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Diss Factsheets
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EC number: 816-455-0 | CAS number: 960253-23-0
- 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:
- 22 November 2016 to 27 Feruary 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- ethyl 2-acetyl-4-methyltridec-2-enoate
- EC Number:
- 816-455-0
- Cas Number:
- 960253-23-0
- Molecular formula:
- C18H32O3
- IUPAC Name:
- ethyl 2-acetyl-4-methyltridec-2-enoate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2 , Batch no.: 17-EKIN-008, See APPENDIX 4).
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing. One of the validated in vitro skin
irritation tests is the EPISKIN test, which is recommended in international guidelines (e.g. OECD and EC). - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Batch no.: 16-EKIN-047).
This model is a three-dimensional human epidermis model, which consists of adult humanderived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The liquid test item was applied undiluted (25 μl) directly on top of the tissue
- Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours at 37°C
- Number of replicates:
- The test was performed on a total of 3 tissues per test item together with negative and positive controls
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 99
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with GR-86-6599 compared to the negative control tissues was 99%. Since the mean relative tissue viability for GR-86-6599 was above 50% after 15 ± 0.5 minutes treatment GR-86-6599 is considered to be non-irritant.
The positive control had a mean cell viability of 22% after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 6%, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Since the mean relative tissue viability for GR-86-6599 was above 50% after 15 ± 0.5 minutes treatment GR-86-6599 is considered to be non-irritant.
Finally, it is concluded that this test is valid and that GR-86-6599 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report and should not be classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations. - Executive summary:
In vitro skin irritation test with GR-86-6599 using a human skin model.
This report describes the ability of GR-86-6599 to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)). The possible skin irritation potential of GR-86-6599 was tested through topical application for 15 minutes.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch 43 of GR-86-6599 was a yellow liquid. GR-86-6599 was applied undiluted (25 μl) directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as
the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
GR-86-6599 did interact with 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT). In addition to the normal procedure, three killed tissues treated with test item and three killed untreated tissues were used for the cytotoxicity evaluation with MTT. The nonspecific
reduction of MTT (NSMTT) by GR-86-6599 was -3.1% of the negative control tissues. Since the %NSMTT was ≤ 0.0, there was no correction applied on the ODs of the test item treated viable tissues.
Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with GR-86-6599 compared to the negative control tissues was 99%. Since the mean relative tissue viability for
GR-86-6599 was above 50% after 15 ± 0.5 minutes treatment GR-86-6599 is considered to be non-irritant.
The positive control had a mean cell viability of 22% after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage
viability of three tissues treated identically was less than 6%, indicating that the test system functioned properly.
Finally, it is concluded that this test is valid and that GR-86-6599 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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