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EC number: 700-527-2 | CAS number: 1271488-66-4
- 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:
- 9 - 29 December 2010
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing of Chemicals, Guideline no. 431: In Vitro Skin Corrosion: Human Skin Model Test (adopted 13 April 2004).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- bis: "in vitro Skin Corrosion: Human Skin Model Test" - Regulation (EC) no. 440/2008.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- methyl trans-3-oxo-2-pentylcyclopentanecarboxylate
- EC Number:
- 700-527-2
- Cas Number:
- 1271488-66-4
- Molecular formula:
- C12H20O3
- IUPAC Name:
- methyl trans-3-oxo-2-pentylcyclopentanecarboxylate
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- The incubations took place in the dark and in air with a humidity of 56-86% containing 0.5±0.5% carbon dioxide at 36.8-37.3°C.
Test system
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- 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). 99.5 µl of the test substance was added to 1 ml MTT and incubated for 1h at room temperature. A negative control of sterile Milli-Q water was included.
The skin tissues were placed into a 6-well plate on 0.9ml Dulbecco's Modified Eagle's Medium (DMEM) per well and incubated for 105 minutes at 37°C in air. The medium was replaced with fresh DMEM just before the test substance was applied.
4 samples plus a negative control of Milli-Q water and positive control of 8N potassium hydroxide was included in the test. Two tissue samples were exposed for 3 minutes and two samples for 1-hour to 50 µl test substance, that was added on top of the tissue. After the exposure, the tissues were rinsed with phosphate buffered saline
The DMEM medium was replaced by 300 µl MTT medium and the tissues were incubated for 3 hours under the same environmental conditions. The tissues were subsequently washed with PBS and the formed formazan was extracted with 2 ml isopropanol overnight at room temperature. The amount of Formazan was determined spectrophotometrically at 540 nm in triplicate. The cell viability was measured against the mean of the negative control.
Results and discussion
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 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 not below 50% after an exposure duration of 3-minutes and 15% after 1 hour, the test substance is not considered corrosive.
Any other information on results incl. tables
Table 1 Absorptions (OD540) in the in vitro skin corrosion test | |||||||||
3-minute application | 1-hour application | ||||||||
A | B | Mean | SD | A | B | Mean | SD | ||
Negative control | 0.960 | 0.998 | 0.972 | 0.033 | 1.040 | 1.076 | 1.044 | 0.035 | |
0.953 | 1.009 | 1.008 | 1.063 | ||||||
0.934 | 0.979 | 1.011 | 1.067 | ||||||
Test substance | 1.008 | 1.063 | 1.031 | 0.050 | 1.101 | 1.098 | 1.099 | 0.001 | |
0.999 | 1.076 | 1.102 | 1.103 | ||||||
0.981 | 1.060 | 1.097 | 1.094 | ||||||
Positive control | 0.084 | 0.075 | 0.077 | 0.002 | 0.055 | 0.072 | 0.580 | 0.004 | |
0.071 | 0.078 | 0.057 | 0.056 | ||||||
0.072 | 0.081 | 0.051 | 0.054 | ||||||
Duplicate exposures are indicated by A and B |
Table 2 Mean tissue viability as % of negative control in the in vitro skin corrosion
Application | 3-minute | 1-hour | |
% | % | ||
Negative control | 100 | 100 | |
Test substance | 106 | 105 | |
Positive control | 8 | 6 |
Table 3 Historical control data for the in vitro skin corrosion studies (Data collected from July 2007 to August 2010)
Negative control | Positive control | ||||
3-minute | 1-hour | 3-minute | 1-hour | ||
Range | 1.226-2.003 | 1.365-2.007 | 0.075-.278 | 0.057-.242 | |
mean | 1.60 | 1.60 | 0.13 | 0.11 | |
SD | 0.15 | 0.12 | 0.05 | 0.04 | |
n | 58 | 58 | 58 | 58 |
SD: standard deviation; n: number of observations
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test is valid and the test substance is not corrosive in the in vitro skin corrosion test under the experimental conditions used.
- Executive summary:
An in vitro skin corrosion test was conducted on a human skin model according to the OECD guidelines. 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 3 minutes and 1 hour. After the exposure, the tissue was incubated with MTT and the formazan that was produced from MTT was spectroscopically determined at 540 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 the same tissue viability as the negative control. The test substance is therefore not considered as corrosive.
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