2-methylcyclohexanone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April-May 2019

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

Final

Deviations:

no

Remarks:

There were no deviations from the study plan

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-methylcyclohexanone

EC Number:

209-513-6

EC Name:

2-methylcyclohexanone

Cas Number:

583-60-8

Molecular formula:

C7H12O

IUPAC Name:

2-methylcyclohexan-1-one

impurity 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

impurity 2

Reference substance name:

Unknown impurities

Molecular formula:

not applicable

IUPAC Name:

Unknown impurities

Test material form:

liquid

Details on test material:

Batch No.: 01246M0002, purity confirmed by analytical certificate

Specific details on test material used for the study:

The test item was used as provided by the sponsor.

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

Room temperature, protected from light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

750 µL of the test substance or control

Duration of treatment / exposure:

10 minutes incubation at 32 ± 1 °C

Duration of post- treatment incubation (in vitro):

2 hours incubation at 32 ± 1 °C

Number of animals or in vitro replicates:

3 replicates for each group

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

25.89

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

In Vitro Irritation Score

Cornea No.  Test Item     Corrected            Corrected          IVIS
                                  Opacity Value      OD490 Value

     1                                 0.39                 0.005

     2          Negative          0.53                 0.006

     3          Control            0.35                 0.001

    MV                               0.43                 0.004              0.49

     4                              18.66                 1.821

     5         Positive          23.47                 1.044

     6         Control           21.82                 1.756

    MV                             21.32                 1.540             44.42

     7                               8.62                  1.035

     8        Test item          7.69                  1.261

     9                               8.29                  1.243

    MV                             8.20                  1.180             25.89

 

MV=mean value
                                  

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the conditions of this experiment - 2-methylcyclohexanone is not eye damaging (Cat. 1). However, no prediction can be made regarding whether it is eye irritating or not classifiable for eye effects.