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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
1,8-naphthylenediamine
EC Number:
207-529-8
EC Name:
1,8-naphthylenediamine
Cas Number:
479-27-6
Molecular formula:
C10H10N2
IUPAC Name:
naphthalene-1,8-diamine

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