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EC number: 807-422-1 | CAS number: 66918-01-2
- 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 / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-04-13 to 2015-06-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study conducted according to the Commission Regulation (EC) No 440/2008, Annex Part B, B.40.Bis: “In Vitro Skin Corrosion: Human Skin Model Test”, Official Journal of the European Union No. L142 (31 May 2008) OECD Guidelines for the Testing of Chemicals, No. 431, “In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method” (26 September 2014)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
- EC Number:
- 807-422-1
- Cas Number:
- 66918-01-2
- Molecular formula:
- C40H78O5
- IUPAC Name:
- 1,4-bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] 2-hydroxybutanedioate
Constituent 1
Test animals
- Species:
- other: Human skin: EpiSkin- SM Kit supplied by SkinEthic, France batch No.: 15-EKIN-017
- Strain:
- other: other: Adult human-derived epidermal keratinocytes
Test system
- Type of coverage:
- other: in vitro test
- Preparation of test site:
- other: in vitro test
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: in vitro test
- Amount / concentration applied:
- - 50 μL of test item was applied evenly to each of two test units and two additional colour control skin units.
- 50 μL of physiological saline was added to each of the two negative control skin units.
- 50 μL of glacial acetic acid was added to each of the two positive control skin units. - Duration of treatment / exposure:
- The plates with the treated epidermis units were incubated for 4 hours (±10 min) at room temperature (23.2-24.6°C) covered with the plate lids. after rincing, the MTT test was performed and cell viability was measured.
- Number of animals:
- Two test units and two additional colour control skin units + two negative control skin units + two positive control skin units.
- Details on study design:
- Disks of EPISKIN (two units) were treated with test item and incubated for 4 hours at room temperature. Exposure of test material was terminated by rinsing with Phosphate Buffered Saline solution. The viability of each disk was assessed by incubating the tissues for 3 hours
with MTT solution. The precipitated formazan crystals were then extracted using acidified isopropanol and quantified spectrophotometrically.
Physiological saline (0.9% (w/v) NaCl solution) and glacial acetic acid treated epidermis were used as negative and positive controls, respectively (two units / control). Two additional disks were used to provide an estimate of colour contribution from the test item. For each treated tissue viability was expressed as a % relative to the negative control. If the mean relative viability after 4 hours of exposure is below 35% of the negative control, the test item is considered to be corrosive to skin.
Following exposure with test item, the mean cell viability was measured compared to the negative control. If above the threshold of 35%, the test item is considered as being non-corrosive.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Relative absorbance (% of Negative Control)
- Basis:
- other: Mean negative control
- Time point:
- other: 4 hours
- Score:
- 100
- Irritation parameter:
- other: Relative absorbance (% of Negative control)
- Basis:
- other: Mean Positive control
- Time point:
- other: 4 hours
- Score:
- 1.7
- Irritation parameter:
- other: Relative absorbance (% Negative Control)
- Basis:
- other: Mean test item
- Time point:
- other: 4 hours
- Score:
- 102.5
- Irritant / corrosive response data:
- Following exposure with Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate, the mean cell viability was 102.5% compared to the negative control. This is above the threshold of 35%, therefore the test item was considered as being non-corrosive. The experiment met the validity criteria, therefore the study was considered to be valid.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Not corrosive to the skin Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, in this in vitro EPISKIN model test with Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate, the results indicate
that the test item is not corrosive to the skin. - Executive summary:
An in vitro skin corrosivity test of Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7- trimethyloctyl] malate test item was performed in a reconstructed human epidermis model. EPISKIN-SM is designed to predict and classify the corrosive potential of
chemicals by measuring its cytotoxic effect as reflected in the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assay . The corrosivity of the test item was evaluated according to the OECD No. 431 guideline.
Disks of EPISKIN (two units) were treated with Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate test item and incubated for 4 hours at room temperature. Exposure of test material was terminated by rinsing with Phosphate Buffered Saline
solution. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution. The precipitated formazan crystals were then extracted using acidified isopropanol and quantified spectrophotometrically.
Physiological saline (0.9% (w/v) NaCl solution) and glacial acetic acid treated epidermis were used as negative and positive controls, respectively (two units / control). Two additional disks were used to provide an estimate of colour contribution from the test item. For each treated tissue viability was expressed as a % relative to the negative control. If the mean relative viability after 4 hours of exposure is below 35% of the negative control, the test item is considered to be corrosive to
skin.
Following exposure with Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate, the mean cell viability was 102.5% compared to the negative control. This is above the threshold of 35%, therefore the test item was considered as being non-corrosive. The
experiment met the validity criteria, therefore the study was considered to be valid.
In conclusion, in this in vitro EPISKIN model test with Bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate, the results indicate that the test item is not corrosive to the skin.
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