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EC number: 630-324-3 | CAS number: 861229-15-4
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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:
- September 1, 1992 - September 15, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Version / remarks:
- EPA FIFRA Subdivision F Guideline 81-4 Primary eye irritation, revised Edition November 1984
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Ethylhexyl (R)-2-(2-methyl-4chlorophenoxy)propionate
- EC Number:
- 630-324-3
- Cas Number:
- 861229-15-4
- Molecular formula:
- C18H27ClO3
- IUPAC Name:
- 2-Ethylhexyl (R)-2-(2-methyl-4chlorophenoxy)propionate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 5007
- sample No.:1505E
- Expiration date of the lot/batch: March 1993
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4°C in the dark
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Huntingdon, Cambridgeshire, England (5) and 1 from Froxfield U.K. Ltd., Petersfield, Hampshire, England
- Age at study initiation: 11- 14 weeks
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: individually in plastic cages with perforated floors
- Diet: ad libitum (Standard laboratory diet SDS Stanrab Rabbit Diet)
- Water: ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 -70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL 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:
- single
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: eyes were not washed 24 h after treatment
SCORING SYSTEM:
Examination of the eyes was made after 1 hour and 1, 2, 3 days (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days after instillation
Ocular irritation was assessed using the prescribed numerical system:
Cornea:
opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of nuermal 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 positive) 1*
No reaction to light, haemorrhage, gross destruction (any or all of these) 2*
Conjunctivae:
Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
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 (lids and/or nictating membranes)
No swelling 0
Any swelling above normal (includes nictating membranes9 1
Obvious swelling with partial eversion of lids 2*
Swelling with lids about half-closed 3*
Swelling with lids more than half-closed 4*
Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed
in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs, and considerable area
around the eye 3
*interpreted as a positive effect
TOOL USED TO ASSESS SCORE: handheld lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal#1
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal#1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal#1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal#1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal#2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal#3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal#4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal#4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal#4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal#4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal#5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal#5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal#5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal#5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal#6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal#6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Remarks:
- animal#6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal#6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- 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
Table 1: Ocular reactions observed after instillation of MCPP-P 2-EHE
Rabbit number (#) |
Region of the eye |
One hour |
Days after instillation |
Result Positive (+) Negative (-) |
|
|
1 2 3 4 7 |
+ |
|||
Animal #1 (male)* |
Cornea |
Density |
0 |
3 2 2 1 0 |
|
Iris |
0 |
0 0 0 0 0 |
|||
Conjunctiva |
Redness |
2 |
1 1 1 1 0 |
||
Chemosis |
1 |
1 1 0 0 0 |
|||
Discharge |
2 |
1 1 0 0 0 |
|||
Animal #2 (female) |
Cornea |
Density |
0 |
0 0 0 0 0 |
+ |
Iris |
0 |
0 0 0 0 0 |
|||
Conjunctiva |
Redness |
2 |
2 1 0 0 0 |
||
Chemosis |
1 |
1 0 0 0 0 |
|||
Discharge |
2 |
1 0 0 0 0 |
|||
Animal #3 (female) |
Cornea |
Density |
0 |
0 0 0 0 0 |
+ |
Iris |
0 |
0 0 0 0 0 |
|||
Conjunctiva |
Redness |
2 |
2 1 0 0 0 |
||
Chemosis |
1 |
1 0 0 0 0 |
|||
Discharge |
2 |
1 0 0 0 0 |
|||
Animal #4 (female) |
Cornea |
Density |
0 |
0 0 0 0 0 |
+ |
Iris |
0 |
0 0 0 0 0 |
|||
Conjunctiva |
Redness |
2 |
2 1 0 0 0 |
||
Chemosis |
1 |
1 0 0 0 0 |
|||
Discharge |
2 |
1 0 0 0 0 |
|||
Animal #5 (female) |
Cornea |
Density |
0 |
0 0 0 0 0 |
+ |
Iris |
0 |
0 0 0 0 0 |
|||
Conjunctiva |
Redness |
2 |
2 1 0 0 0 |
||
Chemosis |
1 |
1 0 0 0 0 |
|||
Discharge |
2 |
1 0 0 0 0 |
|||
Animal #6 (female) |
Cornea |
Density |
0 |
0 0 0 0 0 |
+ |
Iris |
0 |
0 0 0 0 0 |
|||
Conjunctiva |
Redness |
2 |
2 1 0 0 0 |
||
Chemosis |
1 |
1 0 0 0 0 |
|||
Discharge |
2 |
1 0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Instillation of MCPP-P 2-EHE into the rabbit eye elicited a positive response in all of the six treated animals according to EPA FIFRA test critaria, which all resolved seven days after instillation.
- Executive summary:
A GLP-Study to assess the eye irritation potential of MCPP-P 2-EHE on rabbits was performed. The method followed was that described in EPA Pesticide Assessment Guidelines, Subdivision F. Hazard Evaluation: Human and Domestic Animals 81-4 Primary eye irritation (Version 1984). Six rabbits were each administered a single ocular dose of 0.1 mL of the test item and observed for a maximum of seven days after instillation. The administration into the eye of the rabbit elicited corneal opacification in one animal and mild conjunctival irritation. According to Draize score, only one animal showed a corneal opacity (mean score of 2.3), while mean conjunctival redness, chemosis and iris effects were not scored higher than 1 and all reactions had resolved seven days after instillation.
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