[29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

[29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt

EC Number:

222-012-7

EC Name:

[29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt

Cas Number:

3317-67-7

Molecular formula:

C32H16N8Co

IUPAC Name:

[29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt

Test animals / tissue source

Species:

human

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Temperature : 37°C
CO2 : 5%
Humidity : 95%

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

yes, concurrent positive control

Amount / concentration applied:

50 mg

Duration of treatment / exposure:

6 hours

Duration of post- treatment incubation (in vitro):

25 minutes post-exposure immersion period at room temperature in 5 mL of fresh medium to remove any test item absorbed into the tissue, then, the RhCE constructs were incubated for an 18 hours and 01 minute post-exposure incubation at standard culture conditions in 1 mL of fresh medium at 37°C, 5% CO2.

Number of animals or in vitro replicates:

2 replicate per conditions

Details on study design:

The test item Cobalt Phthalocyanine was applied at the dose of 50 mg to 2 living DPBS pre-treated RhCE (EpiOcularTM tissue model) during 6 hours at 37°C, 5% CO2, 95% humidity (standard culture conditions). The exposure period was followed by extensive rinsing with DPBS at room temperature, a 25 minutes post-exposure immersion period at room temperature and an 18 hours and 01 minute post-exposure incubation at standard culture conditions. The tissue viability was measured by performing an MTT assay. Additionally, 2 killed RhCE (EpiOcularTM tissue model) were treated in the same manner in order to generate non-specific MTT reduction. Moreover, 2 living and 2 killed RhCE (EpiOcularTM tissue model) were treated in the same manner but they were incubated in culture medium instead of MTT solution in order to generate non-specific living and killed colour controls.

Results and discussion

In vitro

Results

Irritation parameter:

other: % of viability

Value:

74.42

Negative controls validity:

valid

Remarks:

% viability: 100.00%

Positive controls validity:

valid

Remarks:

% viability : 32.96%

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions adopted and in accordance with the Regulation EC No. 1272/2008, the test item Cobalt Phthalocyanine does not require classification for eye irritation or serious eye damage. It corresponds to the UN GHS No Category. No hazard statement is required.

To conclude, based on OECD 492 (2015), GLP study, Cobalt Phthalocyanine is not considered as eye irritant or serious eye damage according to CLP criteria.