Date: 30 September 2022
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety.
Test system
- Amount / concentration applied:
- 1. Negative Control 50 µL Aqua dest.
2. Positive Control 50 µL methyl acetate
3. Test Item 50 mg - Duration of treatment / exposure:
- incubation: 30 +/- 2 min.
- Observation period (in vivo):
- post soak: 12 +/- 2 min.
post treatment: 120 +/- 15 min. - Details on study design:
- The test was performed on EpiOcular, a reconstituted three-dimensional human corneal epithelium model. 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 30 min exposure period and 120 min post-treatment period and compared to those of the concurrent negative controls.
Results and discussion
In vitro
Results
- Irritation parameter:
- other: mean relative tissue viability
- Run / experiment:
- 1
- Value:
- 999 999.999
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Value Cut off pass/fail
Mean Absolute OD570 nm NC: 1.359 0.8 < NC < 2.8 pass
Mean Relative Viability PC [%]: 34.1 < 50% pass
Max. Difference of % Viability [%] 18.1 < 20% pass
Any other information on results incl. tables
Pre-Experiments
The mixture of 50 mg test item per 1 mL MTT medium showed reduction of MTT as compared to the solvent. The mixture turned blue/purple. Since the mean relative tissue viability of the test item treated tissues (TM) was below the 60% threshold value no killed tissue controls were performed, since the test item has to be classified as irritant in any case.
The mixture of 50 mg test item per 1 mL Aqua dest. and per 2 mL isopropanol showed no colouring as compared to the solvent. Therefore, NSCliving equalled 0%.
The test item showed non-specific reduction of MTT, but no relevant colouring potential after mixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction of possible false-negative results were necessary.
Result of the Test Item cyclic Glucamide C12-C14
Name | Negative Control | Positive Control | Test Item | |||
Replicate Tissue | 1 | 2 | 1 | 2 | 1 | 2 |
Absolute OD570 | 1.461 | 1.240 | 0.384 | 0.581 | 0.079 | 0.079 |
1.496 | 1.240 | 0.378 | 0.631 | 0.082 | 0.082 | |
Mean Absolute OD570 | 1.359**** | 0.494 | 0.080 | |||
OD570 (Blank Corrected) | 1.415 | 1.195 | 0.339 | 0.536 | 0.033 | 0.033 |
1.450 | 1.194 | 0.333 | 0.585 | 0.036 | 0.037 | |
Mean OD570 of the Duplicates | 1.433 | 1.195 | 0.336 | 0.560 | 0.035 | 0.035 |
Total Mean OD570 of the 2 Replicate Tissues (Blank Corrected) | 1.314* | 0.448 | 0.035 | |||
SD of Mean OD570 of the Duplicates (Blank Corrected) | 0.168 | 0.159 | 0.000 | |||
Relative Tissue Viability [%] | 109.1 | 90.9 | 25.6 | 42.7 | 2.6 | 2.7 |
Relative Tissue Viability | 18.1 | 17.1 | 0.0 | |||
Mean Relative Tissue Viability [%] | 100.0 | 34.1** | 2.6 |
* Corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability
** Mean relative tissue viability of the positive control is < 50%
*** Relative tissue viability difference of replicate tissues is < 20%
**** Mean absolute OD570 of the negative control is > 0.8 and < 2.8
Test Acceptance Criteria
| Value | Cut off | pass/fail |
Mean Absolute OD570 nm NC | 1.359 | 0.8 < NC < 2.8 | pass |
Mean Relative Viability PC [%] | 34.1 | < 50% | pass |
Max. Difference of % Viability [%] | 18.1 | < 20% | pass |
Historical Data
| Mean Absolute OD570±30nm NC | Mean Relative | SD Viability [%] |
Mean | 1.690 | 29.1 | 6.6 |
SD | 0.291 | 12.2 | 6.5 |
Range of | 1.109 – 2.271 | 4.6 – 53.6 | 0.0 – 19.6 |
n | 85 | 85 | 383 |
LCL: Lower control limit (95%, mean – 2*SD)
UCL: Upper control limit (95%, mean + 2*SD)
n: number of control values
Applicant's summary and conclusion
- Conclusions:
- In this study under the given conditions the test item showed irritant effects. No prediction of the ocular irritation potential of the test item can be made, thus additional testing will be required.
- Executive summary:
In the present study the eye irritating potential of cyclic Glucamide C12-C14 was analysed. Since irritant substances are cytotoxic to the corneal epithelium after a short time exposure the cytotoxic effects of the test item on EpiOcularÔ, a reconstituted three-dimensional human corneal epithelium model, were determined. Hereby, the test item was applied topically to the EpiOcularÔ tissue. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromid (MTT) after a 6 h exposure period and 18 h post-treatment period and compared to those of the concurrent negative controls.
The test item showed non-specific MTT-reducing potential, but was classified as irritant. Therefore no additional controls were necessary. The test item showed no water-colouring potential.
The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (2.6%).
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