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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
Endpoint summary
Administrative data
Description of key information
OECD 439: irritating
OECD 431: corrosive
OECD 492: irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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 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
- 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%). - 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-06-28 to 2019-07-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guidline study
- 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)
- Specific details on test material used for the study:
- Name: cyclic Glucamide C8-C10
Chemical Name: Amides, C8-C10, N-(1-deoxy-D-glucitol-1-yl)-N-methyl, dehydrated (CAS name)
Batch No.: BP 1c (reactor mix)
CAS No 2290526-77-9
Compounds: UVCB
main compounds: C15H29NO5 (C8-acyl-derivative)
C17H33NO5 (C10-acyl-derivative)
8.5% unidentified components
Aggregate State at RT: highly viscous mass (20°C)
Colour: brown
Storage Conditions: room temperature, dry
Expiry Date: 28 March 2021
Safety Precautions: The routine hygienic procedures were sufficient to assure personnel health and safety. - Amount / concentration applied:
- 50 µL
- 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.
- Irritation parameter:
- other: mean relative tissue viability
- Run / experiment:
- 1
- Value:
- 4.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- Value Cut off pass/fail
Mean Absolute OD570 nm NK 1.924 0.8 < NK < 2.5 pass
Mean Relative Viability PC [%] 47.9 < 50% pass
Max. Difference of % Viability [%] 1.4 < 20% pass - Conclusions:
- In this study under the given conditions the test item showed irritant effects.
- Executive summary:
In the present study cyclic Glucamide C8-C10 was applied topically to the EpiOcular TM tissue for 30 min followed by 12 min post-soaking incubation after removal of the test item. After a 120 min post-treatment period cytotoxic effects were determined via MTT reduction assay.
Ocular irritation potential of the test item was predicted from the relative mean tissue viabilities compared to the negative control tissues concurrently treated with Aqua dest.
The mixture of 50 µL test item per 1 mL MTT medium showed reduction of MTT as compared to the solvent. The mixture turned blue/purple. The killed tissue controls were performed for quantitative correction of results.
NSMTT [%] = [(ODKT- ODKU)/ODNC] * 100 = [(0.042-0.093)/1.877] = -2.72%
Difference of NSMTT of the two duplicate tissues must be < 20%, otherwise not accepted.
NSMTT1 [%] = [meanODKT1- ODKU)/ODNC] * 100 =[(0.042-0.093)/1.877] = -2.72%
NSMTT2 [%] = [meanODKT2- ODKU)/ODNC] * 100 =[(0.042-0.093)/1.877] = -2.72%
NSMTT1 - NSMTT2 =0%
NSMTT was ≤ 60% (-2.72% NSMTT) relative to the negative control of living epidermis and could therefore be used for determination of the killed control corrected viability (KCCV) according to the following formula:
KCCV [%] = viabilityTM– NSMTT = 1.6% - (-2.72%) ≈ 4.2%
The mixture of 50 µL 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 irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (4.2% NSMTT-corrected).
The controls confirmed the validity of the study. The mean absolute OD570 of the two negative control tissues was > 0.8 and < 2.5 (1.924). The mean relative tissue viability (% negative control) of the positive control was < 50% (47.9%). The maximum inter tissue difference of replicate tissues of all dose groups was < 20% (1.4%).
Reference
The mixture of 50 µL test item per 1 mL MTT medium showed reduction of MTT as compared to the solvent. The mixture turned blue/purple. The killed tissue controls were performed for quantitative correction of results.
NSMTT [%] = [(ODKT- ODKU)/ODNC] * 100 = [(0.042-0.093)/1.877] = -2.72%
Difference of NSMTT of the two duplicate tissues must be < 20%, otherwise not accepted.
NSMTT1 [%] = [meanODKT1- ODKU)/ODNC] * 100 = [(0.042-0.093)/1.877] = -2.72%
NSMTT2 [%] = [meanODKT2- ODKU)/ODNC] * 100 = [(0.042-0.093)/1.877] = -2.72%
NSMTT1 - NSMTT2 = 0%
NSMTT was ≤ 60% (-2.72% NSMTT) relative to the negative control of living epidermis and could therefore be used for determination of the killed control corrected viability (KCCV) according to the following formula:
KCCV [%] = viabilityTM– NSMTT = 1.6% - (-2.72%) ≈ 4.2%
The mixture of 50 µL test item per 1 mL Aqua dest. and per 2 mL isopropanol showed no colouring as compared to the solvent.Therefore, NSCliving equalled 0%.
Result of the Test Item cyclic Glucamide C8-C10
Name |
Negative Control |
Positive Control |
Test Item |
|||
Replicate Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
Absolute OD570 |
1.921 |
1.887 |
0.939 |
0.944 |
0.074 |
0.075 |
1.953 |
1.933 |
0.940 |
0.956 |
0.077 |
0.076 |
|
Mean Absolute OD570 |
1.924**** |
0.945 |
0.076 |
|||
OD570(Blank Corrected) |
1.874 |
1.840 |
0.893 |
0.898 |
0.028 |
0.029 |
1.907 |
1.887 |
0.894 |
0.910 |
0.031 |
0.029 |
|
Mean OD570of the Duplicates |
1.891 |
1.864 |
0.893 |
0.904 |
0.029 |
0.029 |
Total Mean OD570of the 2 Replicate Tissues (Blank Corrected) |
1.877* |
0.899 |
0.029 |
|||
TODTT |
- |
- |
0.079 |
|||
SD of Mean OD570of the Duplicates (Blank Corrected) |
0.019 |
0.008 |
0.000 |
|||
Relative Tissue Viability [%] |
100.7 |
99.3 |
47.6 |
48.2 |
1.6 |
1.5 |
Relative Tissue Viability |
1.4 |
0.6 |
0.0 |
|||
Mean Relative Tissue Viability [%] |
100.0 |
47.9** |
1.6 |
|||
Mean Relative Tissue Viability [%] |
- |
- |
4.2 |
* 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 ≤ 2.5
Result of the NSMTT control
NSMTT |
KU |
KT |
Negative Control |
|||||
Replicate Tissue |
1 |
2 |
1 |
2 |
1 |
2 |
||
Absolute OD570 |
0.146 |
0.128 |
0.086 |
0.087 |
1.921 |
1.887 |
||
0.151 |
0.131 |
0.091 |
0.090 |
1.953 |
1.933 |
|||
OD570(Blank Corrected) |
0.100 |
0.081 |
0.040 |
0.041 |
1.874 |
1.840 |
||
0.104 |
0.085 |
0.045 |
0.044 |
1.907 |
1.887 |
|||
Mean OD570of the Duplicates |
0.102 |
0.083 |
0.042 |
0.042 |
1.891 |
1.864 |
||
Total Mean OD570 of the 2 Replicate Tissues (Blank Corrected) |
0.093 |
0.042 |
1.877 |
|||||
SD of Mean OD570of the Duplicates (Blank Corrected) |
0.014 |
0.000 |
0.019 |
|||||
NSMTT [%] |
-2.7 |
- |
||||||
Relative Tissue Viability [%] |
- |
100.7 |
99.3 |
|||||
Relative Tissue Viability |
- |
1.4 |
||||||
Mean Relative Tissue Viability [%] |
- |
100.0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the experimental results, the substance is classified as skin corrosive "Cat. 1B or 1C" accoridng to CLP. The substance also induce irritation effects and classified as causing serious eye damage "Cat. 1" based on skin corrosion property worst-case scenario.
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