3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3a,4,7,7a-tetrahydro-4,7-methanoindene

EC Number:

201-052-9

EC Name:

3a,4,7,7a-tetrahydro-4,7-methanoindene

Cas Number:

77-73-6

Molecular formula:

C10H12

IUPAC Name:

3a,4,7,7a-tetrahydro-1H-4,7-methanoindene

Constituent 2

Reference substance name:

dicyclopentadiene

IUPAC Name:

dicyclopentadiene

Details on test material:

- Name of test material (as cited in study report): DCPD 75%
- Physical state: clear, yellow coloured liquid
- Analytical purity: not reported
- Composition of test material, percentage of components: endo dicyclopentadiene: 71.1, exo dicyclopentadiene: 0.8, m-bicyclozonadiene: 1.4, CPD-MCPD codimers: 15.2, tricyclopentadiene: 0.3, CPD-butadiene codimer: 1.3, CPD-piperylene codimer: 0.3, CPD-isoprene codimer: 0.3, benzene: <0.1, misc.hydrocarbons: balance.
- Lot/batch No.: PD Sample 1
- Stability: Not determined
- Specific gravity (15/15°C) 0.9811
- Other: Gardner colour: 4+; total sulfur: 60 ppm (w/w); flashpoint 39°C pct (w/w)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.45-2.67 kg
- Housing: Individually in suspended metal cages
- Diet: Rabbit Diet ad libitum (Preston Farmers Ltd., New Leake, Boston, Lincolnshire, UK)
- Water: Mains water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 15-20°C
- Humidity: 40-66%
- Air changes (per hr): Approximately 15/hour
- Photoperiod: 12 hrs dark / 12 hrs light):

IN-LIFE DATES: From: 14 November 1988 To: 22 November 1988

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- The eyes were not washed

SCORING SYSTEM:
- According to the numerical system of Draize JH, 1959 and a modified version of the Kay and Calandra system, 1962

TOOL USED TO ASSESS SCORE:
- Standard ophthalmoscope

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72 hour

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 -72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72 hours

Score:

0.43

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: slight redness present in 1 animal at 72 h.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 -72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: slight chemosis in 1 rabbit at 24 h

Any other information on results incl. tables

Dicyclopentadiene 75%: Eye irritation scores according to the Draize scheme

Time	Cornea			Iris			Conjunctiva
							Redness			Chemosis
Animal number	545	544	547	545	544	547	545	544	547	545	544	547
after 1 hour	0	d	d	1	1	1	3	2	2	2	2	2
after 24 hours	0	0	0	0	0	0	1	1	0	0	1	0
after 48 hours	0	0	0	0	0	0	0	1	0	0	0	0
after 72 hours	0	0	0	0	0	0	0	1	0	0	0	0
mean scores 24-72h	0	0	0	0	0	0	0.3	1	0	0	0.3	0

d = dulling of corneal surface

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Dicyclopentadiene 75% was a moderate irritant to the rabbit eye at 1 hour but was practically non-irritating at 24, 48 and 72 hours.

Executive summary:

Eye irritation was assessed in 3 New Zealand white rabbits. 0.1 mL dicyclopentadiene 75% was instilled into the conjunctival sac and the eyes were scored for irritation responses at 1, 24, 48 and 72 hours and at 7 days after instillation. At 1 hour, corneal dulling was present in 2 eyes, iridial inflammation and moderate conjunctival irritation were present in all 3 eyes, giving an overall mean score of 18.5 at 1 hour, which corresponds to moderate irritation (Kay and Callandra, 1962). Signs of irritation regressed to minimal in 2 eyes at 24 hours but persisted in 1 animal at 48 and 72 hours. All effects were fully reversible within 7 days. Dicyclopentadiene 75% was a moderate irritant to the rabbit eye at 1 hour but was practically non-irritating at 24, 48 and 72 hours. According to EEC labelling regulations dicyclopentadiene is a non-irritant and requires no symbol or risk phrase.