1,6-Octadiene, 8-methoxy-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD guidelines for testing of chemicals, Guideline 405 and EEC B.5:L.251.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Females, approx. 15 weeks old and weighing 2672-2846g at the start of treatment, sourced from Broekman Institute, Someren, The Netherlands.

Conditions: Standard Laboratory Conditions. Air-conditioned with 7.5-15 air changes per hour and hourly monitored environment with temperature 20 ± 3°C, relative humidity 30-70 %, 12 hours artificial fluorescent light / 12 hours dark.

Accommodation: Individually in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen, The Netherlands).

Diet: Pelleted standard LKK-20 rabbit maintenance diet (Hope Farms, Woerden, The Netherlands) approx. 100 g per day.

Water: Free access to tap-water diluted with decalcified water.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml

Observation period (in vivo):

7 days.

Number of animals or in vitro replicates:

3

Details on study design:

Prior to test article administration, on day 1, the animals were physically examined and the eyes found to be intact and normal.

The test article (0.1 ml per animal) was instilled in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article . The other eye remained untreated and served as the reference control.

The eyes of each animal were examined approximately 1, 24, 48 and 72 hours, and 7 days after instillation of the test article.

Immediately after the 24 hours observation, a solution of 2% fluorescein in water (pH adjusted to 7.0) was applied to both eyes of each animal to quantitatively examine the potential for corneal injury . The bright green stained area indicating epithelial damage was estimated as a percentage of the total corneal area. This procedure was repeated in one animal on day 4.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 48h

Remarks on result:

other: very slight opacity

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24h

Score:

1.3

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72h

Score:

0.3

Max. score:

1

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24h

Score:

1

Max. score:

1

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 72h

Score:

0.3

Max. score:

1

Irritant / corrosive response data:

Instillation of the test material into one of the eyes of each of three albino rabbits affected the cornea, the iris and the conjunctivae. The very slight opacity of the cornea was reversible in two animals within 24 hours and in the third animal within 48 hours. The injection of the iris disappeared in all animals within 24 hours and the irritation of the conjunctivae was reversible in two animals within 3 days and in one animal within 7 days.

Treatment of the eye with fluorescein 2%, 24 hours after test article instillation revealed slight corneal epithelial damage in one animal only.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test aricle appeared to be mildly irritatant to the rabbit eye by Draize Score:16.3 and no corrosion was observed.