SAFETY DATA SHEET According to the Regulation 1907/2006/EC (REACH) and Regulation 2020/878/EC in force Issued: 02.02.2019. Revisioned: 28.06.2024. SECTION 1: IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND THE COMPANY / ENTERPRISE 1.1. Product ID Name of the material: ELICE VAKCINA Additional name: VACCINE ELICE EK-number: N/A REACH-registration number: No registration required CAS-number: Mixture, cannot be specified 1.2. Properly identified use or rather contra-indicated use of the substance / mixture Appropriate identified use: Plant conditioning preparation Contraindicated uses: Not applicable Justification of contra-indicated uses: N/A 1.3. Details of the supplier of the safety data sheet Manufacturer/Supplier: Research Institute for Medicinal Plants and Herbs Ltd. 1.4. Emergency phone number Health Toxicology Information Service (ETTSZ) Nagyvárad tér 2., H-1096 Budapest Phone number: +36-80/201-199 (can be called free of charge, only from Hungary) +36-1/476-6464 (calls can also be made from abroad for a standard fee) SECTION 2: IDENTIFICATION OF THE HAZARD 2.1. Classification of the substance or mixture According to Regulation (EC) 1272/2008, the product is classified as: mixture. 2.2. Label elements According to Regulation (EC) No. 1272/2008 (CLP) it is not classified as a dangerous substance or mixture. Precautionary statements: Prevention P102 – Keep away from children P264 – After use, hands should be washed thoroughly. P270 – Do not eat, drink or smoke while using the product. P280 – The use of protective gloves and clothing, goggles and face-shield is mandatory. Intervention P305 + P35l+ P338 In case of CONTACT WITH EYES: Rinse with water for several minutes. If necessary, remove contact lenses, if it can be easily solved. Continue rinsing. If eye irritation persists, consult a doctor. 2.3. Other hazards Endocrine disrupting properties – Toxicity and Ecotoxicity This substance/mixture does not contain ingredients with endocrine disrupting properties at levels of 0.1% or higher as defined in point f) of Article 57 of the REACH regulation, the commission delegated Regulation (EU) 2017/2100 or according to Commission Regulation (EU) 2018/605. Results of PBT and vPvB assessment The raw material/mixture does not contain components that can be considered persistent, very bioaccumulative and toxic (PTB) or very persistent bioaccumulative (vPvB) substances in the environment at a concentration of 0.1% or higher. SECTION 3: INFORMATIONS ON INGREDIENTS/COMPOSITION 3.2. Mixture: not applicable SECTION 4: FIRST AID MEASURES 4.1. Description of first aid measures EYE: in case of eye contact, see P305,+P351+P338 in point 2. INGESTION: no instructions are necessary in case of ingestion. 4.2. The most important – acute and delayed – symptoms and effects There is no data available for the product. SECTION 5: Fire protection measures Fire and explosion hazard classification: the product is not flammable and not required to be marked! SECTION 6: ACTIONS AT ACCIDENTAL EXPOSURE 6.1. Personal precautions, personal protective equipment and emergency procedures See section 8. 6.2. Environmental precautions Prevent the spread of the spilled material. 6.3. Methods and materials of territorial delimitation and decontamination Large amounts of leaked or spilled material must be soaked up with an inert absorbent material (sand, soil) and collected in a closed, labeled container. The contaminated material must be disposed of in accordance with the regulations. 6.4. Reference to other sections See section 7 for information on safe storage. See section 8 for information on personal precautions and personal protection. See section 13 for waste treatment information. SECTION 7: HANDLING AND STORAGE 7.1. Precautions for safe handling Keep out of reach of children! Storage: to be stored below 30 ºC in a dry, cool but frost-free place, protected from light, in original, closed packaging. 7.2. Conditions for safe storage, including possible conflicts of interest The bottle must be kept in a dry place in its original, closed packaging. 7.3. Specified end use (end uses) Plant conditioner. SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1. Control parameters Workplace limit values of the components (5/2020. (II.6.) ITM regulation): N/A 8.2. Exposure control Personal protective equipment is not required if the product is used correctly and as intended. Avoid getting the substance into the eyes. 8.2.1 Adequate technical inspection Not necessary. 8.2.2 Personal precautions such as personal protective equipment Eating, drinking and smoking are prohibited during the production and use of the product! Protective measures for production: Respiratory protection: face shield. Hand protection: protective gloves. Eye and face protection: Use of protective gloves/protective clothing/face shield is mandatory. Body protection: Standard work clothes or light protective clothing, chemical-resistant work shoes or boots. Contaminated clothing should be removed and washed before reuse. Work hygiene: Hands must be washed before breaks between productions and at the end of work. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES 9.1. Information on basic physical and chemical properties a) Phase (matter): liquid b) Color: mustard yellow c) Odor, odor threshold: herbal scent d) Melting point / freezing point: no data available e) Boiling point or initial boiling point and boiling point range: no data available f) Flammability: not flammable g) Upper and lower explosion limits: no data available h) Flash point: no data available i) Autoignition temperature: no data available j) Decomposition temperature: no data available k) pH (in original material): 4.80 l) Kinematic viscosity: no data available m) Solubility: it is freely miscible with water n) N-octanol/water partition coefficient (log value): no data available o) Vapor pressure: no data available p) Density and/or relative density: 0.980 g/ml (20 ºC) q) Relative vapor density: no data available r) Particle characteristics: no data available 9.2. Other informations 9.2.1. Information on physical hazard classes Does not exist. 9.2.2. Other safety features Does not exist. SECTION 10: STABILITY AND RESPONSIVENESS 10.1. Responsiveness No dangerous reactions are expected with proper treatment. 10.2. Chemical stability Stable under normal conditions. 10.3. Possibility of dangerous reactions Under normal conditions of storage and use, dangerous reactions do not occur. 10.4. Conditions to avoid Does not exist. 10.5. Incompatible materials Strong oxidizing substances (strong inorganic acids, nitric acid, perchlorates, peroxy compounds, perchloric acid, permanganates, etc.). 10.6. Hazardous decomposition products Not known. SECTION 11: TOXICOLOGICAL INFORMATION 11.1. Information on the hazard classes defined in Regulation (EC) No. 1272/2008 Product details: a) acute toxicity (rat, oral, 10h): not expected in case of intended use. b) skin corrosion/skin irritation: skin irritation is possible c) serious eye damage/eye irritation: in contact with the eyes, it may cause slight irritation d) respiratory or skin sensitization: Vapors in high concentrations can cause mucous membrane irritation, or long-term inhalation has a narcotic effect, causing drowsiness, dizziness, euphoria. e) germ cell mutagenicity: Based on available information, it is not mutagenic f) carcinogenic effect: not known g) reproductive toxicity: not known h) target organ toxicity after single exposure (STOT) no data available i) target organ toxicity after repeated exposure (STOT): no data available j) aspiration hazard: no data available 11.2. Other hazard information 11.2.1. Endocrine disrupting properties Assessment: This substance/mixture does not contain ingredients with endocrine disrupting properties at levels of 0.1% or higher as defined in point f) of Article 57 of the REACH regulation, the commission delegated Regulation (EU) 2017/2100 or according to Commission Regulation (EU) 2018/605. 11.2.2. Other informations No further information. SECTION 12: ECOLOGICAL INFORMATION General description: With professional handling and use, no environmental problems are expected. 12.1. Toxicity It is not expected if the mixture is used as intended. 12.2. Persistence and degradability Not specified for the mixture. 12.3. Bioaccumulative potential Not specified for the mixture. 12.4. Mobility in soil It does not accumulate in the environment. 12.5. Results of PBT and vPvB assessment The substance is not classified as PBT and vPvB according to Annex XIII of Regulation (EC) 1907/2006 of the European Parliament and Council. 12.6. Endocrine disrupting properties No data available. Other adverse effects No data available. SECTION 13: DISPOSAL CONSIDERATIONS 13.1. Waste management methods Specifications for the product: rhe remainder of the material is not considered hazardous waste. Packaging regulations: the emptied roll can be treated as municipal waste after washing with water. SECTION 14: SHIPPING INFORMATION 14.1. UN- number or identification number Not classified. 14.2. UN proper shipping name: It does not apply. 14.3. Transport hazard class(es): – 14.4. Packing group: – 14.5. Environmental hazards: No environmental hazard. 14.6. Special precautions for the users: No special precautions are necessary. 14.7. Shipping in bulk by sea according to IMO regulations No information available SECTION 15: REGULATORY INFORMATION 15.1. Safety, health and environmental protection regulations / legislation related to the substance or mixture Laws and Regulations: · Act No. XXV of 2000 on chemical safety · EüM decree No. 44/2000. (XII.27.) on detailed rules for certain procedures and activities related to dangerous substances and dangerous preparations · Regulation (EC) No 1272/2008 – classification, labelling and packaging of substances and mixtures (CLP) · EU Regulation 1907/2006 (REACH) on the registration, evaluation, authorization and restriction of chemicals · COMMISSION REGULATION (EU) 2015/830 requirements related to the preparation of safety data sheets · ITM decree No. 5/2020. (II.6.) on the protection of the health and safety of workers exposed to chemical pathogenic factors · VM decree No. 72/2013. (VIII.27) on the waste list · Act No. LXXXIX. of 2015. on the promulgation of Annexes „A” and „B” of the European Agreement on the International Carriage of Dangerous Goods by Road, as well as on certain issues of its domestic application · ITM Decree No. 39/2021. (VII. 30.) on the domestic application of Annexes „A” and „B” of the European Agreement on the International Carriage of Dangerous Goods by Road (ADR) · NFM decree No. 62/2013. (X. 17.) on the domestic application of the Regulation on the International Carriage of Dangerous Goods by Rail (RID) · Act No. LXXXIV of 2015 dated May 26, 2000 in Geneva on the promulgation and domestic application of the Regulations attached to the European Agreement on the International Carriage of Dangerous Goods by Inland Waterway (ADN) · NGM decree No. 34/2014. (X. 30.) on the requirements for the distribution of aerosol products and aerosol packaging · Council Directive 75/324/EEC on the approximation of national legislation on aerosol dispensers · BM Decree No. 54/2014. (XII. 5.) on the National Fire Protection Regulations · Regulation 878/2020/EC (June 18, 2020) amending Annex II to Regulation (EC) No. 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). 15.2. Chemical safety assessment No chemical safety assessment is required. SECTION 16: OTHER INFORMATION a. Reference to review points: This safety data sheet was created from the safety data sheet MSDS-013-0. Revised and amended according to Regulation 878/2020/EC (June 18, 2020). b. Abbreviations and acronyms used in the safety data sheet: CAS: Chemical Abstracts Service AK-value: average concentration (allowed average concentration that does not normally have a harmful effect on the worker’s health) CK-value: peak concentration (maximum concentration exceeding the АК value allowed for a short period of time) LD50: Lethal Dose LC50: Lethal Concentration EC50: Effective Concentration UN: four-digit identification number (UN number, United Nations Organization) ADR: European Agreement on the International Carriage of Dangerous Goods by Road RID: Regulations on the International Transport of Dangerous Goods by Rail CLP Regulation: (European Regulation on Classification, Labelling and Packaging of chemical substances) European Union regulation on the classification, labeling and packaging of dangerous substances and mixtures. REACH Regulation: Registration, Evaluation, Authorisation and Restriction of Chemicals; lays down regulations related to the registration, evaluation, authorization and restriction of chemical substances EGK: The European Economic Community, also known in English (and Hungarian) as the Common Market, was an international organization EK: European Community NGM: The Ministry of National Economy – instead of the previous Ministry of Finance ITM: Ministry of Innovation and Technology c. Sources and references of the data used to compile the data sheet: https://echa.europa.eu/hu/, és https://pubchem.ncbi.nlm.nih.gov/ d. Other information and data: The classification of the mixture was determined based on the hazardous properties of the components and the packaging. |