PRODUCT TECHNICAL DOSSIER L-ORNITHINE HCL

Transcription

1 PRODUCT TECHNICAL DOSSIER L-ORNITHINE HCL Product Code: P15090 Raw Material Full Name: L-Ornithine HCL (Vegan) Raw Material Full Botanical/Chemical/Latin/Trade Name/Synonyms: (S)-2,5-Diaminovaleric acid monohydrochloride This material is Food Grade: Yes Means of Identification: Infrared spectroscopy Vegan / Vegetarian Status: Suitable CAS Number: EC/EINECS Number: Molecular Formula for the raw material: C5H12N2O2 HCL Average Molecular weight: Solubility in Water: Dissolved in water (21, 15%) Solubility in Alcohol: Not soluble in alcohol. Particle Size: 20 Mesh Product Code: P15090 Version: 1 Page 1 of 17

2 Percentage passed through: 100% Bulk Density: 0.32g/ml Tapped Density: 0.65g/ml ph: 5.0 ~ 6.0 Loss on Drying: 0.20% Residue on Ignition: 0.10% Country of Origin: China Country of Origin of the Manufacture: China Base Source/Start Material: L- Arginine (fermentation) from corn Origin of Product Synthetic, Plant, Mineral, Animal, Fish or Fermented: Fermented Material is: L-Ornithine HCL (Vegan) Shelf Life from Date of Manufacture: Minimum 2 Years Storage Conditions: Room temperature, this material is to be stored in a tightly sealed bag/container and to be kept in a cool place away from moisture (humidity less than 70%) and direct sunlight. Appearance (Fine/Crystals/Crystalline/Hygroscopic): Crystalline Product Code: P15090 Version: 1 Page 2 of 17

3 Colour: White Flavour/Taste: Characteristic taste Odour: Slight characteristic odour Microbiological Test Total Viable Count: 1000cfu/g Yeast & Moulds: 100cfu/g E. coli: Negative Salmonella: Negative Heavy Metals Lead (Pb): 3ppm Cadmium (Cd): 1ppm Mercury (Hg): 0.1ppm Arsenic (As): 1ppm There are no nuts in this recipe; however, we cannot guarantee that the raw materials entering the site are nut free. Product Code: P15090 Version: 1 Page 3 of 17

4 Please note that surveillance testing may mean that not all the parameters stated on this specification are tested for every batch. ALLERGENS Product Contains YES/NO Listed Item on Site at Manufacturer YES/NO Peanuts and Peanut Derivatives (including possible cross contamination) No No Other Nut and Nut Derivatives No No Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut (Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis (Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera), Macadamia nut and Queensland nut (Macadamia ternifolia) Sesame Seeds and Sesame Seed Derivatives No No Other Seeds and Seed Derivatives (Poppy Seeds, Cotton Seeds, Sunflower Seeds) No No Milk and Milk Derivatives (including lactose) No No Egg and Egg Derivatives No No Cereals and Derivatives containing OR POTENTIALLY CONTAMINATED WITH Gluten No No (wheat, wheatgrass, faro, freekeh, spelt, kamut, rye, oats, barley, barley grass) Soya and Soya Derivatives No No Lupin and Lupin Derivatives No No Mustard and Mustard Derivatives No No Celery or Celery Derivatives (including Celeriac) No No Fish and Fish Derivatives No No Molluscs and their Derivatives No No Crustaceans and their Derivatives No No Sulphur Dioxide and Sulphites (E220, E228) at levels > 10mg/kg or 10mg/litre No No If YES, Please Comment Product Code: P15090 Version: 1 Page 4 of 17

5 ADDITIVES / CONTAMINANTS / DIETARY REQUIREMENTS Product Contains YES/NO Listed Item on Site at Manufacturer YES/NO Additives No No Antioxidants No No Ethylene Oxide No No Gelatine No No Flavourings (Artificial / Nature Identical / Natural / Smoked) No No Maize / Corn and any Derivatives No No Legumes / Pulses No No Rice and Rice Derivatives No No Added Salt No No Added Sugar / artificial or natural sweeteners No No Aspartame No No BHA / BHT (E320 / E321) No No Caffeine No No Colours (Artificial / Nature Identical / Natural / Smoked) No No Dextrose No No Dioxins No No MSG (Added and Naturally Occurring E621) or Glutamates (E620 to E625) No No Nucleotides (E627, E630, E631, E635) No No Polyols (sugar alcohols) No No Benzoates (E210 / E219) No No Sorbic Acid (E200, E203) No No Any other Preservatives No No Ethanol No No Honey No No Lactose No No Yeast and Yeast Derivatives No No All Animal Products (Beef, Pork, Poultry or other) and Derivatives (which may include No No growth/yield hormones, antibiotics etc.) Bovine Products or Derivatives (which may include growth/yield hormones, antibiotics etc.) No No If YES, Please Comment Product Code: P15090 Version: 1 Page 5 of 17

6 PRODUCTION FLOW CHART Product Code: P15090 Version: 1 Page 6 of 17

7 CONFIRMATION OF BSE/TSE STATUS This is to certify that this product complies with all relevant current UK and EU Legislative requirements in regard to Transmissible Spongiform Encephalopathies (TSE) and Bovine Spongiform Encephalopathy (BSE) for human food, and so is free of TSE/BSE. This is also to certify that, during the course of their manufacture, the above-mentioned product did not come into contact with any materials, which could be derived from TSE/BSE risk materials. CONFIRMATION OF GM STATUS This is to certify that this product is not manufactured from GM raw materials and is therefore not subject to labelling under regulations 1829/2003/EC and 1830/2003/EC. CONFIRMATION OF NON IRRADIATION STATUS This is to certify that this product, whole or in part, has not been subjected to Ionising Radiation as per European Directives 1999/3/EC. CONFIRMATION OF NANDROLONE STATUS This is to certify that this product, whole or in part, has not come into contact with Nandrolone or any of its precursors in any way. CONFIRMATION OF IOC PRODUCT STATUS This is to certify that this product, whole or in part, has not come into contact with any product/s, which is banned by the IOC (International Olympics Committee) and or WADA. CONFIRMATION OF ANIMAL TESTING STATUS This is to certify that all the products sold by Cambridge Commodities have not been tested on animals in any part of its manufacture in accordance with regulation 86/609/EEC. CONFIRMATION OF PESTICIDES STATUS This is to certify that the above-mentioned product complies with the regulation (EC) No.396/2005 of 23rd February 2005 and commission Regulation (EU) No. 559/2011 of 7th June 2011 amending annexes II and III of the above Regulation. CONFIRMATION OF NANOPARTICLE STATUS This is to certify that unless otherwise stated, the above-mentioned product is free of nanoparticles. Commission Recommendation 2011/696/EU, defines as follows: "'Nanomaterial' means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm nm". Product Code: P15090 Version: 1 Page 7 of 17

8 MATERIAL SAFETY DATA SHEET Section 1 Identification of the Substance/Mixture and of the Company/Undertaking Product name: Chemical formula: Synonym: Company: L-Ornithine hydrochloride C 5 H 12 N 2 O 2 Â HCl (S)-(+)-2,5-Diaminopentanoic acid (S)-2,5-Diaminopentanoic acid Cambridge Commodities Limited Lancaster Way, Ely, Cambridgeshire, CB6 3NX Tel: qa@c-c-l.com Section 2 Hazards Identification Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 Eye irritation (Category 2), H319 For the full text of the H-Statements mentioned in this section, see Section 16. Classification according to EU Directives 67/548/EEC or 1999/45/EC Xi Irritant R36 For full text of the R-Phrases mentioned in this section, see section 16. Label elements: Labelling according to Regulation (EC) No 1272/2008 Pictogram: Hazard Statement(s) H319: Causes serious eye irritation Precautionary statement(s) P305+P351+P338: If in eyes rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Supplementary Hazard statements Precautionary statement(s) P305+P351+P338: If in eyes rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Product Code: P15090 Version: 1 Page 8 of 17

9 Section 3 Composition/Information on Ingredients Substances Synonyms: (S)-(+)-2,5-Diaminopentanoic acid. (S)-2,5-Diaminopentanoic acid L-Ornithine Formula: C 5 H 12 N 2 O 2 Â HCl Molecular weight: 168,62 g/mol CAS-No: EC-No: Hazardous ingredients according to Regulation (EC) No 1272/2008 Component Classification Concentration L-Ornithine monohydrochloride CAS-No EC-No Eye Irrit. 2; H319 <= 100 % Hazardous ingredients according to Directive 1999/45/EC Component Classification Concentration L-Ornithine monohydrochloride CAS-No EC-No Xi, R36 <= 100 % For the full text of the H-Statements and R-Phrases mentioned in this Section, see Section 16 Product Code: P15090 Version: 1 Page 9 of 17

10 Section 4 Emergency and First Aid Measures Description of first aid measures General advice Consult a physician. Show this safety data sheet to the doctor in attendance. If inhaled If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician. In case of skin contact Wash off with soap and plenty of water. Consult a physician. If swallowed Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician. Most important symptoms and effects, both acute and delayed The most important known symptoms and effects are described in the labelling (see section 2) and/or in section 11. Indication of any immediate medical attention and special treatment needed Section 5 Fire-fighting measures Extinguishing media Suitable Extinguishing media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide. Special hazards arising from the substance or mixture Carbon oxides, nitrogen oxides (NOx), Hydrogen Chloride gas Advice for firefighters Wear self-contained breathing apparatus for firefighting if necessary. Further information. Section 6 Accidental Release Measures Personal precautions, protective equipment and emergency procedures Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Avoid breathing dust. For personal protection see section 8. Environmental precautions Do not let product enter drains. Methods and materials for containment and cleaning up Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal. Product Code: P15090 Version: 1 Page 10 of 17

11 Reference to other sections For disposal see section 13. Section 7 Handling and Storage Precautions for safe handling Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed. Normal measures for preventive fire protection. For precautions see section 2. Conditions for safe storage, including any incompatibilities Store in cool place. Keep container tightly closed in a dry and well-ventilated place. Specific end use(s) Apart from the uses mentioned in section 1 no other specific uses are stipulated Section 8 Exposure Controls/Personal Protection Control parameters Components with workplace control parameters Appropriate engineering controls Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. Personal protective equipment Eye/face protection Safety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Skin protection Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it. Full contact Material: Nitrile rubber Minimum layer thickness: 0,11 mm Break through time: 480 min Product Code: P15090 Version: 1 Page 11 of 17

12 Material tested: Dermatril (KCL 740 / Aldrich Z677272, Size M) Splash contact Material: Nitrile rubber Minimum layer thickness: 0,11 mm Break through time: 480 min Material tested: Dermatril (KCL 740 / Aldrich Z677272, Size M) Test method: EN374 If used in solution, or mixed with other substances, and under conditions which differ from EN 374, contact the supplier of the CE approved gloves. This recommendation is advisory only and must be evaluated by an industrial hygienist and safety officer familiar with the specific situation of anticipated use by our customers. It should not be construed as offering an approval for any specific use scenario. Body Protection Impervious clothing, the type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Respiratory protection For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator. For higher level protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU). Control of environmental exposure Do not let product enter drains. Section 9 Physical and Chemical Properties Information on basic physical and chemical properties a) Appearance Form: powder Colour: white b) Odour no data available c) Odour Threshold no data available d) ph no data available e) Melting point/freezing point Melting point/range: 245 C f) Initial boiling point and boiling range no data available g) Flash point no data available h) Evaporation rate no data available i) Flammability (solid, gas) no data available no data available j) Upper/lower flammability or explosive limits no data available Product Code: P15090 Version: 1 Page 12 of 17

13 k) Vapour pressure no data available l) Vapour density no data available m) Relative density no data available n) Water solubility no data available o) Partition coefficient: n- octanol/water no data available p) Auto-ignition temperature no data available q) Decomposition temperature no data available r) Viscosity no data available s) Explosive properties no data available t) Oxidizing properties no data available Other safety information no data available Section 10 Stability and Reactivity Reactivity Chemical stability Stable under recommended storage conditions. Possibility of hazardous reactions Conditions to avoid Incompatible materials Strong oxidizing agents Hazardous decomposition products Other decomposition products - no data available in the event of fire: see section 5 Section 11 Toxicological Information Information on toxicological effects Acute toxicity LD50 Oral - rat mg/kg Product Code: P15090 Version: 1 Page 13 of 17

14 Remarks: Behavioural: Altered sleep time (including change in righting reflex). Behavioural: Ataxia. Lungs, Thorax, or Respiration: Dyspnea. Skin corrosion/irritation Serious eye damage/eye irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity IARC: No component of this product present at levels greater than or equal to 0.1% is identified as probable, possible or confirmed human carcinogen by IARC. Reproductive toxicity Specific target organ toxicity - single exposure Specific target organ toxicity - repeated exposure Aspiration hazard Additional Information RTECS: Not available Section 12 Ecological Information Toxicity Persistence and degradability Product Code: P15090 Version: 1 Page 14 of 17

15 Bioaccumulative potential Mobility in soil Results of PBT and vpvb assessment PBT/vPvB assessment not available as chemical safety assessment not required/not conducted Other adverse effects Section 13 Disposal Considerations Waste treatment methods Product Offer surplus and non-recyclable solutions to a licensed disposal company. Contact a licensed Professional waste disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Contaminated packaging Dispose of as unused product. Section 14 Transport Information UN number ADR/RID: - IMDG: - IATA: - UN proper shipping name ADR/RID: Not dangerous goods IMDG: Not dangerous goods IATA: Not dangerous goods Transport hazard class(es) ADR/RID: - IMDG: - IATA: - Packaging group ADR/RID: - IMDG: - IATA: - Transport hazard class(es) ADR/RID: - IMDG: - IATA: - Packaging group ADR/RID: - IMDG: - IATA: - Section 15 Regulatory Information Product Code: P15090 Version: 1 Page 15 of 17

16 This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006. Safety, health and environmental regulations/legislation specific for the substance or mixture no data available Chemical Safety Assessment For this product a chemical safety assessment was not carried out Section 16 Other Information The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. We shall not be held liable for any damage resulting from handling or from contact with the above product. This advice is given by Cambridge Commodities Ltd who accepts no legal liability for it. The information contained herein is based on the present state of our knowledge and is intended to describe our products from the point of view of safety requirements. It should not therefore be construed as guaranteeing specific properties. Individuals working with chemicals should consider all chemicals to be potentially hazardous even if their individual hazards may be uncharacterised or unknown. This Information provided in this document is subject to change and the batch specific Certificate of Analysis should always be referenced. To be used as per local legislation. Product Code: P15090 Version: 1 Page 16 of 17

17 Change History Version Change Customer Notification required Yes / No 1 First Issue N/A Document Approval Originator Job Title Quality Specialist Approver Job Title Assistant Quality Manager Product Code: P15090 Version: 1 Page 17 of 17

18 P15090-L-Ornithine HCL- Technical Dossier Adobe Sign Document History 01/08/2018 Created: 01/08/2018 By: Status: Transaction ID: Matthew Vincent Signed CBJCHBCAABAAybmDZBW4NYdQpy35v9P0VaHiuiPbapOC "P15090-L-Ornithine HCL-Technical Dossier" History Document uploaded by Matthew Vincent from Acrobat 01/08/2018-5:10:27 AM PST- IP address: Document e-signed by Matthew Vincent Signature Date: 01/08/2018-5:11:19 AM PST - Time Source: server- IP address: Document ed to Richard Cecil (Richard.Cecil@c-c-l.com) for signature 01/08/2018-5:11:20 AM PST Document viewed by Richard Cecil (Richard.Cecil@c-c-l.com) 01/08/2018-8:19:10 AM PST- IP address: Document e-signed by Richard Cecil (Richard.Cecil@c-c-l.com) Signature Date: 01/08/2018-8:23:36 AM PST - Time Source: server- IP address: