Registration Dossier
Registration Dossier
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EC number: 696-003-5 | CAS number: 924726-92-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
LOCAL LYMPH NODE ASSAY IN THE MOUSE
Introduction. A study was performed to assess the skin sensitisation potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The methodology for the LLNA is detailed in the OECD Guideline for the Testing of Chemicals, No. 429, and Method B.42 of Commission Regulation (EC) No. 440/2008. The study described in this document is based on these test methods but has been refined in order to reduce the number of animals required. The reduced LLNA (rLLNA) has been endorsed by the non-Commission members of the European Centre for the Validation of Alternative Methods (ECVAM) Scientific Advisory Committee (ESAC) at its 26th meeting held on 26 - 27 April 2007 at ECVAM, Ispra, Italy.
Methods. Following a preliminary screening test in which no clinical signs of toxicity were noted at a maximum attainable concentration of 10% w/w, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. A group of five animals was treated with 50 µL (25 µL per ear) of the test item as a solution in dimethyl formamide at a concentration of 10% w/w. A further group of five animals was treated with dimethyl formamide alone.
Results. The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is as follows:
Concentration (% w/w) in dimethyl formamide
Stimulation Index
Result
10
0.89
Negative
Conclusion. The test item was considered to be a non-sensitiser under the conditions of the test. The test item did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
Migrated from Short description of key information:
GSK2609973A is considered to be non-sensitising to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test item was considered to be a non-sensitiser under the conditions of the test. The test item did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
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