Tetradecaaluminium tetrastrontium pentacosaoxide, dysprosium and europium doped

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 March to 12 May 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study undertaken at a GLP accredited laboratory, to internationally accepted guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 437 (The Bovine Corneal Opacity & Permeability Assay (BCOP))

Deviations:

yes

Remarks:

The description of the substance was amended to light yellowish green powder as required by the Sponsor.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

LumiNova Blue Green

IUPAC Name:

LumiNova Blue Green

Details on test material:

- Name of test material (as cited in study report): LumiNova Blue Green
- Substance type: Phosphorescent pigment
- Physical state: Light yellowish green powder
- Analytical purity: > 99%
- Lot/batch No.: PBM-029
- Expiration date of the lot/batch: 04 February 2012
- Storage condition of test material: Room temperature in the dark

Test animals / tissue source

Species:

other: isolated bovine corneas

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Not applicable as the assay uses isolated bovine corneas as a means of assessing the ocular corrosivity or severe irritancy potential of test substances in vitro. The isolated corneas were obtained as a by-product of the meat production industry.

Test system

Vehicle:

other: 0.9% sodium chloride solution

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 750 µl
- Concentration (if solution): 0.9% NaCl solution

CONTROLS (positive and negative)
- Amount(s) applied: 750 µl
- Concentration (if solution): 0.9% NaCl solution


VEHICLE
- Amount applied: 750 µl
- Concentration (if solution): 0.9%

Duration of treatment / exposure:

4 hours ± 5 minutes

Observation period (in vivo):

None

Number of animals or in vitro replicates:

Not applicable

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours ± 5 minutes

SCORING SYSTEM: In Vitro Irritancy Score = Corrected Opacity Value + (15 x Corrected OD490 Value)

TOOL USED TO ASSESS SCORE: Minimal Essential Medium (cMEM)

Results and discussion

In vivo

Results

Irritation parameter:

other: In Vitro Irritancy score

Basis:

other: In Vitro Irritancy Score = Corrected Opacity Value + (15 x Corrected OD490 Value)

Time point:

other: Not applicable

Score:

5.3

Reversibility:

other: not applicable

Remarks on result:

other: Data for maximum score not applicable for BCOP study.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information The IVIS score from the swabbed corneas in assay 3 was considered to be the conclusive result. Criteria used for interpretation of results: OECD GHS

Conclusions:

In assay 3, the IVIS for the corneas washed using the usual procedure was greater than that for the swabbed corneas. The results for assay 3 show that adherence of the test material to the corneas greatly increased the IVIS and thereby gave an artifactual result. The IVIS score from the swabbed corneas in assay 3 was considered to be the conclusive result. The test substance, LumiNova Blue Green, elicited an In Vitro Irritancy Score of 5.3 ± 1.0. This value was substantially below the classification threshold of 55.1 and therefore LumiNova Blue Green was predicted to be a non-corrosive/non-severe eye irritant.