EFF. Date : 13-03-20 Better Pharma Co., Ltd. Page 1 of 6 Superseded Revision No : 2 Document Code : BP-SUP-SDLN-60-018 Revision No. : 3 EFF. Date of Superseded Rev. : 01-05-19 Document Title : Safety Data Sheet of Nexgen Gel 800 (ENG) Issued by : Proprietary Information : This document and the contents here of are considered proprietary and confidential information of Better Pharma Co., Ltd, Thailand. Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without the prior written consent of Better Pharma, Thailand. Filename : BP-SUP-SDLN-60-018 Rev.3 Safety Data Sheet of Nexgen Gel 800 (ENG) SDS Safety Data Sheet of Nexgen Gel 800 Change History Rev No. DAR No. Description Effective Date 0 N/A Initial 01-08-15 1 BP-SUP-SDLN60-023 - แก ้ไขข ้อมูลการใชงานให ้เป็นปัจจุบัน ้ 16-10-18 2 BP-SUP-SDLN60-039 - แก ้ไขเพิ่มหัวข ้อ "Flash point" - เพิ่มข ้อมูลการใชงานให ้เป็นปัจจุบันมากขึ้น ้ 01-05-19 3 BP-SUP-SDLN60-057 - แก ้ไขตามข ้อก าหนดตามการใชงานที่เป็นปัจจุบัน ้ 13-03-20 Documentation Responsibility Documentation Responsibility Name Title Signature Date Written by Sasitorn Prasantanakorn Senior Researcher Sasitorn Prasantanakorn 12/03/2020 Reviewed by Piyachat Kiattiphansodsai Senior Department ManagerProduct Development Piyachat Kiattiphansodsai 12/03/2020 Reviewed by Sanya Hokputsa Pharmaceutical Product R&D Director Sanya Hokputsa 12/03/2020 Reviewed by Chalermpan Boonchum Senior Safety Health and Environment Department Manager Chalermpan Boonchum 13/03/2020 Approved by Sumaporn Khaokham Quality Assurance Director Sumaporn Khaokham 13/03/2020 Printed by Tassanee Sinlapasorn on 13/03/2020 19:13 (Effective Date : 13/03/2020)
EFF. Date : 13-03-20 Better Pharma Co., Ltd. Page 2 of 6 Superseded Revision No : 2 Document Code : BP-SUP-SDLN-60-018 Revision No. : 3 EFF. Date of Superseded Rev. : 01-05-19 Document Title : Safety Data Sheet of Nexgen Gel 800 (ENG) Issued by : Proprietary Information : This document and the contents here of are considered proprietary and confidential information of Better Pharma Co., Ltd, Thailand. Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without the prior written consent of Better Pharma, Thailand. Filename : BP-SUP-SDLN-60-018 Rev.3 Safety Data Sheet of Nexgen Gel 800 (ENG) 1. Identification of the substance and of the supplier 1.1 Product Name : Nexgen Gel 800 1.2 Application : Waterless hand cleaner. 1.3 Manufacture address : Better Phama Co.,Ltd. 216 Moo 1 Saraburi-Lomsak Road, Chongsarilka, Pattananikom, Lopburi 15220 Thailand Tel. (036) 638610-21, Fax (036) 638-333 2. Hazards identification : 2.1 Classification of Substance GHS 2.1.1 Flammable liquids (Category 2) 2.1.2 Serious eye damage/eye irritation (Category 2A) 2.2 Pictograms GHS Signal Word : DANGER 2.3 Hazard Statements H225 Flammable liquid and vapor H319 Causes serious eye irritation 2.4 Precautionary statements Prevention : P210 Keep away from heat, hot surfaces, open flames, sparks. - No smoking. P233 Keep container tightly closed. Response : P305 + P351+ P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337 + P313 If eye irritation persists: Get medical advice or attention. Storage : P403 + P235 Store in a well-ventilated place. Keep cool. Disposal : P501 Dispose of contents/ container to an approved waste disposal plant. Printed by Tassanee Sinlapasorn on 13/03/2020 19:13 (Effective Date : 13/03/2020)
EFF. Date : 13-03-20 Better Pharma Co., Ltd. Page 3 of 6 Superseded Revision No : 2 Document Code : BP-SUP-SDLN-60-018 Revision No. : 3 EFF. Date of Superseded Rev. : 01-05-19 Document Title : Safety Data Sheet of Nexgen Gel 800 (ENG) Issued by : Proprietary Information : This document and the contents here of are considered proprietary and confidential information of Better Pharma Co., Ltd, Thailand. Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without the prior written consent of Better Pharma, Thailand. Filename : BP-SUP-SDLN-60-018 Rev.3 Safety Data Sheet of Nexgen Gel 800 (ENG) 3. Composition / Information on Ingredients Components CAS No. % By volume Ethanol 64-17-5 70.00 Other non hazardous ingredients Not Applicable qs.to 100.00 4. First Aid Measures 4.1 First Aid Measures 4.1.1 Eye contamination 4.1.1.1 Rinse cautiously with water for 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical advice/attention. 4.1.2 Skin contamination 4.1.2.1 No skin irritation. 4.1.3 Inhalation 4.1.3.1 Get medical attention if symptoms occur. 4.1.4 Ingestion 4.1.4.1 Rinse mouth. Get medical attention if symptoms occur. 5. Fire Fighting Measures 5.1 Suitable extinguishing media 5.1.1 Dry chemical, CO2, water spray or all-purpose-type foam. 5.2 Non-suitable extinguishing media 5.2.1 Not Applicable. 5.3 Hazards caused by the chemicals 5.3.1 Development of hazardous combustion gases or vapors possible in the event of fire. 5.4 Special protective equipment for fire-fighters 5.4.1 Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode. 6. Accidental Release Measures 6.1 Personal Precautions 6.1.1 Use appropriate safety equipment. 6.1.2 Evacuate area. 6.1.3 Keep people away from and upwind of spill. 6.1.4 Ventilate area of leak or spill. 6.1.5 Only trained and properly protected personnel must be involved in clean-up operations. 6.1.6 Do not spray or aerosolize the undiluted form of the product. Full personal protective equipment is required for dilutions or mixtures of the product used in spray application. 6.1.7 Absorb the spill with an inert material and put the spilled material in an appropriate waste disposal. Printed by Tassanee Sinlapasorn on 13/03/2020 19:13 (Effective Date : 13/03/2020)
EFF. Date : 13-03-20 Better Pharma Co., Ltd. Page 4 of 6 Superseded Revision No : 2 Document Code : BP-SUP-SDLN-60-018 Revision No. : 3 EFF. Date of Superseded Rev. : 01-05-19 Document Title : Safety Data Sheet of Nexgen Gel 800 (ENG) Issued by : Proprietary Information : This document and the contents here of are considered proprietary and confidential information of Better Pharma Co., Ltd, Thailand. Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without the prior written consent of Better Pharma, Thailand. Filename : BP-SUP-SDLN-60-018 Rev.3 Safety Data Sheet of Nexgen Gel 800 (ENG) 6.1.8 Keep the spilled material with in sealed containers for disposal. 6.2 Environmental precautions. 6.2.1 Prevent from entering into soil, ditches, sewers, waterways and/or groundwater. 7. Handling and Storage 7.1 Precautions for safe handling 7.1.1 Keep away from fire, sparks and heated surfaces. 7.2 Conditions for safe storage 7.2.1 Keep tightly closed in a dry, cool and well-ventilated place. 7.2.2 Keep away from heat and sources of ignition. 8. Exposure Controls / Personal Protection 8.1 Exposure Standards (TLVs) 8.1.1 Ethanol NIOSH REL : 1000 ppm (1,900 mg/m3) TWA OSHA PEL : 1000 ppm (1,900 mg/m3) TWA 8.2 Appropriate engineering controls 8.2.1 Good general ventilation requirements. 8.3 Personal Protective equipment 8.3.1 No special ventilation requirements. 9. Physical and Chemical Properties 9.1 Appearance : Clear, blue gel 9.2 Odor : Alcohol-like 9.3 Odor threshold : No data available 9.4 pH (100%) : 6.80 – 7.50 9.5 Specific gravity (25C) : 0.790 – 0.990 9.6 Melting point / freezing point : No data available 9.7 Initial boiling point and boiling range : 100.3 oC 9.8 Flash point : Not flash up to 100.3 oC 9.9 Evaporation rate : No data available 9.10 Flammability : No data available 9.11 Upper/lower flammability or explosive limits (%,v/v) Lower explosion limit : No data available Upper explosion limit : No data available 9.12 Vapor pressure : No data available 9.13 Vapor density (Air = 1) : No data available 9.14 Relative density (Water = 1) : No data available 9.15 Solubility : No data available Printed by Tassanee Sinlapasorn on 13/03/2020 19:13 (Effective Date : 13/03/2020)
EFF. Date : 13-03-20 Better Pharma Co., Ltd. Page 5 of 6 Superseded Revision No : 2 Document Code : BP-SUP-SDLN-60-018 Revision No. : 3 EFF. Date of Superseded Rev. : 01-05-19 Document Title : Safety Data Sheet of Nexgen Gel 800 (ENG) Issued by : Proprietary Information : This document and the contents here of are considered proprietary and confidential information of Better Pharma Co., Ltd, Thailand. Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without the prior written consent of Better Pharma, Thailand. Filename : BP-SUP-SDLN-60-018 Rev.3 Safety Data Sheet of Nexgen Gel 800 (ENG) 9.16 Partition coefficient : n-octanol/water (Log Kow) : No data available 9.17 Auto-ignition temperature : No data available 9.18 Decomposition temperature : No data available 9.19 Viscosity : No data available 10. Stability and Reactivity 10.1 Chemical stability 10.1.1 Stable under normal conditions. 10.2 Decomposition 10.2.1 Decomposition products depend upon temperature, air supply and the presence of other materials. Combustion products may include and are not limited to: carbon monoxide, carbon dioxide. 10.3 Conditions to avoid 10.3.1 Keep away from open flames, hot surfaces and sources of ignition. 10.3.2 Do not store in direct sunlight. 10.4 Incompatible materials 10.4.1 Oxidizing materials. 10.4.2 Do not mix with other chemicals. 11. Toxicological Information 11.1 Information on likely routes of exposure 11.1.1 Eyes : Causes eye irritation. 11.1.2 Skin : No symptoms known or expected. 11.1.3 Ingestion : No symptoms known or expected. 11.1.4 Inhalation : No symptoms known or expected. 11.2 Toxicity 11.2.1 Acute oral toxicity (LD50, rat) : >5,000 mg/kg 11.2.2 Acute inhalation toxicity (LC50) : No data available 11.2.3 Acute dermal toxicity : No data available 11.2.4 Skin corrosion/irritation : No data available 11.2.5 Serious eye damage/irritation : Causes eye irritation. 11.2.6 Respiratory or skin sensitization : No data available 11.2.7 Germ cell mutagenicity : No data available 11.2.8 Carcinogenicity : No data available 11.2.9 Reproductive toxicity : No data available 11.2.10 Specific target organ toxicity : No data available (single exposure) 11.2.11 Specific target organ toxicity : No data available (repeated exposure) 11.2.12 Aspiration hazard : No data available Printed by Tassanee Sinlapasorn on 13/03/2020 19:13 (Effective Date : 13/03/2020)
EFF. Date : 13-03-20 Better Pharma Co., Ltd. Page 6 of 6 Superseded Revision No : 2 Document Code : BP-SUP-SDLN-60-018 Revision No. : 3 EFF. Date of Superseded Rev. : 01-05-19 Document Title : Safety Data Sheet of Nexgen Gel 800 (ENG) Issued by : Proprietary Information : This document and the contents here of are considered proprietary and confidential information of Better Pharma Co., Ltd, Thailand. Disclosure to unauthorized individuals or dissemination, publication or copying is prohibited without the prior written consent of Better Pharma, Thailand. Filename : BP-SUP-SDLN-60-018 Rev.3 Safety Data Sheet of Nexgen Gel 800 (ENG) 12. Ecological Information 12.1 Ecotoxicity : No data available 12.2 Persistence and degradability : No data available 12.3 Bioaccumulation potential : No data available 12.4 Mobility in Soil : No data available 13. Disposal Considerations 13.1 Dispose of this material and its container at hazardous or special waste collection point. Hazardous waste due to toxicity. Avoid release to the environment. Dispose in a safe manner in accordance with local/national regulations. 14. Transport Information 14.1 UN number : 1170 14.2 Proper Shipping Name : ETHANOL 14.3 Danger Class (ADR/RID) : Class 3 14.4 Packaging group : II 14.5 Label : No data available 14.6 Marine pollution : No data available 15. Regulatory Information 15.1 Thailand 15.1.1 Thailand implemented GHS through the Hazardous Substance Act and Hazard Classification and Communication System of Hazardous Substances B.E. 2555 (2012). 16. Other Information 16.1 Created date : 16/04/2020 16.2 Reference 16.2.1 European Chemicals Agency (ECHA), https://echa.europa.eu 16.2.2 The National Institute for Occupational Safety and Health(NIOSH): NIOSH Pocket Guide to Chemical Hazards, http://www.cdc.gov/niosh/npg/npgdcas.html 16.2.3 United Nations Recommendations on the Transport of Dangerous Goods (UNRTDG) 16.2 Disclaimer 16.2.1 This information relates only to the specific material designated and may not be valid for such a material used in conjunction with any other materials or in any process. Such information is, to the best of the company’s knowledge and belief, accurate and reliable as of the date indicated. However, no warranty, quarantine or representation is made as to its accuracy, reliability or completeness. It is the user’s responsibility to satisfy himself as to the suitability of such information for his own particular use. Printed by Tassanee Sinlapasorn on 13/03/2020 19:13 (Effective Date : 13/03/2020)