The Biocidal Common Basic Dataset

For the biocidal product and biocidal active substance basic dataset you need in the term of the biocidal license, you can contact our subject matter experts. Please contact us for detailed information on the requirements and procedure for the term of the biocidal license.

COMMON BASIC DATASET FOR ACTIVE SUBSTANCES ANNEX-IIA
Document files relating to chemically active substances should contain the topics specified in the regulation. Answers should support the information given. It is not necessary to provide information that is not related to the use of the biocidal product.

Annex 2, a basic dataset for active substances, contains various information and details about the active substance. Scientific data must prove the information and details given.

We can summarize some of these details as follows:
Relative density of the biocidal active substance, Melting point, boiling point,
Vapor pressure of the biocidal active substance
The absorption spectrum is the mass spectrum, with relevant molar breakdowns at appropriate wavelengths
Solubility in water, including the effect of the pH of the biocidal active substance and, where relevant, the solubility temperature
Flammability of the biocidal active substance, including automatic ignition of combustion products and the identity of the biocidal active substance
The surface tension of the biocidal active substance
Explosive properties of the biocidal active substance
Oxidizing properties of the biocidal active substance
The reaction of the biocidal active substance to the carrier (container) packaging
Toxicological and metabolic investigations of the biocidal active substance
Efficacy of the biocidal active substance against target organisms and intended uses
The appearance of the biocidal active substance (physical condition, color)
Flashpoint of the biocidal active substance
Thermal stability of the biocidal active substance, the identity of relevant degradation products
Effect of pH and temperature of the biocidal active substance, n partition octanol-water coefficient
Short-term repeated dose toxicity of the biocidal active substance
Reproductive toxicity of biocidal active substance

Creating a basic dataset for biocidal active substance; basic dataset for the biocidal license, biocidal active substance basic dataset

COMMON BASIC DATASET FOR BIOCIDAL PRODUCTS ANNEX-II B
We can summarize some of the requirements for the common basic dataset for biocidal products as follows; the important thing is always to take the necessary precautions to minimize testing on animals.

Physical state and nature of the biocidal product
Oxidizing properties of the biocidal product
Analytical method for determining the concentration of the biocidal active substance(s) in the biocidal product
Nature of the biocidal product and intended use
Biocide type and intended use
Technical characteristics of the biocidal product such as pourability and dustability
Intended use and benefit of the biocidal product
Measures for the protection of humans, animals, and the environment
Classification, packaging, and labeling of the biocidal product
Toxicological studies of the biocidal product
Effects of the biocidal product on target organisms
The application rate of the biocidal product and, where appropriate, the final concentration of the biocidal product and the active substance in the system in which the preparation is used
User: industrial, professional, general public (non-professional)
Analytical method for determining the concentration of the active substance(s) in the biocidal product

Biocidal products common basic dataset II  B, basic datasets application, biocidal data dataset, biocidal data entry, biocidal license regulation, biocidal licensing regulation annexes.

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