SAFETY DATA SHEET. This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006

Transcription

1 SAFETY DATA SHEET This safety datasheet complies with the requirements of Regulation (EC) No. 1907/ IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING Product Name Material Number Synonyms Chemical nature Recommended use Porzyme TP-100(HP) PTPB Not applicable. Enzyme Preparation. Animal feed Company/undertaking identification:danisco Animal Nutrition PO Box 777 Marlborough Wiltshire SN81XN United Kingdom Tel: address Emergency telephone: +32 (0) HAZARDS IDENTIFICATION R42 May cause sensitisation by inhalation. Properties affecting health Physico-chemical properties Environmental properties Granule enzyme preparations are dust-free preparations. However, inappropriate handling may cause formation of aerosols or dust. of enzyme aerosols or dust may induce sensitization and may cause allergic type reactions in sensitized individuals. Prolonged skin contact may cause minor irritation. The data available do not support any physical or chemical hazard. Contains no substances known to be hazardous to the environment or not degradable in waste water treatment plants. Page 1 / 8

2 3. COMPOSITION/INFORMATION ON INGREDIENTS Description Enzyme Preparation. Chemical Name % CAS-No EINECS-No REACH No Hazardous IUB Code classification Wheat flour NE - Notes Endo 1,4 beta-glucanase R Xylanase < R Alpha Amylase < R Subtilisins (proteolytic < Xi;R37/38 R41 R Calcium propionate < NE - E 282 For the full text of the R-phrases mentioned in this Section, see Section FIRST AID MEASURES Eye contact Skin contact Ingestion Notes to physician Flush eyes with water at least 15 minutes. Get medical attention if eye irritation develops or persists. Flush skin with large amounts of water. If irritation develops and persists, get medical attention. Rinse mouth with water. Get medical attention immediately if symptoms occur. Remove person to fresh air. If signs/symptoms continue, get medical attention. May cause allergic respiratory reaction. 5. FIRE-FIGHTING MEASURES Suitable extinguishing media Extinguishing media which must not be used for safety reasons Standard procedure for chemical fires. Foam. Water. None in particular. Specific hazards during fire fighting May cause sensitisation by inhalation and skin contact. Special protective equipment for fire-fighters Wear self-contained breathing apparatus and protective suit. Page 2 / 8

3 6. ACCIDENTAL RELEASE MEASURES Personal precautions Environmental precautions Methods for cleaning up Use only with adequate ventilation/personal protection. Avoid breathing dust or spray mist. Avoid formation of dust and aerosols. For personal protection see section 8. Prevent further leakage or spillage if safe to do so. Use appropriate personal protection (see Section 8). Avoid any contact with the product. Contain spilled product. Take up spilled substance by mechanical means or with a vacuum cleaner equipped with a high efficiency filter. After spillage avoid raising aerosols or dust from dried preparation. Avoid splashing and high pressure washing (formation of aerosols). Provide for sufficient ventilation. Wash with plenty of water. 7. HANDLING AND STORAGE Handling Technical measures/precautions Storage Avoid breathing vapours or mists. Avoid contact with skin and eyes. Handle in accordance with good industrial hygiene and safety practice. For personal protection see section 8. Ensure adequate ventilation. Keep container tightly closed in a dry and well-ventilated place. Additional information available from product literature. Page 3 / 8

4 8. EXPOSURE CONTROLS/PERSONAL PROTECTION Exposure limits Chemical Name UK WEL UK MEL Ireland Germany France Subtilisins (proteolytic = mg/m 3 TWA mg/m 3 TWA: mg/m 3 STEL: mg/m 3 Chemical Name Denmark Finland Norway Sweden The Netherlands Subtilisins (proteolytic Ceiling: LLV: 3 glycineunit/m 3 mg/m 3 LLV: 1 glycineunit/m 3 Chemical Name Italy Portugal Spain Austria Switzerland Subtilisins (proteolytic Ceiling: VLA-EC: STEL: mg/m 3 mg/m 3 mg/m 3 Occupational exposure controls Engineering measures Hygiene measures Ventilation systems. Handle in accordance with good industrial hygiene and safety practice. Personal protective equipment Respiratory protection Eye protection Skin and body protection Hand protection Environmental exposure controls Wear suitable respiratory protection in case of aerosol/dust formation. P3 filters are recommended. Safety glasses with side-shields. Goggles. Wear protective gloves/clothing. Practical experience has shown that gloves of nitrile rubber, butyl rubber, latex, and polyvinyl chloride (PVC) offer sufficient protection. Protective gloves complying with EN 374. Avoid dispersion to the environment. 9. PHYSICAL AND CHEMICAL PROPERTIES General Information Physical state Appearance Odour Fine granular Light brown Odorless Other information: ph Not determined Flash point Not applicable. Boiling Point/Range Not determined Autoignition temperature Not applicable. Vapour pressure Not determined Viscosity No information available Water solubility Soluble Specific Gravity No information available Evapouration rate No information available Vapour density Not determined Decomposition temperature Not determined Flammability Limits in Air Not applicable. Explosion limits Not determined Melting point/range Not determined Freezing point Not determined Page 4 / 8

5 10. STABILITY AND REACTIVITY Stability Conditions to avoid Incompatible products Stable under normal conditions. None known. None known. Hazardous decomposition products None known. Hazardous polymerisation Hazardous polymerisation does not occur. 11. TOXICOLOGICAL INFORMATION Product Information Ingestion Skin contact Eye contact Sensitization Reproductive effects Carcinogenicity There is no data available for this product. There is no data available for this product. May cause irritation. There is no data available for this product. of enzyme mist/dust may cause allergic respiratory reactions, including asthma, in susceptible individuals on repeated exposure. This product does not contain any known or suspected reproductive hazards. Contains no ingredient listed as a carcinogen. Component Information Component information below is as complete as possible. Any fields not shown indicate no data is presently available. Subtilisins (proteolytic Oral Dermal Eye irritation Skin irritation Respiratory irritation Sensitisation Reproductive effects Xylanase Oral Dermal Eye irritation Skin irritation Sensitisation LD50/oral/rat > 2000 mg/kg LD50/dermal/rabbit > 2 ml/kg. LC50/inhalation/4h/rat 0.8 mg/l Contact with eyes may cause irritation. May cause skin irritation. Patch test on human volunteers did not demonstrate sensitisation properties. In a 90-day feeding study with rats, no evidence of toxicity attributed to treatment was seen at levels up to ppm/d. A NOAEL was established at > ppm/d. Negative in chromosomal aberration using human lymphocytes. Negative in Ames assay with and without metabolic activation up to 5000 µg/plate. Not expected to produce reproductive or developmental toxicity. LC50/inhalation/4h/rat > 5.1 mg/l May cause sensitisation by inhalation Page 5 / 8

6 11. TOXICOLOGICAL INFORMATION In a 91-day feeding study in rats, the NOAEL can be established at > 37,500 U/kg/day. Negative in Ames assay up to 5000 µg/plate. Negative in chromosome aberration studies using Chinese hamster ovary cells. Alpha Amylase Oral Eye irritation Skin irritation Endo 1,4 beta-glucanase Oral LD50/oral/rat 2000 mg/kg Single dose rat LC mg/l Not an irritant. Not an irritant. In a 90-day study with rats, the NOEL was found to be 1000 ppm. In a 14-day feeding study with rats, a NOAEL was established at 5,000 ppm. Data from similar enzyme. Negative in Ames assay with and without metabolic activation up to 5000 µg/plate. Negative in chromosome aberration using human lymphocytes with and without metabolic activation up to 5000 µg/ml. Data from similar enzyme. LD50/oral/rat 2000 g/kg. LC50/inhalation/4h/rat 2.42 mg/l In a 90-day study in rats, there were no indications of toxicity or other changes attributed to treatment. A NOAEL can be established at 2000 mg/kg/d. Negative in the Ames test. Negative in chromosomal aberration using human lymphocytes. 12. ECOLOGICAL INFORMATION Ecotoxicity effects Mobility Persistence and degradability Bioaccumulative potential Contains no substances known to be hazardous to the environment or that are not degradable in waste water treatment plants. Soluble. Enzymes are considered readily biodegradable. Bioaccumulation is unlikely. Component Information Chemical Name Toxicity to algae Toxicity to fish Toxicity to daphnia Biodegradation Subtilisins (proteolytic LC50: 16 mg/l (96 h) NOEC: 0,5 mg protein/l Rainbow trout (48 h) NOEC: 0.63 mg protein/l (48 h) Selenastrum capricornutum Average degradation was 55-79% over the test period of 28 days. Page 6 / 8

7 13. DISPOSAL CONSIDERATIONS Waste from residues / unused products Empty packaging Dispose of as hazardous waste in compliance with local and national regulations. Dispose of in accordance with the European Directives on waste and hazardous waste. Empty containers should be taken to an approved waste handling site for recycling or disposal. Dispose of in accordance with local regulations. 14. TRANSPORT INFORMATION Dangerous goods Not dangerous goods in the meaning of ADR/RID, ADNR, IMDG-Code, ICAO/IATA-DGR. 15. REGULATORY INFORMATION Contains Hazardous classification : Beta glucanase, Xylanase, Alpha-amylase and Subtilisins (proteolytic (granule enzyme blend). Xn - Harmful R-phrase(s) R42 - May cause sensitisation by inhalation S-phrase(s) S22 - Do not breathe dust S24 - Avoid contact with skin S36/37 - Wear suitable protective clothing and gloves National regulatory information. Germany Water Endangering Classes (WGK): WGK: 1 Chemical Name TA Luft List (Germany) Occupational Illnesses (R-463-3, France) Subtilisins (proteolytic RG63 Xylanase RG63 Alpha Amylase RG 63 Page 7 / 8

8 16. OTHER INFORMATION Full text of R-phrases referred to under sections 2 and 3 R42 - May cause sensitisation by inhalation. Issuing date 05/11/2010 Recommendations on Use Training advice Literature data and/or investigation reports are available from the manufacturer. Details on the safe handling of enzymes can be found in the 'AMFEP Guide to the Safe Handling of Enzymes' ( This safety datasheet complies with the requirements of Regulation (EC) No. 1907/2006 Disclaimer The information provided on this SDS is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guide for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered as a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other material or in any process, unless specified in the text End of Safety Data Sheet Issuing date 05/11/2010 Page 8 / 8 EU REACH format