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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:
24 January 1990 to 22 March 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-2-(4-chloro-2-methylphenoxy)propionic acid
EC Number:
240-539-0
EC Name:
(R)-2-(4-chloro-2-methylphenoxy)propionic acid
Cas Number:
16484-77-8
Molecular formula:
C10H11ClO3
IUPAC Name:
(R)-2-(4-chloro-2-methylphenoxy)propionic acid
Test material form:
solid: flakes
Remarks:
Brown coloured hard flakes
Details on test material:
- Storage conditions: Room temperature protected from light.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Two and one-half to three months of age on arrival. The rabbit was approximately three months old on the day of dosing.
- Weight at study initiation: Bodyweight on the day of dosing was 2.79 kg.
- Housing: Individually housed in suspended stainless-steel cage mounted in mobile batteries. The cage measured 61 x 76 x 46 cm high and was fitted with perforated counter-sunk floor panels. A tray beneath the floor was lined with absorbent crepe paper which was changed regularly.
- Diet: ad libitum access to a commercially available standard pelleted rabbit diet.
- Water: ad libitum access to tap water supplied to each cage by an automatic piped system. The water was supplied by the East Anglian Water Company.
- Acclimation period: An acclimatisation period of at least seven days was allowed before administration of the test material. During this time the health status of the animal was monitored and a record kept. This record was consulted before the animal was allocated to study.

ENVIRONMENTAL CONDITIONS
- Temperature: Target value for temperature was 18 °C (range 15 - 23 °C)
- Humidity: Target value for humidity was 55 % R.H. (range 40 - 70 % R.H.)
- Air changes: Approximately 15 complete air changes per hour without re-circulation
- Photoperiod: 12 hours of artificial light per day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g of the test material
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
The animal was sacrificed by intravenous injection of sodium pentobarbitone B.Vet.C immediately after the 72 hour examination.
Number of animals or in vitro replicates:
One acclimatised male rabbit was used on this study.
Details on study design:
- Both eyes of the animal were examined before administration of the test material for signs of pre-existing irritation, reaction or abnormality which would prevent it from being used on the study.
- Bodyweight was recorded for the animal on the day of receipt and at regular intervals thereafter, until the rabbit began treatment.
- The dose was instilled into the right eye by pulling the lower eyelid away from the eyeball to form a cup into which 0.1 g of the test material was dropped. The eyelid was gently held together for one second and then released. The left eye remained untreated.
- The behaviour of the rabbit was observed for several minutes immediately following instillation of the test material to allow assessment of the initial pain response
- The animal was returned to its cage and checked at least twice during the first hour after dosing and at regular intervals throughout the day to ensure no severe injury passed un-noticed. Ocular reactions to treatment were assessed one hour, 24, 48 and 72 hours after treatment.
- The untreated eye was used as a comparison with the treated eye during assessment of ocular lesions.
- The animal was checked daily to ensure the treated eye was not subject to infection or causing distress.

REMOVAL OF TEST SUBSTANCE
The test material was not removed.

SCORING SYSTEM:
Cornea
0 = No opacity
1 = Scattered or diffuse areas of opacity, (other than slight dulling of normal lustre) details of iris clearly visible
2 = Easily discernible translucent areas, details of iris slightly obscured
3 = Nacreous areas, no details of iris visible, size of pupil barely discernible
4 = Complete corneal opacity, iris not discernible
The presence or absence of ulceration or stippling of the cornea was designated by + (positive) or - (negative). Redness of the cornea such as pannus formation is described on an individual basis.

Iris
0 = Normal
1 = Markedly deepened folds, congestion, swelling, moderate circumcorneal injection (any of these or any combination of them), iris still reacting to light (sluggish reaction is positive)
2 = No reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae: Redness (refers to palpebral and bulbar conjunctivae)
0 = Vessels normal
1 = Some vessels definitely injected
2 = Diffuse, crimson-red, individual vessels not easily discernible
3 = Diffuse beefy-red

Chemosis (lids and/or nictitating membrane)
0 = No swelling
1 = Any swelling above normal (including nictitating membrane)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half-closed
4 = Swelling with lids more than half-closed
The presence or absence of necrosis or ulceration of the conjunctiva was designated by + (positive) or - (negative).

TOOL USED TO ASSESS SCORE:
- An ophthalmoscope was used to facilitate inspection of the eyes.
- The presence of corneal lesions was confirmed by fluorescein treatment. One drop of Fluorescein Sodium B.P. (Smith and Nephew Limited) was dropped directly onto the cornea. The rabbit was allowed to blink before excess fluorescein was flushed out of the eye with physiological saline. Corneal damage was confirmed by distinctive yellow colouration of any injured areas when viewed under ultra-violet illumination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
not specified
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
- Injection of the conjunctival blood vessels, a diffuse crimson-red and a beefy-red appearance to the conjunctiva, very slight and slight chemosis and slight and moderate discharge with mucus were apparent during the 72 hour observation period.
- Slight opacity covering the entire cornea was observed one hour after instillation and was accompanied by two discrete areas of severe opacity (total of approximately half of the area of the cornea) at the 24, 48 and 72 hour examinations.
- Iridial congestion was apparent at the 72 hour examination.
- Due to the severity of the reaction, the animal was humanely killed following the 72 hour examination. No further animals were committed to the study.
- Instillation of the test material caused very slight initial pain response.

Applicant's summary and conclusion

Interpretation of results:
other: Classified according to EU criteria as Category 1
Conclusions:
Under the conditions of this study the test material was considered to be 'severely irritant' with irreversible effects to the eye.
Executive summary:

The eye irritation potential of the test material was assessed according to the standardised guidelines OECD 405 and US EPE OPP 81-4 and in compliance with GLP.

The potential of the test material to cause damage to the conjunctiva, iris or cornea was assessed in one New Zealand White rabbit subjected to a single ocular instillation of 0.1 g of the test material on Day 1. Ocular reactions were examined 1, 24, 48 and 72 hours after treatment.

Injection of the conjunctival blood vessels, conjunctival redness (diffuse and beefy-red appearance), slight chemosis and moderate discharge with mucus were apparent during the 72 hour observation period.

Slight opacity (covering the entire cornea) was observed one hour after instillation and was accompanied by two discrete areas of severe opacity (total of approximately half of the area of the cornea) at the 24, 48 and 72 hour examinations. Iridial congestion was apparent at the 72 hour examination. Due to the severity of the reaction, the animal was humanely killed following the 72 hour examination. No further animals were committed to the study.

Instillation of the test material caused very slight initial pain response.

Under the conditions of this study the test material was considered to be 'severely irritant' with irreversible effects to the eye.