Reaction mass of (2R*,4R*,4aR*,9bS*)-2,4-dimethyl-4,4a,5,9b-tetrahydroindeno[1,2-d][1,3]dioxine and (2R*,4R*,4aS*,9bR*)-2,4-dimethyl-4,4a,5,9b-tetrahydroindeno[1,2-d][1,3]dioxine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 - 16 Feb 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted Feb 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Jan 1997

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,4-dimethyl-2H,4H,4aH,5H,9bH-indeno[1,2-d][1,3]dioxine

EC Number:

944-528-8

Molecular formula:

C13H16O2

IUPAC Name:

2,4-dimethyl-2H,4H,4aH,5H,9bH-indeno[1,2-d][1,3]dioxine

Test animals / tissue source

Species:

rabbit

Strain:

other: SPF albino rabbits

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.9 - 3.3 kg
- Housing: during a pre-period of at least one week and throughout the experiment the rabbits were caged individually in PPO cages (floor area: 2576 cm²) with perforated floor.
- Diet: Altromin 2123 (Altromin 2123, Lage, Germany), ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours
Reading time points: 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

4 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with 20 mL 0.9% sodium chloride solution.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

One hour after application of the test substance 2 animals showed an iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible, a swelling above normal and a discharge with moistening of the lids and hairs, and considerable area around the eye. An iris with markedly deepened folds, congestion, swelling, moderate circumcorneal injection and existence of reaction to light, a diffuse, crimson red conjunctiva with individual vessels not easily discernible , a swelling above normal and a discharge with moistening of the lids and hairs just adjacent to lids were observed in the other 2 animals. 24 hours alter application of the test substance all animals showed some conjunctival vessels definitely injected. 48 and 72 hours after application of the test article all four animals were free of any signs of eye irritation.

Any other information on results incl. tables

Table 1. Results of the eye irritation study

Animal	Time (h)	Conjunctivae		Cornea	Iris
		Redness	Chemosis
1	1	2	1	0	1
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.3	0	0	0
2	1	2	1	0	1
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.3	0	0	0
3	1	2	1	0	1
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.3	0	0	0
4	1	2	1	0	1
	24	1	0	0	0
	48	0	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.3	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.