Methyl 1,2,3,4-tetrahydro-6-naphthyl ether

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 1,2,3,4-tetrahydro-6-naphthyl ether

EC Number:

217-049-0

EC Name:

Methyl 1,2,3,4-tetrahydro-6-naphthyl ether

Cas Number:

1730-48-9

Molecular formula:

C11H14O

IUPAC Name:

6-methoxy-1,2,3,4-tetrahydronaphthalene

Test material form:

other: liquid

Details on test material:

Test item: Methoxy-tetraline
CAS number: 1730-48-9
Batch number: S41214K
Physical state: Liquid
Coluor: Brown
Storage: At a temperature of 15 to 30 °C

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species and strain: New Zealand white rabbit
Source: S&K LAP Kft.
Hygienic level during the study: good conventional
Number of animal: 3 males
Age of animals: adult rabbits, 11 weeks old
Body weight range at the beginning of the study: 2750 - 2854 g
Body weight range at the end of the study: 2860 - 2966 g
Acclimatisation time: 5 days in first animal, 6 days in second animal and 7 days in third animal
Animal health: Only animals in acceptable health condition were used for the test.

Housing: Animals were housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The contralateral eye served as control.

Amount / concentration applied:

0.1 ml test item was used for the study, as a single dose.

Duration of treatment / exposure:

The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after the application.

Number of animals or in vitro replicates:

3 male

Details on study design:

In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. The contralateral eye served as control.
In the initial test slight irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second animal. No irritant effect was observed in second animal 24 hours after treatment. The confirmatory test was conducted using a third animal.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 0.33

Max. score:

0.33

Reversibility:

fully reversible within: 48h

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Treated and control eyes were examined at 1, 24, 48 and 72 hours after the application.
1 hour after the single application of test item into the eye of the rabbits, slight redness, slight chemosis and slight discharge of the conjunctivae occurred, as well.
24 hour after the treatment, slight redness of the conjunctivae was observed in one animal. Two animals became free of symptoms.
72 hours after the treatment the study was finished, because all animals were free of symptoms.

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Remarks:

Migrated information

Conclusions:

In conclusion, test item Methoxy-tetraline (CAS 1730-48-9) applied to the rabbits' eye mucosa caused slight conjunctival irritant effects which were fully reversible within 48 hours. The test item can be classified into hazard Category 2B.