# World Heart, Inc. — Hazardous Materials Safety Interpretation - **operation:** document - **citation:** 01-0120 - **title:** World Heart, Inc. — Hazardous Materials Safety Interpretation - **source type:** guidance - **agency:** Pipeline and Hazardous Materials Safety Administration - **status:** guidance - **official:** true - **published on:** 2001-07-13 - **effective on:** Not available - **summary:** 01-0120 response to World Heart, Inc. concerning 172.101. - **machine formats:** - **json:** https://regulus.evalyn.ai/document/phmsa-interpretation-01-0120.json - **markdown:** https://regulus.evalyn.ai/document/phmsa-interpretation-01-0120.md - **app url:** https://regulus.evalyn.ai/document/phmsa-interpretation-01-0120 - **source url:** https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2001/010120.pdf **body:** <<>> S. Departmer Transportatic 100 Seventh St., Sv Nashington, D.C. 2059 JUL 1 3 2001 Ms. Carol McCulley Explant Services Reference No.: 01-0120 World Heart, Inc. 7799 Pardee Lane Oakland, CA 94612 This is in response to your May 10, 2000 letter requesting clarification of the proper shipping name for a Formaldehyde solution containing 10% neutral buffered formalin under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask whether "Aviation regulated liquid, n.o.s." the proper shipping name should be "Environmentally hazardous substances, liquid, n.o.s." or Either shipping name may be used, however, the preferred proper shipping name is "Aviation regulated liquid, n.o.s." The entry "Aviation regulated liquid, n.o.s." was added to the § 172.101 Hazardous Materials Table in a final rule published March 5, 1999 (Docket HM-215C; 64 FR 10741) for alignment with the ICAO Technical Instructions and the UN Recommendations. I trust you find the information helpful. Sincerely, Hotle 2. Mittel Hattie L.Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards <<>> Corbin $172.101 WORLDHE RT ma Proper Shipping hime 10 May, 2000 Attention: Edward Mazzulo Director of Hazardous Materials Standards Department of Transportation 400 7th Street, SW Washington, D.C. 20590 Dear Mr. Mazzulo: We provide a shipping box for our customers to return our Left Ventricular Assist Device when it is removed from a patient. The box contains a total amount of approximately 560 ml of 10% neutral buffered formalin in five containers when returned to us. We do not provide the 10% neutral buffered formalin. Currently, our shipping information is: Environmentally hazardous substances, liquid, 1.o.s. (formaldehyde), UN3082, packing group III, hazard class 9. I have MSDS forms from various manufacturers of 10% neutral buffered formalin. They disagree as to the proper shipping name and UN classification. I have been informed by the manufacturer of the shipping box we use that the correct information should now be: Aviation regulated liquid, n.o.s. (10% buffered formalin), UN3334, no packing group, hazard class 9. We would appreciate confirmation that Aviation regulated liquid, n.o.s. (10% buffered formalin) UN3334, no packing group, hazard class 9 is the proper shipping name/description and shipping information. Thank you very much. Regards, Carlie-ally, Carol McCulley Explant Services World Heart, Inc. (510) 563-4971 (phone) (510) 569-4914 (fax) carol.mcculley@worldheart.com (e-mail) Attachments: 4 MSDS forms from various manufacturers <<>> ... WORLD HEART INC WORLDHE RT OAKLAND. CA 84821 1SA 7709 PARDEE LANE TEL. 510-363-5000 FAX. 310•303•3005 Department of Transportation Director of Hazardous Materials <<>> ...- SIGMA-ALDRICH Material Safety Data Sheet Date upated: 0027/2000 Version 1,20 Section 1 - Product and Company Information Product Number Product Name FORMALDEHYDE Brand Sigma Chemical F1635 Company Street Address Sigma-Aldrich Technical Phone: City, State, Zip, Country 3050 Spruce Street St. Louls, MO 63103 US Fax: 314 771 5765 800 325 5052 Emergency Phone: 414 273 3850 Ext.5996 Section 2 - Composition/Information on Ingredient FORMALDEHYDE Substance Name 60-00-0 SARA 313 Yes Formula Synonyms CH2O Aldehyde formique (French), Aldehyd mravenci (Czech), Aldeide formica (Italian), BFV, Fannofom -ormaldehyde (ACGIH:OSHA), Formaldehyd (Czech, Polish), Formaldehyde, gas, Formalin, Section 3 - Hazards Identification Toxic. Emergency Overview Toxic by Inhalation, in contact with skin, and if swallowed. Causes bums. May cause sensitizaton by inhalation and skin contact. Potential cancer hazard. Contains formaldehyde. Readily absorbed through skin. Lachrymator. Combustible liquid. Target organ(s): Possible risk of irreversible effects. May cause heritable genetic damage. Health: 3* HMIS Rating •Flammability: 2 Reactivity: 1 Health: 3 NFPA Rating Flammability: 2 Reactivity: 1 *additional chronic hazards present. For additional information on toxicity, please refer to Section 11. Section 4 - First Aid Measures If swallowed, wash out mouth with water provided person is conscious. Call a physician immediately. Oral Exposure Inhalation Exposure If inhaled, remove to fresh air. It not breathing give artificial respiration. if breathing is difficult, give oxygen. - • <<>> • In case of skin contact, flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing and shoes. Call a Dermal Exposure physician. in case of contact with eyes, flush with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating the Eye Exposure eyelids with fingers. Call a physician. Section 5 - Fire Fighting Measures Flash Point: 147.2°F 64 °C Explosion Limits: - NoT Chan! Lower: 7% Upper: 73% Autoignition Temp: 300 °C Class 3! castiar Extinguishing Media Suitable Carbon dioxide, dry chemical powder, or appropriate foam. Firelighting Protective Equipment Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. Specific Hazard(8) Specific Method(8) of Fire Fighting Combustible lIquid. Emits toxic fumes under fire conditions, Use water spray to cool fire-exposed containers. Section 6 - Accidental Release Measures Evacuate area. Procedure to be Followed in Case of Leak or Spill /ear self-contained breathing apparatus, rubber boots, and heavy rubber glove rocedure(s) of Personal Precaution(t Cover with dry lime or soda ash, pick up, keep in a closed container, and hold for waste disposal. Ventilate area and wash spill site Methods for Cleaning Up after material pickup is complete. Section 7 - Handling and Storage Handling User Exposure Do not breathe vapor. Do not get in eyes, on skin, on clothing. Avold prolonged or repeated exposure. Storage Suitable • man Keep tightly closed. Keep away from heat and open flame. Store in a cool dry place. Section 8 - Exposure Controls / PPE Engineering Controls : Use only in a chemical fume hood, Safety shower and eye bath. Personal Protective Equipment Respiratory Hand NIOSH/MSHA-approved respirator. Compatible chemical-resistant gloves. Page 2 Sigma Chemical - F1635 Sigma-Aldrich Corporation www.oigma-aldrich.com - <<>> • Chemical safety goggles. Eye Other Faceshield (8-inch minimum). ash Contamient eating before reus. Discard conkaminated shoes. Wash thoroughly after handling. Exposure Limits, RTECS USA Country ACGIH Source LYDE Celllry Value USA MSHA Standard concentration 0.37 MG/M3 (0.3 PPM) Remarks Celling 2 PPM (3 MG/M3) • New Zealand USA OEL OSHA. percentration SEE 1910.1048 USA NIOSH TWA Celling concentration 0.016 PPM 0.1 PPM/15M check ACGIH TLV Section 9 - Physical/Chemical Properties Appearance Liquid Physical State Color Coloress Clear liquid Form Molecular Weight: 30.03 AMU Property Value At Temperature or Pressure pH MP/MP Range BP/BP Range N/A N/A Freezing Point N/A N/A Vapor Pressure Vapor Density 1.03 g/l 52 mmHg 37 °C SG/Density Saturated Vapor Conc. N/A Bulk Density N/A 1.016 g/cm3 Volatile% Odor Threshold N/A Water Content VOC Content N/A N/A Evaporation Rate Solvent Content N/A N/A Viscosity N/A Partition Coefficient N/A N/A Been Pointion Temp. N/A Flash Point °C 147.2 °F Explosion Limite Lower: 7% 64 °C Refractive Index Autoignition Temp Upper: 73% 300 °C Solubility 1.339 N/A Sigma Chemical - F1635 Page 3 Sigma-Aldrich Corporation : www.sigma-aldrich.com <<>> • Section 10 - Stability and Reactivity Stability Stable Stable. Materials to Avoid Peroratible with aniline, phenol, locyanates, anhydrides, Strong acids, Strong bases, Strong oxidizing agents, Amines, Hazardous Decomposition Products Hazardous Decomposition Products Carbon monoxide, Carbon dioxide. Hazardous Polymerization Will not occur. Hazardous Polymerization Section 11 - Toxicological Information oute of Exposur kin Contac Causes burns. Skin Absorption Readily absorbed through skin. Toxic if absorbed through skin. Causes burns. Eye Contact Inhalation Ingestion Toxic if inhaled. Material is extremely destructive to the tissue of the mucous membranes and upper respiratory tract. affecting the ability to breathe, circulatory shock, and convulsions. Toxic if swallowed. Ingestion can cause immediate burning pain in the mouth, throat, abdomen; severe swelling of the larynx and skeletal paralysis Sensitization Sensitization May cause allergic respiratory and skin reactions Eyes, Kidneys, Liver. Heart. Target Organ(s) or Systems) Material is extremely destructive to tissue of the mucous membranes and upper respiratory tract, eyes, and skin. Inhalation may result Signs and Symptoms of Exposure in spasm, inflammation and edema of the larynx and bronchi, chemical pneumonitis, and pulmonary edema. Symptoms of exposure cause: Coughing, chest pains, difficulty in breathing. Gastrointestinal disturbances. May cause convulsions. To the best of our may include buming sensation, coughing, wheezing, laryngitis, shortness of breath, headache, nausea, and vomiting, Exposure can knowledge, the chemical, physical, and toxicological properties have not been thoroughly Investigated. RECS Number: LP8925000 ...... Toxicity Data Oral - Woman: 108 mg/kg (LDLO) - •• Oral - Woman: 1 ML/KG (LDLO) Remarks: Behavioral:Coma. Gastrointestinal:Alteration in gastric secretion. Cardiac:Other changes. Oral - Rat: 100 mg/kg (LD50) Page 4 Sigma Chemical - F1635 Sigma-Aldrich Corporation www.sigma-aldrich.com <<>> •. Subcutaneous - Rat: 420 MG/KG (LD50) Remarks: Lungs, Thorax, or Respiration:Acute pulmonary edema. Lungs, Thorax, or Respiration:Broncholar constriction. Intravenous - Rat: 87 MG/KG (LD50) Oral - Mouse: 42 mg/kg (LD50) Remarks: Behavioral:Somnolence (general depressed activity). Behavioral:Convulsions or effect on seizure threshold. Behavioral:Excitement. Inhalation - Mouse: 454,000 mg/m3 (LC50) Subcutaneous - Mouse: 300 MG/KG (LD50) Remarks: Lungs, Thorax, or Respiration:Acute pulmonary edema. Lungs, Thorax, or Respiration:Bronchiolar constriction, Skin - Rabbit: 270 UL/KG (LD50) Oral - Guinea pig: 260 mg/kg (LD50) Irritation Data Skin - Human: 0.15 mg 3D | Remarks: Mild irritation effect Eyes - Human: 4 ppm 5M Eyes - Human: 1 ppm SM Remarks: Mild irritation effect Skin - Rabbit: 2 mg 24H Remarks: Severe irritation effect Skin - Rabbit: 540 mg Remarks: Open irritation test Skin - Rabbit: 50 mg 24H Remarks: Moderate irritation effect Eyes - Rabbit: 0.75 mg 24H Remarks: Severe Irritation effect Eyes - Rabbit: 0.75 mg Remarks: Severe imitation effect Eyes - Rabbit: 10 mg Remarks: Severe irritation effect Chronic Exposure Carcinogen Result: This product is or contains a component that has been reported to be possibly carcinogenic based on its ARC, ACGIH, NTP, or EPA classification. Rat - Oral: 109 GM/KG 2Y C Result: Tumorigenic: Carcinogenic by RTECS criteria, Gastrointestinal:Tumors. Blood:Leukemia Rat - Inhalation: 14300 PPB 6H/2Y 1 Hes: Tumorge:Carcingenle by RECS criteria. Sense Organs and Special Senses (Nose, Eye, Ear, and Taste): Olfaction: Tumors. -.. un... Result: Tumorigenic: Equivocal tumorigenic agent, by. RECS criteria. Tumorigenic: Tumors at site or application. Rat - Subcutaneous: 1170 MG/KG 65W 1 Mouse - Inhalation: 14300 PB 6H/2Y | Result: TumorigencEquivocal tumorigenic agent by RTECS criteria, Sense Organs and Special Senses (Nose, Eye, Ear, and Taste): Olfaction: Tumors. Rat Inhalation: 15 PM 64/78W 1 Taste):Olfaction:Tumors. Result: Tumorigenic:Carcinogenic by RECS cnteria. Sense Organs and Special Senses (Nose, Eye, Ear, and Rat Subtaneous: 350 MG/ 78W | Result: Tumorigenic:Equivocal tumorigenic agent by RTECS criteria, Skin and Appendages: Other: Tumors. Tumorigenic:Tumors at site or application. Page 5 Sigma Chemical - F1635 Sigma-Aldrich Corporation www.sigma-aldrich.com - • <<>> .. Rat - Inhalation: 6 PPM 6H/2Y | Result: Tumorigenic:Equivocal tumorigenic agent by RTECS criterla. Sense Organs and Special Senses (Nose, Eye, Ear, and Taste):Olfaction:Tumors. Rat - Inhalation: 15 PM 6H/86W 1 Resuit: Tumorigenic:Carcinogenic by RTECS criteria. Sense Organs and Special Senses (Nose, Eye, Ear, and Taste): Olfaction: Tumors. Rat - Inhalation: 14 PPM 6H/84W | Result: Tumorigenic: Carcinogenic by RTECS criteria. Sense Organs and Special Senses (Nose, Eye, Ear, and Taste):Olfaction:Tumors, Rat - Inhalation: 18750 UG/M3 2Y- | Result: Tumorigenic: Equivocal tumorigenic agent by RECS criteria. Sense Organs and Special Senses (Nose, Eye, Ear, and Taste):Olfaction:Tumors. Mouse - Inhalation: 15 PM 6H/104W 1 Result: Tumorigenic: Equivocal tumorigenic agent by RTECS criteria. Sense Organs and Special Senses (Nose, Eye, Ear, and Taste): Olfaction: Tumors. Rat - Inhalation: 15 PPM 6H/2Y | Result: Tumorigenic: Carcinogenic by RTECS criteria, Sense Organs and Special Senses (Nose, Eye, Ear, and Taste):Olfaction:Tumors. Rat - Inhalation: 5600 PB HRY | Result: Tumorigenic: Equivocal tumorigenlc agent by RTECS criteria. Sense Organs and Special Senses (Nose, Eye, Ear, and Taste):Olfaction:Tumors. OSHA Carcinogen List Patential cancer hazard. LARC Carcinogen List Rating Group 2A NTP Carcinogen List Rating Anticipated to be a carcinogen. ACGIH Carcinogen List Rating A2 Chronic Exposure - Teratogen Species Rat Route of Application Exposure Time Rosul-Specie Development Abnormies Headilary system. (1-21D PREG) Rat Resut lets on My relus: Cylogic lange induting somalie el genetie materia. 1 MG/3/24H Rat 500 UG/M3/4H (1-19D PREG) Rat Result:Specific Developmental Abnormalities: Hepatobiliary system. 168 MG/KG Oral (1-21D PREG) Mouse (7-14D PREG) Spect Desomena porales raid a prince su on gu. Mouse Specific Developmental Abnormalities: Musculoskeletal system. Result: Effects on Embryo or Fetus: Fetal death. 240 MG/KG Intraperitoneal (7-14D PREG) Mouse ResultSpectic DeVelopmental Abnormalities: other developmental abnomil PREG) 160 MG/KG Intraperitoneal Page 6 Sigma Chemical - F1635 Sigma-Aldrich Corporation www.sigme-aldrich.com - <<>> • Species Chronic Exposure - Mutagen Result: May aer genetic materialute Exposure Time Cell Type Mutation test - Sigma Chemical - F1635 Page 7 igma-Aldrich Corporatic ww.sigma-aldrich.cr <<>> • DNA damage lung DNA damage DNA damage DNA damage Unscheduled DNA synthesis DNA inhibition DNA inhibition Other mutation test systems Cytogenetic analysis Other mutation test systems Cytogenetic analysis • Sister chromatid exchange Oral 30H Micronucieus test Mutation In mammalian somatic cells. • - 3Н Inhalation liver DNA damage Morphological transformation. Oral DNA damage DNA damage DNA damage DNA damage Oral Unscheduled DNA synthesis Siver Unscheduled DNA synthesis Unscheduled DNA synthesis DNA inhibition 500 Inhalation Cytogenetic analysis Other mutation test systems Inhalation Intraperitoneal 5D Intraperitoneal Oral 5D Dominant lethal test Cytogenetic analysis 5D spem sperm Mutation In microorganisms DNA damaga Morphological transformation. Oral Cytogenetic analysis DNA damage Intraperitoneal Mutation in mammalian somatic cells. Cytogenetic analysis Morphological transformation. Host-medlated assay Morphological transformation. DNA damage Cytogenetic analysis Phage inhibition capacity Cytogenetic analysis Sister chromatid exchange Sister chromatid exchange DNA damage Mutation In mammalian somatic cells. Intratesticular sperm - - Ф DNA DNA damage Sigma Chemical - F1635 Page 8 Sigma-Aldrich Corporation www.sigma-aldrich.com - <<>> .. Chronic Exposure - Reproductive Hazard Species Rat Dose 200 MG/KG Route of Application Oral Expasure Time (1D MALE) Rat Result: Paternal Effects: Spermatogenesis (including genetic material, sperm morphology,motility, and count). Result: Effects on Newborn: Biochemical and metabolic. 168 MG/KG (1-21D PREG) Rat 12 UG/M3/24H inhalation PREG) (15D PRE/1-22D effects. Result: Effects on Newborn: Growth statistics (e.g., reduced weight gain). Effects on Newborn: Other postnatal measures or Rat 12 UG/M3/24H Inhalation (1-22D PREG) Rat Result: Effects on Newborn: Biochemical and metabolic. Result: Paternal Effects: Spermatogenesis (including genetic material, sperm morphology,motility, and count), Paternal 35 UG/M3/8H Inhalation (BOD MALE) Rat Effects: Other effects on male. Inhalation PREG) (20D PRE/1-22D Rat Result: Effects on Newborn: Biochemical and metabolic. 80 MG/KG Result: Pateral Elects: Testes, epididymis, sperm duct. Paternal Effects: Prostate, seminal vessicle, Cowper's gland, Intraperitoneal (10D MALE) Rat accessory glands. Result: Patemal Effects: Testes, epicidymis, sperm duct. 46243 MG/KG Subcutaneous (20D MALE) Rat Result: Effects on Merily: Male fertily die a t males imprep ating males per it males exposed to fertile nonpregnant females). Result: Paternal Effects: Spermatogenesis (including genetic material, sperm morphology, motility, and count). 500 MG/KG Result: Effects on Feiny: Post implantation oraly (a g, dead and or resorbed implanka per total number of Implants). Dog Effects on Embryo or Fetus: Fetal death. Result: Paternal Effects: Testes, epididymis, sperm duct. 7 MG/KG Intratesticufar (1D MALE) Monkey 4 MG/KG Intratesticular (1D MALE) Domestic Result: Paternal Effects: Spermatogenesis (Including genetic material, sperm morphology, motility, and count). Animals 6687 UG/KG Intratesticular (1D MALE) Result: Paternal Effects: Spermatogenesis (Including genetic material, sperm morphology, motility, and count). Patemal Effects: Testes, epididymis, sperm duct. Section 12 - Ecological Information Section 13 - Disposal Considerations Appropriate Method of Disposal of Subetance or Preperation contact a licensed professional waste disposal service to dispose of this material. •. Observe all,tederal, state, and local environmental regulations. Dissolve or mix the material with a combustible solvent and burn in a chemical Incinerator equipped with an afterburner and scrubber Section 14 - Transport information "DOT— UN#: 1198 Proper Shipping Name: Formaldehyde, solutions, flammable Class: 3 pa face 472F PIH: Not PIH Packing Group: Packing Group Ill • Not Class 3! LATA Proper Shipping Name: Formaldehyde solution, flammable Hazard Class: 3 IATA Number: 1198 Packing Group: III Page 9 Sigma Chemical - F1635 Sigma-Aldrich Corporation www.sigma-aldrich.com <<>> Section 15 - Regulatory Information EU Directives Classification Indication of Danger Symbol of Danger: T Toxic. Rick Statements Toxic by inhalation, in contact with skin, and if swallowed. Causes burns. Possible risk of irreversible effects. May cause R: 23/24/25 34 40 43 Safety Statements In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. Wear suitable protective clothing and gloves. Wear eye/ace protection. in case of accident or if you feel unwell, seek medical advice Immediately (show the label where possible). Use only in well ventilated areas. US Classification and Label Text . Toxic. Indication of Danger Risk Statements Toxic by inhalation, in contact with skin, and If swallowed. Causes burns. May cause sensitization by inhalation and skin contact. Possible risk of Irreversible effects. May cause heritable genetic damage. Safety Statements In case or coat ire in ran ay with or you we rand e neil dice maritaly her the take who. US Statements possible). Use only in well ventilated areas. Potential cancer hazard. Contains formaldehyde, Readily absorbed through skin. Lachrymator. Combustible liquid. Target organ(s): Eyes. Kidneys. Listed: Yes United States Regulatory Information Deminimis: 0.1 % Notes: This product is subject to SARA section 313 reporting requirements. TSCA Inventory Item: Yes California Prop - 65 United States - State Regulatory Information Proposition 65: This product is or contains chemical(s) known to the state of California to cause cancer. California Proposition 65: This product is or contains chemical(s) known to the state of California to cause cancer. Califomia Section 16 - Other Information unlimited paper copies for internal use only. • Sigma Chemical - F1635 Page 10 Sigma-Aldrich Corporation www.sigma-eldrich.com - <<>> Emergency Tacon: 420 350 54.065 SIGMA-ALDRICH www.sigma-aidrich.com Fax: 800 325 5052 4/18/01 Sigma-Aldrich MSDS The MSDS that surpasses them all. The MSDS for more than 85,000 Sigma, Aldrich, Fluka, Supelco, and Riedel-de Haen chemicals on compact disc or magnetic tape. MSDS are arranged in 16 chapter format and are available in six languages: • English • Dutch * German • French Italian • Spanish updated safety information. The CD-ROM includes versions for Microsoft Window...etc. Subscribers receive quarterly updates on a new CD-ROM or magnetic tape that includes new products and To order call your local Sigma-Aldrich office or visit www.sigma-aldrich.com www.sigma-aldrich.com has a new look! We have made some exciting upgrades to our website as well as given it a new look. Some of the things familiarize yourself with our new, more unified, navigation system. you've been familiar with are improved upon and have possibly been relocated. Please take some time to • Weare Committed to the Succees of our Customers; Employees and Shareholdera through Life Sclence, Technology and Service. <<>> • St. Louis, MO 63103 U 3050 Spruce Stree Technical Phone: 314 771 5765 SIGMA-ALDRICH Emergency Phone: 414 273 3850 Ex. 5096 www.sigma-aidrich.com Fax: 800 325 5052 7799 PARDEE LN CAROL MCCULLEY 4/18/01 US OAKLAND, CA 94621 Phone number: 5105634971 Fax: 5105694914 Dear Sigma-Aldrich Customer We recently reorganized our MSDS to better serve you, our valued customer. In addition to an updated look, our sheets now feature a revision date, NFPA/HMIS ratings, and transportation Information. you have any questions or comments As always, customer service is our top priority. Please contact the MSDS department toll-free at 800-521-8956 ext. 2143 i MSDS Reference Number: P10515789 Attached please find the Material Safety Data Sheets you requested. Material: Sigma Chemical - F1635 FORMALDEHYDE Substance: 50-00-0 FORMALDEHYDE SARA 313: Yes - We are Committed to the Success of our Customers, Employees and Shareholders through Life Sclence, Technology and Sorvice. <<>> - Material Safety Data Sheet 10 % Buffered Formalin ACC# 41129 Section 1 - Chemical Product and Company Identification MSDS Name: 10 % Buffered Formalin Synonyms: None. Catalog Numbers: SF99 20, SF99 4, SF9920, SF994 - Company Identification: Fisher Scientific Fair Lawn, NJ 07410 1 Reagent Lane For information, call: 201-796-7100 Emergency Number: 201-796-7100 For CHEMTREC assistance, call: 800-424-9300 For International CHEMTREC assistance, call: 703-527-3887 Section 2 - Composition, Information on Ingredients CAS# Chemical Name 50-00-0 Percent EINECS/ELINCS Formaldehyde 67-56-1 3.9-4.0 Methyl Alcohol 200-001-8 2.0 % 127-09-3 200-659-6 Sodium Acetate 7732-18-5 1.2-2.0 Water Balance 204-823-8 231-791-2 Section 3 - Hazards Identification EMERGENCY OVERVIEW Appearance: not available, Flash Point: > 194 deg F. Danger! May cause allergic respiratory fetal effects in animals. May cause central nervous system depression. Causes eye and skin reaction. May cause allergic skin reaction. This substance has caused adverse reproductive and irritation. Causes digestive and respiratory tract irritation. Contains formaldehye. Potential Target Organs: Central nervous system. Potential Health Effects Eye: Causes eye irritation. Skin: Causes skin irritation. May cause skin sensitization, an allergic reaction, which becomes evident upon re-exposure to this material. Ingestion: Cannot be made non-poisonous. May cause central nervous system depression, kidney damage, and liver damage. Causes gastrointestinal irritation with nausea, vomiting and diarrhea. Inhalation: Causes respiratory tract irritation. May cause allergic respiratory reaction. Chronic: May cause cancer according to animal studies. May cause reproductive and fetal effects. https://fscimage.fishersci.com/msds/41129.htm 4/18/01 <<>> - Section 4 - First Aid Measures the upper and lower eyelids. Get medical aid. Eyes: Immediately flush eyes with plenty of water for at least 15 minutes, occasionally lifting Skin: Get medical aid. Flush skin with plenty of soap and water for at least 15 minutes while removing contaminated clothing and shoes. Ingestion: Do NOT induce vomiting. If victim is conscious and alert, give 2-4 cupfuls of milk or Inhalation: Remove from exposure to fresh air immediately. If not breathing, give artificial water. Never give anything by mouth to an unconscious person. Get medical aid. respiration. If breathing is difficult, give oxygen. Get medical aid. • Notes to Physician: Treat symptomatically and supportively. Section 5 - Firefighting Measures General Information: As in any fire, wear a self-contained breathing apparatus in pressure- and highly toxic gases may be generated by thermal decomposition or combustion. demand, MSHA/NIOSH (approved or equivalent), and full protective gear. During a fire, irritating Extinguishing Media: For small fires, use dry chemical, carbon dioxide, water spray or alcohol- resistant foam. Cool containers with flooding quantities of water until well after fire is out. Section 6 - Accidental Release Measures General Information: Use proper personal protective equipment as indicated in Section 8. Spills/Leaks: Absorb spill with inert material, (e.g., dry sand or earth), then place into a Equipment section. chemical waste container. Clean up spills immediately, observing precautions in the Protective Section 7 - Handling and Storage .._Handling: Wash thoroughly after handling. Wash hands before eating. Use only in a well- ingest or inhale. ventilated area. Do not get in eyes, on skin, or on clothing. Keep container tightly closed. Do not incompatible substances. Storage: Store in a tightly closed container. Store in a cool, dry, well-ventilated area away from Section 8 - Exposure Controls, Personal Protection Engineering Controls: Use adequate general or local exhaust ventilation to keep airborne concentrations below the permissible exposure limits. Exposure Limits https://fscimage.fishersci.com/msds/41129.htm 4/18/01 <<>> • - Chemical Name ACGIH NIOSH OSHA - Final PELs 0.016 ppm TWA; NIOSH Formaldehyde C 0.3 ppm Potential Occupational Appendix A Potential Carcinogen - see ppm STEL; 0.5 ppm TWA 0.75 ppm TWA PEL; 2 NIOSH carcinogen. action leve Methyl Alcohol 200 ppm; 250 ppm STEL; cutaneous absorption skin - potential for 200 ppm TWA; 260 mg/m3 TWA 6000 ppm 200 ppm TWA; 260 Sodium Acetate .IDLH mg/m3 TWA Thone listed none listed none listed Water /none listed none listed none listed OSHA Vacated PELs: Formaldehyde: 3 ppm TWA (unless specified in 1910.1048) Methyl Personal Protective Equipment OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard EN166. Skin: Wear appropriate protective gloves to prevent skin exposure. Clothing: Wear appropriate protective clothing to prevent skin exposure necessary. Section 9 - Physical and Chemical Properties Physical State: Liquid Odor: None reported Appearance: not available pH: Not available. Vapor Pressure: Not available. Vapor Density: Not available. Evaporation Rate:Not available. Viscosity: Not available. Boiling Point: Not available. Freezing/Melting Point:Not available. Decomposition Temperature:Not available. Autoignition Temperature: Not applicable. Flash Point: > 194 deg F (> 90.00 deg C) NFPA Rating: Not published. Explosion Limits, Lower:Not available. Upper: Not available. Solubility: Soluble in water. Specific Gravity/Density:Not available. Molecular Formula: Mixture Molecular Weight:Not applicable. Section 10 - Stability and Reactivity • rai -Chemical Stability: Stable under normal temperatures and pressures. Conditions to Avoid: Incompatible materials, excess heat. https://fscimage.fishersci.com/msds/41129.htm 4/18/01 <<>> - incompatibilities with Other Materials: Strong oxidants. lazardous Decomposition Products: Irritating and toxic gases lazardous Polymerization: Has not been reported Section 11 - Toxicological Information RTECS#: CAS# 50-00-0: LP8925000 CAS# 67-56-1: PC1400000 CAS# 7732-18-5: ZC0110000 CAS# 127-09-3: A14300010 LD50/LC50: CAS# 50-00-0: Inhalation, mouse: LC50 =400 mg/m3/2H; Inhalation, rat: LC50 =203 mg/m3; Oral, mouse: LD50 = 42 mg/kg; Oral, rat: LD50 = 100 mg/kg; Skin, rabbit: LD50 = 270 mg/kg; CAS# 67-56-1: Inhalation, rat: LC50 =64000 ppm/4H; Oral, mouse: LD50 = 7300 mg/kg; Oral, rabbit: LD50 = 14200 mg/kg; Oral, rat: LD50 = 5628 mg/kg; Skin, rabbit: LD50 = 15800 mg/kg; CAS# 127-09-3: Oral, mouse: LD50 = 6891 mg/kg; Oral, rat: LD50 = 3530 mg/kg; CAS# 7732-18-5: Oral, rat: LD50 = >90 mL/kg; Carcinogenicity: CAS# 50-00-0: ACGIH: A2 - suspected human carcinogen California: carcinogen; initial date 1/1/88 NIOSH: occupational carcinogen NTP: Suspect carcinogen OSHA: Possible Select carcinogen TARC: Group 2A carcinogen CAS# 67-56-1: Not listed by ACGIH, IARC, NIOSH, NTP, or OSHA. CAS# 127-09-3: Not listed by ACGIH, IARC, NIOSH, NTP, or OSHA. CAS# 7732-18-5: Not listed ... by ACGIH, IARC, NIOSH, NTP, or OSHA. Epidemiology: No information available. biochemical/metabolic and reduced weight gain, ihl-rat TCLo=12 ug/m3/24H. Embryo or Fetus: Teratogenicity: Formaldehyde effects on Newborn: behavioral, ihl-rat TCLo=50 ug/m3/4H; cytological changes, ihl-rat TCLo=1 mg/m3/24H; stunted fetus and death, ipr-mouse TDLo=240 mg/kg. Specific Developmental Abnormalities: craniofacial and musculoskeletal, ipr-mouse TDLo=240 mg/kg. Reproductive Effects: Formaldehyde effects on Fertility: male index, itt-rat TDLo=400 mg/kg; post- implantation mortality, ims-mouse TDLo=259 mg/kg. Paternal Effects: spermatogenesis, Neurotoxicity: No information available. orl-rat TDLo=200 mg/kg; testes/sperm duct/epididymis, ipr-rat TDLo=80 mg/kg. Mutagenicity: Formaldehyde DNA Damage: human fibroblast 100 umol/L DNA Inhibition: human cell types 210 umol/L. Unscheduled DNA Synthesis: rat cell types 50 umol/L. Gene Other Studies: No data available. Mutation in Mammalian Cells: human lymphocyte 130 umol/L. https://fscimage.fishersci.com/msds/41129.htm 4/18/01 <<>> Section 12 - Ecological Information Ecotoxicity: Atlantic salmon LC50=173 uL/L/96H; Catfish (fresh water) TLm=32ppm/24H; Flounder (salt water) TLm=100-330 ppm/48H; Fathead minnowLC50=10-100 uL/L/96H; Rainbow trout LC50= 168mg/L/48H; Zebrafish LC50=41mg/L/96H; Water flea LC50=52 (96Hr.) fathead minnow = 24.1 mg/L; flowthrough conditions; LC50 (96Hr.) bluegill = 0.10 mg/L/24H.Cas# 50-00-0: LC50(96Hr.) rainbow trout = 0.12 mL/L; flowthrough bioassay; LC50 photobacterium phospherum = 3.00-10.2 mg/L; Microtox. mg/L; Flow-through conditions;EC50 (96Hr.) water flea = 20 mg/L; EC50 (30 min) Environmental Fate: No information found. Physical/Chemical: No information found. Other: Not available. Section 13 - Disposal Considerations nazardous waste. US EPA guidelines for the classification determination are listed in 40 CFR Chemical waste generators must determine whether a discarded chemical is classified as a regulations to ensure complete and accurate classification. Parts 261.3. Additionally, waste generators must consult state and local hazardous waste RCRA P-Series: None listed. RCRA U-Series: CAS# 50-00-0: waste number U122. CAS# 67-56-1: waste number U154; (Ignitable waste). Section 14 - Transport Information US DOT IATA RID/ADR IMO Canada TDG AVIATION Shipping Name: LIQUID,N.O.S. REGULATED No FORMALIN) (10% information available. Hazard Class: 9 UN Number: UN3334 Päcking Group! Section 15 - Regulatory Information US FEDERAL TSCA CAS# 50-00-0 is listed on the TSCA inventory. CAS# 67-56-1 is listed on the TSCA inventory. CAS# 127-09-3 is listed on the TSCA inventory. CAS# 7732-18-5 is listed on the TSCA inventory. None of the chemicals are on the Health & Safety Reporting List. Health & Safety Reporting List https://fscimage.fishersci.com/msds/41129.htm 4/18/01 <<>> Laguvul l Chemical Test Rules None of the chemicals in this product are under a Chemical Test Rule. Section 12b None of the chemicals are listed under TSCA Section 12b. TSCA Significant New Use Rule SARA None of the chemicals in this material have a SNUR under TSCA. Section 302 (RQ) CAS# 50-00-0: final RQ = 100 pounds (45.4 kg) CAS# 67-56-1: final RQ = 5000 pounds (2270 kg) Section 302 (TPQ) CAS# 50-00-0: TPQ = 500 pounds; RQ = 100 pounds (does not meet toxici ty criteria but SARA Codes because of high production volume and recognized toxic ity is considered a chemical of concern) CAS # 50-00-0: acute, chronic. CAS # 67-56-1: acute, flammable. Section 313 This material contains Formaldehyde (CAS# 50-00-0, 3 9 4 0%), which is subject to the reporting requirements of Section 313 of SARA Title III and 40 CFR Part 373. This material Section 313 of SARA Title III and 40 CFR Part 373. contains Methyl Alcohol (CAS# 67-56-1, 2 0%),which is subject to the reporting requirements of Clean Air Act: CAS# 50-00-0 is listed as a hazardous air pollutant (HAP). CAS# 67-56-1 is listed as a hazardous air pollutant (HAP). This material does not contain any Class 1 Ozone depletors. This Clean Water Act: material does not contain any Class 2 Ozone depletors. CAS# 50-00-0 is listed as a Hazardous Substance under the CWA. None of the chemicals in this listed as Toxic Pollutants under the CWA. product are listed as Priority Pollutants under the CWA. None of the chemicals in this product are OSHA: CAS# 50-00-0 is considered highly hazardous by OSHA. STATE Florida, Pennsylvania, Minnesota, Massachusetts. CAS# 50-00-0 can be found on the following state right to know lists: California, New Jersey, CAS# 67-56-1 can be found on the following state right to know lists: California, New Jersey, Florida, Pennsylvania, Minnesota, Massachusetts. CAS# 7732-18-5 is not present on state lists from CA, PA, MN, MA, FL, or NJ. CAS# 127=09-3. is not present on. state lists from CA, PA, MN, MA, FL, or NJ. The following statement(s) is(are) made in order to comply with the California Safe state of California to cause cancer. California No Significant Risk Level: CAS# 50-00-0: no Drinking Water Act: WARNING: This product contains Formaldehyde, a chemical known to the significant risk level = 40 ug/day European/International Regulations European Labeling in Accordance with EC Directives Hazard Symbols: Risk Phrases: Not available. Safety Phrases: WGK (Water Danger/Protection) CAS# 50-00-0: 2 CAS# 67-56-1: 1 CAS# 127-09-3: 1 CAS# 7732-18-5: No information available. Canada CAS# 50-00-0 is listed on Canada's DSL/NDSL List. https://fscimage.fishersci.com/msds/41129.htm 4/18/01 <<>> rage / OI / CAS# 67-56-1 is listed on Canada's DSL/NDSL List. CAS# 127-09-3 is listed on Canada's DSL/NDSL List. CAS# 7732-18-5 is listed on Canada's DSL/NDSL List. This product has a WHMIS classification of D1B, D2A. CAS# 50-00-0 is not listed on Canada's Ingredient Disclosure List. CAS# 67-56-1 is not listed on Canada's Ingredient Disclosure List. CAS# 127-09-3 is not listed on Canada's Ingredient Disclosure List. Exposure Limits CAS# 7732-18-5 is not listed on Canada's Ingredient Disclosure List. STRALIA:TWA 1 ppm (1,5 mg/m3);STEL 2 ppm (3 mg/m3);CAR OEL-BELGIUM:TW CAS# 50-00-0: OEL-ARAB Republic of Egypt:TWA 2 ppm (3 mg/m3) OEL-AU A 1 ppm (1.2 mg/m3);STEL 2 ppm (2.5 mg/m3); CAR OEL-CZECHOSLOVAKIA:TWA 0.5 mg/m3;STEL 1 mg/m3 OEL-DENMARK:STEL 0.3 ppm (0.4 mg/m3); Carcinog en OEL-FINLAND:STEL 1 ppm (1.3 mg/m3); Skin OEL-FRANCE:STEL 2 ppm (3 mg/m3) OEL-GERMANY:TWA 0.5 ppm (0.6 mg/m3); Carcinogen OEL-HUNGARY:ST EL 0.6 mg/m3;Carcinogen OEL-JAPAN: TWA 0.5 ppm (0.61 mg/m3);Carcinogen THE PHILIPPINES: TWA 5 ppm (6 mg/m3) OEL-POLAND:TWA 2 mg/m3 OEL-RUSSI DEL-IHE NETHERLANDS:TWA 1 ppm (1.5 mg/m3);STEL 2 ppm (3 mg/m3) OEL- A:TWA 0.5 ppm;STEL 0.5 mg/m3;Skin OEL-SWEDEN: TWA 0.5 ppm (0.6 mg/m3); STEL 1 ppm (1. mg/m3) OEL-SWITZERLAND:TWA 0.5 ppm (0.6 mg/m3);STEL 1 PP (1.2 mg/m3) OEL-THAILAND: TWA 3 ppm;STEL 5 ppm OEL-TURKEY: TWA 5 pp m (6 mg/m3) OEL-UNITED KINGDOM:TWA 2 ppm (2.5 mg/m3);STEL 2 ppm (2.5 IN NEW ZELAND, SINGAPORE, VIETNAM check ACGI TLV mg/m3) OEL IN BULGARIA, COLOMBIA, JORDAN, KOREA check ACGIH TLV OEL CAS# 67-56-1: OEL-ARAB Republic of Egypt: TWA 200 ppm (260 mg/m3);Ski n OEL-AUSTRALIA: TWA 200 ppm (260 mg/m3);STEL 250 ppm;Skin OEL-BELGIU M: TWA 200 ppm (262 mg/m3);STEL 250 ppm;Skin OEL-CZECHOSLOVAKIA:TWA 10 0 mg/m3;STEL 500 mg/m3 OEL-DENMARK: TWA 200 ppm (260 mg/m3); Skin OEL- FINLAND: TWA 200 ppm (260 mg/m3);STEL 250 ppm;Skin OEL-FRANCE:TWA 200 ppm (260 mg/m3);STEL 1000 ppm (1300 mg/m3) OEL-GERMANY:TWA 200 ppm (2 -JAPAN: TWA 200 ppm (260 mg/m3);Skin OEL-THE NETHERLANDS: TWA 200 ppm ( 60 mg/m3);Skin OEL-HUNGARY:TWA 50 mg/m3;STEL 100 mg/m3;Skin JAN9 OEL 260 mg/m3);Skin OEL-THE PHILIPPINES:TWA 200 ppm (260 mg/m3) OEL-POLA ND: TWA 100 mg/m3 OEL-RUSSIA:TWA 200 ppm;STEL 5 mg/m3;Skin OEL-SWEDEN :TWA 200 ppm (250 mg/m3);STEL 250 ppm (350 mg/m3);Skin OEL-SWITZERLAN D: TWA 200 ppm (260 mg/m3);STEL 400 ppm;Skin OEL-THAILAND: TWA 200 ppm (260 mg/m3) OEL-TURKEY:TWA 200 ppm (260 mg/m3) OEL-UNITED KINGDOM:TW RDAN, KOREA check ACGIH TLV OEL IN NEW ZELAND, SINGAPORE, VIETNAM ch A 200 ppm (260 mg/m3); STEL 250 ppm;Skin OEL IN BULGARIA, COLOMBIA, JO eck ACGI TLV Section 16 - Additional Information MSDS Creation Date: 7/12/1999 Revision #3 Date: 8/02/2000 https://fscimage.fishersci.com/msds/41129.htm 4/18/01 <<>> • Material Safety Data Sheet Formalin Neutral Buffered 10% w/v ACC# 41127 Section 1 - Chemical Product and Company Identification MSDS Name: Formalin Neutral Buffered 10% w/v Catalog Numbers: SF100 20, SF100 200, SF100 4, SF10020, SF100200, SF1004 Synonyms: None company Identification: Fisher Scientific 1 Reagent Lane For information, call: 201-796-7100 Fair Lawn, NJ 07410 Emergency Number: 201-796-7100 For International CHEMTREC assistance, call: 703-527-3887 For CHEMTREC assistance, call: 800-424-9300 Section 2 - Composition, Information on Ingredients CAS# Chemical Name Percent 50-00-0 / EINECS/ELINCS Formaldehyde 4.0 200-001-8 67-56-1 Methyl alcohol 1.0-2.0 200-659-6 7558-79-4 Sodium phosphate dibasic 0.65 231-448-7 7732-18-5 Water 10049-21-5 91.9-92. 231-791-2 Sodium phosphate, Monobasic, Monohydrate 0.4 unlisted Section 3 - Hazards Identification EMERGENCY OVERVIEW Appearance: clear. Danger! May cause allergic skin reaction. This substance has caused •..adverse reproductive. and fetal effects. in animals. May cause centraL nervous system depression. formaldehye. Respiratory sensitizer. Potential cancer hazard. Causes eye and skin irritation. Causes digestive and respiratory tract irritation. Contains Target Organs: Central nervous system. Potential Health Effects Eye: Causes eye irritation. Contact may cause ulceration of the conjunctiva and cornea. Skin: Causes skin irritation. May cause skin sensitization, an allergic reaction, which becomes evident upon re-exposure to this material. Ingestion: Causes gastrointestinal irritation with nausea, vomiting and diarrhea. May cause dizziness, drowsiness, and nausea. Advanced stages may cause collapse, unconsciousness, central nervous system depression, characterized by excitement, followed by headache, coma and possible death due to respiratory failure. May cause systemic toxicity including central nervous system depression, convulsions, coma, and possible death due to respiratory failure. https://fscimage.fishersci.com/msds/41127.htm 4/18/01 <<>> - Inhalation: May cause asthmatic attacks due to allergic sensitization of the respiratory tract. Chronic: Formaldehyde has been associated with nasal and nasopharyngeal cancers. Repeated exposure may cause skin discoloration and thickening and nail decay. Section 4 - First Aid Measures Eyes: Flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and l - **truncated:** true - **body characters:** 69159