Hydrocarbons, C12-C16, n-alkanes, isolkanes, alkenes

Eye irritation

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

Test material information

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

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 hr

Score:

>= 0 - <= 5

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 8

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 9

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 11

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 12

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 13

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

2

Reversibility:

fully reversible

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 17

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 18

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0.66

Max. score:

2

Reversibility:

fully reversible

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible

Results 20

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 21

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 22

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 23

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 24

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 25

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.