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Toxicological information

Eye irritation

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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:
1992
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

Constituent 1
Chemical structure
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
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.