Polyclonal antibody and conjugates

SECTION 2: Hazards identification

The following safety data sheet identifies the hazards related to the polyclonal antibody product and any additional substances in the product that are listed on the Product data sheet. The hazard classification information above in section 2 relates to the chemical in its concentrated form. The ingredients are used in a diluted form in these monoclonal antibody products and therefore the risk of harm being caused by certain ingredients during handling of this product may be reduced compared with the undiluted ingredient. However, the hazards are still present and users should handle the product with care accordingly. This assessment should be used as a guide only and does not represent an all-inclusive study of the product. This product contains material of animal origin (as specified on product data sheet) which is a biological material that could potentially contain a biological agent (e.g. virus). It should therefore be handled as a potential biohazard. As with all biological material, reduce direct handling to a minimum and wear appropriate protective clothing. A chemical hazard may be associated with this product in accordance with the constituents stated in the individual product data sheet. Refer to safety guidance information on each constituent in this material safety data sheet. Buffers - All constituents of the buffers in which monoclonal antibodies are supplied contain chemicals designated as non-regulated (NR) by the UN Hazard Classification unless otherwise stated on the product data sheet. Bovine Serum Albumin is added to some purified monoclonal antibody preparations as a preservative/stabilising agent- usually at a level of 1% w/v. Note: Bovine serum albumin used carries a North American certificate of origin. Preservatives Sodium Azide - Most monoclonal antibodies contain sodium azide as a preservative at a maximum level of 0.1% w/v. In its concentrated form, sodium azide is highly toxic by inhalation, in contact with the skin and if swallowed. It may cause heritable genetic damage, it is readily absorbed through skin and the advice is to avoid contact with metals. Although sodium azide is present in low levels in our products it is advisable to avoid ingestion or contact with skin and eyes, and to wear appropriate protective clothing such as protective gloves and long sleeve laboratory coat. Thiomersal - Also referred to as Thimerosal (SIGMA) and Merthiolate (Eli Lilly and Co) Some monoclonal antibody products (e.g. peroxidase conjugates) contain thiomersal as a preservative at a level of 0.01% w/v, see individual product data sheet. Thiomersal is a toxic substance and an irritant to eyes and skin. Although this substance is present in low levels in our products it is advisable to avoid ingestion or contact with skin and eyes. Wear appropriate protective clothing. Bronidox – Bronidox is suitable for use in surface cosmetics which do not remain in contact with the skin including child shampoos and cleansing creams and that the toxicological risk associated with this chemical is low. It is advised that direct contact of the concentrated chemical with the skin and mucous membrane should be avoided. However, the level present in GenWay Biotech’s products is usually 0.02% w/v and thus our assessments require no additional special handling requirements for products containing this preservative. ‘Stabilzyme’ HRP Conjugate Stabiliser – Some peroxidase conjugates are supplied in the aqueous ‘Stabilzyme’ HRP Conjugate Stabiliser - Though complete toxicity information on Stabilzyme HRP Conjugate Stabiliser is not available, none of its components are known to be toxic or hazardous at use concentrations. Stabilzyme contains three mercury free preservatives ProClin 300 (20 ppm), methylisothiazolone (0.02%) and bromonitrodioxane (0.02%), all of which can produce adverse health effects in their concentrated form. For more specific toxicity data refer to supplier safety data on these components from Boehringer Mannheim Corporation and Rohm and Haas respectively. ProClin 300 - is a corrosive substance when in concentrated form, which can cause eye damage, skin burns and allergic skin reaction. It may cause allergic skin reaction. See product data sheet for preservative concentration. Although this substance is present in low levels in our products it is advisable to avoid ingestion or contact with skin and eyes. Wear appropriate protective clothing. Benzamidine (hydrochloride) Some purified mouse polyclonal proteins contain Benzamidine at a concentration of 0.01% (see individual data sheets). Benzamidine is an irritant to the eyes (may cause chemical conjunctivitis), skin and can cause respiratory tract irritation (delayed pulmonary oedema). Benzamidine can permeate the skin. The effects may be delayed chronically. Epsilon-Aminocaproic acid (EACA) Some purified mouse polyclonal proteins contain EACA at a concentration of 0.1% (see individual data sheets). EACA may cause eye, skin and respiratory tract irritation of the mucous membranes and upper respiratory tract. In the concentrated form, EACA has shown to be harmful if inhaled or swallowed and may be harmful if absorbed through the skin. It has also been shown to alter behaviour in mice, and at chronic exposure it is considered a reproductive hazard in rats. Target organs: kidneys and blood. Ethylenediaminetetraacetic acid (EDTA) Some purified mouse polyclonal proteins contain EDTA at a concentration of 1mM (see individual data sheets). EDTA may be harmful by inhalation, ingestion and by skin absorption. It can also cause irritation to the eyes, skin, mucous membranes and upper respiratory tract. Gentamicin Sulphate In its concentrated form it may cause sensitisation and irritation of the eyes, skin, mucous membranes and upper respiratory tract. It is harmful if swallowed. Exposure can cause nausea, headache, and vomiting. Aminoglycosides are associated with significant toxicity to kidneys, ears and nerves. It causes photosensitivity in its concentrated form. It may cause an allergic respiratory reaction. Prolonged or repeated exposure may cause allergic reactions in sensitive individuals. In long term use it is known to be a mutagen, teratogen and a reproductive hazard in rats. Conjugates Fluorescein Isothiocyanate (FITC) Supplied as: Pale fluorescent green/yellow colour conjugate of monoclonal antibody and FITC in solution. The safety data sheet for FITC sensitising agent by inhalation and skin contact, and an irritant to eyes, respiratory system and skin.. Fluorescein isothiocyanate is present in conjugated products at very low levels ( less than 0.002% w/v maximum) at 1mg/ml antibody concentration, however, special care must be taken when handling sensitising and irritant substances to protect the routes of entry listed above by wearing appropriate personal protective equipment .e.g. Chemical resistant gloves. Wash thoroughly after handling and Avoid prolonged or repeated exposure. R. Phycoerythrin (RPE) Supplied as: Fluorescent pink colour conjugate in solution. Phycobilliprotein extracted from seaweed. This protein is of biological plant origin and thus it must be considered that it has a potential of containing a biological agent. May be harmful by inhalation, ingestion, or skin absorption. Causes eye irritation. May cause skin irritation. Alkaline Phosphatase Supplied as: Pale yellow colour conjugate in solution. Alkaline Phosphatase is present in the product at very low levels, however in concentrated powder form. Alkaline phosphatase has been listed as an irritant by skin contact, to the eyes, by ingestion and by inhalation. The substance may cause allergic reactions in sensitive individuals. It is therefore advisable to be aware of this information and avoid contact of these conjugates with eyes and skin and wear protective disposable gloves. Horseradish peroxidise Supplied as: Pale brown colour conjugate in solution. In pure concentrated powder form Horseradish peroxidase is sensitising by inhalation and can cause allergic reactions in sensitised individuals. Horseradish peroxidase is however, present in conjugated products at very low levels but it is advisable to be aware of this information and avoid creating aerosols of this product by excessive mixing or splashing. Biotin Supplied as: EZ-Link TM Sulfo-NHS-LC-Biotin. In its concentrated pure form, Biotin is an irritant by inhalation, to the respiratory system and to the eyes. It is harmful by inhalation and in contact with the skin. It may cause harm to the unborn child. Biotin is however, present in conjugated products at very low levels, but it is advisable to be aware of this information and prevent contact with the eyes. APC (Allophycocyanin) conjugated products. Supplied as: Lyophilised pale blue powder or blue conjugate solution. APC is a substance isolated from a blue-green alga and is thus of biological origin. May be harmful by inhalation, ingestion, or skin absorption. Causes eye irritation. May cause skin irritation. APC is present in the conjugated product at very low levels (less than 0.1%). RPE-Cy5 (Idotricarbocyanine) dye conjugated products e.g. PE-Cy5 Supplied as: Straw coloured conjugate solution The concentrated unconjugated Cy5 dye is a harmful irritant. Therefore, although RPE-Cy5 is present in the conjugated product at very low levels, it is advisable to be aware of this information and avoid contact with to skin, eyes and respiratory system, or by inhalation or ingestion. Texas red Supplied as: pale red conjugate solution Texas red is present in the conjugated product at very low levels. In concentrated solid form, Texas red is toxic and a possible carcinogen, therefore although Texas red is present in the conjugated product at very low levels, it is advisable to be aware of this information, and avoid contact by inhalation, eyes, skin or ingestion and wear protective disposable gloves. Tetramethylrhodamine isothiocyanate isomer R (TRITC) TRITC has been classified with the following hazards: Limited evidence of a carcinogenic effect. Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Please note that in it’s concentrated form, TRITC contains n-hexane (CAS#110-54-3) a suspected neurotoxin. TRITC can cause skin irritation by skin contact and may be harmful if absorbed through the skin. Causes eye irritation. by contact. May be harmful if inhaled and it is irritating to the mucous membranes and upper respiratory tract. TRITC is harmful if swallowed. It may cause nervous system disturbances. Chronic exposure it is a mutagen and may alter genetic material, plus it is a reproductive hazard in animals. Pacific blue Avoid temperatures over temperatures over 120 degrees Fahrenheit. In the concentrated form, the liquid, aerosols and vapours of this product are irritating eye contact. It causes skin irritation. Allergic reactions are possible. Prolonged or repeated contact can result in defatting and drying of the skin which may result in skin irritation and dermatitis. Prolonged inhalation may be harmful. This material may be harmful or fatal if swallowed. Irritating to mouth, throat and stomach. RPE-Cy7 Refer to entry under RPE-Cy5