Registration Dossier
Registration Dossier
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EC number: 458-880-0 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24. April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 458-880-0
- EC Name:
- -
- Cas Number:
- 85209-93-4
- Molecular formula:
- Hill formula: C29 H42 O4 P Li
- IUPAC Name:
- 2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo- [d,g][1,3,2]dioxaphosphocin 6-oxide, lithium salt
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Albino New Zealand White rabbits
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Weight at study initiation: 2.0 - 3.5 kg
- Age at study initiation: 12 - 20 weeeks
- Housing: individually in suspended metal cages, with environmental enrichment items
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322), BCM IPS Limited, London, UK
- Water (e.g. ad libitum): mains drinking water ad libitum
- Acclimation period: 5 days
- Temperature (°C): 17 - 23
- Humidity (%): 30 to 70
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1-ml of the test material (0.027 g) was administered into the conjunctival sac of one eye per rabbit. The other eye remained untreated to serve as a control. - Duration of treatment / exposure:
- Eyes kept unwashed.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- SCORING SYSTEM: Irritation was graded and scored according to the Draize technique (Draize, J. H. 1977). Classification of the ocular irritancy potential was done according to a modified system (Kay, J. H. and Calandra, J. C., 1962).
TOOL USED TO ASSESS SCORE: The light source of a standard ophtalmoscope facilitated eye examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Corneal irritation or opacity was not evident during the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Corneal irritation or opacity was not evident during the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Corneal irritation or opacity was not evident during the study
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: iridal changes were not evident during the study
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: iridal changes were not evident during the study
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- The test material produced iridal inflammation and moderate conjunctival irritation when instilled into the eyes of three rabbits.
Two treated eyes appeared normal at the 48-hour observation and the remaining eye appeared normal at the 72-hour observation.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating according to European Regulation (EC) 1272/2008.
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