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EC number: 938-347-3 | CAS number: 28068-91-9
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted by GLP accredited laboratory. Method according to OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing of Chemicals, Guideline no. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (adopted 22 July 2010).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of (2R,4R)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone and (2S,4S)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone
- EC Number:
- 938-347-3
- Cas Number:
- 28068-91-9
- Molecular formula:
- C13H24O
- IUPAC Name:
- Reaction mass of (2R,4R)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone and (2S,4S)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone
- Test material form:
- other: undercooled liquid
- Details on test material:
- - Name of test material (as cited in study report): Iriswood
- Substance type: pure active substance
- Physical state: undercooled liquid
1
Test animals
- Species:
- human
Test system
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 10µl undiluted test material. The same amount is applied to the positive and negative control.
- Duration of treatment / exposure:
- 15 minutes at room temperature.
- Details on study design:
- Prior to the analysis, the test substance was checked for possible direct reduction of 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue; CAS number 298-93-1) (MTT).
10 µl of the test substance was added to 2.2 ml MTT solution and incubated for 3h at 37°C, 5% CO2. A negative control of distilled water was included.
Three tissues per test were treated with the test material. Three tissues were treated with the negative control and three tissues were exposed to the positive control (5% aqueous solution of sodium dodecylsulphate-SDS CAS 151-21-3). The tissue samples were exposed to the test substance / controls for 15 minutes. After the exposure, the tissues were rinsed with phosphate buffered saline (PBS) and incubated for 42h at 37°C, 5% CO2.
After the incubation, the tissues were subsequently incubated for another 3h in the presence of 2.2ml MTT. The formed formazan was extracted with 0.5 ml isopropanol for 2h under agitation in the dark. The amount of Formazan was determined spectrophotometrically (Optical Density - OD) at 570 nm in duplicate. The cell viability was measured against the mean of the negative control.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Viability
- Value:
- 14.6
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Max. score: 100.0. (migrated information)
In vivo
- Irritant / corrosive response data:
- The test substance was visually checked for possible direct MTT reduction causing a colour change. No interaction with MTT was observed.
Details of the data and the mean of the spectroscopic measurements can be found in Table 1. Table 2 presents the mean relative tissue viability obtained after 15 minutes treatment with the test substance being the mean of the absorption of the test substance divided by the negative control mean for each application. Since the mean relative tissue viability of the test substance was below 50% after an exposure duration of 15 minutes, the test substance is considered to be irritant.
Any other information on results incl. tables
Table 1 Absorptions (OD570) in the in vitro skin irritation test
15-minute exposure | ||||
1 | 2 | 3 | Mean | |
Negative control | 0.548 | 0.529 | 0.507 | 0.528 |
Test substance | 0.066 | 0.101 | 0.064 | 0.077 |
Positive control | 0.104 | 0.071 | 0.076 | 0.084 |
Table 2 Mean tissue viability as % of negative control in the in vitro skin irritation
Exposure | 15-minutes | SD |
% | ||
Negative control | 100 | 3.8 |
Test substance | 18 | 3.9 |
Positive control | 10 | 3.4 |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test is complies with the acceptability criteria and the test substance is considered an irritant in the in vitro skin irritation test under the experimental conditions used.
- Executive summary:
An in vitro skin irritation test was conducted on a human skin model according to the OECD guideline 439. The basis of the test is that the cell viability was determined by using the MTT reduction assay. The test substance was applied undiluted on top of the skin tissue for 15 minutes. After the exposure, the tissue was incubated with MTT and the formazan that was produced from MTT was spectroscopically determined at 570 nm. The relative mean tissue viability of the test substance expressed as the absorption of the test substance against the negative control showed that the test substance has a relative mean tissue viability of ≤50% compared to the negative control. The test substance is therefore considered an irritant.
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