HemosIL D-Dimer

Hazard statements (CLP)

H300, H314, H315, H319, H335, H360FD, H400, H410

Code

Statements

H300

Fatal if swallowed

2.1 Classification of the substance or mixture

ELINCS n° w/w Name ELINCS n° CAS n° w/w

67/548/EEC

1272/2008/EC Borax decahydrate(**) 215-540-4 1303-96-4 < 0.5 % Repr. Cat. 2, R60-61 Repr. 1B, H360FD Specific Conc. Limits: Repr. Cat. 2, R60-61: Repr. 1B, H360FD: c ≥ 8,5 % Sodium Azide (*) 247-852-1 26628-22-8 < 0.1 % T+, R28 Acute Tox. 2, H300 R32 Aquatic Acute 1, H400 N, R50-53 Aquatic Chronic 1, H410 EINECS/ Conc. % 1272/2008/EC Skin Corr. 1B, H314 STOT SE 3, H335 C; R34 Xi; R37 Specific Conc. Limits: 7647-01-0 Skin Corr. 1B; H314: Hydrochloric acid 231-595-7 (Hydrogen < 0.05 % c ≥ 25 % (aqueous solution) (*) chloride Specific Conc. Limits: anhydrous) C; R34-37: c ≥ 25 % Skin Irrit. 2, H315: Xi; R36/37/38: 10 % ≤ c < 25 % Eye Irrit. 2, H319: 10 % ≤ c < 25 % STOT SE 3, H335: c ≥ 10 % For exposure limits see ch. 8, for phrases R and hazard statements text see ch. 16 44.. FFIIRRSSTT AAIID D M MEEAASSUURREESS Ingestion: If swallowed rinse mouth with plenty of water provided person is conscious. Get medical advice if adverse symptoms appear. Inhalation exposure: If inhaled, move person to fresh air. Get medical advice if adverse symptoms appear. Contact with skin: Remove contaminated clothes and shoes. Wash affected area with soap or mild detergent and plenty of water. Get medical advice if adverse symptoms appear. Contact with eyes: Wash immediately with plenty of water or normal saline. Keep eyelid open with the finger. Get medical advice if adverse symptoms appear. 55.. FFIIRREE--FFIIGGH HTTIIN NGG M MEEAASSUURREESS Suitable extinguishing means: Water spray or regular foam, CO2, dry powder. Mean of extinguishing NOT to be Not known. used: Known hazards caused by Thermal decomposition or combustion may generate toxic and hazardous fumes (COx, NOx, Na2O, combustion: HCl). Equipment for self-protection: Self-contained breathing apparatus, flame and chemical resistant clothing, boots and gloves. (fire fighters): 66.. AACCCCIIDDEEN NTTAALL RREELLEEAASSEE MEEAASSUURREESS M Personal precautions: Suitable protective clothing, rubber or polythene gloves, rubber shoes, safety glasses. Environmental precautions: Do not let the product enter drainage system, surface and ground-water or soil. Contact local authorities in case of environmental release. Do not empty into drains. Cleaning procedure to recover Soak up with inert absorbent material, and clean with plenty of water. Send to the storage waiting for spilled material: disposal procedures. 77.. H HAAN ND DLLIIN NGG AAN ND D SSTTO ORRAAGGEE 7.1 Handling Handling procedures: Wear suitable protective clothing, gloves, eye protection. When use do not eat, drink or smoke. Provide sufficient ventilation in all work areas. Work/Hygienic practices: Wash hands with soap and water after use. 7.2

Storage

Room ventilation: Well ventilated workplace. Special precautions: Avoid environmental release. (see also Section 8) Recommended temperature: Store at 2 – 8°C. Humidity, light and other Avoid light exposure and keep away from heat sources and non compatible materials. environmental factors: Containers: Keep containers tightly closed and labelled with the name of the product. Other storage precautions: Keep away from food and drinks. Keep away from contamination with heavy metals. Sodium azide has been reported to form lead or copper azide in laboratory plumbing which may explode on percussion. 88.. EEXXPPO OSSUURREE CCO ON NTTRRO OLLSS//PPEERRSSO ON NAALL PPRRO OTTEECCTTIIO ON N 8.1 Exposure limit values TLV (ACGIH): TWA = 2 mg/m3; STEL = 6 mg/m3(inhalable), EU OEL: 0.1 mg/m³ as TWA, 0.3 mg/m3 as STEL (skin) for Sodium azide 2007, for Borax decahydrate (1) (2) TLV (ACGIH, 2000) (HCl anhydrous) 2 ppm, 3 mg/m3 Ceiling US OSHA PEL FINAL-CL 0.3 mg/m3 (as NaN3) (skin) for Sodium azide (3) TLV/TWA: 0.1 mg/m3 for Sodium azide (2) OEL-STEL (HCl anhydrous) : 15 mg/m3 (2000/39/EC Directive) TLV /STEL: 0.3 mg/m3 for Sodium azide (2) OEL Belgium: time-weighted average 2 mg/m3, short term exposure limit (1) TLV-CEILING (ACGIH): 0.29 mg/m3 for Sodium azide (2) 6 mg/m3, Mar 2002, for Borax decahydrate NIOSH REL: 10 hour time-weighted average 5 mg/m3, for OEL UK: time-weighted average 5 mg/m3, 2005, for Borax decahydrate (1) Borax decahydrate NIOSH Recommended Exposure Limit (REL) (HCl anhydrous) OEL France VME 5 mg/m3, Feb 2006, for Borax decahydrate (1) 5 ppm, 7 mg/m3 Ceiling (3) NIOSH Immediately Dangerous To Life or Health MAK: 0.2 mg/m3, inhalable fraction for Sodium azide (4) Concentration (IDLH) (HCl anhydrous): 50 ppm (3) 8.2 Exposure Controls Respiratory protection: Respiratory protection is not required. Where risk assessment shows air-purifying respirators are appropriate, use masks with approved filter. Skin protection: Protective clothing, rubber or polythene gloves. Eye protection: Safety glasses. Hand protection: Rubber or polythene gloves. Other protective systems: Personal protective equipment (PPE) useful for reducing individual exposure. Environmental protection: Avoid any release into the environment. 99.. PPH HYYSSIICCAALL AAN ND D CCH HEEM MIICCAALL PPRRO OPPEERRTTIIEESS 9.1 General information

Appearance/Odor

Liquid Odorless Color: Colorless 9.2 Important health, safety and environmental information Value Related to pH: 8.4 – 8.6 Mixture Boiling point/range: not available Flash point: not available Vapor pressure: not available Density: not available Solubility: not available Water Solubility: miscible Mixture Viscosity: not available Vapor density: not available Evaporation rate: not available 9.3

Further information

Melting point/range: not available 1100.. SSTTAABBIILLIITTYY AAN ND D RREEAACCTTIIVVIITTYY Stability: The product is stable until the expiration date shown on the box and on the labels when stored at 2 - 8°C. 10.1 Conditions to avoid: Keep out from heat, water, humidity and light. 10.2 Materials to avoid: Strong oxidising agents. Sodium azide has been reported to form lead or copper azide in laboratory plumbing which may explode on percussions. Sodium azide reacts vigorously with heated water. 10.3 Hazardous decomposition Thermal decomposition or combustion may include toxic and hazardous fumes of COX, NOX, Na2O, products: HCl. 1111.. TTO OXXIICCO OLLO OGGIICCAALL IIN NFFO ORRM MAATTIIO ON N 11.1 Toxicokinetic effects (ADME) Absorption: Absorption of borates via the oral route is nearly 100%. Dermal absorption though intact skin is very low. (5) Sodium azide is rapidly absorbed from the gastrointestinal tract and from injection sites. (6) Distribution: Borates are distributed rapidly and evenly through the body, with concentrations in bone 2 - 3 higher (5) than in other tissues. Metabolism: not available Excretion: Boron is excreted rapidly, with elimination half-lives of 1h in the mouse, 3h in the rat and < 27.8 h in humans, and has low potential for accumulation. Boric acid is mainly excreted in the urine. (5) 11.2 Acute toxicity Value m.u. Effects Related to Oral: LD50 (rat) = 2,660 mg/Kg (7) Borax decahydrate LD50 (rat) = 27 mg/Kg (8) Sodium azide LD50 (rat) = not mg/Kg Single administration of 1 ml caused (9) HCl 2% solution available stomach damage LD50 (rabbit) = 900 mg/Kg (9) HCl Dermal: LD50 (rat) > 2,000 mg/Kg (5) Borax decahydrate LD50 (rat) = 50 mg/Kg (8) Sodium azide Inhalation: LC50 (rat) > 2.03 mg/l In an inhalation study in which rats were (5) Borax decahydrate exposed to boric acid at concentrations of 2.12 mg (0.37 mg B)/L (highest attainable concentration) for 4 hours, no deaths were observed. LC50 (rat) = 37 mg/m3 Structural or functional change in trachea (8) Sodium azide or bronchi, effects on eye, convulsions or effect on seizure threshold LC50 (rat) = 3,124 ppm (9) HCl anhydrous Other data: not available 11.3 Irritation Skin: In animal studies, 10 ml of 5% Borax (Disodium Tetraborate Decahydrate) in water caused a very mild irritation on rabbit skin; in Guinea pigs, neither boric acid nor borax was irritating when applied on abraded skin. (5) Hydrochloric acid 1% aqueous solution proved to be not irritating on rabbits after 5 applications of 0.5 ml within 5 days. Hydrochloric acid 17% and 37% aqueous solutions produced severe damage to the (9) skin of rabbits. Eye: Two animal studies with Disodium Tetraborate Decahydrate have been carried out, both indicating eye irritancy. In normal handling and use the large glassy crystals would not be able to enter the eye easily and in addition over 50 years of occupational exposure to all borate has indicated no adverse effects (5) on the human eye. Hydrochloric acid 0.33% and 3.3% aqueous solutions proved to be not irritating and slightly irritating respectively, after an application of 0.1 ml into the conjunctivial sac (observation period: 48 hours). Rabbits treated with 0.1 ml of HCl 10% solution showed severe irritation to eyes. (9) Inhalation: There is no data from animal studies on boric acid, disodium tetraborate anhydrous, disodium tetraborate pentahydrate and disodium tetraborate decahydrate that indicated respiratory irritation. (5) Rabbits exposed by inhalation to 0.15 mg/l of HCl for 6 hours/day for 5 days showed irritation of the nasal mucosa and eyes. (9) 11.4 Sensitization: Skin sensitization: No signs of skin sensitisation were observed in a Buehler method skin sensitisation test with Disodium tetraborate decahydrate. There is no evidence of skin sensitisation in humans exposed occupationally (5) to borates. Sensitization by inhalation: Disodium tetraborate decahydrate is not a respiratory sensitizer. (5) 11.5 Prolonged exposure A number of studies in which rats were fed boric acid or disodium tetraborate decahydrate in their diet toxicity: or drinking water for periods of 70 days to two years in rats, mice and dogs indicated that the main target organ for toxicity is the testis. Other effects observed at high doses include rapid respiration, hunched position, bloody nasal discharge; urine stains on the abdomen, inflamed bleeding eyes, desquamation and swollen paws and tail, reduced food consumption and body weight gain. Based on the clinical effects and the testicular atrophy the lowest NOAEL for the effects of boron is 17.5 mg B/kg bw/day (equivalent to 100mg boric acid or 155 mg disodium tetraborate decahydrate/kg bw/day). (5) Rabbits, exposed by inhalation at the dose of 0.05 mg/l of HCl for 4 weeks, showed irritation of the eyes and the mucous membranes. (9) 11.6 CMR effects Related to Mutagenicity: Ames test: Sodium azide was mutagenic in Salmonella (10) Sodium azide typhimurium strains TA100 and TA1535 with or without exogenous metabolic activation (S9); it was not mutagenic in strain TA1537 or TA98. negative (9) HCl (purity 95%) Mouse lymphoma: negative (9) HCl (purity 95%) Chromosomal aberration: not available Cytogenetic tests with Sodium azide induced sister chromatid (10) Sodium azide Chinese hamster ovary cells: exchanges, but not chromosomal aberrations. Micronucleus test: negative (9) HCl (purity 95%) Teratogenesis: Developmental effects have been observed in three species, rats, mice and rabbits, the most sensitive species being the rat. This is based on a reduction in mean foetal body weight/litter, increase in wavy ribs and an increased incidence in short rib XIII at 76 mg/kg bw/day (13.3 mg B/kg bw/day). At maternally toxic doses, visceral malformations observed included enlarge lateral ventricles and cardiovascular effects. The NOAEL (rat) for this endpoint is 9.6 mg B/kg corresponding to: 55 mg boric acid/kg/day, or 85 mg disodium tetraborate decahydrate/kg/day. (11) Repeated dose studies in several animal species have consistently demonstrated that the testis is a primary target organ for boron. Based on the data from the 2 years feeding study with boric acid in rats, the overall NOAEL for fertility is therefore 100 mg/kg bw/day, equal to 17.5 mg B/kgbw/day. This conclusion is supported by the study with disodium tetraborate decahydrate. (12) In a teratogenic study employing albino rats treated orally with technical Sodium azide at dose levels of 0.5, 1.5, or 5.0 mg/kg daily during gestation days 6 through 15, no teratogenic effects due to Sodium azide were found. Sterility has been produced in male mice given sodium azide.(6) Carcinogenesis: In carcinogenicity studies in mice and rats no evidence of a carcinogenic effects of boric acid or sodium tetraborate decahydrate was observed. (12) Carcinogenicity studies were conducted by administering sodium azide (greater than 99% pure) in distilled water by gavage to groups of male and female rats once daily, 5 days per week for 14 days, 13 weeks, or 2 years. Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of sodium azide in male or female rats administered 5 or 10 mg/kg. Sodium azide induced necrosis in the cerebrum and the thalamus of the brain in both male and female rats. (10) HCl is not listed in NTP, IARC and OSHA lists.(9) 1122.. EECCO OLLO OGGIICCAALL IIN NFFO ORRM MAATTIIO ON N 12.1 Ecotoxicology Value m.u. Related to Acute toxicity with fish: LC50 Carassius auratus = 178 mg/l/72 h (13) Borax decahydrate LC50 bluegill fish = 0.7 mg/l/96 hours (6) Sodium azide LC50 (Leuciscus idus) = 862 mg/l/48 hours (9) HCl solution 3% Acute toxicity with Daphnia (13) Borax decahydrate Magna: EC50 Daphnia magna = 1,085 – 1,402 mg/l/48 hours EC50 daphnia pulex = 4.2 mg/l/96 hours (6) Sodium azide Acute toxicity with algae: IC50 - Desmodesmus subspicatus = 158 mg/l/96 hours (13) Borax decahydrate 12.2 Mobility: The dissipation of azides in soil is not by microbial action but is strictly a chemical process accelerated by increasing acidity and elevated temperatures. (6) The high water solubility of HCl indicates high mobility in soil.(3) 12.3 Persistency and not available degradability: 12.4 Bioaccumulation potential: not available 12.5 Evaluation PBT result: not available 12.6 Other toxic effects: not available 1133.. DDIISSPPO OSSAALL CCO ON NSSIID DEERRAATTIIO ON N National laws on disposal must be considered, local and UE requirements for wastes recycling must be respected. Used waste product, surplus product or spillage products shall be disposed of in accordance with national, state and local laws. 1144.. TTRRAAN NSSPPO ORRTT IIN NFFO ORRM MAATTIIO ON N Not classified for transport in accordance with ADR/RID, IMDG, IATA and DOT regulations. 1155.. RREEGGUULLAATTO ORRYY IIN NFFO ORRM MAATTIIO ON N Regulatory information on labeling according to 67/548/EEC, to 1999/45/EEC Directive and to 1272/2008 Regulation (EC)(European reinforcement of GHS), and according to their following amendments/atp. According to 67/548/EEC and According to 1999/45/EEC Directives 1272/2008/EC Regulation Classification: Not classified as dangerous Not classified as hazardous Labeling symbols: none (signal word) Labeling risk phrases: none (hazard statements) Labeling safety phrases: none (precautionary statements) Other labeling details: ≈ 8.3 % of this mixture consist of ingredient(s) of unknown toxicity for health and for aquatic environment. Safety precautions: Wear suitable protective clothing, gloves and eye/face protection. Authorization: The mixture contains a substance included in the Candidate List of Substances of Very High Concern (Borax decahydrate). Restriction: No 1166.. O OTTH HEERR IIN NFFO ORRM MAATTIIO ON N Phrases R: R28: Very toxic if swallowed. R32: Contact with acids liberates very toxic gas. R34: Causes burns. R36/37/38: Irritating to eyes, respiratory system and skin. R37: Irritating to the respiratory system. R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R60: May impair fertility. R61: May cause harm to the unborn child. Hazard Statements: H300: Fatal if swallowed. H314: Causes severe skin burns and eye damage. H315: Causes skin irritation. H319: Causes serious eye irritation. H335: May cause respiratory irritation H360FD: May damage fertility. May damage the unborn child. H400: Very toxic to aquatic life. H410: Very toxic to aquatic life with long lasting effects. The contained information in this MSDS are in accordance with Annex II of Regulation no.1907/2006 (REACH) and in accordance with ANSI “Standard for Hazardous Industrial Chemicals - Material Safety Data Sheets – Preparation” (ANSI Z400.1-2004) as recommended by US OSHA. Bibliographic references: (1) RTECS:VZ2275000, The Registry of Toxic Effects of Chemical Substances, Sodium borate, decahydrate (2) International Chemical Safety Cards, Sodium azide (3) www.OSHA.gov, Chemical Sampling Information, Hydrogen Chloride (4) Haz-Map Occupational exposure to hazardous Agents, Sodium azide (5) European Union Risk Assessment Report: Disodium tetraborate, Anhydrous boric acid, Boric acid crude natural, Risk assesment (6) HSDB Hazardous Substances Databank, Sodium azide (7) ChemIDplus Lite, Borax, full record (8) ChemIDplus Lite, Sodium azide, full record (9) IUCLID file, Hydrogen Chloride (10) National Toxicology Program database Search Application, Toxicology and Carcinogenesis Studies of Sodium azide (CAS: 26628-22- 8) in F344 Rats (Gavage Studies) (11) J Am Coll Toxicol 1990;9(2):279-88 (12) Directive 98/8/EC concerning the placing biocidal products on the market, Assessment Report, 20 February 2009 (13) Sigma Aldrich, Material Safety Data Sheet for Sodium tetraborate decahydrate, Revision date 12.03.2010 (*) Classification in Annex I of Dir 67/548/EEC and in Annex VI of the 1272/2008/EC Regulation (**) Commission Regulation (EC) No 790/2009 of 10 August 2009 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures NTTIIFFIICCAATTIIO ON N OFF O TTH HEE M MIIXXTTUURREE AAN NDD O OFF TTH HEE CCO OM MPPAAN NYY 1.1 Identification of the mixture Product Name: Reaction Buffer Product Number: 0020008521 1.2 Use of the mixture: For in vitro diagnostic use. 1.3 Company identification: MANUFACTURER: DISTRIBUTOR EU: Instrumentation Laboratory Co. Via Roma, 103 180 Hartwell Road, 20040 Cavenago Brianza (Italy) Bedford, MA 01730-2443 (USA) Tel. +1 800 678 0710 DISTRIBUTOR US/CANADA: Fax +1 781 863 9928 Beckman Coulter Inc. 250 S. Kraemer Blvd. Brea, CA 92821, U.S.A E-mail address of the competent person: infosds@mail.ilww.it 1.4 Emergency phone: +44 (0)3700 492 795 +1 215 207 0061 (USA and Canada) 22.. H HAAZZAARRD DSS IID DEEN NTTIIFFIICCAATTIIO ON N 2.1 Mixture classification (see also ch. 15) Classified: not dangerous according to 67/548/EEC and 1999/45/EEC Directives Classified: not hazardous according to 1272/2008/EC Regulation 2.2 Potential health and environmental effects