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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 to 18 April 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 439 (Reconstructed Human Epidermis Test Method)
Deviations:
yes
Remarks:
The description of the colour of the test substnce was amended to light yellowish green powder as required by the Sponsor. The change in description of the test material is not considered to affect the scientific integrity of the study.
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

Species:
other: None
Strain:
other: None
Details on test animals or test system and environmental conditions:
Not applicable

Test system

Type of coverage:
other: Not applicable
Preparation of test site:
other: Not applicable
Vehicle:
other: Not applicable
Controls:
other: No control animals were used but control substances were employed.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 10 ± 2 mg

VEHICLE
- Amount applied: none
Duration of treatment / exposure:
15 ± 0.5 minutes
Observation period:
42 hours
Number of animals:
None; in vitro study
Details on study design:
TEST SITE
- Area of exposure: 0.38 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): each tissue was rinsed with 25 ml sterile Dulbeccos Phosphate Buffered Saline (DPBS) to remove residual test substance.
- Time after start of exposure: 15 ± 0.5 minutes

CONTROLS
The negative control was sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium.
The positive control was 5% (w/v) Sodium Dodecyl Sulphate (SDS) in distilled water.

SCORING SYSTEM: If the mean tissue viability was equal to or less than 50% of the negative control value, the sample was classed as Irritant R38 (EU classification) or Category 2 (GHS classification).

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: Optical density
Value:
99.5
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 45 hours. Max. score: 100.9. Reversibility: no data. (migrated information)

Any other information on results incl. tables

EPISKIN results -  Tissue viability as percentage of mean OD negative control

 Sample        Replicate tissues  Mean ± SD  Prediction MTT endpoint
   a  b  c    
Negative control  92.1  97.3  110.5  100 ± 9.5  Not applicable

 Positive control

 38.7  29.6  26.9  31.8 ± 6.2  Irritant

 LumiNova Blue Green

 100.9  100.5  96.9  99.5 ± 2.2  Non-irritant

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
It was concluded that the test substance, LumiNova Blue Green, with a mean tissue viability of 99.5 ± 2.2%, was predicted as a non - irritant to the skin.