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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: Scientifically acceptable and well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

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 vitro

Results
Irritation parameter:
other: cell viability
Run / experiment:
60 minutes followed by a 16 h post treatment period
Value:
56.76
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

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

Gelbpigment E4GN was detected as non-irritant to the cornea epithelium in this test model.

Compound                                   Cell viability [%]        Evaluation

1,8-naphthylendiamine                      56.76                  non-irritant

Positive control                                   38.57                     irritant

Negative control                               100.00                   non-irritant

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

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

Undiluted 1,8-naphthylenediamine 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 57 % (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 1,8-naphthylenediamine is predicted as non-irritant under the conditions of this test method