1,4:5,8-Dimethanonaphthalene, 2-ethylidene-1,2,3,4,4a,5,8,8a-octahydro-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 November 2011 - 24 November 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to EC, OECD, and other official test guidelines, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(3R,6S,9E)-9-ethylidenetetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene; (3S,6R,9E)-9-ethylidenetetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene

EC Number:

700-518-3

Cas Number:

38233-76-0

Molecular formula:

C14H18

IUPAC Name:

(3R,6S,9E)-9-ethylidenetetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene; (3S,6R,9E)-9-ethylidenetetracyclo[6.2.1.1³,⁶.0²,⁷]dodec-4-ene

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 42 to 45 weeks
- Weight at study initiation: 4.80 to 5.03 kg.
- Housing: Housed individually in plastic cages with perforated floors.
- Diet (e.g. ad libitum): Each animal was offered 125g of standard laboratory diet per day.
- Water (e.g. ad libitum): Drinking water was provided ad libitum.
- Acclimation period: at least 30 weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 20°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours darkness.

IN-LIFE DATES: From: 08 Nov 2011 To: 24 Nov 2011

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

The eyelids were gently held together for one second before releasing.

Observation period (in vivo):

72 hours (ocular reactions to treatment were assessed 1, 24, 48, and 72 hours after treatment).

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Consistent with the system described in the EU test method (Commision regulation 440/2008, Part B, method B5).

TOOL USED TO ASSESS SCORE: An opthalmoscope or pencil beam torch was available.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

(Corneal opacity)

Basis:

animal: 13F - 15F

Time point:

other: Mean of 24, 48, and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

animal: 13F - 15F

Time point:

other: Mean of 24, 48, and 72 hours

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(Redness of Conjunctiva)

Basis:

animal: 13F - 15F

Time point:

other: Mean of 24, 48, and 72 hours

Score:

0.7 - 1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 13F - 15F

Time point:

other: Mean of 24, 48, and 72 hours

Score:

0 - 0.3

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Injection of the conjunctival blood vessels or a crimson-red conjunctival appearance with very slight or slight chemosis and slight discharge was apparent in all animals during the first 24 hours after instillation. All animals had conjunctival injection at the 48 hour examination and the treated eye of each animal was overtly normal 72 hours after instillation.

Instillation of the test substance gave rise to practically no pain response.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The highest total mean score was 11.3 occurring at the one hour observation; accordingly under the criteria Kay and Calandra (1962) ETD was classified as “minimally irritating” to the eye. ETD did not require labelling in accordance with European Commission regulation 1272/2008.