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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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 404 (Acute Dermal 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 at room temperature
FORM AS APPLIED IN THE TEST (if different from that of starting material): The test material was moistened with 1% carboxymethylcellulose (CMC) in deionized water.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Inc. Thompson Station, Tenessee
- Age at study initiation: Approximately 12 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: The animals will be individually housed in stainless steel cages. The cages conform to standards set forth in the Guide for the Care and Use of Laboratory Animals, National Academy Press, Washington, D.C., 1996.
- Diet (e.g. ad libitum): Teklad Certified Rabbit Diet #8630 will be provided at approximately 125 grams per day. This diet is routinely analyzed by the manufacturer for nutritional components and environmental contaminants. Results of the manufacturer's analyses are on file at Primedica Redfield.
- Water (e.g. ad libitum): Filtered tap water will be provided ad libitum. Samples of the water are analyzed for totat dissotved solids, hardness, and specified microbiological content, and for environmental contaminants. Results of these analyses are on file at Primedica Redfield.
- Acclimation period: Animals were acclimated for 16 days prior to study day 1.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22 C (61-72 F)
- Humidity (%): 30-70%
- 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: 24 May 2000 To: 1 June 2000
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: 1% Carboxymethylcellulose (CMC)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (moistened with 1% carboxymethylcellulose in deionized water)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 females (nulliparous and non-pregnant)
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 6 cm2 on the dorsal area of the trunk
- Type of wrap if used: Gauze patch held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm tap water and gauze
- Time after start of exposure: 4 hours post exposure
OBSERVATION TIME POINTS
Dermal scoring at 60 minutes, and then 24, 48, and 72 hours after patch removal
SCORING SYSTEM:
- Method of calculation:Draize scoring method (Draize et. aL 1944, J. Pharmacol. Exptl. Thera. 82:377-390)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2, and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 2, and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Other possible dermal findings
- Basis:
- animal: 1, 2, and 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- As indicated in all rabbits, 500 mg of T-7485 failed to induce erythema, edema, or other possible dermal findings during the scoring periods.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the study, application of 500 mg T-7485 is not a skin irritant.
- Executive summary:
The primary skin irritation/corrosion potential of T-7485 was evaluated in New Zealand White rabbits. This study was performed in accordance with OECD GLP (1981) and US FDA GLP 21 CFR 58. The study design was based on OECD 404 (year not reported). The hair was clipped from the dorsal skin of three female rabbits. The test material (500 mg T-7458 moistened with 1% carboxymethylcellulose in deionized water) was placed under gauze on the back of each animal and secured with non-irritating tape for a 4-hour exposure. Residual test material was removed with warm tap water and gauze. Observations for skin irritation (erythema and edema) were recorded at time of patch removal and at 24, 48 and 72 hours after unwrapping. The Primary Irritation Index (PII) was calculated. There were no abnormal clinical signs or changes in body weight. All erythema and edema scores were 0 throughout the study. The PII was 0.0/8.0. Based on the results of this study, T-7485 is not a skin irritant.
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