Registration Dossier
Registration Dossier
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EC number: 214-071-2 | CAS number: 1077-28-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-01-04 - 2017-02-23
- 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)
- Version / remarks:
- 2016-07-29
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5-(dithiolan-3-yl)valeric acid
- EC Number:
- 214-071-2
- EC Name:
- 5-(dithiolan-3-yl)valeric acid
- Cas Number:
- 1077-28-7
- Molecular formula:
- C8H14O2S2
- IUPAC Name:
- 5-(1,2-dithiolan-3-yl)pentanoic acid
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- solid: bulk
- Details on test material:
- This composition is the usual techical grade of AlzChem AG. It will be used when test substance has this composition (or is very closed) or no specific information is available
Constituent 1
impurity 1
impurity 2
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: NHEC: normal human-derived epidermal keratinocytes
- Justification for test system used:
- The EpiDerm(TM) Skin Model is a well established organotypic, three-dimensional model of the human epidermis and is used for in vitro experiments many years. It is known for its similaryty to huaman skin.
- Vehicle:
- water
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm(TM) (MatTek). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell(R)). The EpiDerm(TM) epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Negative control: 50 µL distilled Water
Positive control: 50 µL 8 N KOH
Test Item: 25 mg + 25 µL H2O - Duration of treatment / exposure:
- 3 min; 60 min
- Number of replicates:
- 4 per dose group
2 repliocates for each treatment period
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- ca. 97.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- ca. 77.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Conclusions:
- In the study under the given conditions the test item showed no corrosive effects. The test item is classified as "non-corrosive".
- Executive summary:
In the present study the skin corrosivity of Thioctic Acid was analysed. Since corrosive chemicals are cytotoxic after a short tim exposure to the stratum corneum of the epidermis the cytotoxic effects of the test item on EpiDerm(TM), a reconstituted three-dimensional human epidermis model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogensase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
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