INFORMATION REQUIRED FOR THE TECHNICAL DOSSIER FOR A FULL NOTIFICATION UNDER REGULATION 4(1)
[For substances to which the Reduced Test package for Intermediates has been applied see the 2002 Amendment to the regulations.]
Tests under this Part shall be according to methods recognised and recommended by the competent international bodies where such recommendations exist.
If it is not technically possible or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated and be subject to acceptance by the competent authority.
The name of the body or bodies responsible for carrying out the studies shall be mentioned.
| 0. | IDENTITY OF MANUFACTURER AND THE IDENTITY OF THE NOTIFIER: LOCATION
OF THE PRODUCTION SITE For substances manufactured outside the Communities and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, the identities and addresses of the importers who will be bringing the substance into the Communities. |
| 1. | IDENTITY OF THE SUBSTANCE top |
| 1.1 | Name |
| 1.1.1 | Names in the IUPAC nomenclature |
| 1.1.2 | Other names (usual name, trade name, abbreviation) |
| 1.1.3 | CAS number and CAS name (if available) |
| 1.2 | Molecular and structural formula |
| 1.3 | Composition of the substance |
| 1.3.1 | Degree of purity (%) |
| 1.3.2 | Nature of impurities, including isomers and by-products |
| 1.3.3 | Percentage of (significant) main impurities |
| 1.3.4 | If the substance contains a stabilizing agent or an inhibitor or other additives, specify: nature, order of magnitude: ...ppm; ...% |
| 1.3.5 | Spectral data (UV, IR, NMR or mass spectrum) |
| 1.3.6 | Chromatographic data (HPLC, GC) |
| 1.4 | Methods of detection and determination A full description of the methods used or the appropriate bibliographical references. Apart from methods of detection and determination, information shall be given on analytical methods which are known to the notifier and allow detection of a substance and its transformation products after discharge into the environment as well as determination of the direct exposure of humans. |
| 2. | INFORMATION ON THE SUBSTANCE |
| 2.0 | Production Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure, associated with the production process. Precise details of the production process, particularly those of a commercially sensitive nature, are not required. |
| 2.0.1 | Technological process used in production |
| 2.0.2 | Exposure estimate related to production: - working environment, - environment |
| 2.1 | Proposed uses Information given in this section should be sufficient to allow an approximate but realistic estimation of human and environmental exposure to the substances as associated with the proposed/expected uses. |
| 2.1.1 | Types of use: description of the function and the desired effects |
| 2.1.1.1 | Technological process(es) related to the use of the substance (where known) |
| 2.1.1.2 | Exposure estimate(s) related to the use (where known): - working environment, - environment |
| 2.1.1.3 | Form under which the substance is marketed: substance, preparation, product |
| 2.1.1.4 | Concentration of the substance in marketed preparations and products (where known) |
| 2.1.2 | Fields of application with approximate breakdown: - industries, - farmers and skilled trades, - use by the public at large |
| 2.1.3 | Where known and where appropriate, the identity of the recipients of the substance |
| 2.1.4 | Waste quantities and composition of waste resulting from the proposed uses (where known) |
| 2.2 | Estimated production and/or imports for each of the anticipated uses or fields of application |
| 2.2.1 | Overall production and/or imports in tonnes per year: - the first calendar year, - the following calendar years For substances manufactured outside the Communities and for which, for the purpose of notification, the notifier has been designated as the manufacturer's sole representative, this information must be given for each of the importers identified under section 0 above. |
| 2.2.2 | Production and/or imports, broken down in accordance with 2.1.1 and
2.1.2 expressed as a percentage: - the first calendar year, - the following calendar years |
| 2.3 | Recommended methods and precautions concerning: |
| 2.3.1 | - Handling |
| 2.3.2 | - Storage |
| 2.3.3 | - Transport |
| 2.3.4 | Fire (nature of combustion gases or pyrolysis, where proposed uses justify this) |
| 2.3.5 | Other dangers, particularly chemical reaction with water |
| 2.3.6 | If relevant, information concerning the susceptibility of the substance to explode when presented in the form of a dust. |
| 2.4 | Emergency measures in the case of accidental spillage |
| 2.5 | Emergency measures in the case of injury to persons (e.g. poisoning) |
| 2.6 | Packaging |
| 3. | PHYSICO-CHEMICAL PROPERTIES OF THE SUBSTANCE |
| 3.0 | State of the substance at 20oC and 101.3 kPa |
| 3.1 | Melting point |
| 3.2 | Boiling point |
| 3.3 | Relative density |
| 3.4 | Vapour pressure |
| 3.5 | Surface tension |
| 3.6 | Water solubility |
| 3.8 | Partition coefficient n-octanol/water |
| 3.9 | Flash point |
| 3.10 | Flammability |
| 3.11 | Explosive properties |
| 3.12 | Self ignition temperature |
| 3.13 | Oxidising properties |
| 3.15 | Granulometry: For those substances which may be marketed in a form which gives rise to the danger of exposure by the inhalatory route, a test should be conducted to determine the particle size distribution of the substance as it will be marketed. |
| 4. | TOXICOLOGICAL STUDIES top |
| 4.1 | Acute toxicity For tests 4.1.1 to 4.1.3, substances other than gases shall be administered via at least two routes, one of which should be the oral route. The choice of the second route will depend on the nature of the substance and the likely route of human exposure. Gases and volatile liquids should be administered by the inhalative route. |
| 4.1.1 | Administered orally |
| 4.1.2 | Administered by inhalation |
| 4.1.3 | Administered cutaneously |
| 4.1.5 | Skin irritation |
| 4.1.6 | Eye irritation |
| 4.1.7 | Skin sensitisation |
| 4.2 | Repeated dose The route of administration should be the most appropriate having regard to the likely route of human exposure, the acute toxicity and the nature of the substance. In the absence of contra-indications the oral route is usually the preferred one. |
| 4.2.1 | Repeated dose toxicity (28 days) |
| 4.3 | Other effects |
| 4.3.1 | Mutagenicity The substance shall be examined in two tests. One shall be a bacteriological (reverse mutation) test, with and without metabolic activation. The second shall be a non-bacteriological test to detect chromosome aberrations or damage. In the absence of contra-indications, this test should normally be conducted in vitro, both with and without metabolic activation. In the event of a positive result in either test, further testing according to the strategy described in Annex V to the Directive should be carried out. |
| 4.3.2 | Screening for toxicity related to reproduction. |
| 4.3.3 | Assessment of the toxicokinetic behaviour of a substance to the extent that can be derived from base set data and other relevant information. |
| 5. | ECOTOXICOLOGICAL STUDIES |
| 5.1 | Effects on organisms |
| 5.1.1 | Acute toxicity for fish |
| 5.1.2 | Acute toxicity for daphnia |
| 5.1.3 | Growth inhibition test on algae |
| 5.1.6 | Bacteriological Inhibition In those cases where biodegradation may be affected by the inhibitory effect of a substance on the bacteria, a test of bacterial inhibition should be carried out prior to undertaking the biodegradation. |
| 5.2 | Degradation - biotic, - abiotic: If the substance is not readily biodegradable then consideration should be given to the need to carry out the following tests: hydrolysis as a function of pH. |
| 5.2 | Absorption/desorption screening test |
| 6. | POSSIBILITY OF RENDERING THE SUBSTANCE HARMLESS top |
| 6.1 | For industry/skilled trades |
| 6.1.1 | Possibility of recycling |
| 6.1.2 | Possibility of neutralization of unfavourable effects |
| 6.1.3 | Possibility of destruction: - controlled discharge, - incineration, - water purification station, - others |
| 6.2 | For the public at large |
| 6.2.1 | Possibility of recycling |
| 6.2.2 | Possibility of neutralisation of unfavourable effects |
| 6.2.3 | Possibility of destruction: - controlled discharge, - incineration, - water purification station, - others. |
Reproduced from "Statutory Instruments, 1993 No. 3050" with the permission of the Controller of Her Majesty's Stationery Office