sccs_opinions
The SCCP is of the opinion that the study included in the present submission is not sufficient to answer the concerns about mucous membrane irritation. Before any further consideration, the following information is required: a study on mucous membrane irritation at the intended use concentration of 5%, in accordance with the SCCP Notes of Guidance.
Key concerns: Mucous membrane (eye) irritation concern unresolved; choline chloride was tested at only 0.5% instead of the requested use concentration of 5%; BCOP assay is a screening method not suitable for risk characterisation; additional mucous membrane irritation study at 5% required.
Opinion date: 2008-04-15