012335 ThermoFisher Buffered Formalin SDS.pdf

SAFETY DATA SHEET

Creation Date 22-February-2010 Revision Date 22-July-2019 Revision Number 5

1. Identification Product Name Protocol™ 10% Neutral Buffered Formalin

Cat No. : 2300528, 2300532, 2300545, 2300546, 23005500, 23011120, 23032059, 23032060, 23245684, 23245685, 23253998, 23305510, 23316154, 23316155, 23426796, 23426797, 23427098, 51601BMT

Synonyms No information available

Recommended Use In vitro diagnostic.

Uses advised against Food, drug, pesticide or biocidal product use

Details of the supplier of the safety data sheet

2. Hazard(s) identification Classification

WHMIS 2015 Classification Classified as hazardous under the Hazardous Products Regulations (SOR/2015-17)

Label Elements

Signal Word Danger

Hazard Statements Causes skin irritation May cause an allergic skin reaction

Company Fisher Diagnostics A Division of Fisher Scientific Company, LLC A Part of Thermo Fisher Scientific, Inc.

8365 Valley Pike Middletown, VA 22645-1905 Tel: (800) 528-0494

Manufacturer Fisher Scientific One Reagent Lane Fair Lawn, NJ 07410 Tel: (201) 796-7100

Emergency Telephone Number Chemtrec US: (800) 424-9300 Chemtrec EU: 001 (202) 483-7616

Skin Corrosion/irritation Category 2 Serious Eye Damage/Eye Irritation Category 1 Skin Sensitization Category 1 Carcinogenicity Category 1A Specific target organ toxicity (single exposure) Category 1 Target Organs - Central nervous system (CNS).

Specific target organ toxicity - (repeated exposure) Category 2 Target Organs - Kidney, Liver, spleen, Blood.

Page 1 / 8

ITEM# 012335

Protocol™ 10% Neutral Buffered Formalin Revision Date 22-July-2019

Causes serious eye damage May cause drowsiness and dizziness May cause cancer Causes damage to organs May cause damage to organs through prolonged or repeated exposure

Precautionary Statements Prevention Do not breathe dust/fumes/gas/mist/vapours/spray Wash face, hands and any exposed skin thoroughly after handling Obtain special instructions before use Do not handle until all safety precautions have been read and understood Do not eat, drink or smoke when using this product Use only outdoors or in a well-ventilated area Contaminated work clothing should not be allowed out of the workplace Wear protective gloves/protective clothing/eye protection/face protection Response IF ON SKIN: Wash with plenty of soap and water IF INHALED: Remove person to fresh air and keep comfortable for breathing IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing If exposed or concerned: Call a POISON CENTER/ doctor Immediately call a POISON CENTER/doctor Take off contaminated clothing Storage Store locked up Store in a well-ventilated place. Keep container tightly closed Disposal Dispose of contents/container to an approved waste disposal plant

3. Composition/Information on Ingredients

Component CAS-No Weight % Water 7732-18-5 > 90

Formaldehyde 50-00-0 3.5 - 4.0 Methyl alcohol 67-56-1 1.0 - 2.0

Sodium phosphate, monobasic 7558-80-7 < 1.0 Sodium phosphate dibasic 7558-79-4 < 1.0

4. First-aid measures

Eye Contact Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Get medical attention.

Skin Contact Wash off immediately with plenty of water for at least 15 minutes. Obtain medical attention.

Inhalation Move to fresh air. If breathing is difficult, give oxygen. Get medical attention immediately if symptoms occur.

Ingestion Do not induce vomiting. Obtain medical attention.

Page 2 / 8

Most important symptoms/effects Causes eye burns. May cause allergic skin reaction. Symptoms of allergic reaction may include rash, itching, swelling, trouble breathing, tingling of the hands and feet, dizziness, lightheadedness, chest pain, muscle pain or flushing

Notes to Physician Treat symptomatically

5. Fire-fighting measures Suitable Extinguishing Media Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

Unsuitable Extinguishing Media No information available

Flash Point > 93.3 °C / 199.9 °F

Method - No information available

Autoignition Temperature No information available Explosion Limits

Upper No data available Lower No data available Sensitivity to Mechanical Impact No information available Sensitivity to Static Discharge No information available

Specific Hazards Arising from the Chemical Thermal decomposition can lead to release of irritating gases and vapors. Keep product and empty container away from heat and sources of ignition.

Hazardous Combustion Products Thermal decomposition can lead to release of irritating gases and vapors Protective Equipment and Precautions for Firefighters As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear.

NFPA

6. Accidental release measures Personal Precautions Use personal protective equipment. Ensure adequate ventilation. Remove all sources of ignition. Avoid contact with skin, eyes and clothing.

Environmental Precautions Should not be released into the environment. See Section 12 for additional ecological information.

Methods for Containment and Clean Up

Remove all sources of ignition. Soak up with inert absorbent material. Keep in suitable, closed containers for disposal.

7. Handling and storage Handling Use only under a chemical fume hood. Wear personal protective equipment. Keep away from open flames, hot surfaces and sources of ignition. Do not breathe vapors or spray mist. Do not get in eyes, on skin, or on clothing.

Storage Keep containers tightly closed in a dry, cool and well-ventilated place. Keep away from heat and sources of ignition.

8. Exposure controls / personal protection Exposure Guidelines

Component Alberta British Columbia

Ontario TWAEV Quebec ACGIH TLV OSHA PEL NIOSH IDLH

Health

Flammability

Instability

Page 3 / 8

Physical hazards N/A

Formaldehyde Ceiling: 1 ppm Ceiling: 1.3 mg/m3

TWA: 0.75 ppm TWA: 0.9 mg/m3

TWA: 0.3 ppm Ceiling: 1 ppm

STEL: 1 ppm CEV: 1.5 ppm

Ceiling: 2 ppm Ceiling: 3 mg/m3

TWA: 0.1 ppm STEL: 0.3 ppm

(Vacated) TWA:

3 ppm

(Vacated) STEL:

10 ppm

(Vacated) Ceiling: 5 ppm TWA: 0.75 ppm STEL: 2 ppm

IDLH: 20 ppm TWA: 0.016 ppm Ceiling: 0.1 ppm

Methyl alcohol TWA: 200 ppm

TWA: 262

mg/m3

STEL: 250 ppm

STEL: 328

mg/m3

Skin

TWA: 200 ppm STEL: 250 ppm

Skin

TWA: 200 ppm STEL: 250 ppm

Skin

TWA: 200 ppm

TWA: 262

mg/m3

STEL: 250 ppm

STEL: 328

mg/m3

Skin

TWA: 200 ppm STEL: 250 ppm

Skin

(Vacated) TWA:

200 ppm

(Vacated) TWA:

260 mg/m3

(Vacated) STEL:

250 ppm

(Vacated) STEL:

325 mg/m3

Skin TWA: 200 ppm

TWA: 260

mg/m3

IDLH: 6000 ppm TWA: 200 ppm

TWA: 260

mg/m3

STEL: 250 ppm

STEL: 325

mg/m3

Legend

ACGIH - American Conference of Governmental Industrial Hygienists

OSHA - Occupational Safety and Health Administration

NIOSH IDLH: The National Institute for Occupational Safety and Health Immediately Dangerous to Life or Health

Engineering Measures Use only under a chemical fume hood. Ensure adequate ventilation, especially in confined areas. Ensure that eyewash stations and safety showers are close to the workstation location.

Wherever possible, engineering control measures such as the isolation or enclosure of the process, the introduction of process or equipment changes to minimise release or contact, and the use of properly designed ventilation systems, should be adopted to control hazardous materials at source

Personal protective equipment

Eye Protection Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard

EN166.

Hand Protection Wear appropriate protective gloves and clothing to prevent skin exposure.

Inspect gloves before use. observe the instructions regarding permeability and breakthrough time which are provided by the supplier of the gloves. (Refer to manufacturer/supplier for information) gloves are suitable for the task: Chemical compatability, Dexterity, Operational conditions, User susceptibility, e.g. sensitisation effects, also take into consideration the specific local conditions under which the product is used, such as the danger of cuts, abrasion. gloves with care avoiding skin contamination.

Respiratory Protection When workers are facing concentrations above the exposure limit they must use appropriate certified respirators. Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European Standard EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are exceeded or if irritation or other symptoms are experienced.

To protect the wearer, respiratory protective equipment must be the correct fit and be used and maintained properly

When RPE is used a face piece Fit Test should be conducted

Environmental exposure controls No information available.

Hygiene Measures Handle in accordance with good industrial hygiene and safety practice. Keep away from food, drink and animal feeding stuffs. Do not eat, drink or smoke when using this product. Remove and wash contaminated clothing before re-use. Wash hands before

Glove material Breakthrough time Glove thickness Glove comments Nitrile rubber See manufacturers recommendations

- Splash protection only

Page 4 / 8 breaks and at the end of workday.

9. Physical and chemical properties Physical State Liquid Appearance Colorless Odor Characteristic formaldehyde Odor Threshold No information available pH 6.9 - 7.1 Melting Point/Range No data available Boiling Point/Range 102 °C / 215.6 °F Flash Point > 93.3 °C / 199.9 °F Evaporation Rate No information available Flammability (solid,gas) No information available Flammability or explosive limits

Upper No data available Lower No data available

Vapor Pressure No information available Vapor Density No information available Specific Gravity 1.0 Solubility No information available Partition coefficient; n-octanol/water No data available Autoignition Temperature No information available Decomposition Temperature No information available Viscosity No information available

10. Stability and reactivity

Reactive Hazard None known, based on information available

Stability Stable under normal conditions.

Conditions to Avoid Incompatible products. Heat, flames and sparks.

Incompatible Materials Strong oxidizing agents

Hazardous Decomposition Products Thermal decomposition can lead to release of irritating gases and vapors

Hazardous Polymerization Hazardous polymerization does not occur.

Hazardous Reactions None under normal processing.

11. Toxicological information Acute Toxicity

Product Information No acute toxicity information is available for this product Oral LD50 Based on ATE data, the classification criteria are not met. ATE > 2000 mg/kg.

Dermal LD50 Based on ATE data, the classification criteria are not met. ATE > 2000 mg/kg.

Vapor LC50 Based on ATE data, the classification criteria are not met. ATE > 20 mg/l.

Component Information

Component LD50 Oral LD50 Dermal LC50 Inhalation Water - Not listed Not listed

Formaldehyde 500 mg/kg (Rat) LD50 = 270 mg/kg (Rabbit) 0.578 mg/L (Rat) 4 h

Methyl alcohol Calc. ATE 60 mg/kg LD50 > 1187 – 2769 mg/kg ( Rat )

Calc. ATE 60 mg/kg LD50 = 17100 mg/kg ( Rabbit )

Calc. ATE 0.6 mg/L (vapours) or

0.5 mg/L (mists)

LC50 = 128.2 mg/L ( Rat ) 4 h Sodium phosphate, monobasic LD50 = 8290 mg/kg ( Rat ) LD50 > 7940 mg/kg ( Rabbit ) Not listed

Sodium phosphate dibasic LD50 = 17 g/kg ( Rat ) Not listed Not listed

Page 5 / 8

Toxicologically Synergistic Products

No information available

Delayed and immediate effects as well as chronic effects from short and long-term exposure

Irritation Risk of serious damage to eyes Irritating to respiratory system and skin

Sensitization May cause sensitization by skin contact

Carcinogenicity The table below indicates whether each agency has listed any ingredient as a carcinogen.

Component CAS-No IARC NTP ACGIH OSHA Mexico Water 7732-18-5 Not listed Not listed Not listed Not listed Not listed

Formaldehyde 50-00-0 Group 1 Known A1 X A2 Methyl alcohol 67-56-1 Not listed Not listed Not listed Not listed Not listed

Sodium phosphate, monobasic

7558-80-7 Not listed Not listed Not listed Not listed Not listed

Sodium phosphate dibasic

7558-79-4 Not listed Not listed Not listed Not listed Not listed

IARC: (International Agency for Research on Cancer) IARC: (International Agency for Research on Cancer) Group 1 - Carcinogenic to Humans Group 2A - Probably Carcinogenic to Humans Group 2B - Possibly Carcinogenic to Humans

NTP: (National Toxicity Program) NTP: (National Toxicity Program) Known - Known Carcinogen Reasonably Anticipated - Reasonably Anticipated to be a Human Carcinogen

ACGIH: (American Conference of Governmental Industrial Hygienists)

A1 - Known Human Carcinogen A2 - Suspected Human Carcinogen A3 - Animal Carcinogen ACGIH: (American Conference of Governmental Industrial Hygienists)

Mutagenic Effects Mutagenic effects have occurred in humans.

Reproductive Effects Experiments have shown reproductive toxicity effects on laboratory animals.

Developmental Effects Developmental effects have occurred in experimental animals. Component substance is listed on California Proposition 65 as a developmental hazard.

Teratogenicity Teratogenic effects have occurred in experimental animals.

STOT - single exposure Central nervous system (CNS) STOT - repeated exposure Kidney Liver spleen Blood

Aspiration hazard No information available

Symptoms / effects,both acute and delayed

Symptoms of allergic reaction may include rash, itching, swelling, trouble breathing, tingling of the hands and feet, dizziness, lightheadedness, chest pain, muscle pain or flushing

Endocrine Disruptor Information No information available

Other Adverse Effects See actual entry in RTECS for complete information.

12. Ecological information Ecotoxicity

Component Freshwater Algae Freshwater Fish Microtox Water Flea Formaldehyde Not listed Leuciscus idus: LC50 = 15 mg/L 96h Not listed EC50 = 20 mg/L 96h

EC50 = 2 mg/L 48h Methyl alcohol Not listed Pimephales promelas: LC50

> 10000 mg/L 96h EC50 = 39000 mg/L 25 min EC50 = 40000 mg/L 15 min EC50 = 43000 mg/L 5 min

EC50 > 10000 mg/L 24h

Page 6 / 8

Persistence and Degradability No information available

Bioaccumulation/ Accumulation No information available.

Mobility .

Component log Pow Formaldehyde -0.35 Methyl alcohol -0.74

13. Disposal considerations Waste Disposal Methods Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste. Chemical waste generators must also consult local, regional, and national hazardous waste regulations to ensure complete and accurate classification.

Component RCRA - U Series Wastes RCRA - P Series Wastes Formaldehyde - 50-00-0 U122 - Methyl alcohol - 67-56-1 U154 -

14. Transport information DOT Not regulated TDG Not regulated IATA Not regulated IMDG/IMO Not regulated

15. Regulatory information

International Inventories

Component DSL NDSL TSCA EINECS ELINCS NLP PICCS ENCS AICS IECSC KECL Water X - X 231-791-2 - X - X X KE-3540

Formaldehyde X - X 200-001-8 - X X X X KE-1707

Methyl alcohol X - X 200-659-6 - X X X X KE-2319

Sodium phosphate, monobasic X - X 231-449-2 - X X X X KE-3157

Sodium phosphate dibasic X - X 231-448-7 - X X X X KE-1234

Canada

SDS in compliance with provisions of information as set out in Canadian Standard - Part 4, Schedule 1 and 2 of the Hazardous Products Regulations (HPR) and meets the requirements of the HPR (Paragraph 13(1)(a) of the Hazardous Products Act (HPA)).

Component Canada - National Pollutant Release Inventory (NPRI)

Canadian Environmental Protection Agency (CEPA)

- List of Toxic Substances

Canada's Chemicals Management Plan (CEPA)

Formaldehyde Part 1, Group A Substance Part 5, Individual Substances Part 4

Substance

Schedule I

Methyl alcohol Part 1, Group A Substance Part 5, Individual Substances Part 4

Substance

16. Other information Prepared By Regulatory Affairs

Thermo Fisher Scientific Email: EMSDS.RA@thermofisher.com

Page 7 / 8

Creation Date 22-February-2010 Revision Date 22-July-2019 Print Date 22-July-2019 Revision Summary This document has been updated to comply with the requirements of WHMIS 2015 to align with the Globally Harmonised System (GHS) for the Classification and Labelling of Chemicals.

Disclaimer The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text

End of SDS

Page 8 / 8