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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
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study with up-to-date OECD method on the registration substance with a high purity

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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 / tissue source

Species:
other: bovine eyes

Test system

Vehicle:
physiological saline
Controls:
yes
Duration of treatment / exposure:
4 hours
Number of animals or in vitro replicates:
3 eyes per group

Results and discussion

In vivo

Results
Irritation parameter:
other: In vitro Irritancy scores
Basis:
mean
Time point:
other: 4 hours
Score:
-0.4

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 did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.4 after 240 minutes of treatment.
Finally, it is concluded that this test is valid and that C. I. Pigment Violet 55 is not irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report.
Since C. I. Pigment Violet 55 induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
Executive summary:

C. I. Pigment Violet 55 was tested in a 20% (w/w) suspension. The individual in vitro irritancy scores for the negative controls ranged from -1.8 to 1.5. The individual positive control in vitro irritancy scores ranged from 137 to 153 (APPENDIX 2, Table 5). The corneas treated with the positive control were turbid after the 240 minutes of treatment.

The corneas treated with C. I. Pigment Violet 55 showed opacity values ranging from -3 to 0 and permeability values ranging from 0.018 to 0.092. The corneas were clear after the 240 minutes of treatment with C. I. Pigment Violet 55. No pH effect of the test substance was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -2.4 to 1.7 after 240 minutes of treatment with C. I. Pigment Violet 55.