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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-04-14 to 2021-04-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 18 June 2019, corrected 26 June 2020
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 2019/1390, L-247, Part B.46. “In vitro Skin Irritation: Reconstructed Human Epidermis Test Method”
- Version / remarks:
- 31-Jul-2019
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Corporation Protocol for: In Vitro EpiDermTM Skin Irritation Test (EPI-200-SIT) For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm (EPI-200-SIT)
- Version / remarks:
- Version 02-Oct-2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, 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:
- Name: cyclic Glucamide C12-C14
Chemical Name: anhydro –D-glucitol, 1-deoxy-1-(methylamino)-, N-[C12-14(even numbered) acryl] derivs.; Amides, C12-C14, N-(1-deoxy-D-glucitol-1-yl)-N-methyl, dehydrated
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
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Justification for test system used:
- This test uses the EpiDerm™ reconstructed human epidermis model (MatTek) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Details on test system:
- This in vitro method is designed to predict and classify the skin irritation potential of a chemical by assessment of its effect on EpiDermTM, a reconstituted three-dimensional human epidermis model. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 60 min exposure period.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Dose Groups
1. Negative control 30 µL Dulbecco’s phosphate buffered saline
2. Positive control 30 µL 5% sodium dodecyl sulfate solution
3. Test Item 25 mg + 25 µL Dulbecco’s phosphate buffered saline - Duration of treatment / exposure:
- 60 ± 1 min
- Duration of post-treatment incubation (if applicable):
- 24 ± 2 h + 18 ± 2 h (42 ± 2 h)
- Number of replicates:
- The test was performed on a total of 3 tissues per dose group.
Test system
- Details on study design:
- The test was performed on EpiDerm, an organotypic reconstructed three-dimensional model of the human epidermis. 3 replicate tissues are dosed with the test item, the negative control (30 µL DPBS) and the positive control (30 µL 5% SDS), respectively. After 60 ± 1 min treatment period at 37°C (35 min) and room temperature (25 min) the test item and the controls are rinsed off with DPBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours and extracted with isopropanol for at least 2h. The extracts are measured photometrically at 570 nm.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 2.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- Test Acceptance Criteria
The test meets acceptance criteria if:
- mean absolute OD570 nm of the three negative control tissues is ≥ 0.8 and ≤ 2.8
- mean relative tissue viability of the three positive control tissues is < 20%
- standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is ≤ 18%.
Any other information on results incl. tables
Pre-Experiments:
The mixture of 25 mg test item per 1 mL MTT medium showed reduction of MTT compared to the solvent. The mixture turned blue/purple. The coloured test material or MTT reducing substance was classified as “Irritant” i.e. mean tissue viability is < 50%. Therefore, no correction procedures were necessary.
The mixture of 25 mg of the test item per 300 μl aqua dest. and/or per 300 μL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equalled 0%.
Experiment:
Name |
Negative Control |
Positive Control |
Test Item |
||||||
Replicate Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
Absolute OD570 |
2.400 |
2.075 |
2.298 |
0.111 |
0.105 |
0.115 |
0.086 |
0.098 |
0.094 |
2.546 |
2.085 |
2.267 |
0.112 |
0.101 |
0.109 |
0.088 |
0.098 |
0.092 |
|
Mean Absolute OD570 |
2.279**** |
0.109 |
0.092 |
||||||
OD570(Blank Corrected) |
2.354 |
2.029 |
2.252 |
0.065 |
0.059 |
0.069 |
0.040 |
0.052 |
0.048 |
2.500 |
2.040 |
2.222 |
0.066 |
0.055 |
0.063 |
0.042 |
0.052 |
0.046 |
|
Mean OD570of the Duplicates |
2.427 |
2.034 |
2.237 |
0.065 |
0.057 |
0.066 |
0.041 |
0.052 |
0.047 |
Total Mean OD570of the 3 Replicate Tissues (Blank Corrected) |
2.233* |
0.063 |
0.047 |
||||||
SD of Mean OD570of the 3 Replicate Tissues (Blank Corrected) |
0.196 |
0.005 |
0.006 |
||||||
Relative Tissue Viability [%] |
108.7 |
91.1 |
100.2 |
2.9 |
2.6 |
2.9 |
1.8 |
2.3 |
2.1 |
Mean Relative Tissue Viability [%] |
100.0 |
2.8** |
2.1 |
||||||
SD of Relative Tissue Viability [%]*** |
8.8 |
0.2 |
0.2 |
||||||
CV [% Viabilities] |
8.8 |
7.8 |
11.8 |
* Blank-corrected mean OD570 nm of the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is < 20%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In this study under the given conditions the test item showed irritant effects. The test item is therefore classified as “irritant” in accordance with UN GHS “Category 2”.
- Executive summary:
In the present study the skin irritant potential of cyclic Glucamide C12-C14 was analysed. The EpiDerm™-Standard Model (EPI-200™), a reconstituted three-dimensional human epidermis model, was used as a replacement for the Draize Skin Irritation Test (OECD TG 404, [7]) to distinguish between UN GHS “Category 2” skin irritating test substances and not categorized test substances (“No Category”) which may be considered as non-irritant. 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 60 min exposure and 42 h post-incubation period and compared to those of the concurrent negative controls.
The mixture of 25 mg test item per 1 mL MTT medium showed reduction of MTT compared to the solvent. The mixture turned blue/purple. The coloured test material or MTT reducing substance was classified as “Irritant” i.e. mean tissue viability is < 50%. Therefore, no correction procedures were necessary.
The mixture of 25 mg of the test item per 300 μl aqua dest. and/or per 300 μL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equalled 0%.
The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 50% (2.1%) after 60 min treatment and 42 h post-incubation.
.
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