Registration Dossier
Registration Dossier
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EC number: 700-402-2 | CAS number: 860035-10-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- 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
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 50/50% w/w
- No. of animals per dose:
- 4
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- ca. 19.01
- Test group / Remarks:
- 10% w/w
- Parameter:
- SI
- Value:
- ca. 25.72
- Test group / Remarks:
- 25% w/w
- Parameter:
- SI
- Value:
- ca. 23.32
- Test group / Remarks:
- 50% w/w
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Test 2: Vehicle; 5303.06 dpm 10% w/w: 100805.40dpm 25% w/w 136381.00dpm 50% w/w 123647.30
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- GSK1873183A produced a SI>3 at doses of 10, 25 and 50% w/w and is considered to be a skin senitiser under the conditions of the test.
- Executive summary:
A study was performed to assess the skin sentitising potential of GSK1873183A in CBA.Ca strain mice following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of OECD No 429 and Method B42 of Commission directive 2004/73/EC. Doses of 50mcl (25mcl per ear) of the test material in dimethylformamide were applied at concentrations of 10%, 25% and 50% w/w. The Stimulation Index expressed as radioactive incorporation was 19.01, 25.72 and 23.32 at the concentrations 10, 25 and 50% and the test material was considered to be a sensitiser under the conditions of the test.
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