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Diss Factsheets
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EC number: 904-304-2 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the O.E.C.D. Draft Testing Guideline (2009) for "In Vitro Skin Irritation" with GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: O.E.C.D. Draft Testing Guideline (2009) for "In Vitro Skin Irritation", EPISKIN method.
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (1E)-1,3-dichloroprop-1-ene; 1,2-dichloropropane
- EC Number:
- 904-304-2
- Molecular formula:
- Multi-constituent: C3H4Cl2 and C3H6Cl2
- IUPAC Name:
- (1E)-1,3-dichloroprop-1-ene; 1,2-dichloropropane
- Reference substance name:
- Crude 1,3-dichloropropene
- IUPAC Name:
- Crude 1,3-dichloropropene
- Details on test material:
- As per IUCLI5 Sections 1.1. - 1.4.
Constituent 1
Constituent 2
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Details on animal used as source of test system:
- The study was conducted in vitro with human keratinocyte derived model tissue (EPISKIN) cultured in maintenance medium at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. The test system in kit form was acquired from EPISKIN, SNC, Lyon, France.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test involves the application of the test substance for 15 minutes to the EPISKIN threedimensional human skin model. The model consists of normal, human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type 1 matrix coated with type IV collagen. After 13 days in culture a multilayered, highly differentiated model of the human epidermis with a functional multi-layered stratum corneum has formed. The epidermis surface area supplied is 0.38cm2. The EPISKIN kit included assay medium, maintenance medium, 12 well plates and the tissues which are shipped on nutritive agar. The principle of the assay is that irritant substances are sufficiently cytotoxic to cause cell
death in the cell layers. The cell viability is determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) to a soluble, coloured, formazan product measured by Optical Density.
To initiate the assay the tissues were removed from the agar and placed into wells of 12 well plates containing 2 ml pre-warmed maintenance medium per well. The tissues were incubated for a minimum of 24 hours at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. The negative control was sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium and the positive control irritant was 5% Sodium Dodecyl Sulphate (SDS) in sterile water.
After incubation of at least 24 hours in maintenance medium, triplicate tissues were dosed for 15 ± 0.5 minutes with test substance, negative or positive control at room temperature. After 15 ± 0.5 minutes, each tissue was rinsed with 25 ml sterile Dulbeccos Phosphate Buffered Saline (DPBS) to remove residual test substance. Inserts were then blotted on absorbent paper to remove remaining DPBS. Each insert was then transferred to a well containing 2 ml maintenance medium and incubated for 42 ± 1 hour at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. After 42 ± 1 hour each insert was transferred to a well containing 2 ml of 0.3 mg/ml MTT and incubated for 3 hours ± 5 minutes at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air. At the end of 3 hours ± 5 minutes the triplicate inserts were blotted on absorbent paper. The epidermis was removed from the insert using a biopsy punch, the epidermis separated from the collagen matrix using forceps and both parts placed in a micro tube.
The tissues were extracted by vortexing with 500 μl of acidic isopropanol (0.04 N HCl final concentration) and and storing at 2-8 ºC, protected from light, for 70 hours. Duplicate 200 μl aliquots of the extractant from each micro tube were assessed for absorbance at 540 nm with acidified
isopropanol solution as a blank. - Control samples:
- yes, concurrent positive control
- Amount/concentration applied:
- 10 uL at 100%.
- Duration of treatment / exposure:
- 42 hours
- Duration of post-treatment incubation (if applicable):
- 3 hours ± 5 minutes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 8.4
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Following treatment with neat Crude 1,3-Dichloropropene, the individual relative percent viabilities of the epidermal cell cultures were, 9.8, 7.1, and 8.3 wwith a mean value of 8.4 ± 1.3%. The positive control 5% Sodium Dodecyl Sulphate (SDS) had a mean percent viability of 14.0 ± 3.0.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: O.E.C.D. Draft Testing Guideline (2009) "In Vitro Skin Irritation" with relative percent viability of < 50% is Irritant.
- Conclusions:
- With a relative percent viability of 8.4 ± 1.3, Crude 1,3-dichloropropene is judged to be a skin irritant. Therefore, Classification and Labeling as "Irritating to Skin" is required.
- Executive summary:
Crude 1,3 -dichloropropene was assessed for skin irritating potential by O.E.C.D. Draft Testing Guideline "In Vitro Skin Irritation" with the human keratinocyte EPISKIN tissue model. With a relative percent viability of 8.4 ± 1.3, Crude 1,3-dichloropropene is judged to be a skin irritant. Therefore, Classification and Labeling as "Irritating to Skin" is required.
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