MK1 Diesel Fuel

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because it is an acceptable and well-documented study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

64742-81-0

IUPAC Name:

64742-81-0

Constituent 2

Reference substance name:

straight run kerosine

IUPAC Name:

straight run kerosine

Test material form:

other: low viscosity liquid hydrocarbon

Details on test material:

Test substance: Straight run kerosine (F-155)

Test animals / tissue source

Species:

rabbit

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Number of animals or in vitro replicates:

3

Details on study design:

Comment: not rinsed

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

80

Remarks on result:

other: unrinsed eye

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

10

Remarks on result:

other: unrinsed eye

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

12

Remarks on result:

other: unrinsed eye

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

8

Reversibility:

fully reversible within: 48 hrs

Remarks on result:

other: unrinsed eye

Any other information on results incl. tables

One hour after instillation of test material, all rabbits demonstrated slight irritation with an average score of 8.0. 24 hours after treatment only one animal had an ocular response (score of 2). No responses were observed at 72 hours. The average irritation score was 0.3

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

One hour after instillation of test material, all rabbits demonstrated slight irritation. By 24 hours after treatment only one animal had an ocular response (conjunctivae score of 2). No responses were observed at 48 or 72 hours. The mean cornea, iris, and conjunctivae scores for the 24, 48, and 72 hour readings were 0.0, 0.0, and 0.22, respectively.

Executive summary:

In an eye irritation study, 0.1 mL of undiluted test material was instilled onto one eye of three rabbits. The eyes were examined for ocular effects before the test and again at 1, 24, 48 and 72 hours after application of test material. Assessment and scoring for ocular lesions was preformed according to the Draize scale. Fluorescein was used as an aid to assessing corneal damage. One hour after instillation of test material, all rabbits demonstrated slight irritation with an average score of 8.0. By 24 hours after treatment only one animal had an ocular response (conjunctivae score of 2). No responses were observed at 48 or 72 hours. The mean cornea, iris, and conjunctivae scores for the 24, 48, and 72 hour readings were 0.0, 0.0, and 0.22, respectively. The test substance is considered not irritating to the eye according to EU criteria.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and well-documented study report.