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EC number: 253-649-9 | CAS number: 37743-18-3
- 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
- Study period:
- 2003-10-31 to 2003-10-31
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Only a study summary was available for review which provided limited details on the test substance and methodology; however, sufficient information was provided to deem the study reliable with restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
- Principles of method if other than guideline:
- The ocular irritancy potential of the test material was assessed using the Rabbit Enucleated Eye Test (REET). This method involved the apploication of the test material onto the cornea of the enucleated eye.
Direct effect on the cornea is assessed by evaluation of corneal thickness, opacity, alteration of corneal epithelium, and fluorescein uptake. The data for all endpoints are assessed and an estimate of ocular irritancy potential is made. - GLP compliance:
- no
- Remarks:
- performed in facility operating to GLP, but no formal claim or audit by the QA unit
Test material
- Reference substance name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- EC Number:
- 253-649-9
- EC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Cas Number:
- 37743-18-3
- Molecular formula:
- C18H20NO.Br
- IUPAC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- no data
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Five enucleated eyes, obtained from the New Zealand White strain of rabbit.
- The eyes were maintained at a temeprature of 32°C +/-1.5°C within the superfusion apparatus, except for 180 and 240 minutes post dosing when the temperature was slightly below the stated range. This deviation from the Standard Test Method was considered not to affect the purpose or integrity of the study.
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 65 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): 0.9% sodium chloride - Duration of treatment / exposure:
- single application
- Number of animals or in vitro replicates:
- 3 treated eyes, 2 control eyes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
OBSERVATION TIME POINTS
- corneal opacity and corneal epithelium condition: 60, 120, 180 and 240 min
- fluorescein uptake: 240 min
- corneal swelling: 60, 120 and 240 min
SCORING SYSTEM:
- Method for Evaluation of Ocular Irritation by Slit-Lamp Biomicroscopic Examination (McDonald Shadduck Score System)
- The scoring scheme measures the severity of corneal cloudiness and the area of the cornea involve d. Severity of corneal cloudiness is graded as follows:
0 = Normal cornea. Appears with the slit-lamp as having a bright grey line on the epithelial surface and a bright grey appearance of the stroma.
1 = Some loss of transparency. Only the anterior half of the stroma is involved as observed with an optical section of the slit-lamp. The underlying structures are clearly visible with diffuse illumination, although some cloudiness can be readily apparent with diffuse illumination.
2 = Moderate loss of transparency. In addition to involving the anterior stroma, the cloudiness extends all the way to the endothelium. The stroma has lost its marble-like appearance and is homogeneously white. With diffuse, illumination, underlying structures are clearly visible.
3 = Involvement of the entire thickness of the stroma. With optical section, the endothelial surface is still visible. However, with diffuse illumination the underlying structures are just visible.
4 = Involvement of the entire thickness of the stroma. With the optical section cannot clearly visualise the endothelium. With diffuse illumination, the underlying structures cannot be seen.
5
The surface of the cornea relative to the area of cloudiness is divided into five grades from 0 to 4:
0 = Normal cornea with no area of cloudiness
1 = 1 to 25% area of stromal cloudiness
2 = 26 to 50% area of stromal cloudiness
3 = 51 to 75% area of stromal cloudiness
4 = 76 to 100% area of stromal cloudiness
FLUORESCEIN
- The use of fluorescein is a valuable aid in defining epithelial damage for fluorescein staining. The a rea can be judged as a 0 to 4 scale using the same terminology as for corneal cloudiness. The intensity of fluorescein staining can be divided into a 0 to 4 scale:
0 = Absence of fluorescein staining
1 = Slight fluorescein staining confined to a small focus. With diffuse illumination the underlying struc tures are clearly visible, although there is some loss of detail.
2 = Moderate fluorescein staining confined to a small focus. With diffuse illumination the underlying str uctures are clearly visible, although there is some loss of detail.
3 = Marked fluorescein staining. Staining may involve a larger portion of the cornea. With diffuse illu mination underlying structures are barely visible but are not completely obliterated.
4 = Extreme fluorescein staining. With diffuse illumination the underlying structures cannot be seen.
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean of 3 eyes - cloudy
- Run / experiment:
- 60 minutes post dosing
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean of 3 eyes - area
- Run / experiment:
- 60 minutes post dosing
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean of 3 eyes - cloudy
- Run / experiment:
- 120 minutes post dosing
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean of 3 eyes - area
- Run / experiment:
- 120 minutes post dosing
- Value:
- 3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean of 3 eyes - cloudy
- Run / experiment:
- 180 post dosing
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean of 3 eyes - area
- Run / experiment:
- 180 minutes post dosing
- Value:
- 4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean of 3 eyes - cloudy
- Run / experiment:
- 240 minutes post dosing
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean of teyes - area
- Run / experiment:
- 240 minutes post dosing
- Value:
- 4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean of 3 eyes (intensity)
- Run / experiment:
- 240 minutes post dosing
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- fluorescein retention score
- Remarks:
- mean of 3 eyes (area)
- Run / experiment:
- 240 minutes post dosing
- Value:
- 4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean of 3 eyes
- Run / experiment:
- 60 minutes post dosing
- Value:
- 14.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean of 3 eyes
- Run / experiment:
- 120 minutes post dosing
- Value:
- 19.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Irritation parameter:
- percent corneal swelling
- Remarks:
- mean of 3 eyes
- Run / experiment:
- 240 minutes post dosing
- Value:
- 29.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not applicable
- Other effects / acceptance of results:
- negative control eyes:
- corneal opacity: 0 (mean of 2 eyes)
- corneal epithelium condition: normal (2 eyes)
- fluorescein uptake: 0 (mean of 2 eyes)
- corneal swelling: 4.7 at 60 min post dosing, 4.4 at 120 minutes post dosing and 2.8 at 240 minutes post dosing
Corneal epithelium condition of test item treated eyes was normal at all timepoints
Any other information on results incl. tables
The test item adhered to the surface of the cornea.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material was considered to have the potential to cause severe ocular irritancy in vivo.
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