Registration Dossier
Registration Dossier
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EC number: 286-344-4 | CAS number: 85209-91-2
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:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to an internationally accepted technical guideline and in compliance with GLP in a recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt
- EC Number:
- 286-344-4
- EC Name:
- 2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt
- Cas Number:
- 85209-91-2
- Molecular formula:
- C29H43O4P.Na
- IUPAC Name:
- sodium 5,7,13,15-tetra-tert-butyl-10-oxo-9,11-dioxa-10λ⁵-phosphatricyclo[10.4.0.0³,⁸]hexadeca-1(12),3,5,7,13,15-hexaen-10-olate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Species, Strain: albino rabbits, Hra:(NZW)SPF
- Source: Hazleton Research Products, Inc., Denver PA
- Weight prior to dosing (Day 1): 2006 - 2224 g
- Husbandry and housing: individually in screen-bottom cages; according to standards outlined in the "Guide for the Care and Use of Laboratory" (NIH Publication.86-23 (revised 1985)).
- Diet (ad libitum): measured amount of High Fiber Rabbit Chow® 5326, Purina Mills, Inc.,
- Water(ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.9 - 23.3
- Humidity (%): 48 - 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 dose, 0.03 g - Duration of treatment / exposure:
- Eyes kept unwashed.
- Observation period (in vivo):
- observations: 1, 24, 48, and 72 hours after treatment
- Number of animals or in vitro replicates:
- 3 male, 3 female rabbits
- Details on study design:
- SCORING SYSTEM: Irritation was graded and scored according to the Draize technique.
TOOL USED TO ASSESS SCORE: At the 72-hour reading, sodium fluorescein was used to aid in revealing possible corneal injury.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 6 animals and 4 time points
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 320
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 10
- Reversibility:
- fully reversible within: 48-72 h
- Remarks on result:
- other: 3 of 6 animals concerned
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 48 h
- Score:
- 0.8
- Max. score:
- 10
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 3 of 6 animals concerned
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 24 h
- Score:
- 6.7
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 2 animals: symptom "discharge" resolved
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 48 h
- Score:
- 6
- Max. score:
- 20
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: redness of conjunctivae remained in all animals, chemosis only in 1 animal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 20
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 6 animals
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The test material produced iridal involvement and moderate conjunctival irritation when instilled into the eyes of six albino rabbits.
All ocular irritation cleared within 72 hours after instillation of the test material.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
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