Registration Dossier
Registration Dossier
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EC number: 219-976-6 | CAS number: 2589-57-3
Skin irritation / corrosion
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:
- 2 016
- 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
- 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'-azobis(2-methylpropionate)
- Test material form:
- solid: flakes
Constituent 1
- 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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