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Toxicological information

Skin irritation / corrosion

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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:
2016
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.