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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study for read-across substance performed according to established protocol.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Lehman, A.J. et al., in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc., Food and Drug Officials of the U.S., Second Printing, Topeka, Kansas 1965
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C11-C14, isoalkanes, cyclics <2% aromatics
IUPAC Name:
Hydrocarbons, C11-C14, isoalkanes, cyclics <2% aromatics
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100%
Duration of treatment / exposure:
One-time treatment of one eye per rabbit
Observation period (in vivo):
Test animals observed at 1, 24, 48, and 72-hour, and 7 days.
Number of animals or in vitro replicates:
Six
Details on study design:
Six New Zealand albino rabbits were used to determine the degree of ocular irritation resulting from the addition of the test material, Conoco LPA Solvent 8558-G, into the conjunctival sac of the animals.
The animals were individually housed in metal cages elevated above the droppings with feed, consisting of Purina Rabbit Chow and tap water freely available at all times.
Both eyes of each animals were examined with Fluoroscein Sodium Ophthalmic solution U.S.P. 4 hours before testing and only those animals without observable eye defects or irritation were used.
One-tenth milliliter of the test material was placed in one eye of each animals by gently pulling the lower lid away from the eyeball to form a cup into which the test material was deposited. The lids were then gently held together for one second and the animals was released. The other eye was not treated and served as a control. The eyes were not washed following instillation of the test material except as noted below. All animals were immobilized in a suitable animal restrainer for 1 hour subsequent to treatment.
The eyes were examined and the grade of ocular reaction was recorded at 1, 24, 48 and 72 hours and at 7 days, using the scale for scoring ocular lesions as outlined by Lehman, A.J. et al., in Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics Assoc., Food and Drug Officials of the U.S., Second Printing, Topeka, Kansas 1965. The evaluation of the data was in accordance with Section 191.12 Chapter 1, Title 21, Code of Federal Regulations under the FHSA.
After the initial examination at 24 hours all eyes were washed with sufficient clean tap water at body temperature to remove the residual test sample. All eyes were further examined by placing one drop of Fluorescein Sodium Ophthalmic solution U.S.P. on the cornea. After 5 minutes the excess fluoroscein was flushed out with sufficient tap water. Injured areas of the cornea appeared greenish yellow following application of fluoroscein.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hr
Score:
>= 0 - <= 5
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Within one hour, barely perceptible erythema of the palpebral and bulbar conjunctivae, chemosis of the lids and an accumulation of watery discharge (3 animals only). The erythema and discharge did not last 24 hours. The chemosis was present at a barely perceptible level in three test eyes for 72 hours. All animals were normal by 7 days. A maximum average score of 5.0 was recorded at 1 hour.

Any other information on results incl. tables

RESULTS:

Rabbit No.

Structure

1 Hour

24 Hours

48 Hours

72 Hours

7 Days

1

Cornea

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

6

2

2

0

0

2

Cornea

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

4

2

0

0

0

3

Cornea

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

4

0

0

0

0

4

Cornea

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

6

2

2

2

0

5

Cornea

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

4

2

0

0

0

6

Cornea

0

0

0

0

0

Iris

0

0

0

0

0

Conjunctivae

6

2

2

2

0

  Average

5.0

1.7

1.0

0.7

0.0

 

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Reported results of cornea, iris, and conjunctivae scores for all six test animals do not meet the criteria for classification as an irritant.
Executive summary:

Conoco LPA Solvent 8558 -G, when instilled undiluted into the conjunctival sac of six New Zealand albino rabbits and the treated eyes not washed following instillation of the test material, produced, within 1 hour, a barely perceptible to slight erythema, chemosis and water discharge (3 of 6 animals). This showed improvement throughout the study period. By 24 hours, the erythema had disappeared and only chemosis remained (5 of 6). By 72 hours only a barely perceptible chemosis remained in 3 of 6 test eyes. At 7 days, all test eyes were normal.

Mean corneal opacity, iritis, and conjuctivae scores for the test animals averaged over 24, 48, and 72 hours were insufficient to classify; therefore, the test material is considered not irritating.

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