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EC number: 931-485-5 | CAS number: -
- 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:
- July 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to relevant recognized method
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, Draft Proposal for a new Guideline: In Vitro Skin Irritation: REconstructed Human Epidermitis (RhE) Test Method
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission regulation (EC) N° 440/2008, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.46 "In Vitro Skin Irritation: Reconstructed Human Epidermitis Model Test"
- Deviations:
- no
- Principles of method if other than guideline:
- The test is based on the experience that irritant chemicals show cytotoxic effects following short term exposure to the stratum corneum of the epidermis. The test is designed to predict and classify the skin irritation potential of a test substance by assessment of its effect on a three dimensional human epidermis model.
The test consists of topical application of Reaction mass containing mainly 2-chloropropene on the skin tissue for 15 minutes. After exposure the skin tissue is thoroughly rinsed to remove the test substance and transferred to fresh medium. After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect is performed.
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment. - GLP compliance:
- yes
Test material
- Reference substance name:
- 2-chloropropene
- EC Number:
- 209-187-5
- EC Name:
- 2-chloropropene
- Cas Number:
- 557-98-2
- Molecular formula:
- C3H5Cl
- IUPAC Name:
- 2-chloroprop-1-ene
- Reference substance name:
- 2-chloropropane
- EC Number:
- 200-858-8
- EC Name:
- 2-chloropropane
- Cas Number:
- 75-29-6
- Molecular formula:
- C3H7Cl
- IUPAC Name:
- 2-chloropropane
- Reference substance name:
- 1-chloropropene
- EC Number:
- 209-675-8
- EC Name:
- 1-chloropropene
- Cas Number:
- 590-21-6
- IUPAC Name:
- 1-chloroprop-1-ene
- Details on test material:
- Identification Reaction mass containing mainly 2-chloropropene
Molecular formula C3H5Cl
Molecular weight 76.53
CAS Number 557-98-2
Description Clear light yellow to brown liquid (determined at NOTOX)
Batch RBA100301A
Purity Minimum 60.0%
Test substance storage In refrigerator (2-8°C) in the dark
Stability under storage conditions Stable
Expiry date 08 March 2011 (allocated by NOTOX, 1 year after receipt of the test substance)
Study specific test substance information:
General information Extremely flammable
Test substance handling If necessary, handling after sampling will be performed on dry ice in order to keep the test substance liquefied
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- Test system:
EPISKIN Standard ModelTM (EPISKIN-SMTM, 0.38 cm2, Lot no.: 10-EKIN-020).
This model is a three-dimensional human epidermis model, which consists of adult human-derived 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.
Rationale
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).
Source
SkinEthic Laboratories, Nice, France.
Environmental conditions:
All incubations, with the exception of the test substance incubation of 15 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 76 - 92%), containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C (actual range 35.7 - 37.5°C). Temperature and humidity were continuously monitored throughout the experiment. The CO2 percentage was monitored once on each working day. Temporary deviations from the temperature (in the range of 35.7- 36.0°C) and humidity (with a maximum of 4%) occurred that were caused by opening and closing of the incubator door, but the time of these deviations did not exceed 1 hour. Based on laboratory historical data these deviations are considered not to affect the study integrity.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- The test was performed on a total of 3 tissues per test substance together with negative and positive controls. Ten µl of the undiluted test substance was added (with a pipette) into 12-well plates on top of the skin tissues. Three tissues were treated with 10 µl PBS (negative control) and 3 tissues with 10 µl 5% SDS (positive control) respectively. The positive control was
re-spread after 7 minutes contact time. After the exposure period of 15 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test substance. After rinsing the cell culture inserts were each dried carefully. The skin tissues were kept in new 12-well plates on 2 ml pre-warmed maintenance medium until all tissues were dosed and rinsed. Subsequently the skin tissues were incubated for 42 hours at 37°C. - Duration of treatment / exposure:
- Exposure of 15 minutes
- Observation period:
- Incubation for 42 hours
- Details on study design:
- Test for reduction of MTT by the test substance:
Reaction mass containing mainly 2-chloropropene has been tested previously for possible direct MTT reduction in the Skin corrosion test using EpiDerm as a skin model (NOTOX project 492886). The MTT solution colour was not turned blue / purple and a blue / purple precipitate was not observed. Reaction mass containing mainly 2-chloropropene did not interact with MTT.
Cell viability measurement:
After incubation, cell culture inserts were dried carefully to remove excess medium and were transferred into a 12-wells plate prefilled with 2 ml MTT-medium (0.3 mg/ml). The tissues were incubated for 3 h at 37°C. After incubation the tissues were placed on blotting paper to dry the tissues. Total biopsy was made by using a biopsy punch. Epidermis was separated from the collagen matrix and both parts were placed in prelabeled microtubes and extracted with 500 µl isopropanol. Tubes were stored refrigerated and protected from light for 70 hours. The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with the Multiskan Spectrum (Thermo Labsystems).
Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test substance was classified according to remaining cell viability following exposure of the test substance.
Electronic data capture:
Observations/measurements in the study were recorded electronically using the following programme(s):
REES Centron Environmental Monitoring system version SQL 2.0 (REES Scientific, Trenton, NJ, USA): Temperature and humidity.
Multiskan spectrum version 1.00 (Thermo labsystems, Breda, The Netherlands) for optical density measurement.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: cell viability
- Value:
- 84
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes. Remarks: Score correspond to the relative mean tissue viability compared to the negative control tissues (%). (migrated information)
In vivo
- Irritant / corrosive response data:
- The mean absorption at 570 nm measured after treatment with Reaction mass containing mainly 2-chloropropene and controls are presented in Table 1.
Table 2 shows the mean tissue viability obtained after 15 minutes treatment with Reaction mass containing mainly 2-chloropropene compared to the negative control tissues. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Reaction mass containing mainly 2-chloropropene compared to the negative control tissues was 84%. Since the mean relative tissue viability for Reaction mass containing mainly 2-chloropropene was above 50% Reaction mass containing mainly 2-chloropropene is considered to be non-irritant.
The positive control had a mean cell viability after 15 minutes exposure of 7%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range (See Appendix II). The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.
Any other information on results incl. tables
Table1 Mean absorption in thein vitroskin irritation test with Reaction mass containing mainly 2-chloropropene
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean (OD570) |
|
SD |
Negative control |
0.889 |
0.879 |
0.883 |
0.884 |
± |
0.005 |
Test substance |
0.765 |
0.745 |
0.727 |
0.746 |
± |
0.019 |
Positive control |
0.053 |
0.062 |
0.068 |
0.061 |
± |
0.008 |
OD = optical density
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
Test substance = Reaction mass containing mainly 2-chloropropene
In this table the values are corrected for background absorption. Isopropanol was used to measure the background absorption.
Table2 Mean tissue viability in thein vitro skin irritation test with Reaction mass containing mainly 2-chloropropene
|
Mean tissue viability (percentage of control) |
Negative control |
100 |
Reaction mass containing mainly 2-chloropropene |
84 |
Positive control |
7 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other:
- Conclusions:
- Finally, it is concluded that this test is valid and that Reaction mass containing mainly 2-chloropropene is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
- Executive summary:
This report describes the ability of Reaction mass containing mainly 2-chloropropene to induce skin irritation on a human three dimensional epidermal model (EPISKIN Standard model (EPISKIN-SMTM)). The possible skin irritation potential of Reaction mass containing mainly 2-chloropropene 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 RBA100301A of Reaction mass containing mainly 2-chloropropene was a clear light yellow to brown liquid with a purity of 60.0% (minimum). Reaction mass containing mainly 2-chloropropene was applied undiluted (10 µl) directly on top of the skin tissue. After a 42 hour 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.
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Reaction mass containing mainly 2-chloropropene compared to the negative control tissues was 84%. Since the mean relative tissue viability for Reaction mass containing mainly 2-chloropropene was above 50% after 15 minutes treatment Reaction mass containing mainly 2-chloropropene is considered to be non-irritant.
The positive control had a mean cell viability after 15 minutes exposure of 7%. 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 18%, indicating that the test system functioned properly.
Finally, it is concluded that this test is valid and that Reaction mass containing mainly 2-chloropropene is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
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