Registration Dossier
Registration Dossier
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EC number: 429-370-5 | CAS number: 220410-74-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-01-13 to 1999-04-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
- Reference Type:
- other: Amendment Final 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)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 429-370-5
- EC Name:
- -
- Cas Number:
- 220410-74-2
- Molecular formula:
- C34H67N3O13
- IUPAC Name:
- tris(1,4-dihydroxy-2,2,6,6-tetramethylpiperidin-1-ium) 2-hydroxypropane-1,2,3-tricarboxylate
- Test material form:
- other: Ivory-peach flakes
- Details on test material:
- - Identification: TKA 45021
- Analytical purity: 93.64%
- Appearance: Ivory-peach flakes
- Lot/batch No.: pax 2068 rd 100 / RD100
- Test Item arrived at Test Facility: 1998-11-25
- Storage: at room temperature and desiccated
Constituent 1
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, Thompson Station, TN, USA
- Weight at study initiation: 2.432 g, 2.527 g and 2.704 g (three females)
- Fasting period before study: no
- Housing: individually in suspended stainless steel cages
- Diet: PPMI Certified Rabbit Chow #5322 (Purina Mills, Inc.) ad libitum
- Water: municipal tap water treated by reverse osmosis ad libitum
- Acclimation period: minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature: 18°C to 22°C
- Humidity: 26-46 %
- Air changes: 10 to 15 air changes per hour
- Photoperiod: 12-hour light / 12-hour dark cycle
IN-LIFE DATES: From: 1999-01-29 To: 1999-02-08
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL (determined to be 0.0270 g of processed test item) - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and up to 10 days after dosing
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes were not washed after instillation
SCORING SYSTEM:
Ocular Grading System based on Draize. EEC Ocular Scores (Corneal Opacity, Iris Lesions, Conjunctival Redness, Conjunctival Edema)
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Based on the EEC Eye Irritation Evaluation Criteria, the test item is considered to be a nonirritant to the eye of the rabbit.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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