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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
Eye irritation
Administrative data
- Endpoint:
- eye 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 O.E.C.D. Testing Guideline No. 437 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:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- not specified
- 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 IUCLID5 Sections 1.1 - 1.4.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- The study was conducted in vitro using isolated bovine cornea. The bovine eyes, supplied by Joseph Morris Abattoir, were excised by an abattoir employee and collected as soon after slaughter as possible. Excised eyes were maintained and transported to the laboratory, at ambient temperature, in sufficient Hanks Balanced Salt Solution (HBSS), containing 1% (v/v) Penicillin/Streptomycin solution, to cover all the eyes in the receptacle. The eyes were used within 4 hours of slaughter (incubation of mounted corneas commenced.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 750 uL undiluted
- Duration of treatment / exposure:
- ten minutes
- Observation period (in vivo):
- two hr
- Number of animals or in vitro replicates:
- Study was conducted in vitro, no animals were placed on study.
- Details on study design:
- The corneas were excised and rinsed in fresh HBSS plus 1% Penicillin/Streptomycin solution prior to mounting. The corneas were mounted in the cornea holders with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was then positioned on top of the cornea and secured with screws. Both compartments of the holder were filled with Complete Minimal Essential Medium Eagles with 5% v/v fetal calf serum (cMEM), using a syringe. The holders were then plugged and incubated, in an upright position, for 60 minutes ± 5 minutes at 32°C ± 1°C in a waterbath. The waterbath temperature remained within the limits of 32°C ± 1°C throughout the experiment. At the end of the 60 minute incubation period, the medium was removed from both the anterior and posterior compartments using a pipette tip attached to a vacuum pump. The compartments were refilled with fresh cMEM.
Corneas were treated in triplicate with either the test substance, Crude 1,3-dichloropropene, positive control ethanol (91.4%) or negative control (0.9% sodium chloride solution). Immediately prior to treatment, the medium was removed from the anterior compartment of the holder. Seven hundred and fifty μl (750 μl) of test substance, positive control or negative control was introduced into the anterior part of each holder. Following application, the anterior compartment was plugged and the holder turned to a horizontal position and slightly rotated to ensure uniform distribution of the test substance over the surface of the cornea. The test material or controls were in contact with the cornea for a total of 10 minutes (± 30 seconds). Each holder was incubated in a horizontal position at 32°C ± 1°C in a waterbath. Following incubation, the test substance, positive and negative controls were removed and the epithelial surface of the cornea washed, three times with MEM with phenol red. The anterior compartment was then filled with cMEM and compartment was re-plugged and the holders returned to the waterbath and incubated, in an upright position, for two hours ± 10 minutes at 32°C ± 1°C.
Following completion of the two hour incubation period, the medium was removed from both compartments and replaced with fresh cMEM. The posterior compartment was re-plugged and the opacity of each cornea measured and recorded. The opacitometer measured the light transmission through the centre of each mounted cornea, displaying a numerical opacity value (arbitrary unit).
Following the final opacity measurement, the medium was removed from the anterior compartment of the holder. One ml of the sodium fluorescein solution ( 4 mg/L) was added to the anterior compartment using a micropipette. Following addition of the sodium fluorescein solution to the anterior side of the holder, the compartment was plugged and the corneas incubated in a horizontal position at 32°C ± 1°C for 90 ± 5 minutes in a waterbath. Following incubation an aliquot of the mixed medium from the posterior compartment was removed and
transferred to a 1 cm path length cuvette. A spectrophotometer was adjusted to read at 490nm (OD490) and a sample of cMEM read as a blank before other sample ODs were taken.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 43.2
- Vehicle controls validity:
- valid
- Other effects / acceptance of results:
- Sample Opacity ± SD Permeability ± SD In vitro irritancy Score ± SD Classification
____________________________________________________________________________________________________________________________________
Crude 1,3-Dichloropropene 11.33 ± 2.0 2.13 ± 0.69 43.2 ± 9.9 Non Corrosive/ Non Severe
Ethanol 19.33 ± 2.65 1.43 ± 0.097 40.8 ± 3.8 Non Corrosive/Non Severe t
0.9% Saline -0.333 ± 1.155 0.004 ± 0.001 Not applicable Not applicable
SD= Standard
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: O.E.C.D. Guideline for Testing No. 437.
- Conclusions:
- With an In Vitro Irritancy Score (IVIS) of 43.2 ± 9.9 Crude 1,3-dichloropropene is not an eye irritant under the conditions of this in vitro assay.
- Executive summary:
Crude 1,3 -dichloropropene was evaluated for eye irritation potential in an O.E.C.D. Testing Guideline No. 437 " Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants" with GLP compliance. With an In Vitro Irritancy Score (IVIS) of 43.2 ± 9.9 Crude 1,3-dichloropropene is not an eye irritant under the conditions of this in vitro assay. Therefore, Classification and Labeling as an eye irritant is not required.
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