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EC number: 252-043-1 | CAS number: 34454-97-2
- 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
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- Auto flammability
- Flammability
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- Oxidising properties
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 November 2001 to 19 November 2001 (dates of study plan)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- other: EC Council Directive 67/548/EEC, Annex V, Part B, Methods for the Determination of Toxicity, as last amended by Commission Directive 67/548/EEC, B.5:"Acute Toxicity-Eye Irritation." Official Journal of the European Communities No. L 383, 1992.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- T-7599
- IUPAC Name:
- T-7599
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): T-7599
- Physical state: White powder
- Analytical purity: >99.9% 1-Butanesulfonamide, 2, 2, 3, 3, 4, 4, 5, 5, 5-Nonafluoro-n-(2-Hydroxyethyl)-N-Methyl- and <0.1 % Methylamine
- Lot/batch no.: Lot 6
- Expiration date of the lot/batch: 07 August 2002
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature in the dark
Constituent 1
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: At least 6 weeks old
- Weight at study initiation: Body weights were between 1.0 and 3.5 kg.
- Fasting period before study: None
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 C
- Humidity (%): 30-70%. Temporary deviations due to cleaning procedures but considered not to have an affect on study integrity.
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark.
IN-LIFE DATES: From: To: 12 November 2001 to 19 November 2001
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye in each animal was treated, the other was left untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 62.1 mg test article (volume of approx. 0.1ml) - Duration of treatment / exposure:
- A couple seconds during instillation of the test article.
- Observation period (in vivo):
- 24 hours.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Irritation observed at 1, 24, 48 and 72 hours and 7 days during the observation period.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Immediately after the 24 hour observation, 2% flurescein in water (pH 7.0) was instilled in both eyes to measure corneal epithlial damage. Bright green stained area was estimated as a percentage of total corneal area.
Opthamalic examination was perfomed using an examination lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 48 hours
- Irritant / corrosive response data:
- Scores for corneal and iris irritation averaged zero in all test animals. Conjunctivae irriation shown by eye redness scored a mean of 1.7 in all test animals. Mean chemosis scores were 0.3, 0.7 and 0.7 for the three test animals, repectively.
- Other effects:
- Instillation of approximately 62 mg of the test article into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation (grade 1) was observed in two animals and had resolved within 24 hours. Irritation of the conjunctivae was seen as redness, chemosis and discharage, which had completely resolved within 7 days in all animals. No corneal epthelial damage, ocular corrosion, staining of ocular tissues and symptoms of systemic toxicity were not observed in the animals during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, The test article does not have to be classified and has no obligatory labeling requirement for eye iritation.
- Executive summary:
An acute eye irritation/corrosion study was done in three New Zealand White albino rabbits (according to OECD 405 and EC Council Directive 67/548/EEC). 62.1 mg of the test substance was instilled in the conjunctival sac of one of the eyes and then washed (24 hours later) with a solution of 2% fluorescein in water) to observe corneal epithelial damage, Eyes of the animals were examined approximately 1, 24, 48, 72 hours and 7 days after the instillation of the test substance. The irritation scores and description of local effects were recorded. All iridial irritation (grade 1 at 1 hour) resolved within 24 hours. Conjunctival irritation causes redness, chemosis and discharged and had completely resolved within 7 days in all animals. No corrosion, staining of ocular tissues, systemic toxicity or mortality were based during the test period. Therefore, the test article does not have to be classified and has no obligatory labelling requirements for eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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