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Administrative data

Description of key information

Zinkphthalocyaninsulfonat is not irritating to the skin in an in vitro study. The available in vitro eye irritation studies do not show an eye irritation potential of zinkphthalocyaninsulfonat.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

Zinkphthalocyaninsulfonat was tested using the in vitro EpiDerm™ Skin Corrosion Test (BASF SE, 2011) according to OECD Guidelines 431 and 439 under GLP. The potential of zinkphthalocyaninsulfonat to cause dermal corrosion/irritation was assessed by a single topical application of 25 μL bulk volume (about 10 mg) of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™).

For the corrosion test two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period.

Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.

The viability scores as % of negative control were 94% and 104% for 3 minutes and 1 hour exposure, respectively. The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 102%. Based on the observed results and applying the evaluation criteria it is concluded, that zinkphthalocyaninsulfonat does not show a skin irritation potential in the EpiDerm™ skin corrosion/irritation test under the test conditions chosen.

 

Eye irritation

Zinkphthalocyaninsulfonat was tested using the in vitro EpiOcular™ Test (BASF SE, 2011) under GLP. The potential of zinkphthalocyaninsulfonat to cause ocular irritation was assessed by a single topical application of 50 μL bulk volume (about 18 mg) of the test substance to a reconstructed three dimensional human cornea model (EpiOcular™). Four EpiOcular™ tissue samples were incubated with the test substance for 90 minutes followed by a 18-hours post-incubation period. Because of the color of the test substance four tissues were treated with the test substance; two of the tissues serving as a color control (CC) in order to differentiate between formazan production and test-substance residues in the colorimetric test.

Due to the color of the test substance it could not be determined whether the test substance is able to reduce tetrazolium salt (MTT)directly. Therefore an additional MTT reduction control (KC) was introduced.

Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with MTT was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability.

The result of the KC did not indicate an increased MTT reduction. In addition, the CC tissues did not indicate interference due to the color of the test substance though a slight discoloration of the tissues was still noticed after the washing procedure. The mean viability of the test-substance treated tissues was 74%.

Based on the observed results and applying the evaluation criteria it is concluded, that zinkphthalocyaninsulfonat does not show an eye irritation potentialin the EpiOcular™ eye irritation test under the test conditions chosen.

 

Zinkphthalocyaninsulfonat was also tested using the in vitro Bovine Corneal Opacity and Permeability Test (BASF SE, 2011) according to OECD Guideline 437 under GLP. The potential of zinkphthalocyaninsulfonat to cause serious damage to the eyes was assessed by a single topical application of 750 μL of a 20% test-substance preparation to the epithelial surface of isolated bovine corneas.

Three corneas were treated with the test-substance preparation for an exposure period of 4 hours. Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance relative to the control corneas.

The mean opacity value was 9.9, the mean permeability value was 0.006 and the In Vitro Irritancy Score was 10.0. The negative control values were 4.4, -0.004 and 4.4 and the positive control values were 59.6, 2.725 and 100.5, respectively.

Based on the observed results and applying the evaluation criteria it is concluded, that zinkphthalocyaninsulfonat does not cause serious eye damagein the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen. The test method does, however, not yet allow for the evaluation of eye irritation. The result does not exclude an irritation potential of the test substance.

Justification for classification or non-classification

Based on the available in vitro data, the substance does need not to be classified for skin or eye irritation according to Directive 67/548/EEC and according EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.