(6a,8xi,11b,14xi,16a)-6,9-difluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4- dien-21-yl benzoate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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:
A study were carried out on a read-across test material with a conclusion of non-sensitising to skin.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

A study were carried out on a the read-across substance GSK2609973A.

Not expected to produce sensitisation following contact with skin.

·     GSK2609973A is structurally similar to GSK2619294A, but which possesses an epoxide moiety produced a negative result in the mouse local lymph node. Stimulation index of 2.33 when tested at a concentration of 25% w/v in DMF compared to vehicle control.

·     No alerts for sensitisation were obtained using DEREK, Lhasa, UK.

Although commonly prescribed for inflammatory conditions, some active steroids have produced contact hypersensitivity. However, this appears less common with fluorinated glucocorticoids.