Council Regulation (EEC) No 2377/90 of 26 June 1990 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (repealed) (c. 2377)

[F1 ANNEX V U.K. Information and particulars to be included in an application for the establishment of a maximum residue limit for a pharmacologically active substance used in veterinary medicinal products

Textual Amendments

F1 Substituted by Commission Regulation (EEC) No 762/92 of 27 March 1992 modifying Annex V to Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin.

Administrative particulars U.K.

A. Safety documentation U.K.

A.0. Expert report U.K.

A.1. Precise identification of the substance concerned by the application U.K.

1.1 International non-proprietary name (INN). U.K.

1.2 International Union of Pure and Applied Chemistry (IUPAC) name. U.K.

1.3 Chemical Abstract Service (CAS) name. U.K.

1.4 Classification: U.K.

• therapeutic;

• pharmacological.

1.5 Synonyms and abbreviations. U.K.

1.6 Structural formula. U.K.

1.7 Molecular formula. U.K.

1.8 Molecular weight. U.K.

1.9 Degree of impurity. U.K.

1.10 Qualitative and quantitative composition of impurities. U.K.

1.11 Description of physical properties: U.K.

• melting point;

• boiling point;

• vapour pressure;

• solubility in water and organic solvents, expressed in grams per litre, with indication of temperature;

• density;

• refractive index, rotation, etc.

A.2. Relevant pharmacological studies U.K.

2.1 Pharmacodynamics. U.K.

2.2 Pharmacokinetics. U.K.

A.3. Toxicological studies U.K.

3.1 Single dose toxicity. U.K.

3.2 Repeated dose toxicity. U.K.

3.3 Tolerance in the target species of animal. U.K.

3.4 Reproductive toxicity, including teratogenicity. U.K.

3.4.1 Study of the effects on reproduction. U.K.

3.4.2 Embryotoxicity/fetotoxicity, including teratogenicity. U.K.

3.5 Mutagenicity. U.K.

3.6 Carcinogenicity. U.K.

A.4. Studies of other effects U.K.

4.1 Immunotoxicity. U.K.

4.2 Microbiological properties of residues. U.K.

4.2.1 On the human gut flora; U.K.

4.2.2 On the organisms and microorganisms used for industrial food-processing. U.K.

4.3 Observations in humans.] U.K.