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EC number: 256-370-0 | CAS number: 49556-16-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07.03.2018 - 09.05.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tin(2+) neodecanoate
- EC Number:
- 256-370-0
- EC Name:
- Tin(2+) neodecanoate
- Cas Number:
- 49556-16-3
- Molecular formula:
- C20H38O4Sn
- IUPAC Name:
- λ²-tin(2+) bis(2,2-dimethyloctanoate)
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- other: EpiDerm™ (EPI-200-SCT, Lot no. 25899) MatTek In Vitro Life Science Laboratories, s.r.o, Mlynské Nivy 73, 821 05 Bratislava II, Slovak Republic.
- Details on test animals or test system and environmental conditions:
- EpiDerm™ is cultured from normal human keratinocytes.
Test system
- Amount / concentration applied:
- 50 µl
- Duration of treatment / exposure:
- Quality control (Triton X-100, 1 % solution)
Positive control 3 min + 60 min (± 1 min) (8 N KOH)
Negative control 3 min + 60 min (± 1 min) (sterile deionised water)
Test substance 3 min + 60 min (± 1 min) undiluted - Number of animals:
- The test was performed in duplicate.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Exposure: 3 min
- Value:
- ca. 24.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- exposure: 60 min
- Value:
- ca. 9.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Exposure 3 min:
Test substance: mean viability 24.4 %
Negative control: mean viability 100 %
Positive control: mean viability 9.2 %
Exposure 60 min:
Test substance: mean viability 9.1 %
Negative control: mean viability 100 %
Positive control: mean viability 4.4 %
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Topical application of the test substance on top of the stratum corneum of the reconstructed human epidermis model EpiDerm™ (duplicate)
resulted in a mean cell viability of 24.4% (after 3 min exposure) and 9.1% (after 60 min exposure) when compared to the corresponding negative conrol. According to the evaluation scheme of OECD test
guideline 431 the test substance has to be predicted as corrosive to the skin. - Executive summary:
The purpose of this study was to determine cytotoxic properties of Neodecanoic acid, tin(2+) salt (2:1) to skin cells, which might lead to human skin
corrosion, by using an artificial three-dimensional model of human skin. The EpiDermTM model was employed.
Duplicate tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed
as relative percentage of viability of the negative control-treated tissues.
Neodecanoic acid, tin(2+) salt (2:1) was applied as liquid test item topically undiluted to the model skin surface. Sterile deionised water was used as the negative control. 8 N KOH was used as the positive reference item. An exposure time of 3 min and
60 minutes was employed.
The mean viability of cells exposed to Neodecanoic acid, tin(2+) salt (2:1) was 24.4% (after 3 min exposure) and 9.1% (after 60 min exposure) of the negative controls and, hence, was below the cut-off percentage cell viability value that distinguishes corrosive from non-corrosive test items of ≤ 50%. Neodecanoic acid, tin(2+) salt (2:1) was
considered to be cytotoxic and predicted to be corrosive to skin in accordance with UN GHS category 1 (H314).
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