IIP 1.11 (pheromones and other semiochemicals – active ingredient)

 

Circumstances in which the data are required

The information is always required.

 

Test substance

Information to be provided for: technical grade active ingredient (TGAI)

 

Typical information to be provided by the applicant

IIA 1.11.1 / IIP 1.11.1:  Analytical profile of batches.

Representative samples of the active ingredient should be analysed for content of pure active ingredient, inactive isomers, impurities and additives, as appropriate. The analytical results reported should include quantitative data, in terms of g/kg content, for all components present in quantities of more than 1 g/kg and typically should account for at least 98 % of the material analysed. The actual content of components which are particularly undesirable because of their toxicological, ecotoxicological or environmental properties, should be determined and reported. Data reported should include the results of the analysis of individual samples and a summary of that data, to show the minimum or maximum and typical content of each relevant component, as appropriate.

Generally, profiles for 5 production batches should be provided.

Where an active ingredient is produced in different plants this information must be provided for each of the plants separately.

IIA 1.11.2 / IIP 1.11.2:  Results of analyses of batches produced in laboratory or pilot scale production systems and used in toxicological testing

 

Guidelines