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EC number: 216-036-7 | CAS number: 1478-61-1
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 - 26 April 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted in accordance with International guidelines and in accordance with GLP. All guideline validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Cas Number:
- 1478-61-1
- Molecular formula:
- C15H10F6O2
- IUPAC Name:
- 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature and in the dark.
- Stability under test conditions: Not reported
- Solubility and stability of the test substance in the solvent/vehicle: Not reported
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not reported
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No
- Preliminary purification step (if any): No
- Final dilution of a dissolved solid, stock liquid or gel: N/A
- Final preparation of a solid: N/A
FORM AS APPLIED IN THE TEST (if different from that of starting material): N/A
OTHER SPECIFICS: Test item instilled into test system as delivered by Sponsor.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: minimum of 6 weeks old
- Weight at study initiation: between 1.0 - 3.5 kg
- Housing: Animals individually housed in cages with perforated floors (Scanbur, Denmark - 53.5 x 63 x 38.5 cm)
- Diet (e.g. ad libitum): Stadard laboratory diet (Charles River breeding and maintenance diet for rabbits, Altromin, Germany). 100 g/ day supplied to each individual. Hay was also provided wice weekly.
- Water (e.g. ad libitum): Tap water supplied ad libitum
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12:12 light:dark
IN-LIFE DATES: From: To: Not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 33 mg of unchanged test item
- Concentration (if solution): n/a
VEHICLE
- Amount(s) applied (volume or weight with unit): n/a
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 (males)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: n/a
SCORING SYSTEM:
Immediately after the 24 h observation, a solution of 2 % fluoroscein in water (pH 7) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any stained areas (indicating epitheleal damage) was estimated as a percentage of the total corneal area.
Irritation was assessed once daily for 3 days. The key parameters measured were; corneal irritation (including % of cornea involved), changes to the iris, conjunctival irritation, chemosis and discharge. Each parameter was measured on a numerical scale as described in OECD 405 TG.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 72 hrs
- Other effects:
- OTHER EFFECTS:
- Visible damage on test system:
Corneal injury was seen as opacity (max. grade 3) and epitheleal damage (max. 90 % of corneal area). The corneal injury persisted until termination (72 h).
Iridial irritation (grade 1) was observed and persisted until termination.
Irritation of the conjunctivae was seen as redness, chemosis and discharge and persisted until termination.
Grey/ white discolouration (sign of necrosis) of the nicititating membrane was noted in two animals at 48 and 72 h. Reduced elasticity of the eyelids was noted in one animal at 48 hours in all animals at 72 h after instillation.
Based on the severity of the ocular lesions observed, no reversibility was expected- the animals were humanely sacrificed at 72 h.
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Not indicated
- Acceptance criteria met for positive control: N/A
- Range of historical values if different from the ones specified in the test guideline: N/A
Any other information on results incl. tables
Table 1: Irritant/ corrosive response data for each animal at each observation time up to the removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Discharge |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max. score: 3 |
|
60 min |
1 / 1 / 1 |
0 / 1 / 0 |
1 / 1 / 1 |
2 / 2 / 2 |
1 / 1 / 2 |
24 h |
2 / 1 / 2 |
1 / 0 / 1 |
2 / 2 / 3 |
2 / 3 / 2 |
1 / 2 / 2 |
48 h |
2 / 1 / 2 |
1 / 1 / 1 |
3 / 3 / 3 |
2 / 3 / 2 |
1 / 2 / 2 |
72 h |
3 / 2 / 3 |
1 / 1 / 1 |
3 / 3 / 3 |
2 / 2 / 2 |
1 / 2 / 2 |
Max. area effected (% of total cornea) |
80 / 80 / 90 |
n/a |
n/a |
n/a |
n/a |
Reversibility* |
nr |
n/a |
n/a |
n/a |
n/a |
Average time (unit) for reversion |
n/a |
n/a |
n/a |
n/a |
n/a |
nr: not reversible
n/a: not applicable
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item can be classified as a Category 1 eye irritant based on GHS criteria.
- Executive summary:
In a primary eye irritation study (OECD 405), ca. 33 mg (equivalent to ca. 0.1 mL) of test item was instilled into the conjunctival sac of young adult, New Zealand White rabbits (3 males). Animals then were observed for 3 days. Irritation was scored by the numerical scoring system described in OECD 405 TG.
Severe and non-reversible corneal injury occurred in all three individuals. Irritation of the conjunctivae, chemosis, discharge and necrosis of the nictitating membrane was also observed and persisted until study termination.
In this study, test item was found to be extremely irritant to the eye based on the ocular corrosion that occurred.
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