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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March - May 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The purpose of this study was to determine the skin irritation potential of the test item using the SkinEthic Reconstructed Human Epidermal model (RHE, SkinEthic Laboratories, Nice, France) following treatment periods of 4 and 24 hours. The test is based on the hypothesis that irritant chemicals are able to penetrate the stratum corneum of the SkinEthic RHE model and are sufficiently cytotoxic to cause cell death in the underlying cell layers.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-dimethylpropanethioamide
EC Number:
677-829-5
Cas Number:
630-22-8
Molecular formula:
C5H11NS
IUPAC Name:
2,2-dimethylpropanethioamide
Test material form:
solid: crystalline
Details on test material:
Purity or Composition 100.0 %

In vitro test system

Test system:
human skin model
Source species:
human
Cell source:
other: The model consists of an airlifted, living, multi-layered epidermal tissue construct, produced in polycarbonate inserts in serum-free and chemically defined medium, featuring normal ultra-structure and functionally equivalent to human epidermis in vivo.
Details on animal used as source of test system:
The model consists of an airlifted, living, multi-layered epidermal tissue construct, produced in polycarbonate inserts in serum-free and chemically defined medium, featuring normal ultra-structure and functionally equivalent to human epidermis in vivo.
Justification for test system used:
The model consists of an airlifted, living, multi-layered epidermal tissue construct, produced in polycarbonate inserts in serum-free and chemically defined medium, featuring normal ultra-structure and functionally equivalent to human epidermis in vivo.
Vehicle:
unchanged (no vehicle)
Details on test system:
SkinEthic Reconstructed Human Epidermal model
Control samples:
yes, concurrent no treatment
yes, concurrent positive control
Amount/concentration applied:
25 mg of test item and exposed for 4 hours and 24 hours
Duration of treatment / exposure:
25 mg of test item and exposed for 4 hours and 24 hours
Number of replicates:
Triplicate tissues were treated
Duplicate tissues were left untreated to serve as negative controls
Duplicate tissues treated with 50 μL of Triton X-100 (0.1% w/v) served as positive controls

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
4 h
Value:
7.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Remarks on result:
positive indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
24h
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The relative mean viability of the test item treated tissues was 7.5% after the 4-Hour exposure period and 0.0% after the 24-Hour exposure period.
It was considered unnecessary to proceed with tissue histology or analysis of inflammatory mediator levels.
The test item was considered to be an Irritant.
GHS: Category 2.
No corrosion potential was identified in the corrosivity screening test.