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SAFETY DATA SHEET
SDS No.: 73558E
Issue Date: December 10, 2002
AUTION Sticks 10EA
IDENTIY
1. PRODUCT 鈥? COMPANY IDENTIFICATION
PRODUCT NAME: AUTION Sticks 10EA
PRODUCT IDENTIFICATION:
This product is an in vitro diagnostic reagent strip intended for the determination of Glucose, Protein,
Bilirubin, Urobilinogen, pH, Specific Gravity, Blood, Ketones, Nitrite and Leucocytes in urine.
This is intended for professional use with the AUTION Analyzer.
MANUFACTURER: ARKRAY FACTORY, Inc.
Address: 1480 Kojiumeda, Konan-Cho, Koka-Gun, Shiga 520-3306, Japan
SUPPLIER:(In Japan) ARKRAY, Inc.
Address: 57 Nishi Aketa-Cho, Higashi Kujo, Minami-Ku, Kyoto 601-8045, Japan
Telephone number & Emergency telephone number: +81-75-662-8958
Facsimile: +81-75-661-9435
AUTHORIZED REPRESENTATIVE:(In EUROPE) ARKRAY, Inc. European Office
Address: Schumannstr. 109 40237 D眉sseldorf Germany
Telephone number & Emergency telephone number:+49-211 6980162
Facsimile: +49-211 6980164
2. COMPOSITION / INFORMATION ON INGREDIENTS
This reagent is composed of a plastic strip affixed with reagent areas for Glucose, Protein, Bilirubin,
Urobilinogen, pH, Specific Gravity, Blood, Ketones, Nitrite and Leucocytes determination and a pad for
calibration. They contain a little amount of chemical substances as follows:
Glucose
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
Glucose oxidase(GOD) 9001-37-0 --- --- 700 I.U. 1.0 or less
Peroxidase(POD) 9003-99-0 --- 232-668-6 175 P.U. 1.0 or less
4-Aminoantipyrine(4-AAP) 83-07-8 --- 201-452-3 14.0 mg 1.0 or less
1-Naphthole-3,6-disulfonic acid,
313222-89-8 --- --- 14.0 mg 1.0 or less
disodium salt
Protein
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
Tetrabromophenol blue(TBPB) 4430-25-5 --- --- 0.35 mg 1.0 or less
Bilirubin
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
2-Methyl-5-nitroaniline 99-55-8 --- --- 1.9mg 1.0 or less
Sodium nitrite 7632-00-0 --- 231-555-9 1.0mg 1.0 or less
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Urobilinogen
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
3,3鈥?-Dimethoxy-4,4鈥?-diazo-
--- --- --- 0.16 mg 1.0 or less
-biphenyl tetrafluoride borate
pH
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
Bromocresol green 76-60-8 --- 200-972-8 0.07 mg 1.0 or less
Bromoxylenol blue 4007-59-5 --- 2547804 0.72 mg 1.0 or less
Specific Gravity
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
Di(2-ethylhexyl) phodphoric acid
298-07-7 --- --- 8.0 mg 1.0 or less
(D-2-EHPA)
Bromothymol blue 76-59-5 --- 200-971-2 0.7 mg 1.0 or less
Blood
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
Cumen hydroperoxide(CHP) 80-15-9 --- 2012547 30.0 mg 1.0 or less
3,3鈥?-5,5鈥?-Tetramethylbenzidine
54827-17-7 --- 2593646 15.0 mg 1.0 or less
(TMBZ)
Ketones
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
238-373-9
Sodium nitroprusside 13755-38-9 --- 12.0 mg 1.0 or less
Nitrite
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
Sulfanilamide 63-74-1 --- 2005-63-4 3.9 mg 1.0 or less
N-1-Naphthyl
-ethylenediaminedihydrochloride 1465-25-4 --- 215-981-2 0.3 mg 1.0 or less
(NEDA-2HCl)
Leucocytes
Concentration
Symbol and
Composition CAS No. EINECS No.
(in 100strips) (wt%)
R 鈥損hrases(*)
3-(N-Toluenesulfonyl-
--- --- --- 0.49 mg 1.0 or less
-L-alanyloxy) indole(TAI)
2-Methoxy-4-(n-morpholino-
67801-08-5 --- --- 0.17 mg 1.0 or less
-benzenediazoniumu(MMB)
This product is not classified as a dangerous preparation according to 1999/45/EC and 67/548/EEC and
following amendments and modifications.
* See section 2.4 Directive 2001/58/EC
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The identification of danger: SYMBOL: -----, R-phrases: -----
3.HAZARDS IDENTIFICATION
May be harmful if ingested.
May cause eye and skin irritation.
4. FIRST-AID MEASURES
Eye Contact
Immediately wash eyes with plenty of clean water for at least 15 minutes and seek medical advice.
Skin Contact
Immediately wash thoroughly with water and soap. Immediately seek medical advice if it causes itchiness
and inflammation etc.
Ingestion
Rinse mouth, give plenty of water to dilute the substance. Never give anything by mouth to an unconscious
person. Immediate medical treatment is required.
5. FIRE-FIGHTING MEASURES
Extinguishing Media: water, etc.
Special Fire-Fighting Procedures: None
6. ACCIDENTAL RELEASE MEASURES
Individual protection: Use personal protective devices.
Please refer to point 8 for specific protection measures.
Environmental precautions: Dispose in compliance to the law in force. Clean spillage area.
Cleaning methods: Rinse with running water.
7. HANDLING 鈥? STORAGE
For in vitro diagnostic use only.
Store at temperature between from 1 to 30鈥⑴? avoiding humidity, direct sunlight or heat. Improper storage
may cause insufficient performance of test strips. Do not use deteriorated, discolored or blackened test
strips.
Use test strips as soon as possible after opening the container.
Avoid contamination by volatile chemicals.
# See the package insert for further handling information.
8. EXPOSURE COTROLS / PERSONAL PROTECTION
Occupational Exposure Limit: Not available
Eye Protection: Use safety goggles (glasses), if necessary.
Skin Protection: Use rubber gloves and suitable protective clothing, if necessary.
9. PHYSICAL 鈥? CHEMICAL PROPERTIES
Appearance : This is a dry reagent strip and is consists of a plastic strip affixed with reagent areas.
pH: Not available
10. STABILITY 鈥? REACTIVITY
Condition to avoid: Sunlight, heat
Stability and Reactivity: Stable
Materials To Avoid: Volatile chemicals
Hazardous Decomposition Products: Not available
11. TOXICOLOGICAL INFORMATION
Irritation (skin, eye)鈥 May cause irritating skin and eyes
Acute toxicity : Not available as the mixture
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Sensitizing: Not available as the mixture
Chronic Toxicity: Not available as the mixture
Mutagenicity: Not available as the mixture
Carcinogenicity: IARC; Not listed, NTP; Not listed, OSHA; Not listed, ACGUH; Not listed
Reproductive Toxicity: Not available as the mixture
12. ECOLOGICAL INFORMATION
Ecotoxicity : hr LC50: Not available
Mobility: Not available
Persistence and degradability: Not available
Bioaccumulative potential: Not available
Other adverse effect: Not available
13. DISPOSAL CONSIDERATION
Dispose of used strips as biohazardous waste in accordance with all applicable regulations. Any disposal
practice must be in complicated with company, local, state, and federal laws and regulations. (Contact
country, local or state environmental agency for specific rules.)
14. TRANSPORT INFORMATION
IATA: Not restricted as the mixture.
15. REGULATORY INFORMATION
This product is not classified as a dangerous preparation according to 1999/45/EC and 67/548/EEC and
2001/58/EC.
16. OTHER INFORMATION
MODIFICATION LIST
January 12, 1998 : Prepared
December 10, 2002 : Revised all items according to 鈥淒irective 2001/58/EC鈥?.
The above information contained herein is based on the data available to us and is believed to be correct.
However, ARKRAY, Inc. bears no warranty, expresses or implies regarding the accuracy of these data
or the results to be obtained from the use thereof.
ARKRAY, Inc. assumes no responsibility for injury caused from the use of the product described herein.
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