23-0015
23-0015
Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration July 17, 2023 Marcel Cisneros President UralKali Trading 3031 N Rocky Point Dr. Suite 115 Tampa, FL 33607 Reference No. 23-0015 Dear Mr. Cisneros: This letter is in response to your March 1, 2023, letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the classification of ammonium nitrate-based fertilizer. Specifically, you request classification of your material, known by the trade name of “NS 30:7.” Under § 173.22, it is the shipper’s responsibility to properly classify a hazardous material in accordance with classification criteria provided in the HMR prior to offering it for transportation to—or within—the United States. This Office does not normally perform this function. In accordance with Special Provision 150 of § 172.102, ammonium nitrate-based fertilizer must be classified using the procedures of the UN Manual of Tests and Criteria, Part III, Section 39, “Classification Procedure and Criteria Relating to Solid Ammonium Nitrate Based Fertilizers” (incorporated by reference, see § 171.7). If your material meets the composition and testing requirements described in Section 39 for classification as UN 2067, a competent authority approval is not needed for transportation. If your material does not fulfill the requirements for UN 2067, you may need to obtain a competent authority approval prior to offering it for transportation, in accordance with § 107.709. 1200 New Jersey Avenue, SE Washington, DC 20590 I hope this information is helpful. Please contact us if we can be of further assistance. Sincerely, Dirk Der Kinderen Chief, Standards Development Branch Standards and Rulemaking Division#
Page 2URALKALI UKT CHICAGO, INC 3031 N Rocky Point Dr W, Suite 155, Tampa, FL 33607 Phone: 847-212-5715 Email: usa@uralkali-trading.com Patrick 23-0015 March 1, 2023 Mr. Shane Kelley Director, Standards and Rulemaking Division U.S. DOT/PHMSA (PHH-10) 1200 New Jersey Avenue, SE East Building, 2nd Floor Washington, DC 20590 Dear Shane, Please accept our formal request for an official classification by the US DOT/PHMSA of a Russian produced fertilizer called NS 30:7. We have included the Spec Sheet and the European MSDS sheet for this product, for your reference. We are at your disposal to provide any additional information required. Please let us know what you need in order to provide Uralkali with an official US DOT/PHMSA product classification. I can be reached via email or phone at 847-2120408 or m.cisneros@uralkali-trading.com for further discussion. We appreciate your help and consideration.#
Page 3PRODUCT DATA SHEET MANUFACTURER'S NAME AND ADDRESS: YURALCHEM KCKK Branch of Uralchem JSC in Kirovo-Chepetsk www.uralchem.com Pozharny Pereulok 7, Kirovo-Chepetsk Tel.: +7 (83361) 9-42-24, Kirov Oblast, 613040, Russia E-mail: kckk@uralchem.com Fax: +7 (83361) 9-43-62, NS 30:7 URALCHEM's innovative product. Combination of ammoniacal and nitric forms of nitrogen provides Perfectly balanced ratio of Nitrogen: Sulphur. Improves quality of grain, increases oil content in oil crops, plant nutrition during the entire growing period. as well as protein in cereals. Appearance White to light grey-yellowish granules of which Total nitrogen (N) 30+1% ammoniacal N (N-NHa), min nitric N (N-NO3), max 18% 12% Water-soluble Sulphur S (SO3), min 7% (17.5%) Moisture, max 1% ... . . under 1mm, max Granulometric composition: 2-5 mm, min 1% under 6.3 mm 95% 100% Granule static strength, min 3 MPa Free flowing 100% .......... Packaging and transportation: Should be stored eider love big-bags 50-100 g). R System of Management Certified for Compliance with ISO 9001, ISO 14001 and ISO 45001 The MSDS complying with REGULATION (EC) Nº1907/2006 is available on www.URALCHEM-ASSIST.de Version 08.2020 The latest version is always available on the web-site www.URALCHEM.com#
Page 4Safety Data Sheet According to Regulation (EC) No. 1907/2006 (REACH) with its amendment Regulation (EU) 2020/878 Revision Number: K-5-EN Revision Date: 22-11-2021 SECTION I: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 1.1. Product identifier Product form: Mixture Trade name: NS 30-7 sulphate (CAS 7783-20-2). Synonyms: Sulphonitrate, mixture of ammonium nitrate (CAS 6484-52-2) and ammonium 1.2. Relevant identified uses of the substance or mixture and uses advised against Use of the substance/mixture: Fertilizer. 1.2.1. Relevant identified uses 1.2.2. Uses advised against: No. 1.3. Details of the supplier of the safety data sheet Manufacturer: Uralchem, JSC Presnenskaya Naberezhnaya 6 bldg. 2 Moscow, 123112, Russia Pozharniy Pereulok 7, Kirovo-Chepetsk KCKK Branch of Uralchem JSC in Kirovo-Chepetsk Kirov Oblast, 613040, Russia Tel.: +7 (83361) 9-42-24 E-mail: marketing@uralchem.com Uralchem Assist GmbH Only representative: Johannssenstrasse 10, Tel.: + 49 511 45 99 444 Hannover, D-30159, Germany Email: info@uralchem-assist.com 22/11/2021 (Revision date) EN (English) 1/29#
Page 5E-Mail address for the competent person responsible for the safety data sheet: reach@uralchem.com 1.4. Emergency telephone number +44 (0) 203 394 9870 (Available 24/7) SECTION 2. HAZARDS IDENTIFICATION 2.1. Classification of the substance or mixture xidizing solids, Hazard Category 3; H272 lassification according to Regulation (EC) No. 1272/2008 [CLP Full text of H- and EUH-statements: see section 16 No additional information available Adverse physicochemical, human health and environmental effects 2.2. Label Elements Labelling according to Regulation (EC) No. 1272/2008 [CLP] Hazard pictograms (CLP) : Hazard statements (CLP) Signal word (CLP) : Warning : H272 - May intensify fire; oxidizer Precautionary statements (CLP) : P210 - Keep away from heat, hot surfaces, sparks, open Mao Ked they from stungs, Nother combustible materials. P280 - Wear protective gloves/protective clothing/eye P370+P378 In case of fire: Use water to extinguish. protection/face protection/hearing protection. 22/11/2021 (Revision date) EN (English) 2129#
Page 62.3. Other hazards This substance is not included in the list established in accordance with Article 59(1) of REACH PBT/vPvB: Not applicable (inorganic) for having endocrine disrupting properties or is not identified as having endocrine disrupting 2017/2100 or Commission Regulation (EU) 2018/605. properties in accordance with the criteria set out in Commission Delegated Regulation (EU) SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS Not applicable 3.1 Substance: 3.2 Mixture: Name: Sulphonitrate brand NS 30-7 number EC number CAS Name Concentratio Classification according to Regulation (EC) No 1272/2008 Specific concentration limits/M-Factor under REACH Regulation Registration number 229-347-8 6484-52-2 Ammonium nitrate 69% Oxidising solid 3, H272 Eye Irritation 2, H319 > 80% - <- 100% 231-984-1 7783-20-2 Ammonium Eye Irritation 2, H319 01-2119490981-27-0019 sulphate 29% 01-2119455044-46-0032 Under customer request, the product is processed with an anti-caking additive, registered according to REACH Regulation. Remarks: Mixtures containing less than 80% ammonium nitrate are not classified as irritating to eyes (OECD 405 and OECD 437 studies lead on similar mixtures). SECTION 4. FIRST AID MEASURES 4.1. Description of first aid measures First-aid measures general: if possible). In case of accident or if you feel unwell, seek medical advice immediately (show safety data sheet Self-protection of the first aider: First aid assistant: Pay attention to self-protection! First-aid measures after inhalation: medical advice. Remove casualty to fresh air and keep warm and at rest. Rinse nasal cavity with water. Seek First-aid measures after skin contact: 22/11/2021 (Revision date) EN (English) 3/29#
Page 7After contact with skin, wash immediately with plenty of water and soap. Seek medical advice. First-aid measures after eye contact: In case of contact with eyes, rinse immediately with plenty of flowing water for 10 to 15 minutes holding eyelids apart. Subsequently consult an ophthalmologist. First-aid measures after ingestion: and obtain immediate medical attention. Give activated carbon, in order to reduce the resorption If accidentally swallowed rinse the mouth with plenty of water (only if the person is conscious) in the gastro-enteric tract. 4.2 Most important symptoms and effects, both acute and delayed Symptoms/effects after skin contact Symptoms/effects after eye contact May cause irritation May cause irritation. 4.3. Indication of any immediate medical attention and special treatment needed Treat symptomatically. Get medical advice/attention if you feel unwell. SECTION 5. FIRE-FIGHTING MEASURES 5.1 Extinguishing media Suitable extinguishing media: Water spray. Extinguishing media which must not be used for safety reasons: Foam. Sand. Water steam. 5.2 Special hazards arising from the substance or mixture superphosphate, chloride of lime: Nitrogen oxides (NOx). Can be released in case of fire (>210 °C) and during interaction with sulfur, pyrite sulfur, acids, 22/11/2021 (Revision date) EN (English) 4/29#
Page 85.3 Advice for firefighters Firefighting instructions: Fight fire with normal precautions from a reasonable distance. Protective equipment for firefighters: resistant). Rubber gloves (oil and gasoline resistant). Wear a self-contained breathing apparatus and chemical resistant suit. Rubber boots (heat Helmet. SECTION 6. ACCIDENTAL RELEASE MEASURES 6.1. Personal precautions, protective equipment, and emergency procedures General measures: Provide adequate ventilation. Provide extract ventilation to points where emissions occur. Keep alway from heat ours Lus hot suract park and open flames. For non-emergency personnel Protective equipment: Wear personal protection equipment. Emergency procedures: Evacuate unnecessary personnel. Protective equipment: For emergency responders See protective measures under section 7 and 8. 6.2. Environmental precautions Do not allow water used to extinguish fire to enter drains or waterways. o not allow to enter into soil/subsoil Do not empty into drains or the aquatic environment Wet scrubber for dust elimination of waste gases. 6.3. Methods and material for containment and cleaning up Remove mechanically, placing in appropriate containers for disposal. 22/11/2021 (Revision date) EN (English) 5/29#
Page 96.4. Reference to other sections See protective measures under Section 8 and 13. SECTION 7. HANDLING AND STORAGE 7.1. Precautions for safe handling Do not breathe dust. Provide adequate ventilation. Keep away from heat sources (e.g. hot surfaces), sparks and open flames. Wear personal protection equipment. 7.2. Conditions for safe storage, including any incompatibilities Storage conditions: Storage temperature: <30 °C Keep container tightly closed. Relative room humidity (%): <50% Protect against: Atmospheric precipitation, ground water. Guaranteed shelf life: 6 months after production. For retail: guaranteed shelf life: 18 months after production. Other information: Keep away from children. Keep away from food, drink and animal feedingstuffs. Packaging: PP bags and special plastic disposable containers 7.3. Specific end use(s) Avoid dust production and inhalation. Water dilution product must be used on the same day of preparation. 22/11/2021 (Revision date) EN (English) 6/29#
Page 10SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1. Control parameters 8.1.1. National occupational exposure and biological limit values. Exposure limit values Substance name: 8 h Short term mg/cm' Dust ppm - 10 (inhaled fraction) ppm mg/cm? 8.1.2. Recommended monitoring procedures No additional information available. No additional information available. 8.1.3. Air contaminants formed 8.1.4. DNEL and PNEC Ammonium Nitrate NEL/DMEL: Worker Systemic effects Skin contact - mg/kg bw/day Short term (acute) Inhalation - Local effects Skin contact mg/m? mg/cm? ::: Inhalation mg/m? Systemic effects Skin contact 5.12 mg/kg bw/day Repeated dose toxicity Long term (repeated) Inhalation mg/m? Skin contact Repeated dose toxicity Local effects Inhalation mg/cm? - mg/m' DNEL/MEL: Consumer Short term (acute) effects Systemic Skin contact w/day ng/kg Inhalation mg/m? 22/11/2021 (Revision date) EN (English) 7129#
Page 11Ingestion mg/kg bw/day - Local effects Skin contact mg/cm? Inhalation - mg/m' Systemic Skin contact 2.56 mg/kg bw/day Repeated dose toxicity ffect Inhalation 8.9 mg/m" Long term (repeated) Ingestion 2.56 Repeated dose toxicity Skin contact mg/kg Repeated dose toxicity Local effects Inhalation :: mg/cm? mg/m? Ingestion - mg/kg bw/day - Freshwater PNEC Marine water mg/l mg/l Intermittent releases Sediment mg/l Sediment-marine mg/kg Soil mg/kg Air mg/kg Sewage treatment plant mg/cm? 18 mg/l Extrapolation method Secondary poisoning - mg/kg 8.1.5. Control banding No additional information available. 8.2. Exposure controls 8.2.1. Appropriate engineering controls Provide adequate ventilation. Provide extract ventilation to points where emissions occur. 8.2.2. Personal protection equipment Avoid all unnecessary exposure. Personal protective equipment symbol(s): 22/11/2021 (Revision date) EN (English) 8/29#
Page 128.2.2.1. Eye and face protection: Suitable eye protection: Tightly sealed safety glasses. 8.2.2.2. Skin protection Woolen or cotton suits. Wear suitable working clothes. Leather or rubber boots. Hand protection: Chemical resistant gloves. Suitable material: butyl rubber, neoprene Penetration time (maximum wearing period): < 8h. 8.2.2.3. Respiratory protection Use a suitable respirator. 8.2.2.4. Thermal hazards Wear personal protective equipment. 8.2.3. Environmental exposure controls See section 6. Other information: workplace. Avoid direct contact. Wash hand before breaks and after work. Do not eat, drink or smoke at the SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1. Information on basic physical and chemical properties Physical state: Solid Appearance: Granulate Colour: White to light grey-yellowish granules Odour: Odourless 22/11/2021 (Revision date) EN (English) 9/29#
Page 13Odour threshold: Not applicable (odorless) pH: ≥ 4.5 (10% solution) Melting point/freezing point: 170°C Initial boiling point and boiling range: Decomposes before boiling. Flash point: Not applicable (solid) Flammability (solid, gas): > 600 °C Upper/lower flammability or explosive limits: Not applicable (non-flammable) Explosive properties: Not explosive Oxidising properties: intensify fire: oxidiser. Oxidising Solids, Category 3, H272: May Vapour pressure: REACH for the substances within the No data available (Not required by formulation) Relative density 1.03 - 1.04 g/cm' (bulk density) Solubility: Partially soluble in acetone, ethy alcohols and methyl alcohol (information available for ammonium nitrate). Water solubility: 100% Soluble Partition coefficient: n-octanol/water: Not applicable (inorganic) Viscosity: Not applicable (solid) 22/11/2021 (Revision date) EN (English) 10/29#
Page 14Vapour density: REACH for the substances within the No data available (Not required by formulation) Evaporation rate: REACH for the substances within the No data available (Not required by formulation) Auto-ignition temperature: No data available (Not required by REACH for the substances within the formulation) Decomposition temperature: > 210 °C Particle size: Not available Particle size distribution: Not available Particle shape: Not available Particle aspect ratio: Not available Particle aggregation state: Not available Particle agglomeration state: Not available Particle specific surface area: Not available Particle dustiness: Not available 9.2. Other information 9.2.1. Information with regards to physical hazard classes No data available 9.2.2. Other safety characteristics Relative evaporation rate (butylacetate=1): Not determined 22/11/2021 (Revision date) EN (English) 11/29#
Page 15SECTION 10. STABILITY AND REACTIVITY 10.1. Reactivity See section 10.5 10.2. Chemical stability Not hazardous reaction when handled and stored according to provisions. 10.3. Possibility of hazardous reactions Reacts with: Strong alkalis; Strong acids. 10.4. Conditions to avoid Keep away from: Incompatible materials. Atmosphere influence. Keep away from heat sources (c.g., hot surfaces), sparks and open flames. Welding equipment with traces of fertilizers. 10.5. Incompatible materials Flammable substances, reducers, acids, alkalis, chlorates, chlorides, chromates, nitrites, ermanganates, metal powder, substances containing metals: such as copper, nickel, cobalt inc and their alloys, petroleum products and strong bases: NaOCI 10.6. Hazardous decomposition products Nitrogen and sulfur oxides, ammonia. 22/11/2021 (Revision date) EN (English) 12/29#
Page 16SECTION 11. TOXICOLOGICAL INFORMATION 11.1. Information on toxicological effects: 11.1.1. Acute effects (acute toxicity, irritation and corrosivity): LD50 oral: 2950 mg /kg bw (rat, male/female) DECD 401 (Ammonium nitrate LD50 dermal: > 5000 mg/kgb (rat, male/female) OECD 402 (Ammonium nitrate) LCSO inhalation: No data available Skin corrosion /irritation: Ammonium nitrate: Not an irritant (rabbit) OECD 404 Ammonium nitrate: Serious eye damage/irritation: Irritant (rabbit) OECD 405 Specific target organ toxicity - single exposure: classification criteria are not met. Based on the available data, the 11.1.2. Sensitisation Respiratory sensitisation: No data available Skin sensitisation: Based on the available data, the classification criteria are not met. OECD 429, EU B.42, EPA OPPTS 870.2600 Ammonium nitrate: Not sensitizing (mouse, read-across) 22/11/2021 (Revision date) EN (English) 13/29#
Page 1711.1.3. Repeated dose toxicity: Specific target organ toxicity — repeated exposure: Based on the available data, the classification criteria are not met. Ammonium nitrate: Oral (28 d): NOAEL > 1500 mg/kg bw/day (read-across) (rat; male/female) OECD 422 Oral (52 and 104 weeks): NOAEL: 284 mg/kg bw/day (read-across) (rat; female) NOAEL: 256 mg/kg bw/day (read-across) (rat; male) OECD 453 Ota Y. et al. (2006) Inhalation (2 weeks): NOAEC (systemic) > 185 mg/m? air (rat; male) 11.1.4. CMR effects (carcinogenicity, mutagenicity, and toxicity for reproduction): Ammonium nitrate: Carcinogenicity: No data available. Germ cell mutagenicity: Based on the available data, the classification criteria are not met. Reproductive toxicity: Based on the available data, the classification criteria are not met. Fertility: Oral (28 days): OECD 422 NOAEL (reproduction toxicity) > 1500 mg/kg bw/day (read-across) (rat; male/female) Developmental toxicity: Oral (28 days): OECD 422 NOAEL (developmental toxicity) > 1500 mg/kg bw/day (read-across) (rat; male/female) Reproductive toxicity, effects on or via lactation: No data available. 11.1.5. Aspiration hazard: No data available 22/11/2021 (Revision date) EN (English) 14/29#
Page 1811.2. Information on other hazards 11.2.1. Endocrine disrupting properties: Not classified. Based on available data, the classification criteria are not met. Potential Adverse human health effects and symptoms: Based on available data, the 11.2.2. Other information: classification criteria are not met. SECTION 12. ECOLOGICAL INFORMATION 12.1. Toxicity Acute toxicity to fish LC50: Ammonium nitrate 447 mg/L (freshwater, static) Species: Cyprinus carpio Dabrowska, H. and Sikora, H. (1986) Chronic toxicity to fish NOEC: No data available. Acute toxicity to crustaceans ECS0: Ammonium nitrate: Species: Daphnia magna 490 mg/| (48h) (freshwater, read-across) Dowden, B. F. and Bennett H. J. (1965) 22/11/2021 (Revision date) EN (English) 15/29#
Page 19Chronic toxicity to crustaceans NOEC: No data available. Acute toxicity to algae and other aquatic plants ECSO: Species: Several benthic diatoms Ammonium nitrate > 1700 mg/L (read-across) (10d) (marine water, inhibition of growth rate) Admiraal W. (1977) Toxicity data on soil micro-and macro-organisms and other environmentally relevan rganisms, such as birds, bees, and plants No data available. 12.2. Persistence and degradability The study does not need to be conducted because the substance is inorganic Other relevant information: In water, the substance is completely dissociated. Required removal efficiency (wastewater): Anaerobic conversion of ammonium: Average biodegradation (20 ° C): 52 gN / kg / day. Anaerobic transformation of nitrate: 70 g N/ kg / day.. Average rate of biodegradation (20 ° C): 22/11/2021 (Revision date) EN (English) 16/29#
Page 2012.3. Bioaccumulative potential Experimental BCF: Low bioaccumulation potential Log Pow The study does not need to be conducted because the substance is inorganic. 12.4. Mobility in soil Low adsorption potential. 12.5. Results of PBT and vPvB assessment The study does not need to be conducted because the substance is inorganic. 12.6. Endocrine disrupting properties No additional information available. 12.7. Other adverse effects No data available. SECTION 13. DISPOSAL CONSIDERATIONS 13.1. Waste treatment methods This product and its packaging must be disposed of in a safe way. Generation of waste should 22/11/2021 (Revision date) EN (English) 17/29#
Page 2113.1.1 Product should not be disposed of untreated to the sewer but processed in a suitable effluent treatment Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Waste code 06 10 02 - wastes containing dangerous substances. 13.1.2 Packaging SECTION 14. TRANSPORT INFORMATION In accordance with ADR / IMDG / IATA / ADN / RID ADR IMDG IATA ADN RID 14.1. UN number or ID number UN 2067 UN 2067 Not regulated UN 2067 UN 2067 14.2. UN proper shipping name AMMONIUM AMMONIUM Not regulated AMMONIUM AMMONIUM NITRATE NITRATE NITRATE NITRATE BASED BASED BASED BASED FERTILIZER FERTILIZER FERTILIZER FERTILIZER Transport document description 5.1 5.1 Not regulated 5.1 5.1 14.3. Transport hazard class(es) 14.4. Packing group IlI III Not regulated III IlI 14.5. Environmental hazards 22/11/2021 (Revision date) EN (English) 18/29#
Page 22Not marine Not marine Not regulated Not marine Not marine pollutant. pollutant. pollutant. pollutant. Special precautions for user t is necessary to exclude contact of cargo to heated surfaces from above 50°C Reduces oxygen maintenance in hold atmosphere At humidifying cargo is corrosion active. Overland transport Not applicable Transport by sea Not applicable Air transport Not applicable Inland waterway transport Not applicable Rail transport Not applicable NS 30-7 is transported by rail, road and water transport, in accordance with the rules for the 'arriage of dangerous goods in force for this type of transport (UN 2067) 14.6. Transport in bulk according to Annex IT of Marpol and the IBC Code Not relevant 22/11/2021 (Revision date) EN (English) 19/29#
Page 2314.7. Maritime transport in bulk according to IMO instruments No data available. SECTION 15. REGULATORY INFORMATION 15.1. Safety, health, and environmental regulations/legislation specific for the substance or mixture Regulation (EC) No 2003/2003 of the European Parliament and of the council of 13 October 2003, relating to fertilizers. Directive 2000/60/EC of the European Parliament and of the Council establishing a framework for the Community action in the field of water policy. by Nitrates from Agricultural Sources. Council Directive 91/676/EEC concerning the Protection of Waters against Pollution caused control of major-accident hazards involving dangerous substances. Directive 2012/18/EU of the European Parliament and of the council of 4 July 2012, on the 15.2. Chemical safety assessment For this substance a chemical safety assessment has been carried out. SECTION 16. OTHER INFORMATION 16.1. Indication of changes: Version N° K-5-EN of 22.11.2021 According to Regulation (EU) 2015/830, 2020/878 (REACH Annex II): Change of revision number: K-5-EN. Change of revision date: 22-11-2021. Section 2.3: Other hazards - Added confirmation the product does not contain substances for Section 1.1: Product identifier - Added Product form: Mixture. having endocrine disrupting properties. Section 4.1: Description of first aid measures - Information was divided into the following catorskin coita, first sure asures, Fre ae doesuris aid measures after ang escasures Section 4.2: Added a separate sub-heading for Most important symptoms and effects, both acute and delayed. 22/11/2021 (Revision date) | EN (English) 20/29#
Page 24Section 4.3: Added a separate sub-heading for Indication of any immediate medical attention and special treatment needed. Section S: Added separate sub-headings for Extinguishing media; Special hazards arising from the substance or mixture; Advice for firefighters. Section 6: Added separate sub-headings for Personal precautions, protective equipment, and emergency procedures; Environmental precautions; Methods and material for containment and cleaning up; Reference to other sections. limit values; Recommended monitoring procedures; Air contaminants formed; DNEL and Section 8.1: Added separate sub-headings for National occupational exposure and biological PNEC; Control banding. Section 9: Updated Information on basic physical and chemical properties section 8.2.2: Added Personal protective equipment symbols. Section 12: Updated Ecological information. Section 11: Updated Toxicological information. Section 14: Updated format in a table. and EUH-statements. Section 16: Updated Indications of changes. Added Sources of Key data. Added Full text of H- Version Ne K-4-EN Section 3.2: Clarified classification of the mixture upon contact with eyes. Version Ne K-3-EN Section 13: Adding information on Disposal considerations. Section 15.1: Added Directive 2012/18/EU. Version N° K-2-EN Section 1.3: Change of Manufacturer's name. Section 2.1: Classification per Directive 1999/45/EEC deleted as no longer applicable, effective 1 June 2015. Section 3: Classification per Directive 67/548/EEC deleted as no longer applicable, effective 1 1 June 2015. Section 16: Classification per Directive 1999/45/EEC deleted as no longer applicable, effective Exposure scenario added for main hazardous component: ammonium nitrate. Sections 2.1, 2.2, 3, 8.1, 11.2, 16: Information update according to the new data available in the REACH Registration process. 16.1.2 Abbreviations: DNEL: Derived No-Effect Level. PNEC: Predicted No-Effect Concentration. NOAEL: No Observed Adverse Effect Level. NOS: Lethal Bose 50% The L corresponds to the dose of a tested substance causing 50% lethality during a specified time interval. LC50: Lethal Concentration 50%. The LC50 corresponds to the concentration of a tested substance causing 50% lethality during a specified time interval. ECS0: Effective Concentration 50%. The EC50 corresponds to the concentration of a tested substance causing 50% changes in response (e.g. on growth) during a specified time interval. 22/11/2021 (Revision date) EN (English) 21/29#
Page 25BCF: Bioconcentration factor. VPvB: Very Persistent and very Bioaccumulative PBT: Persistent, bioaccumulative and toxic. 16.1.3 Sources of Key data: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. 16.1.4 Other information: None. Full text of H-and EUH-statements: H272 May intensify fire; oxidiser. Ox. Sol. 3 Oxidising Solids, Category 3 This information is based on our current knowledge and is intended to describe the product for construed as guaranteeing any specific property of the product. the purposes of health, safety and environmental requirements only. It should not therefore be 22/11/2021 (Revision date) EN (English) 22/29#
Page 26ANNEX I Exposure scenario: Ammonium nitrate 1.- Title of exposure scenario number 1: Manufacturing SU 8: Manufacture of bulk, large scale chemicals (including petroleum products) SUI: Manufacture of fine chemicals ERCI: Manufacture of substances PROCI: Use in closed process, no likelihood of exposure PROC2: Use in closed, continuous process with occasional controlled exposure PROC3: Use in closed batch process (synthesis or formulation) facilities PROC&a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated PROC8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC14: Production of preparations or articles by tabletting, compression, extrusion, pelettisation PROC15: Use as laboratory reagent 2.- Exposure scenario 2.1.- Contributing scenario controlling environmental exposure for ERCI Environmental assessment: Not performed. 2.2.- Contributing scenario controlling worker exposure for PROC1, 2, 3, 8a, 8b, 9, 14, 15. Product characteristics Concentration No data available. Physical state Solid Volatility Low Amounts used No data available Frequency and duration of use Duration > 4 hours per day. Human factors not influenced by risk management No data available Other given operational conditions affecting workers exposure Domain Industrial. Indoor / Outdoor Indoor. Technical conditions and measures at process level (source) to prevent release Effectiveness of containment Technical conditions and measures to control dispersion from source towards the worker Ventilation Provide a good standard of general ventilation. 22/11/2021 (Revision date) EN (English) 23/29#
Page 27Local exhaust ventilation (LEV) Not required. Organisational measures to prevent /limit releases, dispersion and exposure Minimise number of staff exposed. Segregation of the emitting process. Effective contaminant extraction. Minimisation of manual phases. Avoidance of contact with contaminated tools and objects. Regular cleaning of equipment and work area. Management/supervision in place to check that the RMMs in place are being used correctly and OCs followed. Training for staff on good practice. Good standard of personal hygiene. Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Not required. Hand protection Not required. Eye protection Goggles. Skin protection Not required. 3.- Exposure estimation and reference to its source Human health assessment: Qualitative assessment (eye irritation, oxidising) Environmental assessment: Not performed. 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES. Predicted exposures are not expected to exceed the DN(M)EL when the Risk Management Measures/Operational Conditions outlined in Section 2 are implemented. Where other Risk Management Measures/Operational Conditions are adopted, then users should ensure that risks are managed to at least equivalent levels. Guidance is based on assumed operating conditions which may not be applicable to all sites; thus, scaling was deemed necessary to define appropriate site-specific risk management measures. 1.- Title of exposure scenario number 2: Industrial use including distribution and other activities related to the processes in industrial settings SU 3: Industrial uses: Uses of substances as such or in preparations at industrial sites SUIO: Formulation [mixing] of preparations and/or re-packaging (excluding alloys) PCI: Adhesives, sealants PC11: Explosives PC12: Fertilizers PC19: Intermediate PC37: Water treatment chemicals ERC2: Formulation of preparations (mixtures) ERC6a: Industrial use resulting in manufacture of another substance (use of intermediates). PROCI: Use in closed process, no likelihood of exposure 22/11/2021 (Revision date) EN (English) 24120#
Page 28PROC2: Use in closed, continuous process with occasional controlled exposure PROC3: Use in closed batch process (synthesis or formulation) PROCS: Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact) facilities PROC&a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated PROC8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC13: Treatment of articles by dipping and pouring PROC15: Use as laboratory reagent 2.- Exposure scenario 2.1.- Contributing scenario controlling environmental exposure for ERC2 and ба Environmental assessment: Not performed. 2.2.- Contributing scenario controlling worker exposure for PC1, 11, 12, 19, 37, PROC1, 2, 3, 5, 8a, 8b, 9,13 and 15 Product characteristics Concentration 100% Physical state Volatility Solid, liquid. Low Amounts used No data available. Frequency and duration of use Duration > 4 hours day. Human factors not influenced by risk management No data available. Other given operational conditions affecting workers exposure Domain Industrial. Indoor / Outdoor Indoor. Effectiveness of containment Technical conditions and measures at process level (source) to prevent release Ventilation Technical conditions and measures to control dispersion from source towards the worker Provide a good standard of general ventilation. Local exhaust ventilation (LEV) Not required. Organisational measures to prevent /limit releases, dispersion and exposure Minimise number of staff exposed. Segregation of the emitting process. Effective contaminant extraction. Minimisation of manual phases. 22/11/2021 (Revision date) EN (English) 25/29#
Page 29Avoidance of contact with contaminated tools and objects. Regular cleaning of equipment and work area. Training for staff on good practice. Management/supervision in place to check that the RMMs in place are being used correctly and OCs followed. Good standard of personal hygiene. Respiratory protection Conditions and measures related to personal protection, hygiene and health evaluation Hand protection Not required. Eye protection Not required. Skin protection Goggles. Not required. 3.- Exposure estimation and reference to its source Human health assessment: Qualitative assessment (eye irritation, oxidising) Environmental assessment: Not performed. 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES. outlined in Section 2 are implemented. Predicted exposures are not expected to exceed the DN(M)EL when the Risk Management Measures/Operational Conditions at least equivalent levels. Where other Risk Management Measures/Operational Conditions are adopted, then users should ensure that risks are managed to to define appropriate site-specific risk management measures. Guidance is based on assumed operating conditions which may not be applicable to all sites; thus, scaling was deemed necessary 1.- Title of exposure scenario number 3: Professional end use PC12: Fertilizers SU 22: Professional uses: Public domain (administration, education, entertainment, services, craftsmen) ERC&b: Wide dispersive indoor use of reactive substances in open systems ERC&e: Wide dispersive outdoor use of reactive substances in open systems PROCI: Use in closed process, no likelihood of exposure PROC2: Use in closed, continuous process with occasional controlled exposure facilities PROC&a: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated PROC8b: Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at dedicated facilities PROC11: Non industrial spraying PROC9: Transfer of substance or preparation into small containers (dedicated filling line, including weighing) PROC15: Use as laboratory reagent PROC19: Hand-mixing with intimate contact and only PPE available 2.- Exposure scenario 2.1.- Contributing scenario controlling environmental exposure for ERC8b and 8e Environmental assessment: Not performed. 2.2.- Contributing scenario controlling worker exposure for PC12, PROC 1, 2, 8a, 8b, 9, 11, 15 and 19 22/11/2021 (Revision date) EN (English) 26/29#
Page 30Product characteristics Concentration Physical state > 25% Volatility Solid, liquid. Amounts used Low. No data available. Frequency and duration of use Duration > 4 hours per day No data available. Human factors not influenced by risk management Domain Other given operational conditions affecting workers exposure Indoor / Outdoor Professional. Indoor / Outdoor. Technical conditions and measures at process level (source) to prevent release Technical conditions and measures to control dispersion from source towards the worker Ventilation Local exhaust ventilation (LEV) Provide a good standard of general ventilation. Not required. Organisational measures to prevent /limit releases, dispersion and exposure Minimise number of staff exposed. Segregation of the emitting process. Effective contaminant extraction. Minimisation of manual phases. Avoidance of contact with contaminated tools and objects. Regular cleaning of equipment and work area. Training for staff on good practice. Management/supervision in place to check that the RMMs in place are being used correctly and OCs followed. Good standard of personal hygiene. Conditions and measures related to personal protection, hygiene and health evaluation Respiratory protection Hand protection Not required. Eye protection Not required. Skin protection Goggles. Not required. 3.- Exposure estimation and reference to its source Environmental assessment: Not performed. Human health assessment: Qualitative assessment (eye irritation, oxidising) 4.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES. 22/11/2021 (Revision date) EN (English) 27/29#
Page 31outlined in Section 2 are implemented [G22]. Predicted exposures are not expected to exceed the DN(M)EL when the Risk Management Measures/Operational Conditions at least equivalent levels [G23]. Where other Risk Management Measures/Operational Conditions are adopted, then users should ensure that risks are managed to to define appropriate site-specific risk management measures [DSU1]. Guidance is based on assumed operating conditions which may not be applicable to all sites; thus, scaling was deemed necessary 1.- Title of exposure scenario number 4: Consumer end use SU21: Consumer uses: Private households (= general public = consumers) PCI1: Explosives PC12: Lawn and garden preparations ERC8b: Wide dispersive indoor use of reactive substances in open systems ERC&e: Wide dispersive outdoor use of reactive substances in open systems 2.- Exposure scenario ERC10a: Wide dispersive outdoor use of long-life articles and materials with low release 2.1.- Contributing scenario controlling environmental exposure for ERC 8b, 8e and 10a Environmental assessment: Not performed. 2.2.- Contributing scenario controlling consumer exposure for PC 11 and 12 Product characteristics No data available. Amounts used No data available. Frequency and duration of use No data available. No data available. Human factors not influenced by risk management No data available. Other given operational conditions affecting consumers exposure Product labelling. Conditions and measures related to information and behavioural advice to consumers Conditions and measures related to personal protection and hygiene Respiratory protection Hand protection Not required. Eye protection Not required. Skin protection Chemical goggles. Not required. 3.- Exposure estimation and reference to its source Human health assessment: Qualitative assessment (eye irritation, oxidising) Environmental assessment: Not performed. 22/11/2021 (Revision date) EN (English) 28/29#
Page 324.- Guidance to DU to evaluate whether he works inside the boundaries set by the ES. Predicted exposures are not expected to exceed the DN(M)EL when the Risk Management Measures/Operational Conditions outlined in Section 2 are implemented [G22]. at least equivalent levels [G23]. Where other Risk Management Measures/Operational Conditions are adopted, then users should ensure that risks are managed to to define appropriate site-specific risk management measures [DSU1]. Guidance is based on assumed operating conditions which may not be applicable to all sites; thus, scaling was deemed necessary 22/11/2021 (Revision date) EN (English) 29/29#
This material provides agency context. It does not replace binding regulatory text, and its legal effect depends on the underlying authority and facts.