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EC number: 423-340-5 | CAS number: 162881-26-7 CGI 819
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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: Guideline study conducted in accordance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
- EC Number:
- 423-340-5
- EC Name:
- Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
- Cas Number:
- 162881-26-7
- Molecular formula:
- C26 H27 O3 P
- IUPAC Name:
- [phenyl(2,4,6-trimethylbenzoyl)phosphoryl](2,4,6-trimethylphenyl)methanone
- Details on test material:
- - Name of test material (as cited in study report): TKA 40135 (CGI 819)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Regal Group UK, Great Bookham, Surrey, England.
- Age at study initiation: 16 to 20 weeks
- Weight at study initiation: 3.6 to 4.0 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory diet SDS Stanrab (P) Rabbit Diet, ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): ca. 19
- Photoperiod (hrs dark / hrs light): 12 hrs / 12 hrs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of each animal served for control
- Amount / concentration applied:
- One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed.
Approximately 73 mg of the test substance, corresponding to an application volume of 0.1 mL, was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. - Duration of treatment / exposure:
- 72 hours since no rinsing
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three animals were used
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
After instillation, the test substance was not removed from the eye.
EXAMINATIONS
Examination of the eyes was made after 1 hour and 1, 2, 3 days (equivalent to 24, 48 and 72 hours) after instillation.
Moreover, the animals were observed daily for signs of ill health or toxicity.
SCORING SYSTEM
Ocular irritation was assessed using the prescribed numerical system:
Cornea
- No ulceration or opacity 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible 1
- Easily discernible translucent areas, details of iris slightly obscured 2
- Nacreous areas, no details of iris visible, size of pupil barely discernible 3
- Opaque cornea, iris not discernible through the opacity 4
Iris
- Normal 0
- Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
- No reaction to light, haemorrhage, gross destruction (any or all of these) 2
Conjunctivae redness
- Blood vessels normal 0
- Some blood vessels definitely hyperaemic (injected) 1
- Diffuse, crimson colour, individual vessels not easily discernible 2
- Diffuse beefy red 3
Chemosis
- No swelling 0
- Any swelling above normal (includes nictating membranes) 1
- Obvious swelling with partial eversion of lids 2
- Swelling with lids about half-closed 3
- Swelling with lids more than half-closed 4
TOOL USED TO ASSESS SCORE
Observation of the eyes was aided by the use of a handheld light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (mean value of the 3 reading time points)
- Basis:
- animal: 1, 2 and 3, respectively
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable as no effects
- Remarks on result:
- other: no signs of corneal opacity were seen at any of the reading time points in any of the three animals.
- Irritation parameter:
- iris score
- Remarks:
- (mean value of the 3 reading time points)
- Basis:
- animal: 1 and 3, respectively
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable as no effects
- Remarks on result:
- other: no signs of iritis were seen at any of the reading time points in any of these two animals.
- Irritation parameter:
- iris score
- Remarks:
- (mean value of the 3 reading time points)
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Iritis graded 1 was seen in the present animal at reading time point 24 hours only.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (mean value of the 3 reading time points)
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: redness graded 2 was seen after one hour; at each of the 3 following time points (24, 48 and 72 hours), redness was still evident but graded 1. After 4 days, redness had disappeared.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (mean value of the 3 reading time points)
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: redness graded 2 was seen after one hour, 24 hours and 48 hours; at time point 72 hours redness was still evident but graded 1. After 4 days, redness had disappeared.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (mean value of the 3 reading time points)
- Basis:
- animal #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: redness graded 2 was seen after one hour; at each of the 2 following time points (24 and 48 hours), redness was still evident but graded 1. At reading time point 72 hours, redness was no more seen.
- Irritation parameter:
- chemosis score
- Remarks:
- (mean of the 3 reading time points)
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: chemosis graded 1 was seen after one hour, 24 hours, 48 hours and 72 hours. After 4 days, chemosis had disappeared.
- Irritation parameter:
- chemosis score
- Remarks:
- (mean of the 3 reading time points)
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: chemosis graded 1 was seen after one hour, 24 hours, 48 hours and 72 hours. After 4 days, chemosis had disappeared.
- Irritation parameter:
- chemosis score
- Remarks:
- (mean of the 3 reading time points)
- Basis:
- animal #3
- Time point:
- other: 24 - 48 - 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable since no chemosis was seen at the reading time points of concern
- Remarks on result:
- other: chemosis graded 1 was seen after one hour, but no more after 24 hours, 48 hours and 72 hours.
- Irritant / corrosive response data:
- No corneal damage was observed.
Iridial inflammation (grade 1) was seen in one animal at reading time point 24 hours only.
A diffuse crimson colouration of the conjunctivae with slight swelling was seen in all animals within one hour of treatment. These reactions gradually ameliorated and the eyes were normal after 3 (i.e 72 hours) or 4 days following instillation. - Other effects:
- There were no signs of toxicity or ill health in any rabbit during the observation period.
Any other information on results incl. tables
Eye reactions, scoring:
Animal
|
Effect |
Reading time points |
||||
1 hour |
Relevant for evaluation |
4 days |
||||
24 h |
48 h |
72 h |
||||
1 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
|
Redness of conjunctivae |
2 |
1 |
1 |
1 |
0 |
|
Chemosis |
1 |
1 |
1 |
1 |
0 |
|
2 |
Corneal opacity |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
1 |
0 |
0 |
0 |
|
Redness of conjunctivae |
2 |
2 |
2 |
1 |
0 |
|
Chemosis |
1 |
1 |
1 |
1 |
0 |
|
3 |
Corneal opacity |
0 |
0 |
0 |
0 |
- |
Iris |
0 |
0 |
0 |
0 |
- |
|
Redness of conjunctivae |
2 |
1 |
1 |
0 |
- |
|
Chemosis |
1 |
0 |
0 |
0 |
- |
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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