Registration Dossier

Diss Factsheets

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

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.