Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: - | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Conducted at GLP-accredited facility to current guidelines
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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MarTek Corporation Protocol for: In Vitro EpiDerm Skin Corrosion Test (EPI-200-SCT)
- Version / remarks:
- 07/11/2014
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vitro test system
- Test system:
- human skin model
- Remarks:
- three-dimensional human skin model EpiDerm
- Source species:
- human
- Cell type:
- other: normal (non-cancerous), human-derived epidermal keratinocytes (NHEK)
- Source strain:
- not specified
- Amount/concentration applied:
- 50 µl
- Duration of treatment / exposure:
- 3 nad 60 min
- Number of replicates:
- 2 replicacates for each treatment period
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min experiment
- Value:
- ca. 97
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- ca. 14.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Remarks:
- and Category 1C
- Conclusions:
- In this study under teh given conditions VSV16 showed corrosive effects. The mean tissue viability (%negative control) was reduced below 15% after 60 min treatment but not below 50% after 3 min treatment. VSV16 is therefore classified as "corrosive" in accordance with a combination of optional UN GHS sub-categories 1B and 1C.
- Executive summary:
VSV16 is classified as "corrosive" in accordance with a combination of optional UN GHS sub-categories 1B and 1C.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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