4-trans-Methoxy-4-trans-propyl-[1,1-bicyclohexyl]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr 12 - Aug 23, 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1r,1's,4r,4'r)-4-methoxy-4'-propyl-1,1'-bi(cyclohexane)

EC Number:

619-269-6

Cas Number:

97398-80-6

Molecular formula:

C₁₆H₃₀O

IUPAC Name:

(1r,1's,4r,4'r)-4-methoxy-4'-propyl-1,1'-bi(cyclohexane)

Test material form:

liquid: viscous

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

Crl:KBL(NZW)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Kifilegg
- Age at study initiation: Approx. 18 weeks
- Weight at study initiation: mean 3.36 kg
- Housing: animals were kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU)
- Diet: ad libitum, Provimi Kliba 3418.0 and ssniff® K snack
- Water: ad libitum, tap water from Makrolon drinking bottles
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 21
- Humidity (%): 42 to 56
- Photoperiod (hrs dark / hrs light): 12/12

The room temperature in the animal room was transiently outside the target range of 16 to 22 °C. This minor and short deviation did not influence the integrity or outcome of the study.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL of the test material was instilled into the conjunctival sac of the left eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test material was placed.

Observation period (in vivo):

1 hour after treatment, after 24, 48, and 72 hours, then daily up to day 5 of the experimental part

Number of animals or in vitro replicates:

3f

Details on study design:

SCORING SYSTEM: Eye changes were evaluated according to DRAIZE, OECD and EEC recommendations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 10

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

No signs of irritation were observed at the cornea or iris. One animal showed redness of the conjunctiva (score 1) on day 2 and the other two animals showed redness (score 1) from the first reading up to day 3 of the experimental part. All animals showed chemosis (score 1) and discharge (score 3) one hour after instillation of the test material. No abnormalities were detected in the untreated eyes.

Other effects:

- Other observations: No signs of clinical toxicity were detected. All animals survived the observation period. Body weight development of the treated rabbits was inconspicuous.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No eye irritating potential could be detected.

Executive summary:

The liquid test material was tested for its eye irritating properties. Prior to testing, the hen's egg test on the chorioallantoic membrane was performed and no irritating potential could be detected. The test for primary eye irritation was performed initially with one animal and followed by the confirmatory test with two further animals.
For the test of primary eye irritation, the test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The other examinations of the eyes were performed daily for a further 7 days. No signs of irritation were observed at the cornea or iris. One animal showed redness of the conjunctiva (score 1) on day 2 and the other two animals showed redness (score 1) from the first reading up to day 3 of the experimental part. All animals showed chemosis (score 1) and discharge (score 3) one hour after instillation of the test material. No eye irritating potential could be detected.