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EC number: 212-377-0 | CAS number: 811-97-2
- 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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The protocols published by Arrêté of 21 September 1984, in the "Journal Officiel de la République Française" of 24 October 1984 and 9 February 1985.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Norflurane
- EC Number:
- 212-377-0
- EC Name:
- Norflurane
- Cas Number:
- 811-97-2
- Molecular formula:
- C2H2F4
- IUPAC Name:
- 1,1,1,2-tetrafluoroethane
- Details on test material:
- - Name of test material (as cited in study report): HFA 134a (1,1,1,2-Tetrafluoroethane)
- Physical state: gas (supplied as a liquefied gas)
- Analytical purity: >99.8%
- Purity test date: June 1989
- Lot/batch No.: 00015 I9 001
- Expiration date of the lot/batch: n/a
- Stability under test conditions: Stable for at least one year under good storage conditions
- Storage condition of test material: in orginal container and protected from heat.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bancel (Albon - 26140 Saint-Rambert-d'Albon - France)
- Age at study initiation: Adult
- Weight at study initiation: 2.35 - 2.70 kg
- Housing: individual housed in polystyrene cages with perforated flooring (internal dimensions 560 x 355 x 315 mm)
- Diet (e.g. ad libitum): about 150 g per animal and per day of complete pelleted rabbit maintenance diet (U.A.R. formulae 112 U.A.R., Villemoisson - 91360 Epinay - S/Orge - France).
- Water (e.g. ad libitum): ad libitum, filtered (15um) and softened mains drinking water (automatic dispenser). Bacteriological and Chemical Analysis performed twice a year.
- Acclimation period: 26 days before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23°C
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12 (photoperiod 07.30 - 19.30)
IN-LIFE DATES: From: To:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Group 1: one 5 second vaporization of neat HFA 134a (in gaseous form)
Group 2: two 15 second vaporizations of neat HFA 134a (in gaseous form)
Admistration was performed 10 cm from the right eye into the inferior conjunctival sac. The left eye was used as control. - Duration of treatment / exposure:
- 5 - 15 seconds
- Observation period (in vivo):
- 1 hour, then on Days 1 (24 hours), 2 and possibly 2, 3, 7. When no more abnormalities were noted in one group of 6 rabbits from Day 3 onwards, examinations were not continued.
- Number of animals or in vitro replicates:
- 2 treated groups of 6 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): administered without rinsing
SCORING SYSTEM: Evaluation of the lesions was done according to the Draize scale
TOOL USED TO ASSESS SCORE: fluorescein / Heine ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- (See Table 1)
- Basis:
- mean
- Time point:
- other: 1 hour
- Max. score:
- 8.83
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: Group 1: one 5 second vaporization
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- (See Table 1)
- Basis:
- mean
- Time point:
- other: 1 hour
- Max. score:
- 11.33
- Reversibility:
- other: Mean Occular Irritation after 2 days = 1.67
- Remarks on result:
- other: Group 2: two 15 second vaporizations
- Irritant / corrosive response data:
- Very slight irritation
Any other information on results incl. tables
Table 1. HFC 134a Mean Occular Irritation (O.I.) indices.
Group | 1 hour | Day 1 | Day 2 | Day 3 | Day 4 | Day 7 | Max OI (Mean OI after 2 days) |
1 | 8.83 | 1.00 | 0.00 | ---- | ---- | ---- | 8.83 (0.00) |
2 | 11.33 | 3.83 | 1.67 | 1.33 | 1.33 | 1.00 | 11.33 (1.67) |
HFC 134a was judged to the Very Slightly Irritant to the rabbit eye. There were no noticable pathological ocular lesions.
Applicant's summary and conclusion
- Interpretation of results:
- other: Vey slightly irritant
- Remarks:
- Criteria used for interpretation of results: other: the indicies obtained were judged accordin to the scale published in the "Journal Officiel de la République Française" (9 February 1985).
- Conclusions:
- Gaseous HFC-134a directed from a distance of 10 cm into the eyes of rabbits for 5 or 15 seconds resulted in very slight irritation.
- Executive summary:
In a group of six male New Zealand white rabbits, following a one 5 second vaporization of HFC 134a to the right eye, the Maximum Mean Occular Irritation index was 8.83, and the Mean Occular Irritation Index (OI) after 2 days was zero. In a second similar group, following two 15 second vaporizations, the Maximum Mean Occular Irritation index was 11.33, and the Mean Occular Irritation Index (OI) after 2 days was 1.67. These results lead to the conclusion that HFC 134a is very slightly irritant to the rabbit eye. There were no noticeable pathological lesions. The observed effects were possibly a physical consequence of the test procedure.
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