Kit Components
Eclectica Diluent 4 Kit
Safety Data Sheet
according to 1907/2006/EC, Article 31
1 Identification of the substance/preparation and of the company/undertaking
· Product details
· Trade name: ECL Diluent 4
· Article number: 1706628
· Application of the substance / the preparation For in vitro diagnostic use only.

· Manufacturer/Supplier:
Adaltis S.r.l.
Via Durini, 2720122 Milano - ItalyTel. +39 0774 5791 Fax. +39 0774
· Further information obtainable from:
Adaltis S.r.l.
[email protected]
· Information in case of emergency:
Policlinico A. Gemelli - Largo Agostino Gemelli, 8 - Roma - Italy - Tel. + 39 063054343 2 Hazards identification
· Information concerning particular hazards for human and environment:
The product does not have to be labelled due to the calculation procedure of the "General Classificationguideline for preparations of the EU" in the latest valid version. · Classification system:
The classification is according to the latest editions of the EU-lists, and extended by company and literaturedata. · GHS label elements
Safety data sheet available on request. · Additional information:
Potential Biohazard.
These reagents contain material of human and animal origin. They have been tested and found non reactivefor the main infectious agents. Because no test can offer complete assurance that infectious agents are absent,these reagents should be considered as potentially biohazardous and handled with the same precautions asapplied to any unknown serum or plasma samples and according to good laboratory practices.
Hazards related to sodium azide.
Sodium azide may react with lead and copper plumbing to form explosive metal azides.Do not throw intosewer system. If treated with acids at pH<4, sodium azide can produce toxic fumes (NH3). Sodium azide canreact with metal cations forming explosive products.
Hazards related to cialit.
All organic compounds containing mercury are veri toxic and can cause diturbances to nervous system andirritation of the kidney.
3 Composition/information on ingredients
· Chemical characterization
· Description:

The reagent contains saline buffer with glycerol, animal protein, tetracycline and sodium azide aspreservatives. · Dangerous components:
Safety Data Sheet
according to 1907/2006/EC, Article 31
Trade name: ECL Diluent 4
· Additional information: For the wording of the listed risk phrases refer to section 16.
4 First aid measures
· General information: No special measures required.
· After inhalation: Supply fresh air; consult doctor in case of complaints.
· After skin contact: Generally the product does not irritate the skin.
· After eye contact: Rinse opened eye for several minutes under running water.
· After swallowing: If symptoms persist consult doctor.
· Information for doctor: The reagents contain materials of animal origin.

5 Fire-fighting measures
· Suitable extinguishing agents: Use fire extinguishing methods suitable to surrounding conditions.
· Protective equipment: No special measures required.

6 Accidental release measures
· Person-related safety precautions: Not required.
· Measures for environmental protection: Do not allow to enter sewers/ surface or ground water.
· Measures for cleaning/collecting:

Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). · Additional information: No dangerous substances are released.
7 Handling and storage
· Handling:
· Information for safe handling: No special measures required.
· Information about fire - and explosion protection: No special measures required.

· Storage:
· Requirements to be met by storerooms and receptacles: No special requirements.
· Information about storage in one common storage facility: Not required.
· Further information about storage conditions: None.

8 Exposure controls/personal protection
· Additional information about design of technical facilities: No further data; see item 7.
· Ingredients with limit values that require monitoring at the workplace:
56-81-5 glycerol
· Additional information: The lists valid during the making were used as basis.
· Personal protective equipment:
· General protective and hygienic measures:

The usual precautionary measures are to be adhered to when handling chemicals. · Respiratory protection: Not required.
· Protection of hands:

Safety Data Sheet
according to 1907/2006/EC, Article 31
Trade name: ECL Diluent 4
· Material of gloves
The selection of the suitable gloves does not only depend on the material, but also on further marks of qualityand varies from manufacturer to manufacturer. As the product is a preparation of several substances, theresistance of the glove material can not be calculated in advance and has therefore to be checked prior to theapplication. · Penetration time of glove material
The exact break trough time has to be found out by the manufacturer of the protective gloves and has to beobserved. · Eye protection: Goggles recommended during refilling
9 Physical and chemical properties
· General Information
According to product specification Odour:
· Change in condition
Melting point/Melting range: Undetermined.
Boiling point/Boiling range: 290°C

· Flash point:
· Ignition temperature:
· Self-igniting:
· Danger of explosion:
Product does not present an explosion hazard. · Explosion limits:
· Vapour pressure at 20°C:
· Density:
· Solubility in / Miscibility with
· Solvent content:
Organic solvents:
Solids content:
10 Stability and reactivity
· Thermal decomposition / conditions to be avoided:
The sodium azide as row material is instable when heating, it decompones at 300°C,producing toxic NOxfumes with rexplision risk. Be careful if the preparation precipitates or become dry. · Materials to be avoided: see point 3
· Dangerous decomposition products: see point 3

11 Toxicological information
· Acute toxicity:
· LD/LC50 values relevant for classification:
26628-22-8 sodium azide
Safety Data Sheet
according to 1907/2006/EC, Article 31
Trade name: ECL Diluent 4
· Primary irritant effect:
· on the skin: No irritant effect.
· on the eye: No irritating effect.
· Sensitization: No sensitizing effects known.
· Additional toxicological information:

The product is not subject to classification according to the calculation method of the General EUClassification Guidelines for Preparations as issued in the latest version.
When used and handled according to specifications, the product does not have any harmful effects to ourexperience and the information provided to us.
12 Ecological information
· Additional ecological information:
· General notes:

Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for waterDo not allow undiluted product or large quantities of it to reach ground water, water course or sewagesystem. 13 Disposal considerations
· Product:
· Recommendation

Must not be disposed together with household garbage. Do not allow product to reach sewage system. · Uncleaned packaging:
· Recommendation: Disposal must be made according to official regulations.

14 Transport information
· Maritime transport IMDG:
· Marine pollutant: No
· UN "Model Regulation": -

15 Regulatory information
· Labelling according to EU guidelines:
Observe the general safety regulations when handling chemicals.
The product is not subject to identification regulations under EU Directives and the Ordinance on HazardousMaterials (German GefStoffV).
· Special labelling of certain preparations:
Safety data sheet available for professional user on request. 16 Other information
This information is based on our present knowledge. However, this shall not constitute a guarantee for anyspecific product features and shall not establish a legally valid contractual relationship.
na= not applicable
· Relevant R-phrases
Contact with acids liberates very toxic gas. 50/53 Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. · Department issuing MSDS: Regulatory Affair Office
Safety Data Sheet
according to 1907/2006/EC, Article 31
Trade name: ECL Diluent 4
· Contact: Adaltis Srl
· Abbreviations and acronyms:

IMDG: International Maritime Code for Dangerous GoodsGHS: Globally Harmonized System of Classification and Labelling of ChemicalsLC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percent



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