Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15 - 23 June 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
Amended by EC No. 761/2009 OJ No. L220, 24 August 2009
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- test material: BiOI-BiOBr
- Substance type: inorganic
- Physical state: orange powder
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
- pH: 7.5 (50 g/L)
- Stability at higher temperatures: stable (maximum temperature: 280°C, maximum duration 4 hours)

Test animals

Species:
human
Details on test animals and environmental conditions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 36.1 - 37.5
- Humidity (%): 80-95

Test system

Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amounts applied: approximately 10 mg, 5 μl Milli-Q water to moisten skin.
Duration of treatment / exposure:
15 minutes
Details on study design:
TEST SITE
EPISKIN Standard ModelTM (EPISKIN-SMTM, 0.38 cm2, Lot no.: 10-EKIN-026). This model is a three-dimensional human epidermis model, which consists of adult human derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
REMOVAL OF TEST SUBSTANCE
Washing: phosphate buffered saline - Time after start of exposure: 15 minutes
POST INCUBATION PERIOD
42 hours
SCORING SYSTEM
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.
NEGATIVE CONTROL
Phosphate buffered saline (PBS, Invitrogen Corporation, Breda, The Netherlands).
POSITIVE CONTROL
5% (aq) sodium dodecyl sulphate (SDS, Sigma Aldrich, Zwijndrecht, The Netherlands) in PBS.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
100
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
8%
Remarks on result:
no indication of irritation

In vivo

Irritant / corrosive response data:
The relative mean tissue viability obtained after 15 minutes treatment compared to the negative control tissues was 100%.
The positive control had a mean cell viability after 15 minutes exposure of 8%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.

Any other information on results incl. tables

Bismuth oxy-iodide bromide was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because no colour change was observed it was concluded that bismuth oxy-iodide bromide did not

interact with MTT.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An in vitro skin irritation test ((EPISKIN Standard model (EPISKIN-SMTM)) was performed according to OECD guideline and GLP principles. Based on this test it is concluded that bismuth oxy-iodide bromide is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
Executive summary:

An in vitro skin irritation test ((EPISKIN Standard model (EPISKIN-SMTM)) was performed according to OECD guideline and GLP principles. The relative mean tissue viability obtained after 15 minutes treatment compared to the negative control tissues was 100%. The positive control had a mean cell viability after 15 minutes exposure of 8%. Since the mean relative tissue viability was above 50% after 15 minutes treatment bismuth oxy-iodide bromide

is considered to be non-irritant.