α,α,α-trifluoro-3-tolyl isocyanate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Principles of method if other than guideline:

In vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model. The model used is standardized and commercially available (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France).

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

α,α,α-trifluoro-3-tolyl isocyanate

EC Number:

206-341-3

EC Name:

α,α,α-trifluoro-3-tolyl isocyanate

Cas Number:

329-01-1

Molecular formula:

C8H4F3NO

IUPAC Name:

1-isocyanato-3-(trifluoromethyl)benzene

Constituent 2

Reference substance name:

alpha,alpha,alpha-trifluoro-3-tolyl isocyanate

IUPAC Name:

alpha,alpha,alpha-trifluoro-3-tolyl isocyanate

Details on test material:

content: > 96.5%

Test animals / tissue source

Species:

other: not applicable - human corneal epithelial model (HCE)

Strain:

other: not applicable - human corneal epithelial model (HCE)

Test system

Vehicle:

other: not applicable - human corneal epithelial model (HCE)

Controls:

other: not applicable - human corneal epithelial model (HCE)

Duration of treatment / exposure:

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was measured

Observation period (in vivo):

not applicable - human corneal epithelial model (HCE)

Number of animals or in vitro replicates:

not applicable - human corneal epithelial model (HCE)

Results and discussion

In vitro

Results

Irritation parameter:

other: cell viability

Run / experiment:

60 minutes followed by a 16 h post-treatment period

Value:

29.21

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: irritant - scores in [%] viability

Any other information on results incl. tables

A test substance is predicted to be an ocular irritant if the mean relative tissue viability (%) exposed to the test substance is<50%.

As can be seen from the information in the Table below the test substance

m-Trifluoromethylphenylisocyanate was detected as irritant to the cornea epithelium in this test model.

Compound                                   Cell viability [%] Evaluation

m-Trifluoromethylphenylisocyanate      29.21               irritant

Positive control                                   20.04              irritant

Negative control                               100.00             non-irritant

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information

Executive summary:

This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2011. The model used is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE); SkinEthic, France).

Undiluted m-trifluoromethylphenylisocyanate was applied topically to the HCE tissue, i.e. 30 mg per insert. (plus 30 µl PBS to moisten and ensure good contact with the skin; three replicates)

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 2% (rounded) as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control

(PC, 1H-1,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

The results show that m-trifluoromethylphenylisocyanate is predicted as ocular irritant under the conditions of this test method.