2-methylcyclopentane-1,3-dione

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:

other: Well documented study according to international accepted guidelines and GLP compliant.

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:

2-methylcyclopentane-1,3-dione

EC Number:

212-153-2

EC Name:

2-methylcyclopentane-1,3-dione

Cas Number:

765-69-5

Molecular formula:

C6H8O2

IUPAC Name:

2-methylcyclopentane-1,3-dione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Test item: Methyl-cyclopentanedioneCAS No.: 765-69-5Batch No.: S39129NPhysical state: solid, crystalline powderColour: beigeStorage: 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 rabbitSource: S&K LAP Kft.Hygienic level during the study: good conventionalNumber of animal: 3 malesAge of animals: adult rabbits, 12 weeks oldBody weight range at the beginning of the study: 2894 - 3052 gBody weight range at the end of the study: 2900 - 3158 gAcclimatisation time: 5 days in first animal, 6 days in second animal and 7 days in third animalAnimal 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 °CRelative 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 g of the finely grounded 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. Slight 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

Remarks:

(opacity)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0.33 - <= 0.66

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

chemosis score

Remarks:

(conjunctival oedema)

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 0.66

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

conjunctivae score

Remarks:

discharge

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0.33 - <= 0.66

Reversibility:

fully reversible within: 48 hours

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 to moderate chemosis and moderate discharge of the conjunctivae occurred, as well.48 hours after the treatment slight redness of conjunctivae was observed in two animals. One animal 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:

IIn conclusion, test item Methyl-cyclopentanedione (CAS 765-69-5) applied to the rabbits' eye mucosa caused slight to moderate conjunctival irritant effects which were fully reversible within 72 hours. According to GHS the test item can be classified into eye irritation hazard category 2B.