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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18.01.2016 - 12.02.2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Qualifier:
according to guideline
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl 2,2'-azobis(2-methylpropionate)
EC Number:
219-976-6
EC Name:
Dimethyl 2,2'-azobis(2-methylpropionate)
Cas Number:
2589-57-3
Molecular formula:
C10H18N2O4
IUPAC Name:
dimethyl 2,2'-diazene-1,2-diylbis(2-methylpropanoate)
Test material form:
solid: flakes
Specific details on test material used for the study:
Batch no. HY9001

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Details on test system:
Commercially available EpiDermTM-Kit.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell cultures inserts.

Origin
EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
Designation of the kit: EPI-200-SIT
Day of delivery: 09. Feb. 2016
Batch no.: 23312
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
Test material: Tissue 1: 24.9 mg; Tissue 2: 25.0 mg; Tissue 3: 25.4 mg
Negative control: 30 μL DPBS buffer per tissue
Positive control: 30 μL 5% SDS-solution per tissue
Duration of treatment / exposure:
60 min
Duration of post-treatment incubation (if applicable):
23 h and 30 min
Number of replicates:
3 tissues

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
115.3
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
2
Value:
110.5
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3
Value:
96.4
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The relative absorbance values were increased to 107.4 % after the treatment. This value is above the threshold for skin irritation (50%). Therefore, the test item is considered as not irritant to skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item is considered as not skin irritant.
Executive summary:

After the treatment, the relative absorbance values were increased to 107.4%. This value is well above the threshold for skin irritation (50 %). The optical density of the negative control was well within the required acceptability criterion

of 0.8 ≤ mean OD ≤ 2.8, the OD was 1.6. The positive control induced a decrease in the relative absorbance as compared to the negative control to 3.7 % (required: < 20 %) for thus ensuring the validity of the test system.

Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18 %). For these reasons, the result of the test is considered valid.

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