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EC number: 271-272-8 | CAS number: 68527-63-9
- 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:
- 2018-01-15 to 2018-03-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 2016-07-29
- Qualifier:
- according to guideline
- Guideline:
- other: 4.2.2 EpiSkinTM Skin Corrosivity Test INVITTOX n° 118, ECVAM DB-ALM: INVITTOX protocol
- Version / remarks:
- March 1997
- Qualifier:
- according to guideline
- Guideline:
- other: EpiSkinTM SOP, Version 1.8 (February 2009), ECVAM Skin Irritation Validation Study: Validation of the EpiSkinTM test method 15 min-42 hours for the predication of acute skin irritation of chemicals.
- Version / remarks:
- Feebruary 2009
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- EC Number:
- 271-272-8
- EC Name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- Cas Number:
- 68527-63-9
- Molecular formula:
- C22H42N2O.C4H10O4S
- IUPAC Name:
- 2-{2-[(8E)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethan-1-ol diethyl sulfate
- Test material form:
- liquid
- Details on test material:
- Test item formulations were found to be homogeneous and stable up to 24 hour in vehicle corn oil.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: R-127., Ltd. / Batch 170825
- Date of manufacture: 2017-06-19
- Expiration date of the lot/batch: 2019-06-19
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Solubility and stability of the test substance in the solvent/vehicle: soluble in water, acetone, alcohol
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- The tissue consisted of normal, human-derived epidermal keratinocytes which have be en cultured to form a multilayered, highly differentiated model of the human epidermis. It consisted of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo.
- Justification for test system used:
- Investigation of skin corrosive properties
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Test system preparation
After receipt of the EpiSkinTM kit, all of the epidermis units used in the study were pre-incubated in maintenance medium (provided by kit supplier) at 37 oC, 5% CO2 for at least 24 hours before dosing.
Dose of test and control substances
Before topical application, the six epidermis units for test substance were transferred to new maintenance medium:
a) Two epidermis units were dosed with 50 µl test item and incubated at room temperature for 3 minutes
b) Two epidermis units were dosed with 50 µl test item and incubated at room temperature for 60 minutes
c) Two epidermis units were dosed with 50 µl test item and incubated at room temperature for 240 minutes
Before topical application, the six epidermis units for negative control substance (0.9% NaCl saline) were transferred to new maintenance medium:
a) Two epidermis units were dosed with 50 µl negative control substance and incubated at room temperature for 3 minutes
b) Two epidermis units were dosed with 50 µl negative control substance and incubated at room temperature for 60 minutes
c) Two epidermis units were dosed with 50 µl negative control substance and incubated at room temperature for 240 minutes
Before topical application, the two epidermis units for positive control substance (glacial acetic acid) were transferred to new maintenance medium. The two epidermis units were dosed with 50 µl positive control substance and incubated at room temperature for 240 minutes
Removal of test chemicals
After treatment, each treated epidermis unit was rinsed with 25ml sterile 0.01M PBS pH 7.4 to remove the residue of test chemicals from the epidermal surface. After rinsing, the unit was placed on absorbent paper to remove the PBS solution from epidermal surface. Cotton-bud was used to sweep the surface carefully when necessary.
MTT assay
The epidermis units were transferred into assay medium with 0.3 mg/ml MTT (protected from light) and incubated at 37 oC, 5% CO2 for 3 hours protected from light.
The epidermis units were dried on absorbent paper at the end of incubation. Each epidermis tissue was then gently separated using forceps from the collagen matrix. Both epidermis tissue and collagen matrix were placed into a micro tube with 500 µl of acidic isopropanol and mixed thoroughly. The micro tubes were stored at room temperature overnight.
The solution in the micro tubes were vortexed to homogenize the solution colour. Two 200 µl of solution from each tube was transferred into a 96-well plate. The absorbance (OD) at 570 nm was read using microplate reader. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 µl
- Concentration (if solution): 0.9 % NaCl saline
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 µl
- Concentration (if solution): glacial acetic acid - Duration of treatment / exposure:
- 3 min, 60 min, 240 min
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 94
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- 82.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 240 min exposure
- Value:
- 74
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Refers to corrosion, only.
- Conclusions:
- Based on the prediction model for the EpiSkinTM skin corrosion test method and associated with UN GHS classification system, the test item- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) is considered as non-corrosive.
- Executive summary:
The potential of corrosive propetries to the skin were eaxamined ina guideline study according to OECD 431 with the reconstructed human epidermis test method.
Based on the prediction model for the EpiSkinTM skin corrosion test method and associated with UN GHS classification system, the test item- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) is considered as non-corrosive.
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