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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:
16th to 25th December 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study following GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name and of test material (as cited in study report): Phenol, tetrapropenyl-, sulfurized, carbonates, calcium salts, overbased
- CAS number of test material (as cited in study report): 122384-87-6

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc. Denver, PA
- Age at study initiation: Young adult
- Weight at study initiation: 2746 to 2999 grams at initiation of dosing
- Housing: Individual suspended wire mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc. in accordance with standard operating procedures.
- Diet (e.g. ad libitum): PMI Nutrition International, Inc. Certified Rabbit LabDiet® 5322 was offered at approximately 150 g per day during the study. Analysis of feed was performed and provided by the manufacturer.
- Water (e.g. ad libitum): Municipal water was provided ad libitum. Water was analyzed in accordance with standard operating procedures. Contaminants were not present in animal feed or water at levels expected to interfere with the objective of this study.
- Acclimation period: The animals were acclimated to laboratory conditions for a minimum of seven days prior to initiation of dosing.

ENVIRONMENTAL CONDITIONS
- Temperature: 68.2-68.8°F
- Humidity (%): 30.2-44.1%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml/right eye
Duration of treatment / exposure:
The test article was placed directly into the cupped lower conjunctival sac of each rabbit's right (test) eye. The eyelids were held closed for approximately one second after instillation. Left eyes were manipulated in an identical manner to simulate the dosing of the right eyes.
Observation period (in vivo):
Treated eyes were examined at 24, 48 and 72 hours and on Days 4 and 7 following treatment according to the Draize methodology. The rabbits were observed twice daily (morning and afternoon) for mortality for the duration of the study.
Number of animals or in vitro replicates:
six, 2 males/4 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Unwashed exposure.

SCORING SYSTEM:
Both eyes of all rabbits were examined macroscopically for ocular irritation in accordance with the method of Draize at approximately one, 24, 48 and 72 hours after dosing and on days 4 and 7 if irritation persisted.

TOOL USED TO ASSESS SCORE:
An ophthalmoscope was used during these observations to examine the corneal tissue. In addition, both eyes were further examined at 72 hours and on day 7 with sodium fluorescein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour after instillation of test material
Score:
5.3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects seen
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 & 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effetcs seen
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
1.5
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.
M.A.S. - Maximum Average Score for 1 hour was 5.3.

Any other information on results incl. tables

There were no deaths during the study.

The left (control) eyes were free of evidence of ocular irritation and other findings for the duration of the study.

There were no remarkable body weight changes noted during the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.
Executive summary:

In an eye irritation study conducted to OED method 405 in compliance with GLP, the primary ocular irritation potential of the test material was evaluated with New Zealand White rabbits.

There was one group of six albino rabbits that received a single, unwashed exposure. Each 0.1-m1 dose of the test article was instilled into the lower conjunctival sac of the right eye. The eyelid was held closed for approximately one second and released. The left eye was manipulated in a similar manner as the right eye and served as a contralateral control.

The eyes were examined for ocular reactions in accordance with the method of Draize at approximately one, 24, 48 and 72 hours after dosing and on days 4 and 7 if irritation persisted. Sodium fluorescein was used to aid in revealing possible corneal damage at 72 hours and on day 7.

Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.

The Maximum Average Score for the test material was 5.3 at one-hour post-instillation.

The mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated and was considered to be non-irritating according to the dangerous substances directive, 67/548/EEC.