Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Strontium oxalate
EC Number:
212-415-6
EC Name:
Strontium oxalate
Cas Number:
814-95-9
Molecular formula:
C2H2O4.Sr
IUPAC Name:
strontium oxalate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Bernardy, STRONTIUM OXALATE
- batch No.: 1702507
- Purity test date: 13/01/2017
- date of reception: 19/12/2017
- Expiry date: 13/01/2022

STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

In vitro test system

Test system:
human skin model
Justification for test system used:
Test system recommended in the OECD 439 Guideline.
Vehicle:
water
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE® model
- Tissue batch number(s): 18-RHE-012
- Delivery date: received on 13 February 2018

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 42 minutes after the test item application, the nylon mesh was removed and the human epidermises were washed with 25 x 1 mL of DPBS (Dutscher - Batch No. 3941117).
- Observable damage in the tissue due to washing: No (comparable coloration to that of the negative control tissues)

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 42 hours post-treatment incubation period (after 42 min of exposure)

FUNCTIONAL MODEL CONDITIONS
- Viability:
Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues. The mean percent viability of the treated tissues was 104.3% (considered as 100%) versus 1.1% in the positive control (5% Sodium Dodecyl Sulfate).
The results were expressed as a viability percentage compared with the negative control : Viability % = OD test item / OD negative control x100

NUMBER OF REPLICATE TISSUES:
Three replicates used for each test chemical and for the controls : 3 replicates for test item, 3 for negative control, 3 for positive control

PREDICTION MODEL / DECISION CRITERIA
The test item is considered as non-irritant to skin in accordance with UN GHS No Category if the mean percent viability after 42 minutes exposure and 42 hours of post-treatment incubation is > 50%.
The test item is identified as requiring classification and labelling according to UN GHS (Category 2) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and the result of a skin corrosion test is “non-corrosive”.
The test item is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after 42 minutes exposure and 42 hours of post-treatment incubation is ≤ 50% and in absence of information on a skin corrosion test.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- Amount applied: dose of 16 mg to the epidermal surface of 3 living Reconstructed Human epidermis previously moistened with 10 μL of distilled water.

VEHICLE
- Amount(s) applied (volume or weight with unit): Reconstructed Human epidermis previously moistened with 10 μL of distilled water.

NEGATIVE CONTROL
DPBS – Dutscher - Batch No. 3941117
- Amount applied: 0.5 g of SDS (SIGMA Batch No. STBG6142V) in a 10 mL volumetric flask qsp 10 mL of distilled water.

POSITIVE CONTROL
5% sodium dodecyl sulfate (SDS)
- Amount applied: in a 10 mL volumetric flask
Duration of treatment / exposure:
42min (application)
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3 for each test chemical and for the controls (3 replicates for test item, 3 for negative control, 3 for positive control).

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
104.3
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with the Regulation EC No. 1272/2008, the test item STRONTIUM OXALATE has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category.
No hazard statement or signal word is required.
Executive summary:

An OECD 439 test was performed on Strontium oxalate in order to investigate the corrosion/irritation potential. In accordance with the Regulation EC No. 1272/2008, the test item STRONTIUM OXALATE has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category. No hazard statement or signal word is required.