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EC number: 249-616-3 | CAS number: 29420-49-3
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
- EC Number:
- 249-616-3
- EC Name:
- Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate
- Cas Number:
- 29420-49-3
- Molecular formula:
- C4HF9O3S.K
- IUPAC Name:
- potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot Number 2
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored in original container at room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Inc.
- Age at study initiation: Approximately 16 weeks old
- Weight at study initiation:
- Housing: Animals were individually housed in stainless steel cages
- Diet (e.g. ad libitum): Tekland Certified Rabbit Diet #8630 provided at approximately 125g per day ad libitum
- Water (e.g. ad libitum): Filtered tap water ad libitum
- Acclimation period: Acclimated for a minimum of 7 days prior to study day 1
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16C to 22C
- Humidity (%):30% TO 70%
- Air changes (per hr): Ten or greater air changes per hour
- Photoperiod (hrs dark / hrs light): 12:12 hour light:dark cycle
IN-LIFE DATES: From: 9 June 2000 To: 29 June 2000
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 80 mg - Duration of treatment / exposure:
- Left eye was exposed to 80 mg T-7485. Both eyes were held close for approximately 2 seconds
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 Females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Both eyes were flushed with approximately 5 mL of 0.9% saline
- Time after start of exposure: After 24-hour score was recorded
SCORING SYSTEM: Draize technique (Hackett, R.B., and McDonald, T.O, Eye Irritation, Dermatotoxicolocly, Fourth Edition, Marzulli, F.N. and Maibach, H.I.: 749-815, 1991)
TOOL USED TO ASSESS SCORE: Fluorescein staining
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Irritation parameter:
- other: Cornea area
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- other: Conjunctivae redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- other: Conjunctivae discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- other: Cornea area
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- other: Conjunctivae redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- other: Conjunctivae discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Irritation parameter:
- other: Cornea area
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- other: Conjunctivae redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Irritation parameter:
- other: Conjunctivae discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Irritant / corrosive response data:
- Maximum average ocular scores for 24- and 72-hours post-dose were 30 and 35, respectively. By definition, the findings at 24- and 72-hours will not maintain the categories of non-irritating, practically non-irritating, or minimally irritating. Ocular irritation scores at the 7-day reading were less than 10 (scores were 6, 4, and 30 for the three rabbits) for 67% of the rabbits. The seven-day mean score was 13. Ocular effects in one animal did not fully reverse by day 21.
- Other effects:
- - Lesions and clinical observations: At one hour post-dose, excessive lacrimation of the left eye was recorded in all three rabbits. The excessive lacrimation of the left eye persisted throughout the remainder of the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results of the study, the test article is corrosive to the eyes of rabbits.
- Executive summary:
The primary ocular irritation/corrosion potential of T-7485 was evaluated in three female New Zealand White rabbits. The study was based on OECD 405 (no year reported) and was certified GLP. Approximately 80 mg of test material, T-7485, was instilled unchanged to the conjunctival sac of the left eye of each rabbit by gently pulling the lower eyelid away from the eye; the right eye of each animal served as a control. Both eyes were held closed for approximately 2 seconds after administration to ensure adequate distribution of the test material. The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours postdose and daily on Days 5-21 using the Draize technique. After the examination at 24 hours postdose, both eyes of each rabbit were rinsed with approximately 5 mL of 0.9% saline. The Primary Irritation Index (PII) was calculated. Corneal opacity was observed in all animals at 1 hour postdose (scores: 1, n=2; 2, n=1) and cleared in 2/3 animals by 48 hours and 7 days postdose, respectively. The individual mean scores (24-72 hours) for corneal opacity were 0.33, 2.0, and 1.67. Iritis was observed in all animals at 1 hour postdose (scores: 1, n=1; 2, n=2) and cleared in 2/3 animals by Days 5 and 6, respectively. All individual mean scores (24-72 hours) for iritis were 1.0. Conjunctival redness was observed in all animals at 1 hour postdose (all scores: 2) and resolved in 2/3 animals by Day 10. The individual mean scores (24-72 hours) for conjunctival redness were 1.67, 2.0, and 2.0. Conjunctival chemosis was observed in all animals at 1 hour postdose (scores: 1, 2, and 4) and cleared in 2/3 animals by Days 7 and 8, respectively. The individual mean scores (24-72 hours) for conjunctival chemosis were 2.0, 2.0, and 2.67. Conjunctival discharge was observed in all animals at 1-72 hours (all scores: 3), Days 5-6 (scores: 2, n=2; 3, n=1), Days 7-12 (all scores: 1), Day 13 (scores: 1, n=2; 2, n=1), Days 14-17 (scores: 1, n=2; 3, n=1), and Day 18 (all scores: 1). Discharge resolved in 2/3 animals by Days 19 and 21, respectively. Ocular irritation still persisted in 1/3 animals on Day 21 (corneal opacity: 4, iritis: 2, redness: 2, chemosis: 3, discharge: 1). The highest mean PII was 36.33/110 at 1 and 48 hours postdose. Occular effects in one animal did not fully reverse by 21 days. Based on the results of the study, the test article is corrosive to the eyes of rabbits.
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