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EC number: 239-405-4 | CAS number: 15373-31-6
- 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:
- 2015-06-03 to 2015-07-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2,3-trimethylcyclopent-3-enylacetonitrile
- EC Number:
- 239-405-4
- EC Name:
- 2,2,3-trimethylcyclopent-3-enylacetonitrile
- Cas Number:
- 15373-31-6
- Molecular formula:
- C10H15N
- IUPAC Name:
- 2-(2,2,3-trimethylcyclopent-3-en-1-yl)acetonitrile
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Details on test animals or test system and environmental conditions:
- Test system:
Epi-200- SIT Kit (Lot No.: 21680)
MTT-100 Assay Kit
Source: both Kits MatTek Corporation (Bratislava, Slovakia)
Test system
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: The applied volume of the test item was adjusted to purity, therefore 30.8 μL instead of 30 μL (47 μL/cm2 according to guideline) of the undiluted test item was dispensed directly atop the EpiDerm™ tissue and spread to match the surface of the tissue. - Duration of treatment / exposure:
- 60 minutes
- Observation period:
- The colour of the test item/water mixture was observed during the whole incubation period (60 min). The measurement of the OD of the test item in water at 570 nm was not required and consequently not performed.
- Number of animals:
- Three individual tissues were used for the test item and the positive control, respectively.
- Details on study design:
- SCORING SYSTEM:
The mean OD of the three negative control tissues was calculated after blank correction. This value corresponds to 100 % tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability is calculated according to the following formula:
Relative viability [%] = (mean OD (test item/positive control) /mean OD (negative control)) * 100
For the test item and the positive control the mean relative viability ± rel. standard deviation of the three individual tissues was calculated and used for classification according to the following prediction model:
For the current test, an irritation potential of a test item according to EU classification R38 (according to directive 67/548/EEC), H315 (according to regulation (EC) 1272/2008), and GHS category 2 according to UN GHS (published 2003, last (3rd) revision 2009) is recommended if the mean relative tissue viability of three individual tissues is reduced ≤ 50% of the negative control.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: relative absorbance ( % of negative control)
- Value:
- 4.7
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean of 3 tissues. Time point: 60 min. Max. score: 100.0. Reversibility: other: not examined. (migrated information)
In vivo
- Irritant / corrosive response data:
- The mean relative absorbance after treatment with the test item was 4.7 (% of negative control). For the positive control the mean relative absorbance was found to be 6.8 (% of negative control).
Any other information on results incl. tables
Results
Dose Group |
Exposure Interval |
Absorbance 570 nm Tissue 1* |
Absorbance 570 nm Tissue 2* |
Absorbance 570 nm Tissue 3* |
Mean Absorbance of 3 Tissues |
Rel. Absor-bance [%] Tissue 1, 2 + 3**
|
Relative standard deviation [%] |
Rel. Absorbance [% of Negative Control]** |
Negative control |
60 min |
1.751 |
1.579 |
1.844 |
1.724 |
101.5 91.5 106.9 |
7.8 |
100.0 |
Positive control |
60 min |
0.129 |
0.115 |
0.109 |
0.118 |
7.5 6.7 6.3 |
8.6 |
6.8 |
Test item |
60 min |
0.111 |
0.073 |
0.062 |
0.082 |
6.5 4.2 3.6 |
31.8 |
4.7 |
* Mean of three replicate wells after blank correction
** relative absorbance per tissue [rounded values]: (100x(absorbance tissue))/ mean absorbance negative control
*** relative absorbance per treatment group [rounded values]: (100x(mean absorbance test item/positive control))/ mean absorbance negative control
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was found to be irritating to skin according to UN GHS and EU CLP regulation.
- Executive summary:
An in vitro study was performed to assess the irritation potential of the test item by means of the Human Skin Model Test. The test item did not reduce MTT (test for direct MTT reduction), and it did not change colour when mixed with deionised water (test for colour interference). Also its intrinsic colour was not intensive. Consequently, additional tests with freeze-killed or viable tissues were not necessary.
Each three tissues of the human skin model EpiDermTM were treated with the test item, the negative or the positive control for 60 minutes.
30.8 μL of the test item were applied to each tissue, and spread to match the surface of the tissue. 30 μL of either the negative control (DPBS) or the positive control (5 % SLS) were applied to each tissue. After treatment with the negative control the absorbance values were well in the required range of the acceptability criterion of mean OD≥0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues. Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 60 minutes treatment interval, and thus assuring the validity of the test system.
After treatment with the test item the mean relative absorbance value decreased to 4.7 % compared to the relative absorbance value of the negative control. This value is below the threshold for irritancy of ≤ 50 %. Therefore, the test item is considered to possess an irritant potential.
In conclusion, it can be stated that in this study and under the experimental conditions reported, the substance is irritating to skin.
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