LiphaTech S.A.S. Difethialone March Some additional information is available under Section A 2.10.
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1 Section A 8 Annex Point IIA VIII.8.1 to VIII.8.6 and IIIA VIII.1 Measures necessary to protect man, animals and the environment Subsection (Annex Point) Official use only 8.1 Recommended methods and precautions concerning handling, use, storage, transport or fire Handling and storage: Some additional information is available under Section A Exposure controls/personal protection: Wear coveralls or long-sleeved protective clothing, gloves, apron and shoes. Wear goggles or face shield and anti dust mask. If possible handle the material under aspiration. General handling precautions: When using do not eat, drink or smoke. Keep only in the original container. Wash hands before eating, drinking, chewing gum, smoking or using the toilet. Wash contaminated clothing before reuse. There are no known materials which are incompatible with the product nor evidence of reactions with containers. Generation of dusts must be avoided. Storage: Store in tightly closed containers in a cool and dark place. Keep locked up and out of reach of children. Keep away from food, drink and animal feedingstuffs. x Transport: Refer to material safety data sheet in Document I.2. x Fire: Difethialone is not classified as highly flammable, oxidising or explosive. There are therefore no special fire or explosion hazards. Suitable extinguishing media: water or foam. 8.2 In case of fire, nature of reaction products, combustion gases, etc. 8.3 Emergency measures in case of an accident Difethialone is not highly flammable but decomposes on heating and may therefore combust under incinerating conditions. The molecule contains mostly carbon, hydrogen and oxygen and so the major combustion products are likely to be water and oxides of carbon. The molecule also incorporates one atom each of sulphur and bromine and so minor combustion or pyrolysis products may include acidic oxides of sulphur and hydrogen bromide/ hydrobromic acid. Advice on emergency treatment in cases of anti-coagulant rodenticide poisoning is presented as an Annex to this document. The active ingredient is manufactured and shipped in unit quantities no greater than 10 kg and securely packaged in sealed hard plastic containers, compliant with ADR regulations, to prevent accidental release.
2 Section A 8 Annex Point IIA VIII.8.1 to VIII.8.6 and IIIA VIII Possibility of destruction or decontamination following release in or on the following: (a) air (b) water, including drinking water (c) soil 8.5 Procedures for waste management of the active substance for industry or professional users Possibility of re-use or recycling Possibility of neutralisation of effects Conditions for controlled discharge including leachate qualities on disposal Conditions for controlled incineration 8.6 Observations on undesirable or unintended sideeffects, e.g. on beneficial and other non-target organisms Measures necessary to protect man, animals and the environment There are no special procedures for destruction or decontamination following release into the environment. It is recommended that spilled material be swept up ensuring the operator is wearing appropriate personal protective equipment. Contamination of air is unlikely because the active substance is not volatile. In the case of contamination of water, prevent entry into drains and waterways. If polluted water reaches drainage systems or water courses, immediately inform the appropriate authorities. Contaminated soil should be collected and incinerated. The active substance is only handled and used within the manufacturing facilities and is not supplied to users in an unformulated state. The active substance is not manufactured in bulk quantities and opportunities for re-use or recycling are minimal. No specific neutralisation procedures are known. Unused active substance should be disposed of by incineration. The active substance is not disposed of using controlled discharges or landfill. Unused active substance should be disposed of by incineration. The active substance may be destroyed by controlled incineration in accordance with local or national legislation. The oxygen content is 6% and the halogen content is 15%, both being at levels not expected to form furans or polyhalogenated dioxins. The active substance does not incorporate chlorine and so polychlorinated dioxins cannot be formed. Discussion about the possibility and prevention of affects on nontarget organisms is presented in the Documents II-C. Apart from the target effect, mortality, no other adverse effects on organisms or non-living items are expected. The active substance is not volatile and will not therefore migrate into the upper atmosphere and contribute to ozone depletion. Its photochemical oxidative degradation half-life is less than one day.
3 Section A 8 Annex Point IIA VIII.8.1 to VIII.8.6 and IIIA VIII Identification of any substances falling within the scope of List I or List II of the Annex to Directive 80/68/EEC on the protection of ground water against pollution caused by certain dangerous substances Measures necessary to protect man, animals and the environment The active substance is an organic compound which contains a covalently bonded halogen atom, consequently the active substance is considered for List 1 of the Annex to Directive 80/68/EEC. Evaluation by Competent Authorities EVALUATION BY RAPPORTEUR MEMBER STATE Date 19 August 2005, revised 28 December 2006 Materials and Methods Results and discussion Conclusion Reliability Acceptability Agree with applicant s version Comment (8.1), Storage and transport: Packing, storage and transport of difethialone is done in plastic bags, placed in cartoon drums, which are UNaccredited in accordance with transport legislation. This drum is made out of Natron-kraftliner coated with PE in six layer. And one inside layer made of aluminium-pe. The top and bottom of the drum are made out of galvanized steel sheet and the closure is a galvanized adaptor ring with rubber sealing. However, difethialone can be packed, stored and transported in many different packaging materials, namely multi layer of paper, cartoon, plastics (e.g. polypropylene, polyethylene, polyethyleneterephthalat). The list of materials can not be considered as exhaustive as difethialone has no known physical-chemical properties which would support the assumption that any reactivity with container material would take place. Agree with applicant s version Agree with applicant s version Acceptable
4 Section A 8 Annex Point IIA VIII.8.1 to VIII.8.6 and IIIA VIII.1 Remarks Measures necessary to protect man, animals and the environment Confer section A 2.10 and SDS on further relevant information on measures, personal protective equipment etc. Comment (Annex : Advice to Physicians the treatment of anticoagulant rodenticide poisoning ) The heading should include the wording long acting or second generation anticoagulants. Mode of action: Because of the long body retention of these substances, administration of Vitamin K1 can be needed for months (not only weeks as stated in this section). Signs of poisoning: Workplace exposure to anticoagulants during manufacturing of active substance, premix or products should have been mentioned as well as possible exposure during handling (application, disposal) of the end use products. Symptoms will not occur immediately. Treatment: Gastric lavage/induced vomiting are indicated in poisonings if the ingestion is recent and the amount could give serious or lethal poisoning. Repeated administration of activated charcoal is useful because of the enterohepatic circulation of these substances (cf. III A ) Prothrombin time should be measured daily and up to 72 hours after exposure to the anticoagulant. If the coagulation status is still normal after 72 hours after the exposure, no further monitoring is needed (Newsletter 2.99 (rev. 2005) the National Poisons Information Centre, Norway Detailed Advice on Management: The Poisons Information Centre in Norway has the following general recommendation on antidotal treatment in severe intoxications (haemorrhages) to long acting anticoagulants: Initially a slow i.v. administration of : mg vitamin K1 2-4 times a day (adults) 5-10 mg vitamin K1 2-4 times a day (children) Close monitoring of the coagulation status is needed. The dosage is adjusted according to the coagulation status. In cases with active bleeding, it is necessary to use fresh frozen plasma to rapidly restore blood clotting factors. Factor concentrate may be needed to avoid volume overload (children). Administration of the antidote may be needed for months Oral administration of vitamin K1 may be sufficient in minor poisonings mg vitamin K1 administered 2 times a day in adults 5-10 mg vitamin K1 administered 2 times a day in children Dosing is adjusted according to coagulation status. (Newsletter 2.99 (rev. 2005) the National Poisons Information Centre, Norway) In the annex, the dose of vitamin K1 for less severe poisoning cases is erroneously given in ml (10-12 ml). The equivalent dose for children given is 0.25mg/kg.
5 ANNEX Advice to Physicians the treatment of anticoagulant rodenicide poisoning
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