Page 1 of 27
Kit MSDS Cover Sheet
Doc. ID: DSL2100-75: Rev. AA
.
Issued (year/month/day) 2008/08/15
Product Information
Product Name
ACTIVE(r) Cortisol RIA
Part Number
DSL2100
Series Name
ACTIVE
(r)
Additional Product
Information
This kit contains coated tubes that are considered articles and thereby
exempt from MSDS requirements
Components
Description
Cortisol Standard A
Cortisol Standard B, C, D, E, F, G/ Control I, II
Cortisol [I-125] Reagent
Cortisol Diluent
Transport Information
Shipping Information
Shipping Name
Radioactive Material, excepted
package-limited quantity of material
UN/ID Number
2910
Packing Group
IATA
Hazard Class
7 Radioactive Material
Subsidiary Risk
None
Special Provisions
Not applicable
IATA ERG Code
7L
IMDG
Hazard Class
7 Radioactive material
Subsidiary Risk
None
Special Provisions
Not applicable
Marine Pollutant
No
US DOT
Hazard Class
7 Radioactive material
Subsidiary Risk
None
Special Provisions
Not applicable
NAERG Number
161
European ADR
ADR Classication
7 Radioactive material
Classication Code/
None
Subsidiary Risk
None
Canadian TDG
PIN
2910
(c)2008 Beckman Coulter, Inc.
Global MSDS  English
Page 2 of 27
Transport Information
(Continued)
TDG Classication
7 Radioactive Materials
Subsidiary Risk
None
Special Provisions
Not applicable
NAERG Number
161
ACTIVE(r) Cortisol RIA
Doc. ID: DSL2100-75 AA
Page 3 of 27
MATERIAL SAFETY DATA SHEET
ACTIVE(r) Cortisol RIA
Doc. ID: DSL2100-75 AA
.
Issued (year/month/day) 2008/08/15
Section 1 Company and Product Identication
Product Name
Cortisol Standard A
Part Number
Component of P/N DSL2100
Product Use
For In Vitro Diagnostic Use. See product literature for details.
Series Name
ACTIVE
(r)
Manufacturer
Manufactured for Beckman Coulter, Inc. by
Diagnostic Systems Laboratories, Inc. (A Beckman Coulter Company)
445 Medical Center Blvd.
Webster, TX 77598, U.S.A.
EC REP Address
OBI - DSL
Cherwell Innovation Centre
Upper Heyford
Oxon OX25 5HD UK
Tel: 018.6923.8077
Distributor and
Emergency Phone No.
Refer to attached list, Document ID:
472050
, for local distributor
and emergency phone numbers.
Section 2 Hazards Identication
Emergency Overview
Light brown; Clear; Liquid; Odorless
Nonammable solution.
Does not meet EU, OSHA or WHMIS criteria for hazardous materials.
Contains material of human origin.
Physical Hazards
Sodium azide forms explosive compounds with heavy metals. This product
contains concentrations of azide <0.1% (w/w) which with repeated contact
with lead and copper commonly found in plumbing drains may result in
the build up of shock sensitive compounds.
Potential Health
Effects Summary
This product does not meet EU, OSHA or WHMIS criteria for hazardous
materials. However, it does contain material of human origin and should
be considered potentially infectious.
See Section 11 Toxicological Information for more detailed health information.
Potential
Environmental Effects
None identied.
Product Hazard
Classications
Meets Hazardous Criteria for Preparation/Mixture
EU:
Not applicable
.
WHMIS:
Exempt
US OSHA:
Not applicable
Section 3 Composition and Information on Ingredients
Hazardous Ingredients:
None
Section 4 First Aid Measures
Inhalation
If product is inhaled, move exposed individual to fresh air. If individual is not
breathing, begin articial respiration immediately and obtain medical attention.
Eye Contact
If product enters eyes, wash eyes gently under running water for 15
minutes or longer, making sure that the eyelids are held open. If pain
or irritation occur, obtain medical attention.
Skin Contact
In case of skin contact, ush with copious amounts of water for at least 15
minutes. If pain or irritation occur, obtain medical attention.
Ingestion
If ingested, wash mouth out with water.
If irritation or discomfort
occurs, seek medical attention.
Section 5 Fire Fighting Measures
Flammable Properties
Nonammable solution.
Extinguishing Media
Use extinguishing media suitable for surrounding re.
Special Fire and Explosion
Hazards
No special hazards determined.
Hazardous Combustion
Products
No combustion products posing signicant hazards are expected from this product.
Protective Equipment
for Fireghters
Self-contained breathing apparatus is recommended for reghters.
Section 6 Accidental Release Measures
Personal Precautions
This product contains material of human origin and should be handled as
though capable of transmitting infectious diseases. Universal precautions
should be followed during clean up procedures.
Spill and Leak
Procedures
As a precautionary measure, treat spilled material with a 1:10 bleach/water solution.
Absorb liquid and place in container suitable for disposal. Avoid generation of
aerosols during clean up. Comply with applicable waste disposal regulations.
Environmental
Precautions
Contain spill to prevent migration.
Section 7 Handling and Storage
Handling Precautions
This product should be handled as though capable of transmitting infectious
diseases. Universal precautions should be followed when using this product.
Recommended Storage
Conditions
Keep away from incompatible material (see Section 10).
To maintain efcacy, store according to the instructions in the product labeling.
ACTIVE(r) Cortisol RIA
Page 4 of 27
Cortisol Standard A
Doc. ID: DSL2100-75 AA
Section 8 Exposure Controls and Personal Protection
Exposure Limits
US OSHA:
None established
ACGIH:
None established
DFG MAK:
None established
NIOSH
None established
Japan
None established
Engineering Controls
No special engineering controls are required. Use with good general ventilation.
Respiratory Protection
Under normal conditions, the use of this product should not require respiratory
protection. If overexposure should occur and ventilation is not adequate to
maintain airborne concentrations at acceptable levels, the use of respiratory
protection should be evaluated by a qualied professional.
Eye Protection
Safety glasses or chemical goggles should be worn to prevent eye contact.
Skin Protection
Impervious gloves, such as Nitrile or equivalent, should be worn
to prevent skin contact.
Section 9 Physical and Chemical Properties
Physical State
Liquid
Color
Light brown
Transparency
Clear
Odor
Odorless
Odor Threshold
Not applicable
pH
7.4
Freezing Point
Not available
Boiling Point
Not available
Flash Point
Not applicable
Evaporation Rate
Not available
Flammability (Solid, Gas)
Not applicable
Flammable Limits
Not applicable
Vapor Pressure
Not available
Vapor Density
Not available
Specic Gravity
1.04 @20°C
Solubility
Water
Miscible
Organic
Not available
ACTIVE(r) Cortisol RIA
Page 5 of 27
Cortisol Standard A
Doc. ID: DSL2100-75 AA
Section 9 Physical and Chemical Properties
(Continued)
Coefcient of Water/Oil
Distribution
Not available
Autoignition Temp.
Not applicable
Decomposition Temperature
Not available
Percent Volatiles
Not applicable
Section 10 Stability and Reactivity
Stability
Stable in closed containers under normal temperatures and pressures.
Hazardous Incompatibilities
Strong acids
Strong bases
Strong oxidizers
Metals and metallic compounds
Sodium azide forms explosive compounds with heavy metals. This product
contains concentrations of azide <0.1% (w/w) which with repeated contact
with lead and copper commonly found in plumbing drains may result in
the build up of shock sensitive compounds.
Hazardous Decomposition
Products
No decomposition products posing signicant hazards would be
expected from this product.
Conditions to Avoid
Keep away from incompatible material.
Section 11 Toxicological Information
Toxicity Data
for Hazardous Ingredients
Not applicable
Primary Routes
of Exposure
Common routes of entry include inhalation, ingestion and eye/skin contact. Specic
paths of concern for potentially infectious materials are skin puncture, contact with
broken skin, contact with mucous membranes and inhalation of aerosolized material.
Potential Effects of
Acute Exposure
This product contains materials of human origin and should be considered potentially
infectious. No other health hazards were identied from a review of available literature.
Potential Effects of Chronic
Exposure
None identied.
Symptoms of Overexposure
None identied.
Carcinogenicity
No ingredients in this product are listed as carcinogens by ACGIH,
IARC, NTP, OSHA or 67/548/EEC Annex I.
Other Effects
None identied.
Conditions Aggravated
by Exposure
None identied.
Section 12 Ecological Information
Ecotoxicity
No information available.
ACTIVE(r) Cortisol RIA
Page 6 of 27
Cortisol Standard A
Doc. ID: DSL2100-75 AA
Section 12 Ecological Information
(Continued)
Biodegradability
No information available.
Bioaccumulation
No information available.
Mobility
No information available.
Other Adverse Effects
No information available.
Section 13 Disposal Considerations
Waste Disposal
Dispose of waste product, unused product and contaminated packaging in
compliance with federal, state and local regulations. If unsure of the applicable
requirements, contact the authorities for information.
Sodium azide preservative may form explosive compounds in metal drain lines.
See NIOSH Bulletin: Explosive Azide Hazard (8/16/76).
Section 14 Transport Information
Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG.
Section 15 Regulatory Information
US Federal and State Regulations
SARA 313
Sodium Azide is subject to reporting requirements of Section 313, Title III of SARA.
CERCLA RG's,
40 CFR 302.4
Sodium Azide is listed.
California Proposition 65
No ingredients listed.
Massachusetts MSL
Sodium Azide is listed.
New Jersey Dept. of
Health RTK List
Sodium Azide is listed.
Pennsylvania RTK
Sodium Azide is listed.
EU Labeling Classication
Preparation not classied.
Canada
This product is exempt from WHMIS label and MSDS requirements.
PIN:
Not applicable
Ingredients on Ingredient
Disclosure List:
Sodium Azide
Ingredients with unknown
toxicological properties:
Product is exempt
Some hazardous ingredients listed in Section 15 are below OSHAs and WHMIS' 1.0% w/w (0.1% for carcinogens)
or EU's ingredient specic concentrations required for reporting in Section 3.
ACTIVE(r) Cortisol RIA
Page 7 of 27
Cortisol Standard A
Doc. ID: DSL2100-75 AA
Section 16 Other Information
Beckman Coulter Safety
Rating
Flammability (Section V): 0
Health (Section XI): 1
Reactivity with Water (Section X): 0
Contact (Section VIII): 1
Code
0=none
1=slight
2=caution
3=severe
Revision Changes
Not applicable
For further information, please contact your local Beckman Coulter representative.
WHILE BECKMAN COULTER, INC. BELIEVES THE INFORMATION CONTAINED HEREIN IS VALID AND ACCURATE, BECKMAN COULTER MAKES NO
WARRANTY OR REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR CURRENCY. BECKMAN COULTER SHALL NOT BE LIABLE OR OTHERWISE
RESPONSIBLE IN ANY WAY FOR USE OF EITHER THIS INFORMATION OR MATERIALS TO WHICH IT APPLIES. DISPOSAL OF HAZARDOUS
MATERIALS MAY BE SUBJECT TO LOCAL LAWS OR REGULATIONS.
Printed in U.S.A.
ACTIVE(r) Cortisol RIA
Page 8 of 27
Cortisol Standard A
Doc. ID: DSL2100-75 AA
Page 9 of 27
MATERIAL SAFETY DATA SHEET
ACTIVE(r) Cortisol RIA
Doc. ID: DSL2100-75 AA
.
Issued (year/month/day) 2008/08/15
Section 1 Company and Product Identication
Product Name
Cortisol Standard B, C, D, E, F, G/ Control I, II
Part Number
Component of P/N DSL2100
Product Use
For In Vitro Diagnostic Use. See product literature for details.
Series Name
ACTIVE
(r)
Manufacturer
Manufactured for Beckman Coulter, Inc. by
Diagnostic Systems Laboratories, Inc. (A Beckman Coulter Company)
445 Medical Center Blvd.
Webster, TX 77598, U.S.A.
EC REP Address
OBI - DSL
Cherwell Innovation Centre
Upper Heyford
Oxon OX25 5HD UK
Tel: 018.6923.8077
Distributor and
Emergency Phone No.
Refer to attached list, Document ID:
472050
, for local distributor
and emergency phone numbers.
Section 2 Hazards Identication
Emergency Overview
Light brown; Clear; Liquid; Odorless
Nonammable solution.
Does not meet EU, OSHA or WHMIS criteria for hazardous materials.
Contains material of human origin.
Physical Hazards
Sodium azide forms explosive compounds with heavy metals. This product
contains concentrations of azide <0.1% (w/w) which with repeated contact
with lead and copper commonly found in plumbing drains may result in
the build up of shock sensitive compounds.
Potential Health
Effects Summary
This product does not meet EU, OSHA or WHMIS criteria for hazardous
materials. However, it does contain material of human origin and should
be considered potentially infectious.
See Section 11 Toxicological Information for more detailed health information.
Potential
Environmental Effects
None identied.
Product Hazard
Classications
Meets Hazardous Criteria for Preparation/Mixture
EU:
Not applicable
.
WHMIS:
Exempt
US OSHA:
Not applicable
Section 3 Composition and Information on Ingredients
Hazardous Ingredients:
None
Section 4 First Aid Measures
Inhalation
If product is inhaled, move exposed individual to fresh air. If individual is not
breathing, begin articial respiration immediately and obtain medical attention.
Eye Contact
If product enters eyes, wash eyes gently under running water for 15
minutes or longer, making sure that the eyelids are held open. If pain
or irritation occur, obtain medical attention.
Skin Contact
In case of skin contact, ush with copious amounts of water for at least 15
minutes. If pain or irritation occur, obtain medical attention.
Ingestion
If ingested, wash mouth out with water.
If irritation or discomfort
occurs, seek medical attention.
Section 5 Fire Fighting Measures
Flammable Properties
Nonammable solution.
Extinguishing Media
Use extinguishing media suitable for surrounding re.
Special Fire and Explosion
Hazards
No special hazards determined.
Hazardous Combustion
Products
No combustion products posing signicant hazards are expected from this product.
Protective Equipment
for Fireghters
Self-contained breathing apparatus is recommended for reghters.
Section 6 Accidental Release Measures
Personal Precautions
This product contains material of human origin and should be handled as
though capable of transmitting infectious diseases. Universal precautions
should be followed during clean up procedures.
Spill and Leak
Procedures
As a precautionary measure, treat spilled material with a 1:10 bleach/water solution.
Absorb liquid and place in container suitable for disposal. Avoid generation of
aerosols during clean up. Comply with applicable waste disposal regulations.
Environmental
Precautions
Contain spill to prevent migration.
Section 7 Handling and Storage
Handling Precautions
This product should be handled as though capable of transmitting infectious
diseases. Universal precautions should be followed when using this product.
Recommended Storage
Conditions
Keep away from incompatible material (see Section 10).
To maintain efcacy, store according to the instructions in the product labeling.
ACTIVE(r) Cortisol RIA
Page 10 of 27
Cortisol Standard B, C, D, E, F, G/ Control I, II
Doc. ID: DSL2100-75 AA
Section 8 Exposure Controls and Personal Protection
Exposure Limits
US OSHA:
None established
ACGIH:
None established
DFG MAK:
None established
NIOSH
None established
Japan
None established
Engineering Controls
No special engineering controls are required. Use with good general ventilation.
Respiratory Protection
Under normal conditions, the use of this product should not require respiratory
protection. If overexposure should occur and ventilation is not adequate to
maintain airborne concentrations at acceptable levels, the use of respiratory
protection should be evaluated by a qualied professional.
Eye Protection
Safety glasses or chemical goggles should be worn to prevent eye contact.
Skin Protection
Impervious gloves, such as Nitrile or equivalent, should be worn
to prevent skin contact.
Section 9 Physical and Chemical Properties
Physical State
Liquid
Color
Light brown
Transparency
Clear
Odor
Odorless
Odor Threshold
Not applicable
pH
7.4
Freezing Point
Not available
Boiling Point
Not available
Flash Point
Not applicable
Evaporation Rate
Not available
Flammability (Solid, Gas)
Not applicable
Flammable Limits
Not applicable
Vapor Pressure
Not available
Vapor Density
Not available
Specic Gravity
1.04 @20°C
Solubility
Water
Miscible
Organic
Not available
ACTIVE(r) Cortisol RIA
Page 11 of 27
Cortisol Standard B, C, D, E, F, G/ Control I, II
Doc. ID: DSL2100-75 AA
Section 9 Physical and Chemical Properties
(Continued)
Coefcient of Water/Oil
Distribution
Not available
Autoignition Temp.
Not applicable
Decomposition Temperature
Not available
Percent Volatiles
Not applicable
Section 10 Stability and Reactivity
Stability
Stable in closed containers under normal temperatures and pressures.
Hazardous Incompatibilities
Strong acids
Strong bases
Strong oxidizers
Metals and metallic compounds
Sodium azide forms explosive compounds with heavy metals. This product
contains concentrations of azide <0.1% (w/w) which with repeated contact
with lead and copper commonly found in plumbing drains may result in
the build up of shock sensitive compounds.
Hazardous Decomposition
Products
No decomposition products posing signicant hazards would be
expected from this product.
Conditions to Avoid
Keep away from incompatible material.
Section 11 Toxicological Information
Toxicity Data
for Hazardous Ingredients
Not applicable
Primary Routes
of Exposure
Common routes of entry include inhalation, ingestion and eye/skin contact. Specic
paths of concern for potentially infectious materials are skin puncture, contact with
broken skin, contact with mucous membranes and inhalation of aerosolized material.
Potential Effects of
Acute Exposure
This product contains materials of human origin and should be considered potentially
infectious. No other health hazards were identied from a review of available literature.
Potential Effects of Chronic
Exposure
None identied.
Symptoms of Overexposure
None identied.
Carcinogenicity
No ingredients in this product are listed as carcinogens by ACGIH,
IARC, NTP, OSHA or 67/548/EEC Annex I.
Other Effects
None identied.
Conditions Aggravated
by Exposure
None identied.
Section 12 Ecological Information
Ecotoxicity
No information available.
ACTIVE(r) Cortisol RIA
Page 12 of 27
Cortisol Standard B, C, D, E, F, G/ Control I, II
Doc. ID: DSL2100-75 AA
Section 12 Ecological Information
(Continued)
Biodegradability
No information available.
Bioaccumulation
No information available.
Mobility
No information available.
Other Adverse Effects
No information available.
Section 13 Disposal Considerations
Waste Disposal
Dispose of waste product, unused product and contaminated packaging in
compliance with federal, state and local regulations. If unsure of the applicable
requirements, contact the authorities for information.
Sodium azide preservative may form explosive compounds in metal drain lines.
See NIOSH Bulletin: Explosive Azide Hazard (8/16/76).
Section 14 Transport Information
Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG.
Section 15 Regulatory Information
US Federal and State Regulations
SARA 313
Sodium Azide is subject to reporting requirements of Section 313, Title III of SARA.
CERCLA RG's,
40 CFR 302.4
Sodium Azide is listed.
California Proposition 65
No ingredients listed.
Massachusetts MSL
Sodium Azide is listed.
New Jersey Dept. of
Health RTK List
Sodium Azide is listed.
Pennsylvania RTK
Sodium Azide is listed.
EU Labeling Classication
Preparation not classied.
Canada
This product is exempt from WHMIS label and MSDS requirements.
PIN:
Not applicable
Ingredients on Ingredient
Disclosure List:
Sodium Azide
Ingredients with unknown
toxicological properties:
Product is exempt
Some hazardous ingredients listed in Section 15 are below OSHAs and WHMIS' 1.0% w/w (0.1% for carcinogens)
or EU's ingredient specic concentrations required for reporting in Section 3.
ACTIVE(r) Cortisol RIA
Page 13 of 27
Cortisol Standard B, C, D, E, F, G/ Control I, II
Doc. ID: DSL2100-75 AA
Section 16 Other Information
Beckman Coulter Safety
Rating
Flammability (Section V): 0
Health (Section XI): 1
Reactivity with Water (Section X): 0
Contact (Section VIII): 1
Code
0=none
1=slight
2=caution
3=severe
Revision Changes
Not applicable
For further information, please contact your local Beckman Coulter representative.
WHILE BECKMAN COULTER, INC. BELIEVES THE INFORMATION CONTAINED HEREIN IS VALID AND ACCURATE, BECKMAN COULTER MAKES NO
WARRANTY OR REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR CURRENCY. BECKMAN COULTER SHALL NOT BE LIABLE OR OTHERWISE
RESPONSIBLE IN ANY WAY FOR USE OF EITHER THIS INFORMATION OR MATERIALS TO WHICH IT APPLIES. DISPOSAL OF HAZARDOUS
MATERIALS MAY BE SUBJECT TO LOCAL LAWS OR REGULATIONS.
Printed in U.S.A.
ACTIVE(r) Cortisol RIA
Page 14 of 27
Cortisol Standard B, C, D, E, F, G/ Control I, II
Doc. ID: DSL2100-75 AA
Page 15 of 27
MATERIAL SAFETY DATA SHEET
ACTIVE(r) Cortisol RIA
Doc. ID: DSL2100-75 AA
.
Issued (year/month/day) 2008/08/15
Section 1 Company and Product Identication
Product Name
Cortisol [I-125] Reagent
Part Number
Component of P/N DSL2100
Product Use
For In Vitro Diagnostic Use. See product literature for details.
Series Name
ACTIVE
(r)
Manufacturer
Manufactured for Beckman Coulter, Inc. by
Diagnostic Systems Laboratories, Inc. (A Beckman Coulter Company)
445 Medical Center Blvd.
Webster, TX 77598, U.S.A.
EC REP Address
OBI - DSL
Cherwell Innovation Centre
Upper Heyford
Oxon OX25 5HD UK
Tel: 018.6923.8077
Distributor and
Emergency Phone No.
Refer to attached list, Document ID:
472050
, for local distributor
and emergency phone numbers.
Section 2 Hazards Identication
Emergency Overview
Red; Clear; Liquid; Odorless
Nonammable aqueous solution.
Does not meet EU, OSHA or WHMIS criteria for hazardous materials.
Contains material of human and animal origin.
Physical Hazards
Sodium azide forms explosive compounds with heavy metals. This product
contains concentrations of azide <0.1% (w/w) which with repeated contact
with lead and copper commonly found in plumbing drains may result in
the build up of shock sensitive compounds.
Iodine 125 is a gamma, X and beta emitter. Radiation is stopped by
1mm of lead. Half life: 59.9 days.
Potential Health
Effects Summary
This product does not meet EU, OSHA or WHMIS criteria for hazardous
materials. However, it does contain material of human and animal origin
and should be considered potentially infectious.
Iodine may accumulate in the thyroid gland.
See Section 11 Toxicological Information for more detailed health information.
Potential
Environmental Effects
No information available.
Section 2 Hazards Identication
(Continued)
Product Hazard
Classications
Meets Hazardous Criteria for Preparation/Mixture
EU:
Not applicable
.
WHMIS:
Exempt
US OSHA:
Not applicable
Section 3 Composition and Information on Ingredients
Hazardous Ingredients:
None
Section 4 First Aid Measures
Inhalation
If product is inhaled, move exposed individual to fresh air. If individual is not
breathing, begin articial respiration immediately and obtain medical attention.
Eye Contact
If product enters eyes, wash eyes gently under running water for 15
minutes or longer, making sure that the eyelids are held open. If pain
or irritation occur, obtain medical attention.
Skin Contact
In case of skin contact, ush with copious amounts of water for at
least 15 minutes. Remove contaminated clothing and shoes. If pain
or irritation occur, obtain medical attention.
Ingestion
If ingested, wash mouth out with water.
If irritation or discomfort
occurs, seek medical attention.
Section 5 Fire Fighting Measures
Flammable Properties
Nonammable aqueous solution.
Extinguishing Media
Use extinguishing media suitable for surrounding re.
Special Fire and Explosion
Hazards
None identied.
Hazardous Combustion
Products
No combustion products posing signicant hazards are expected from
this product (a dilute aqueous solution).
Protective Equipment
for Fireghters
Self-contained breathing apparatus is recommended for reghters
in all chemical re situations.
Section 6 Accidental Release Measures
Personal Precautions
This product contains a material of biological origin. Use universal
precautions during clean up procedures.
Spill and Leak
Procedures
As a precautionary measure, treat spilled material with a 1:10 bleach/water solution.
Absorb liquid and place in container suitable for disposal. Avoid generation of
aerosols during clean up. Comply with applicable waste disposal regulations.
Radioactive material is subject to the regulations of each country.
Environmental
Precautions
Contain spill to prevent migration.
ACTIVE(r) Cortisol RIA
Page 16 of 27
Cortisol [I-125] Reagent
Doc. ID: DSL2100-75 AA
Section 7 Handling and Storage
Handling Precautions
This product should be handled as though capable of transmitting infectious
diseases. Universal precautions should be followed when using this product.
Recommended Storage
Conditions
Keep away from incompatible material (see Section 10).
To maintain efcacy, store according to the instructions in the product labeling.
Section 8 Exposure Controls and Personal Protection
Exposure Limits
US OSHA:
None established
ACGIH:
None established
DFG MAK:
None established
NIOSH
None established
Japan
None established
Engineering Controls
Place vial behind a metal shield, away from the user.
Respiratory Protection
Under normal conditions, the use of this product should not require respiratory
protection. If overexposure should occur and ventilation is not adequate to
maintain airborne concentrations at acceptable levels, the use of respiratory
protection should be evaluated by a qualied professional.
Eye Protection
Safety glasses or chemical goggles should be worn to prevent eye contact.
Skin Protection
Impervious gloves, such as Nitrile or equivalent, should be worn
to prevent skin contact.
Section 9 Physical and Chemical Properties
Physical State
Liquid
Color
Red
Transparency
Clear
Odor
Odorless
Odor Threshold
Not applicable
pH
7.4
Freezing Point
Not available
Boiling Point
Not available
Flash Point
Not applicable
Evaporation Rate
Not available
Flammability (Solid, Gas)
Not applicable
Flammable Limits
Not applicable
Vapor Pressure
Not available
ACTIVE(r) Cortisol RIA
Page 17 of 27
Cortisol [I-125] Reagent
Doc. ID: DSL2100-75 AA
Section 9 Physical and Chemical Properties
(Continued)
Vapor Density
Not available
Specic Gravity
1.07 @20°C
Solubility
Water
Miscible
Organic
Not available
Coefcient of Water/Oil
Distribution
Not available
Autoignition Temp.
Not applicable
Decomposition Temperature
Not available
Percent Volatiles
Not applicable
Section 10 Stability and Reactivity
Stability
Stable in closed containers under normal temperatures and pressures.
Hazardous Incompatibilities
Strong acids
Strong bases
Strong oxidizers
Metals and metallic compounds
Sodium azide forms explosive compounds with heavy metals. This product
contains concentrations of azide <0.1% (w/w) which with repeated contact
with lead and copper commonly found in plumbing drains may result in
the build up of shock sensitive compounds.
Hazardous Decomposition
Products
No decomposition products posing signicant hazards would be expected
from this product (a dilute aqueous solution).
Conditions to Avoid
Keep away from incompatible material.
Section 11 Toxicological Information
Toxicity Data
for Hazardous Ingredients
Not applicable
Primary Routes
of Exposure
Common routes of entry include inhalation, ingestion and eye/skin contact. Specic
paths of concern for potentially infectious materials are skin puncture, contact with
broken skin, contact with mucous membranes and inhalation of aerosolized material.
Potential Effects of
Acute Exposure
This product contains materials of human and animal origin and should be
considered as potentially capable of transmitting infectious diseases.
Potential Effects of Chronic
Exposure
Effects are similar to those for acute exposure.
Symptoms of Overexposure
None identied.
Carcinogenicity
This product does not contain a reportable concentration ( 0.1%) of any ingredient
listed as carcinogen by ACGIH, IARC, NTP, OSHA or 67/548/EEC Annex I.
ACTIVE(r) Cortisol RIA
Page 18 of 27
Cortisol [I-125] Reagent
Doc. ID: DSL2100-75 AA
Section 11 Toxicological Information
(Continued)
Other Effects
Radioactive
Conditions Aggravated
by Exposure
None identied.
Section 12 Ecological Information
Ecotoxicity
No information available.
Biodegradability
No information available.
Bioaccumulation
No information available.
Mobility
No information available.
Other Adverse Effects
No information available.
Section 13 Disposal Considerations
Waste Disposal
Dispose of waste product, unused product and contaminated packaging in
compliance with federal, state and local regulations. If unsure of the applicable
requirements, contact the authorities for information.
Sodium azide preservative may form explosive compounds in metal drain lines.
See NIOSH Bulletin: Explosive Azide Hazard (8/16/76).
Radioactive material is subject to the regulations of each country.
Section 14 Transport Information
Shipping Information
Shipping Name
Radioactive Material, excepted
package-limited quantity of material
UN/ID Number
2910
Packing Group
IATA
Hazard Class
7 Radioactive Material
Subsidiary Risk
None
Special Provisions
Not applicable
IATA ERG Code
7L
IMDG
Hazard Class
7 Radioactive material
Subsidiary Risk
None
Special Provisions
Not applicable
Marine Pollutant
No
US DOT
Hazard Class
7 Radioactive material
Subsidiary Risk
None
Special Provisions
Not applicable
NAERG Number
161
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Section 14 Transport Information
(Continued)
European ADR
ADR Classication
7 Radioactive material
Classication Code/
None
Subsidiary Risk
None
Canadian TDG
PIN
2910
TDG Classication
7 Radioactive Materials
Subsidiary Risk
None
Special Provisions
Not applicable
NAERG Number
161
Section 15 Regulatory Information
US Federal and State Regulations
SARA 313
Methanol is subject to reporting requirements of Section 313, Title III of SARA.
Sodium Azide is subject to reporting requirements of Section 313, Title III of SARA.
CERCLA RG's,
40 CFR 302.4
Methanol is listed.
Sodium Phosphate, Dibasic is listed.
Sodium Azide is listed.
Iodine 125 is listed.
California Proposition 65
Iodine 125 has been identied by the State of California to cause cancer.
The State of California has adopted a regulation which requires a warning
be given to individual who may be exposed to chemicals identied by
the State to cause cancer or reproductive harm. Accordingly, Beckman
Coulter advises you of the following warning:
WARNING: This product contains a chemical known to the State
of California to cause cancer.
Massachusetts MSL
Methanol is listed.
Sodium Phosphate, Dibasic is listed.
Sodium Azide is listed.
Iodine 125 is listed.
New Jersey Dept. of
Health RTK List
Methanol is listed.
Sodium Phosphate, Dibasic is listed.
Sodium Azide is listed.
Iodine 125 is listed.
Pennsylvania RTK
Methanol is listed.
Sodium Phosphate, Dibasic is listed.
Sodium Azide is listed.
Iodine 125 is listed.
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Section 15 Regulatory Information
(Continued)
EU Labeling Classication
Classication
Radioactive
Canada
This product is exempt from WHMIS label and MSDS requirements.
PIN:
2910
Ingredients on Ingredient
Disclosure List:
Methanol
Sodium Azide
Ingredients with unknown
toxicological properties:
Product is exempt
Some hazardous ingredients listed in Section 15 are below OSHAs and WHMIS' 1.0% w/w (0.1% for carcinogens)
or EU's ingredient specic concentrations required for reporting in Section 3.
Section 16 Other Information
Beckman Coulter Safety
Rating
Flammability (Section V): 0
Health (Section XI): 2
Reactivity with Water (Section X): 0
Contact (Section VIII): 2
Code
0=none
1=slight
2=caution
3=severe
Revision Changes
Not applicable
Iodine 125 is a gamma, X and beta emitter. Radiation is stopped by 1mm of lead. Half life: 59.9 days.
For further information, please contact your local Beckman Coulter representative.
WHILE BECKMAN COULTER, INC. BELIEVES THE INFORMATION CONTAINED HEREIN IS VALID AND ACCURATE, BECKMAN COULTER MAKES NO
WARRANTY OR REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR CURRENCY. BECKMAN COULTER SHALL NOT BE LIABLE OR OTHERWISE
RESPONSIBLE IN ANY WAY FOR USE OF EITHER THIS INFORMATION OR MATERIALS TO WHICH IT APPLIES. DISPOSAL OF HAZARDOUS
MATERIALS MAY BE SUBJECT TO LOCAL LAWS OR REGULATIONS.
Printed in U.S.A.
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Page 22 of 27
MATERIAL SAFETY DATA SHEET
ACTIVE(r) Cortisol RIA
Doc. ID: DSL2100-75 AA
.
Issued (year/month/day) 2008/08/15
Section 1 Company and Product Identication
Product Name
Cortisol Diluent
Part Number
Component of P/N DSL2100
Product Use
For In Vitro Diagnostic Use. See product literature for details.
Series Name
ACTIVE
(r)
Manufacturer
Manufactured for Beckman Coulter, Inc. by
Diagnostic Systems Laboratories, Inc. (A Beckman Coulter Company)
445 Medical Center Blvd.
Webster, TX 77598, U.S.A.
EC REP Address
OBI - DSL
Cherwell Innovation Centre
Upper Heyford
Oxon OX25 5HD UK
Tel: 018.6923.8077
Distributor and
Emergency Phone No.
Refer to attached list, Document ID:
472050
, for local distributor
and emergency phone numbers.
Section 2 Hazards Identication
Emergency Overview
Colorless; Clear; Liquid; Odorless
Nonammable aqueous solution.
Does not meet EU, OSHA or WHMIS criteria for hazardous materials.
Contains material of animal origin.
Physical Hazards
Sodium azide forms explosive compounds with heavy metals. This product
contains concentrations of azide <0.1% (w/w) which with repeated contact
with lead and copper commonly found in plumbing drains may result in
the build up of shock sensitive compounds.
Potential Health
Effects Summary
This product does not meet EU, OSHA or WHMIS criteria for hazardous
materials. However, it does contain material of animal origin and should
be considered potentially infectious.
See Section 11 Toxicological Information for more detailed health information.
Potential
Environmental Effects
None identied.
Product Hazard
Classications
Meets Hazardous Criteria for Preparation/Mixture
EU:
Not applicable
.
WHMIS:
Exempt
US OSHA:
Not applicable
Section 3 Composition and Information on Ingredients
Hazardous Ingredients:
None
Section 4 First Aid Measures
Inhalation
If product is inhaled, move exposed individual to fresh air. If individual is not
breathing, begin articial respiration immediately and obtain medical attention.
Eye Contact
If product enters eyes, wash eyes gently under running water for 15
minutes or longer, making sure that the eyelids are held open. If pain
or irritation occur, obtain medical attention.
Skin Contact
In case of skin contact, ush with copious amounts of water for at least 15
minutes. If pain or irritation occur, obtain medical attention.
Ingestion
If ingested, wash mouth out with water.
If irritation or discomfort
occurs, seek medical attention.
Section 5 Fire Fighting Measures
Flammable Properties
Nonammable aqueous solution.
Extinguishing Media
Use extinguishing media suitable for surrounding re.
Special Fire and Explosion
Hazards
No special hazards determined.
Hazardous Combustion
Products
No combustion products posing signicant hazards are expected from
this product (a dilute aqueous solution).
Protective Equipment
for Fireghters
Self-contained breathing apparatus is recommended for reghters.
Section 6 Accidental Release Measures
Personal Precautions
This product contains material of animal origin and should be considered as
potentially capable of transmitting infectious diseases.
Use universal precautions during clean up procedures.
Spill and Leak
Procedures
As a precautionary measure, treat spilled material with a 1:10 bleach/water solution.
Absorb liquid and place in container suitable for disposal. Avoid generation of
aerosols during clean up. Comply with applicable waste disposal regulations.
Environmental
Precautions
Contain spill to prevent migration.
Section 7 Handling and Storage
Handling Precautions
This product should be handled as though capable of transmitting infectious
diseases. Universal precautions should be followed when using this product.
Recommended Storage
Conditions
Keep away from incompatible material (see Section 10).
To maintain efcacy, store according to the instructions in the product labeling.
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Section 8 Exposure Controls and Personal Protection
Exposure Limits
US OSHA:
None established
ACGIH:
None established
DFG MAK:
None established
NIOSH
None established
Japan
None established
Engineering Controls
No special engineering controls are required. Use with good general ventilation.
Respiratory Protection
Under normal conditions, the use of this product should not require respiratory
protection. If overexposure should occur and ventilation is not adequate to
maintain airborne concentrations at acceptable levels, the use of respiratory
protection should be evaluated by a qualied professional.
Eye Protection
Safety glasses or chemical goggles should be worn to prevent eye contact.
Skin Protection
Impervious gloves, such as Nitrile or equivalent, should be worn
to prevent skin contact.
Section 9 Physical and Chemical Properties
Physical State
Liquid
Color
Colorless
Transparency
Clear
Odor
Odorless
Odor Threshold
Not applicable
pH
7.4
Freezing Point
Not available
Boiling Point
Not available
Flash Point
Not applicable
Evaporation Rate
Not available
Flammability (Solid, Gas)
Not applicable
Flammable Limits
Not applicable
Vapor Pressure
Not available
Vapor Density
Not available
Specic Gravity
1.07 @20°C
Solubility
Water
Miscible
Organic
Not available
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Section 9 Physical and Chemical Properties
(Continued)
Coefcient of Water/Oil
Distribution
Not available
Autoignition Temp.
Not applicable
Decomposition Temperature
Not available
Percent Volatiles
Not applicable
Section 10 Stability and Reactivity
Stability
Stable in closed containers under normal temperatures and pressures.
Hazardous Incompatibilities
Strong acids
Strong bases
Strong oxidizers
Metals and metallic compounds
Sodium azide forms explosive compounds with heavy metals. This product
contains concentrations of azide <0.1% (w/w) which with repeated contact
with lead and copper commonly found in plumbing drains may result in
the build up of shock sensitive compounds.
Hazardous Decomposition
Products
No decomposition products posing signicant hazards would be expected
from this product (a dilute aqueous solution).
Conditions to Avoid
Keep away from incompatible material.
Section 11 Toxicological Information
Toxicity Data
for Hazardous Ingredients
Not applicable
Primary Routes
of Exposure
Common routes of entry include inhalation, ingestion and eye/skin contact. Specic
paths of concern for potentially infectious materials are skin puncture, contact with
broken skin, contact with mucous membranes and inhalation of aerosolized material.
Potential Effects of
Acute Exposure
This product contains material of animal origin and should be considered as
potentially capable of transmitting infectious diseases.
Potential Effects of Chronic
Exposure
None identied.
Symptoms of Overexposure
None identied.
Carcinogenicity
No ingredients in this product are listed as carcinogens by ACGIH,
IARC, NTP, OSHA or 67/548/EEC Annex I.
Other Effects
None identied.
Conditions Aggravated
by Exposure
None identied.
Section 12 Ecological Information
Ecotoxicity
No information available.
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Section 12 Ecological Information
(Continued)
Biodegradability
No information available.
Bioaccumulation
No information available.
Mobility
No information available.
Other Adverse Effects
No information available.
Section 13 Disposal Considerations
Waste Disposal
Dispose of waste product, unused product and contaminated packaging in
compliance with federal, state and local regulations. If unsure of the applicable
requirements, contact the authorities for information.
Sodium azide preservative may form explosive compounds in metal drain lines.
See NIOSH Bulletin: Explosive Azide Hazard (8/16/76).
Section 14 Transport Information
Transportation of this product is not regulated under ICAO, IMDG, US DOT, European ADR or Canadian TDG.
Section 15 Regulatory Information
US Federal and State Regulations
SARA 313
Sodium Azide is subject to reporting requirements of Section 313, Title III of SARA.
CERCLA RG's,
40 CFR 302.4
Sodium Phosphate, Dibasic is listed.
Sodium Azide is listed.
California Proposition 65
No ingredients listed.
Massachusetts MSL
Sodium Phosphate, Dibasic is listed.
Sodium Azide is listed.
New Jersey Dept. of
Health RTK List
Sodium Phosphate, Dibasic is listed.
Sodium Azide is listed.
Pennsylvania RTK
Sodium Phosphate, Dibasic is listed.
Sodium Azide is listed.
EU Labeling Classication
Preparation not classied.
Canada
This product is exempt from WHMIS label and MSDS requirements.
PIN:
Not applicable
Ingredients on Ingredient
Disclosure List:
Sodium Azide
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Section 15 Regulatory Information
(Continued)
Ingredients with unknown
toxicological properties:
Product is exempt
Some hazardous ingredients listed in Section 15 are below OSHAs and WHMIS' 1.0% w/w (0.1% for carcinogens)
or EU's ingredient specic concentrations required for reporting in Section 3.
Section 16 Other Information
Beckman Coulter Safety
Rating
Flammability (Section V): 0
Health (Section XI): 1
Reactivity with Water (Section X): 0
Contact (Section VIII): 1
Code
0=none
1=slight
2=caution
3=severe
Revision Changes
Not applicable
For further information, please contact your local Beckman Coulter representative.
WHILE BECKMAN COULTER, INC. BELIEVES THE INFORMATION CONTAINED HEREIN IS VALID AND ACCURATE, BECKMAN COULTER MAKES NO
WARRANTY OR REPRESENTATION AS TO ITS VALIDITY, ACCURACY, OR CURRENCY. BECKMAN COULTER SHALL NOT BE LIABLE OR OTHERWISE
RESPONSIBLE IN ANY WAY FOR USE OF EITHER THIS INFORMATION OR MATERIALS TO WHICH IT APPLIES. DISPOSAL OF HAZARDOUS
MATERIALS MAY BE SUBJECT TO LOCAL LAWS OR REGULATIONS.
Printed in U.S.A.
ACTIVE(r) Cortisol RIA
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Cortisol Diluent
Doc. ID: DSL2100-75 AA