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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:
29 September 1994 - 27 October 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-conducted and documented study performed under GLP; however, no CoA for the test material is included in the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
yes
Remarks:
One mortality check was not conducted and one was conducted but not documented. However, no mortality occurred during the study and the occurences are considered to have had no apparent impact on the outcome of the study.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chemical name: no data
Purity: no data
Lot No.: 0568422701
Receipt Date: September 9, 1994
Physical Description: Light yellow liquid
Storage Conditions: Room temperature
Expiration Date: February 15, 1995

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Adult, New Zealand White rabbits were received at SLS from Myrtle's Rabbitry, Thompson Station, TN. Upon receipt, plastic ear tags displaing unique identification numbers were used to individually identify the animals. Cage cards displaying at least the study number, animal number and sex were affixed to each cage. The animals were housed individually in suspsended stainles steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals.

The animal room temperature and relative humidity rnages were 68 - 70 °F and 46 - 59%, respecitvely. Environmental contrl equipment was monitored and adjusted as necessary to minimize fluctuations in the animal room environment. Light timers were set to maintain a 12-hour light/12-hour dark cycle. There were ten to twelve air changes in the animal room per hour. the animal room temperature and relative humidity were recorded a minimum of once daily.

Purina Certified Rabbit chow #5322 was provided ad libitum to the animals throughout the study. the lot number and expiration date of each batch of diet used during the study were recorded. The feed was analyzed by the supplier for nutritional components and environmental contaminants. Dietary limitation for various environmental contaminants, including heavy metals. pesticides, polychlorinated biphenyls and total aflatoxi are set by the manufacturer. Within these limits, contaminnats which may have bee present were not expected to compromise the purpose of this study. Results of the dietary analyses (Certificates of Analysis) are provided by the manufacturer for each lot of diet. These are maintained by SLS.

Municipal tap water treated by reverse osmosis or deionization (back-up system) was available to the animals ad libitum throughout the study. the purified water was supplied by an automatic watering system. Monitoring of the drinking water for contaminants was conducted by SLS and the records are available for inspetion. Within generally accepted limits, contaminants which may have been present were notexpected to compromise the purpose of this study.

Upon receipt, animals were examined, identified with plastic ear tags and then quarantined for a minimum of five days. The animals chosen for study use were arbitrarily selected from healthy stock animals to avoid potential bias. All animals received a detailed pretest observation prior to dosin. Onlyhealthy animals were chosen for study use. Females were nulliparous and nonpregnant.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Once.
Observation period (in vivo):
The eyes were macroscopically examined with the aid of an auxiliary light source for signs of irritation at 1, 24, 48 and 72 hours after dosing according to the Ocular Grading System presented in Appendix B which is based on Draize. Following macroscopic observations at the 24 hour scoring interval, the fluorescein examination procedure was repeated on all test and control eyes and any residual etst article was gently rinsed from the eye at this time (if possible) using 0.9% physiological saline. If positive fluorescein dye retention was noted at 24 hours, a flurescein exam was conducted on the affected eyes at each subsequent interval until a negative response was obtained.
Number of animals or in vitro replicates:
six
Details on study design:
The test article was instilled into the conjunctival sac of the right eye of each animals after gently pulling the lower lid away from the eye. Following instillation, the eyelids were gently heald together for approximately one second in order to limit test article loss and the animal was returned to its cage. The contralateral eye remained untreated to serve as a control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness + swelling + discharge) x 2
Basis:
mean
Remarks:
mean of all six animals
Time point:
other: 1 hour
Score:
5
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness + swelling + discharge) x 2
Basis:
mean
Remarks:
mean of all six animals
Time point:
other: 24 hours
Score:
2.33
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness + swelling + discharge) x 2
Basis:
mean
Remarks:
mean of all six animals
Time point:
other: 48 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness + swelling + discharge) x 2
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Irritant / corrosive response data:
Exposure to the test article produced conjunctivitis (redness, swelling and/or discharge) in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by the 72 hour scoring interval.
Normal background positive fluorescein dye retention was observed in 1/6 control eyes (stippling) at the 24 hour scoring interval. This finding was resolved by 48 hours and was not considered significant. No corneal opacityI iritis or conjunctivitis was observed in the control eyes.

Any other information on results incl. tables

Summary of ocular lesions

Anim.

No.

Effect

Hours

Days after application

Mean

score cornea

Days

1/2/3

Mean score iritis

Days 1/2/3

Mean score redness Days 1/2/3

Mean score chemosis Days 1/2/3

1

1

2

3

7

14

51369/F

Cornea

Iris

Redness

Chemosis

Discharge

0

0

1

1

1

0

0

1

1

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

-

-

0

 

0

 

 

0.33

 

 

 

0

51370/F

Cornea

Iris

Redness

Chemosis

Discharge

0

0

1

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

-

-

0

 

0

 

 

0

 

 

 

0

51364/F

Cornea

Iris

Redness

Chemosis

Discharge

0

0

1

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

-

-

0

 

0

 

 

0.33

 

 

 

0

51337/F

Cornea

Iris

Redness

Chemosis

Discharge

0

0

1

1

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

-

-

0

 

0

 

 

0.33

 

 

 

0

51362/F

Cornea

Iris

Redness

Chemosis

Discharge

0

0

1

1

0

0

0

1

0

0

0

0

1

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

-

-

0

 

0

 

 

0.66

 

 

 

0

51275/F

Cornea

Iris

Redness

Chemosis

Discharge

0

0

1

1

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

-

-

-

-

-

-

-

-

-

-

0

 

0

 

 

0.33

 

 

 

0

Mean all anim.

0

0

0.33

0

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Slight conjunctival effects were noted in this study; however, they were not severe enough to warrant classification under the former EU Dangerous Substances Directive or any implementation of the Globally Harmonized System of Classification and Labeling of Chemicals.
Executive summary:

The potential eye irritant and/or corrosive effects of the substance were evaluated on New Zealand White rabbits. Each of six rabbits received a 0.1 ml dose of the test article in the conjunctival sac of the right eye. The conralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 72 hours following dosing.

Exposure to the test article produced conjunctivitis (redness, swelling and/or discharge) in 6/6 test eyes at the 1 hour scoring interval. The conjunctival irritation resolved completely in all animals by the 72 hour scoring interval.