Registration Dossier
Registration Dossier
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EC number: 241-555-0 | CAS number: 17586-94-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dioctyltin di(acetate)
- EC Number:
- 241-555-0
- EC Name:
- Dioctyltin di(acetate)
- Cas Number:
- 17586-94-6
- Molecular formula:
- C20H40O4Sn
- IUPAC Name:
- dioctyltin di(acetate)
- Test material form:
- liquid
- Details on test material:
- TK 229 740293
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: reconstructed epidermis (details see test report)
- Cell type:
- other: see test report
- Cell source:
- other: see test report
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 3m, 1h
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3m
- Value:
- ca. 10
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1h
- Value:
- ca. 6.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- This study was conducted to determine whether the test article, Dioctyltin di(acetate),
causes corrosion in the in vitro skin model EpiDermTM.
Duplicate EpiDermTM inserts were treated with test article, purified water (negative
control) and 8N potassium hydroxide (positive control) for 3 minutes and 1 hour. At
the end of the treatment period, the tissues were washed with phosphate buffered
saline (PBS) and cell viability was assessed using the MTT assay. The skin
corrosivity potential was classified according to the remaining cell viability obtained
after test material treatment with either of the two treatment times.
Skin viability after a three minute or one hour exposure to the test article was 10%
and 6.3%, respectively.
The OD values for the negative controls met the acceptance criteria.
Skin viability after a three minute or one hour exposure to the positive control article
was 2% and 9.4%, respectively, demonstrating appropriate performance of the assay.
One positive control replicate was excluded from analysis due to loss of tissue during
wash off procedures. All data was calculated using the remaining replicate only.
The test article, Dioctyltin di(acetate), was considered to be corrosive (Category 1A)
according to the UN GHS classification system.
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