Reaction mass of 5,12-dihydroquino[2,3-b]acridine-7,14-dione and aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate) and dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

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)

GLP compliance:

yes (incl. QA statement)

Remarks:

BASF SE Experimental Toxicology and Ecology 67056 Ludwigshafen, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 5,12-dihydroquino[2,3-b]acridine-7,14-dione and aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate) and dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)

EC Number:

909-092-5

Molecular formula:

Unspecified

IUPAC Name:

Reaction mass of 5,12-dihydroquino[2,3-b]acridine-7,14-dione and aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate) and dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)

Test material form:

solid: particulate/powder

Details on test material:

Batch 22426
100% UVCB
storage at room temperature
storage stability until 10 Dec 2025

Specific details on test material used for the study:

Batch no 22426
pH-value: Ca. 5 (undiluted test substance, moistened with de-ionized water; determined in the lab prior to start of the GLP study
Physical state / color: Solid / violet to brown
Storage conditions: Room temperature
Purity 100% UVCB

Test animals / tissue source

Species:

human

Strain:

other: not applicable

Details on test animals or tissues and environmental conditions:

The EpiOcularTM model (OCL-200) is a three-dimensional non-keratinized tissue construct composed of normal human derived epidermal keratinozytes used to model the human corneal epithelium. The EpiOcularTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and are commercially available as kits (EpiOcular™ 200), containing 24 tissues on shipping agarose.

To assess the ability of the test material to directly reduce MTT a pretest was performed.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: yes (tissue incubations for positive and negative controls included)

Amount / concentration applied:

bulk volume of ca. 50 μL

Duration of treatment / exposure:

6 hours

Duration of post- treatment incubation (in vitro):

18h

Number of animals or in vitro replicates:

Two tissue samples were used per group.

Details on study design:

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 testsubstance treated epidermal tissues is compared to that of negative control tissues. The
quotient of the values indicates the relative tissue viability.

Results and discussion

In vitro

Results

Irritation parameter:

other: viability

Remarks:

[%]

Run / experiment:

mean

Value:

96.8

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Other effects / acceptance of results:

Due to the ability of the test substance to reduce MTT directly, KC tissues were applied in parallel. The results of the KC tissues indicate an increased MTT reduction (mean viability
0.3 % of NC). Thus for the test substance the final mean viability is given after KC correction.

Any other information on results incl. tables

Methyl acetate was used as positive control and deionised water as negative control and both gave the results to satisfy acceptance criteria.

Methyl acetate decreased the mean viability to 12 % of control cultures.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the EpiOcular test (OECD 492, GLP), the substance was found to be non irritating to eyes.