36C25220Q0128-0002007.pdf

ACTM Flex® reagent cartridge

Liquid.

SAFETY DATA SHEET

Product identifier

Product type

Section 1. Identification

ACTM Flex® reagent cartridge

Relevant identified uses of the substance or mixture and uses advised against

DEDM0322

(800) 424-9300 (CHEMTREC) (24/365)

Manufactured/supplied : Siemens Healthcare Diagnostics Inc.

511 Benedict Avenue Tarrytown, NY 10591-5097 USA 1-877-229-3711

Product code : K5088, 10445110

Not applicable.

(2012 OSHA Hazard Communication Standard (29 CFR 1910.1200))

SDS # :

Section 2. Hazards identification

SKIN IRRITATION - Category 2 EYE IRRITATION - Category 2A

Classification of the substance or mixture

Signal word : Warning

Hazard statements : H319 - Causes serious eye irritation.

H315 - Causes skin irritation.

Hazard pictograms :

Precautionary statements

Prevention : P264 - Wash hands thoroughly after handling.

P280 - Wear protective gloves/protective clothing/eye protection/face protection.

Response : P302 + P352 + P362+P364 - IF ON SKIN: Wash with plenty of soap and water. Take off contaminated clothing and wash it before reuse.

P332 + P313 - If skin irritation occurs: Get medical attention.

P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes.

Remove contact lenses, if present and easy to do. Continue rinsing.

P337 + P313 - If eye irritation persists: Get medical attention.

Storage : Not applicable.

Disposal : Not applicable.

GHS label elements

OSHA/HCS status : This material is considered hazardous by the OSHA Hazard Communication Standard

(29 CFR 1910.1200).

Hazards not otherwise classified

: None known.

Not available.

Not available.

Additional information :

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 1/11

Section 3. Composition/information on ingredients sodium carbonate 3.6 497-19-8 o-cresol 1 95-48-7

Ingredient name CAS number%

There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified as hazardous to health or the environment and hence require reporting in this section.

Substance/mixture :

Occupational exposure limits, if available, are listed in Section 8.

Mixture

Any concentration shown as a range is to protect confidentiality or is due to batch variation.

Wash out mouth with water. Remove dentures if any. Remove victim to fresh air and keep at rest in a position comfortable for breathing. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Stop if the exposed person feels sick as vomiting may be dangerous. Do not induce vomiting unless directed to do so by medical personnel. If vomiting occurs, the head should be kept low so that vomit does not enter the lungs. Get medical attention if adverse health effects persist or are severe. Never give anything by mouth to an unconscious person. If unconscious, place in recovery position and get medical attention immediately. Maintain an open airway. Loosen tight clothing such as a collar, tie, belt or waistband.

Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Continue to rinse for at least 10 minutes. Get medical attention.

Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes.

Continue to rinse for at least 10 minutes. Get medical attention. Wash clothing before reuse. Clean shoes thoroughly before reuse.

Remove victim to fresh air and keep at rest in a position comfortable for breathing. If not breathing, if breathing is irregular or if respiratory arrest occurs, provide artificial respiration or oxygen by trained personnel. It may be dangerous to the person providing aid to give mouth-to-mouth resuscitation. Get medical attention if adverse health effects persist or are severe. If unconscious, place in recovery position and get medical attention immediately. Maintain an open airway. Loosen tight clothing such as a collar, tie, belt or waistband. In case of inhalation of decomposition products in a fire, symptoms may be delayed. The exposed person may need to be kept under medical surveillance for 48 hours.

Section 4. First aid measures

Eye contact

Skin contact

Inhalation

Ingestion :

Description of necessary first aid measures

Most important symptoms/effects, acute and delayed

Inhalation : No known significant effects or critical hazards.

No known significant effects or critical hazards.:Ingestion

Skin contact : Causes skin irritation.

Causes serious eye irritation.:Eye contact

Over-exposure signs/symptoms

Skin contact

Ingestion

Inhalation No specific data.

No specific data.

Adverse symptoms may include the following:

irritation redness

Eye contact : Adverse symptoms may include the following:

pain or irritation watering redness

Potential acute health effects

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 2/11

Section 4. First aid measures

Protection of first-aiders : No action shall be taken involving any personal risk or without suitable training. It may be dangerous to the person providing aid to give mouth-to-mouth resuscitation.

Notes to physician : In case of inhalation of decomposition products in a fire, symptoms may be delayed. The exposed person may need to be kept under medical surveillance for 48 hours.

Specific treatments : No specific treatment.

See toxicological information (Section 11)

Indication of immediate medical attention and special treatment needed, if necessary

Section 5. Fire-fighting measures

Promptly isolate the scene by removing all persons from the vicinity of the incident if there is a fire. No action shall be taken involving any personal risk or without suitable training.

Hazardous thermal decomposition products

Specific hazards arising from the chemical

Decomposition products may include the following materials:

carbon dioxide carbon monoxide nitrogen oxides metal oxide/oxides

In a fire or if heated, a pressure increase will occur and the container may burst.

Fire-fighters should wear appropriate protective equipment and self-contained breathing apparatus (SCBA) with a full face-piece operated in positive pressure mode.

Special protective equipment for fire-fighters

Extinguishing media

None known.

Suitable extinguishing media

Unsuitable extinguishing media

Special protective actions for fire-fighters

In case of fire, use water spray (fog), foam or dry chemical.

Section 6. Accidental release measures

Environmental precautions

Personal precautions, protective equipment and emergency procedures

: No action shall be taken involving any personal risk or without suitable training.

Evacuate surrounding areas. Keep unnecessary and unprotected personnel from entering. Do not touch or walk through spilled material. Avoid breathing vapor or mist.

Provide adequate ventilation. Wear appropriate respirator when ventilation is inadequate.

Put on appropriate personal protective equipment.

Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers. Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air).

Stop leak if without risk. Move containers from spill area. Dilute with water and mop up if water-soluble. Alternatively, or if water-insoluble, absorb with an inert dry material and place in an appropriate waste disposal container. Dispose of via a licensed waste disposal contractor.

Small spill :

Methods and materials for containment and cleaning up

For non-emergency personnel

For emergency responders : If specialized clothing is required to deal with the spillage, take note of any information in Section 8 on suitable and unsuitable materials. See also the information in "For non-emergency personnel".

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 3/11

Section 6. Accidental release measures Stop leak if without risk. Move containers from spill area. Approach release from upwind.

Prevent entry into sewers, water courses, basements or confined areas. Wash spillages into an effluent treatment plant or proceed as follows. Contain and collect spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in container for disposal according to local regulations (see Section 13).

Dispose of via a licensed waste disposal contractor. Contaminated absorbent material may pose the same hazard as the spilled product. Note: see Section 1 for emergency contact information and Section 13 for waste disposal.

Large spill :

Section 7. Handling and storage

Advice on general occupational hygiene

Conditions for safe storage, including any incompatibilities

Eating, drinking and smoking should be prohibited in areas where this material is handled, stored and processed. Workers should wash hands and face before eating, drinking and smoking. Remove contaminated clothing and protective equipment before entering eating areas. See also Section 8 for additional information on hygiene measures.

Store in accordance with local regulations. Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials (see Section 10) and food and drink. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Do not store in unlabeled containers. Use appropriate containment to avoid environmental contamination.

Protective measures Put on appropriate personal protective equipment (see Section 8). Do not ingest. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist. Keep in the original container or an approved alternative made from a compatible material, kept tightly closed when not in use. Empty containers retain product residue and can be hazardous. Do not reuse container.

Precautions for safe handling o-cresol ACGIH TLV (United States, 3/2015).

Absorbed through skin.

TWA: 20 mg/m³ 8 hours. Form: Inhalable fraction and vapor NIOSH REL (United States, 10/2013).

TWA: 10 mg/m³ 10 hours.

TWA: 2.3 ppm 10 hours.

OSHA PEL (United States, 2/2013).

Absorbed through skin.

TWA: 22 mg/m³ 8 hours.

TWA: 5 ppm 8 hours.

OSHA PEL 1989 (United States, 3/1989).

Absorbed through skin.

TWA: 22 mg/m³ 8 hours.

TWA: 5 ppm 8 hours.

Section 8. Exposure controls/personal protection

Ingredient name Exposure limits

Environmental exposure controls

: Emissions from ventilation or work process equipment should be checked to ensure they comply with the requirements of environmental protection legislation. In some cases, fume scrubbers, filters or engineering modifications to the process equipment will be necessary to reduce emissions to acceptable levels.

Appropriate engineering controls

: Good general ventilation should be sufficient to control worker exposure to airborne contaminants.

Control parameters

Individual protection measures

Occupational exposure limits

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 4/11

Section 8. Exposure controls/personal protection

Hand protection

Based on the hazard and potential for exposure, select a respirator that meets the appropriate standard or certification. Respirators must be used according to a respiratory protection program to ensure proper fitting, training, and other important aspects of use.

Chemical-resistant, impervious gloves complying with an approved standard should be worn at all times when handling chemical products if a risk assessment indicates this is necessary. Considering the parameters specified by the glove manufacturer, check during use that the gloves are still retaining their protective properties. It should be noted that the time to breakthrough for any glove material may be different for different glove manufacturers. In the case of mixtures, consisting of several substances, the protection time of the gloves cannot be accurately estimated.

Safety eyewear complying with an approved standard should be used when a risk assessment indicates this is necessary to avoid exposure to liquid splashes, mists, gases or dusts. If contact is possible, the following protection should be worn, unless the assessment indicates a higher degree of protection: chemical splash goggles.

Eye/face protection

Respiratory protection :

Body protection Personal protective equipment for the body should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.

Wash hands, forearms and face thoroughly after handling chemical products, before eating, smoking and using the lavatory and at the end of the working period. Appropriate techniques should be used to remove potentially contaminated clothing. Wash contaminated clothing before reusing. Ensure that eyewash stations and safety showers are close to the workstation location.

Hygiene measures :

Skin protection

Other skin protection : Appropriate footwear and any additional skin protection measures should be selected based on the task being performed and the risks involved and should be approved by a specialist before handling this product.

Section 9. Physical and chemical properties Physical state

Relative density

Liquid.

Not relevant/applicable due to nature of the product.

Not relevant/applicable due to nature of the product.Odor pH

Not relevant/applicable due to nature of the product.Color

Auto-ignition temperature

Flash point

Not available.

[Product does not sustain combustion.]

Not available.

Viscosity Not available.

Partition coefficient: n-octanol/water

Flammability (solid, gas) : Not relevant/applicable due to nature of the product.

Solubility in water : Not relevant/applicable due to nature of the product.

Section 10. Stability and reactivity

Conditions to avoid No specific data.

The product is stable.Chemical stability

No specific data.

Incompatible materials :

Possibility of hazardous reactions

: Under normal conditions of storage and use, hazardous reactions will not occur.

Reactivity : No specific test data related to reactivity available for this product or its ingredients.

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 5/11

Section 10. Stability and reactivity Hazardous decomposition products

Under normal conditions of storage and use, hazardous decomposition products should not be produced.

Section 11. Toxicological information

Acute toxicity sodium carbonate LD50 Oral Rat 4090 mg/kg -o-cresol LD50 Dermal Rabbit 890 mg/kg -

LD50 Dermal Rat 620 mg/kg - LD50 Oral Rat 1350 mg/kg -

Product/ingredient name Result Species Dose Exposure

Carcinogenicity

Not available.

Mutagenicity

Not available.

Teratogenicity

Not available.

Reproductive toxicity

Not available.

Irritation/Corrosion sodium carbonate Eyes - Mild irritant Rabbit - 0.5 minutes 100 milligrams

Eyes - Moderate irritant Rabbit - 24 hours 100 milligrams

Eyes - Severe irritant Rabbit - 50 milligrams - Skin - Mild irritant Rabbit - 24 hours 500 milligrams

Product/ingredient name Result Score Exposure Observation

Sensitization

Not available.

Species

Information on the likely routes of exposure

Inhalation : No known significant effects or critical hazards.

No known significant effects or critical hazards.:Ingestion

Skin contact : Causes skin irritation.

Causes serious eye irritation.:Eye contact

Symptoms related to the physical, chemical and toxicological characteristics

Specific target organ toxicity (single exposure)

Specific target organ toxicity (repeated exposure)

Not available.

Not available.

Aspiration hazard

Not available.

Information on toxicological effects

: Not available.

Potential acute health effects

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 6/11

Section 11. Toxicological information

Not available.

No known significant effects or critical hazards.General :

No known significant effects or critical hazards.Carcinogenicity :

No known significant effects or critical hazards.Mutagenicity :

No known significant effects or critical hazards.Teratogenicity :

Developmental effects : No known significant effects or critical hazards.

Fertility effects : No known significant effects or critical hazards.

Skin contact

Ingestion

Inhalation No specific data.

No specific data.

Adverse symptoms may include the following:

irritation redness

Eye contact : Adverse symptoms may include the following:

pain or irritation watering redness

Potential chronic health effects

Delayed and immediate effects and also chronic effects from short and long term exposure

Numerical measures of toxicity

Oral 9409.8 mg/kg Dermal 63475.6 mg/kg

Route ATE value

Acute toxicity estimates

Potential immediate effects

: Not available.

Short term exposure

Potential delayed effects : Not available.

Potential immediate effects

: Not available.

Long term exposure

Potential delayed effects : Not available.

Section 12. Ecological information Toxicity sodium carbonate Acute EC50 242000 µg/l Fresh water Algae - Navicula seminulum 96 hours Acute LC50 176000 µg/l Fresh water Crustaceans - Amphipoda 48 hours Acute LC50 265000 µg/l Fresh water Daphnia - Daphnia magna 48 hours Acute LC50 300000 µg/l Fresh water Fish - Lepomis macrochirus 96 hours o-cresol Acute EC50 100000 µg/l Fresh water Algae - Selenastrum sp. 72 hours Acute EC50 100000 µg/l Fresh water Algae - Selenastrum sp. 96 hours Acute LC50 11800 µg/l Marine water Crustaceans - Elasmopus pectenicrus - Adult 48 hours

Acute LC50 5000 µg/l Fresh water Daphnia - Daphnia magna 48 hours Acute LC50 8400 µg/l Fresh water Fish - Oncorhynchus mykiss 96 hours

Product/ingredient name SpeciesResult Exposure

Persistence and degradability

Not available.

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 7/11

Section 12. Ecological information

LogPow BCF Potential

Bioaccumulative potential

Other adverse effects : No known significant effects or critical hazards.

Product/ingredient name o-cresol 1.95 10.7 low

Soil/water partition coefficient (KOC)

: Not available.

Mobility in soil

Section 13. Disposal considerations The generation of waste should be avoided or minimized wherever possible. Disposal of this product, solutions and any by-products should at all times comply with the requirements of environmental protection and waste disposal legislation and any regional local authority requirements. Dispose of surplus and non-recyclable products via a licensed waste disposal contractor. Waste should not be disposed of untreated to the sewer unless fully compliant with the requirements of all authorities with jurisdiction.

Waste packaging should be recycled. Incineration or landfill should only be considered when recycling is not feasible. This material and its container must be disposed of in a safe way. Care should be taken when handling emptied containers that have not been cleaned or rinsed out. Empty containers or liners may retain some product residues.

Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers.

:Disposal methods

United States - RCRA Toxic hazardous waste "U" List

Cresol 95-48-7 Listed U052

Ingredient CAS # Status Reference number

Section 14. Transport information

Not regulated.

DOT Classification

No.

TDG Classification

Not regulated.

UN number

UN proper shipping name

UN number

UN proper shipping name

Transport hazard class(es)

Packing group

Additional information

Environmental hazards

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 8/11

Section 14. Transport information

Not regulated.

IATA

No.

ADR/RID

Not regulated.

No.

Transport hazard class(es)

Packing group

Additional information

Environmental hazards

UN number

UN proper shipping name

Transport hazard class(es)

Packing group

Additional information

Environmental hazards

Not regulated.

IMDG

No.

UN number

UN proper shipping name

Transport hazard class(es)

UN number

UN proper shipping name

Transport hazard class(es)

Packing group

Additional information

Environmental hazards

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 9/11

Section 14. Transport information

No.

Special precautions for user

Transport in bulk according to Annex II of MARPOL and the IBC Code

Transport within user’s premises: always transport in closed containers that are upright and secure. Ensure that persons transporting the product know what to do in the event of an accident or spillage.

: Not available.

Packing group

Additional information

Environmental hazards

Section 15. Regulatory information U.S. Federal regulations

Clean Water Act (CWA) 307: copper sulphate

Clean Water Act (CWA) 311: o-cresol; ammonium chloride; copper sulphate

SARA 313

Clean Air Act Section 112

(b) Hazardous Air Pollutants (HAPs)

: Listed

Clean Air Act Section 602 Class I Substances

: Not listed

Clean Air Act Section 602 Class II Substances

: Not listed

DEA List I Chemicals (Precursor Chemicals)

: Not listed

DEA List II Chemicals (Essential Chemicals)

: Not listed

TSCA 8(a) CDR Exempt/Partial exemption: Not determined

United States inventory (TSCA 8b): All components are listed or exempted.

SARA 302/304

SARA 304 RQ : 10000 lbs / 4540 kg o-cresol 1 Yes. 1000 / 10000

- 100 -

Composition/information on ingredients

Name % EHS (lbs) (lbs)(gallons) (gallons)

SARA 302 TPQ SARA 304 RQ

SARA 311/312

Classification : Immediate (acute) health hazard sodium carbonate 3.6 No. No. No. Yes. No.

o-cresol 1 No. No. No. Yes. No.

Name % Fire hazard

Sudden release of pressure

Reactive Immediate (acute) health hazard

Delayed (chronic) health hazard

Composition/information on ingredients

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 10/11

Section 15. Regulatory information

The following components are listed: O-CRESOLMassachusetts :

Product name CAS number %

SARA 313 notifications must not be detached from the SDS and any copying and redistribution of the SDS shall include copying and redistribution of the notice attached to copies of the SDS subsequently redistributed.

o-cresol 95-48-7 1 o-cresol 95-48-7 1

Form R - Reporting requirements

Supplier notification

New York : The following components are listed: Cresol(s)

New Jersey : The following components are listed: o-CRESOL; 2-METHYL PHENOL

Pennsylvania : The following components are listed: PHENOL, 2-METHYL-

State regulations

International regulations

Chemical Weapons Convention List Schedule I Chemicals

: Not listed

Chemical Weapons Convention List Schedule II Chemicals

: Not listed

Chemical Weapons Convention List Schedule III Chemicals

: Not listed

Section 16. Other information History

Date of issue/Date of revision

Version

Notice to reader

Indicates information that has changed from previously issued version.

Key to abbreviations : ATE = Acute Toxicity Estimate BCF = Bioconcentration Factor GHS = Globally Harmonized System of Classification and Labelling of Chemicals IATA = International Air Transport Association IBC = Intermediate Bulk Container IMDG = International Maritime Dangerous Goods LogPow = logarithm of the octanol/water partition coefficient MARPOL = International Convention for the Prevention of Pollution From Ships, 1973 as modified by the Protocol of 1978. ("Marpol" = marine pollution) UN = United Nations

5/12/2017

1.05

Allergen :

Date of issue/Date of revision : 5/12/2017 Date of previous issue : 1/22/2016 Version : 1.05 11/11