INFORMATION REQUIRED FOR THE TECHNICAL DOSSIER FOR A NOTIFICATION
UNDER REGULATION 6(1)
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.
In addition to the information requested below, member States may, if they
consider it necessary for the risk assessment, require that the notifier provides
the following additional information:
| 0. |
IDENTITY OF MANUFACTURER AND THE NOTIFIER IF THESE ARE NOT THE SAME:
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 |
| 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(es) 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 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 |
| 2.2 |
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 |
| 2.4 |
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 |
| 3.6 |
Water solubility |
| 3.8 |
Partition coefficient n-octanol/water |
| 3.9 |
Flash point |
| 3.10 |
Flammability |
| 4. |
TOXICOLOGICAL STUDIES |
| 4.1 |
Acute toxicity
For tests 4.1.1 to 4.1.2 one route of administration is sufficient. Substances
other than gases should be treated by oral administration. Gases should
be tested by inhalation. |
| 4.1.1 |
Administered orally |
| 4.1.2 |
Administered by inhalation |
| 4.1.5 |
Skin irritation |
| 4.1.6 |
Eye irritation |
| 4.1.7 |
Skin sensitization |
| 4.3 |
Other effects |
| 4.3.1 |
Mutagenicity
The substance should be examined in a bacteriological (reverse mutation)
test with and without metabolic activation. |
| 5. |
ECOTOXICOLOGICAL STUDIES |
| 5.2 |
Degradation: biotic. |
Reproduced from "Statutory Instruments, 1993 No. 3050"
with the permission of the Controller of Her Majesty's Stationery Office
