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Toxicological information

Eye irritation

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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:
2011

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

Reference
Name:
Unnamed
Type:
Constituent

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 vivo

Results
Irritation parameter:
other: cell viability
Basis:
mean
Time point:
other: 16 h
Score:
108.1
Max. score:
100
Reversibility:
other: not applicable - human corneal epithelial model (HCE)
Remarks on result:
other: non irritant - scores in [%] viability

Any other information on results incl. tables

Compound                             Cell viability [%]        Evaluation

Tetrachlorophthalic

anhydride                                   108.10                     Non irritant (NI)

Positive control  (SDS 5%)            3.42                    Irritant (I)

Negative control                          100.00                    Non irritant (NI)

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

Applicant's summary and conclusion

Interpretation of results:
not 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 (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France).

Undiluted tetrachlorophthalic anhydride was applied topically to the HCE tissue, i.e. 30 µl per insert.

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 108% (rounded) as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control (PC, 1 H-1 ,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

The results show that tetrachlorophthalic anhydride is predicted as non-irritant under the conditions of this test method.