C.I. Pigment Violet 55

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: New GLP study on the registered substance following the latest test guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2,9-dimethoxy-5,12-dihydroquino[2,3-b]acridine-7,14-dione and 2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione

EC Number:

941-220-5

Cas Number:

1126076-86-5

Molecular formula:

PV54: C22H16N2O4 PR202: C20H10Cl2N2O2

IUPAC Name:

Reaction mass of 2,9-dimethoxy-5,12-dihydroquino[2,3-b]acridine-7,14-dione and 2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

other: Human

Strain:

other: Homo sapiens (disambiguation)

Test system

Type of coverage:

other: EPISKIN Small ModelTM (EPISKIN-SMTM, 0.38 cm2, Lot no.: 14-EKIN-048,

Vehicle:

unchanged (no vehicle)

Duration of treatment / exposure:

The test consists of topical application of C. I. Pigment Violet 55 on the skin tissue for 15 minutes.

Observation period:

42 hours

Number of animals:

The test was performed on a total of 3 tissues per test substance together with negative and positive controls

Results and discussion

Any other information on results incl. tables

The mean absorption at 570 nm measured after treatment with C. I. Pigment Violet 55 and controls are presented in APPENDIX 1,Table 1. The individual OD570 measurements are presented in APPENDIX 2.

Table 2 shows the mean tissue viability obtained after 15 minutes treatment with C. I. Pigment Violet 55 compared to the negative control tissues. Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with C. I. Pigment Violet 55 compared to the negative control tissues was 100%. Since the mean relative tissue viability for C. I. Pigment Violet 55 was above 50% C. I. Pigment Violet 55 is considered to be non-irritant.

The positive control had a mean cell viability after 15 minutes exposure of 23%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range (See APPENDIX 3). The standard deviation value of the percentage viability of three tissues treated identically was less than 8%, indicating that the test system functioned properly.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

C. I. Pigment Violet 55 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.

Executive summary:

In vitro skin irritation test with C. I. Pigment Violet 55 using a human skin model.

This report describes the ability of C. I. Pigment Violet 55 to induce skin irritation on a human three dimensional epidermal model (EPISKIN Standard model (EPISKIN-SMTM)). The possible skin irritation potential of C. I. Pigment Violet 55 was tested through topical application for 15 minutes.

The study procedures described in this report were based on the most recent OECD and EC guidelines.

C. I. Pigment Violet 55 was a violet powder with a purity of 98.3%. Skin tissue was moistened with 5 μl of Milli-Q water and 11.4 to 15.4 mg of C. I. Pigment Violet 55 was applied directly on top of the skin tissue for 15 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.

Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with C. I. Pigment Violet 55 compared to the negative control tissues was 100%. Since the mean relative tissue viability for

C. I. Pigment Violet 55 was above 50% after 15 minutes treatment C. I. Pigment Violet 55 is considered to be non-irritant.

The positive control had a mean cell viability of 23% after 15 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 8%, indicating that the test system functioned properly.

Finally, it is concluded that this test is valid and that C. I. Pigment Violet 55 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.