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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: 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: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The purpose of the study wasto determine the skin irritation potential of the test material using the SkinEthic Reconstituted Human Epidermal model (SkinEthic Labs, Nice, France) following treatment periods of 4 and 24hrs. The study consists of a test for direct redution of MTT by the test material followed by determination of skin irritation/corrosion potential. For th determination of skin irritation potential, triplicate SkinEthic tissues were treated with approx. 25mg of the test material and exposued for 4 and 24hrs. . At the end of the treatment period tissues were tested for viability using MTT conversion relative to controls.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-({[(2,5-dioxopyrrolidin-1-yl)oxy]carbonyl}oxy)ethyl 2-methylpropanoate
EC Number:
700-402-2
Cas Number:
860035-10-5
Molecular formula:
C11H15NO7
IUPAC Name:
1-({[(2,5-dioxopyrrolidin-1-yl)oxy]carbonyl}oxy)ethyl 2-methylpropanoate

Test animals

Species:
human

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
4 and 24hrs

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
at 4 hours
Value:
ca. 2.7
Remarks on result:
positive indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
at 24 hours
Value:
ca. 2
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
The relative viability of test material treated tissues was 2.7% after 4hrs exposure and 2.0% after 24hrs exposure.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
GSK1873183A was considered to be a skin irritant
Executive summary:

The purpose of the study was to determine the skin irritation potential of the test material using the SkinEthic Reconstituted Human Epidermal model (SkinEthic Labs, Nice, France) following treatment periods of 4 and 24hrs. The study consists of a test for direct redution of MTT by the test material followed by determination of skin irritation/corrosion potential. For th determination of skin irritation potential, triplicate SkinEthic tissues were treated with approx. 25mg of the test material and exposued for 4 and 24hrs. . At the end of the treatment period tissues were tested for viability using MTT conversion relative to controls. The relative mean viability of the test material treated tissues was 2.7% afetr 4hrs exposure and 2.0% after 24hrs exposure. It was considered unneccesary to proceed with tissue histology and the test material was considered to be a skin irritant (R38)