MRSZ/R01N01.04.21 (2.

0)

Document Security
Technical Document Secret
Type Classification
Document No. Z-0041-015-SJ P. Code 0041
Print
Color Black
Requirement

SDS（English）-ALT

Reference Document(s)

Document No. Description

Document dispatch department：(according to the following

explanation)
1.Tooling、Fixture、all-purpose & Reagent doc must be filled Department of International Market,
in. Logistics Department
2. Confidential & Top secret doc. must be filled in,but only for
needing to release.

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 Security Classification: Secret Z-0041-015-SJ-5.0

Revision Record
Ver Software Ver ECN/CR/PCN/TCN Summary of Revision Reviser Effective
Date
Gaokaix
1.0 / / New
ian

2.0 / PY056 Modify the CAT.NO. Yimin

Renew the TEL.NO. in line with 2012.3.1

3.0 / PY106 Zhang li 9
the label

4.0 / EY163 Add NADH in R1 and Cat.NO Zhang li 2013-11-

22
Refer to EU No.453/2010 and modify
5.0 / PGV012 Zhang li
the SDS

（Comment:The template is added a column ‘Effevtive Date&Time’from version 2.0, so the information
is not included in old versions.）

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 Security Classification: Secret Z-0041-015-SJ-5.0

Safety Data Sheet（SDS）-ALT

SECTION 1: Identification of the substance/mixture and of the

company/undertaking
1.1. Product identifier
Product name: Alanine Aminotransferase Kit (IFCC Method), without pyridoxal
phosphate activation

Product code: ALT0102、ALT0103、ALT0104、ALT1104、ALT0105

1.2. Relevant identified uses of the substance or mixture and uses advised against
Intended use: ALT reagent is intended for quantitative determination of Alanine
Aminotransferase activity in serum or plasma on photometric systems..
1.3. Details of the supplier of the safety data sheet
Manufacturer : SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD.
Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan,
Shenzhen, P.R. China, 518057
Tel: +86 755 81888998
Fax: +86 755 26582680
E-mail Address: service@mindray.com
1.4. Emergency telephone number
Emergency telephone No: +86 755 81888998 (Mon-Fri; 08:30-18:00 Beijing Time)
SECTION 2: Hazards identification
2.1. Classification of the substance or mixture
In vitro diagnostic reagent is belong to mixture
2.2. Label elements

Pictograms：Not Applicable
Signal word：Not Applicable

2.3. Other hazards

PBT or vPvB：Not Applicable

SECTION 3: Composition/information on ingredients

3.1. Substances
Not Applicable
3.2. Mixtures

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 Security Classification: Secret Z-0041-015-SJ-5.0

Components Analysis of Reagent Percent CAS.NO.

R1
Tris Buffer 1.82% 77-86-1
L-Alanine 6.68% 56-41-7
LDH 0.0005% 9001-60-9
NADH 0.031% 58-68-4
Water 91.4685% /
R2
Alpha-Oxoglutarate 4.77% 328-50-7
NADH 0.07% 58-68-4
Water 95.16% /

SECTION 4: First aid measures

4.1. Description of first aid measures

If this chemical contacts the skin, flush the area of skin with
water. If clothing becomes wet or significantly contaminated,
Skin contact
remove and replace clothing. Where there is evidence of skin
irritation, get medical attention.
Immediately flush eye(s) with large volumes of water for at
Eye contact least 15 minutes, occasionally lifting the lower and upper lids.
Get medical attention immediately.
Get medical attention if there has been ingestion of this
product. Do not give anything by mouth to an unconscious
Ingestion
person. Do not induce vomiting unless directed by medical
personnel.
If breathing becomes difficult, remove victim to fresh air. Seek
Inhalation
medical assistance immediately.
Medical Show this safety data sheet to medical personnel. Give
treatment symptomatic treatment and supportive therapy.

4.2. Most important symptoms and effects, both acute and delayed

Acute symptoms Not Applicable

Delayed symptoms Not Applicable
4.3. Indication of any immediate medical attention and special treatment needed
Not Applicable

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 Security Classification: Secret Z-0041-015-SJ-5.0

SECTION 5: Firefighting measures

5.1. Extinguishing media
Use fire extinguishing media appropriate for site conditions.
5.2. Special hazards arising from the substance or mixture
Not applicable
5.3. Advice for firefighters
Fire fighters to wear Self-contained breathing apparatus (SCBA) in confined spaces,
in oxygen deficient atmospheres or if exposed to products of decomposition. Full
protective clothing is also recommended.
SECTION 6: Accidental release measures
6.1. Personal precautions, protective equipment and emergency procedures
Wear gloves and laboratory coat. Prevent skin and eye contacting.
6.2. Environmental precautions
Keeping away from drains, surface- and ground-water and soil.
6.3. Methods and material for containment and cleaning up
Use of absorbent material which should be disposed of in a dustbin. Clean with
plenty of water.
6.4. Reference to other sections
See Sections 8 and 13.
SECTION 7: Handling and storage
7.1. Precautions for safe handling
As with all chemicals, avoid getting this product on you or in you.Wash thoroughly
after handling this product. Do not eat, drink, smoke, or apply cosmetics while handling
this product. Use in a well-ventilated location. Remove contaminated clothing
immediately
7.2. Conditions for safe storage, including any incompatibilities
All employees who handle this material should be trained to handle it safely.
Avoid contact with eyes, skin, and clothing. Empty containers should be completely
drained and disposed of properly.Containers of this product must be properly labeled.
Storage areas of this product should be clearly identified, well illuminated,clear of
obstruction and accessible only to trained and authorized personnel. Store containers in
a cool, dry location away from direct sunlight at temperatures between 2-8 ℃. Keep

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 Security Classification: Secret Z-0041-015-SJ-5.0

product from freezing. Keep container tightly closed when not in use. Observe all
warnings and precautions listed for this product.
7.3. Specific end use(s)
Not Applicable
SECTION 8: Exposure controls/personal protection
8.1. Control parameters

Impervious gloves, such as Nitrile or equivalent, should

Skin protection
be worn to prevent skin contact.
Safety glasses or chemical goggles should be worn to
Eye protection
prevent eye contact.
Under normal conditions, the use of this product should
not require respiratory protection. If overexposure
Respiratory should occur and ventilation is not adequate to
protection maintain airborne concentrations at acceptable levels,
the use of respiratory protection should be evaluated by
a qualified professional.
Enviromental Prevent the product from entering drains and
exposure controls watercourses.

8.2. Exposure controls

No special engineering controls are required. Use with good general ventilation.
SECTION 9: Physical and chemical properties
9.1. Information on basic physical and chemical properties

Appearance R1: Clear liquid,without deposition and floccule

R2: Clear liquid,without deposition and floccule
Odour Inodorousness
Odour threshold Not applicable
pH R1: 9.50±0.10;
R2: 7.30±0.05;
Melting Not Applicable
point/freezing point
Initial boiling point Not Applicable
and boiling range
Flash point (typical) Not Applicable

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 Security Classification: Secret Z-0041-015-SJ-5.0

Evaporation rate Not Applicable

Flammability (solid, Not Applicable,the mixture is liquid
gas)
Upper/lower Not applicable, the mixture is not flammable or
flammability or explosive
explosive limits
Vapour pressure Not Applicable
Vapour density Not Applicable
Relative density 1.005±0.004 g/ cm3
Solubility(ies) Diffluent
Partition Not Applicable
coefficient:
n-octanol/water
Auto-ignition Not Applicable, the mixture is not auto-ignition
temperature
Decomposition Not Applicable
temperature
Viscosity Not Applicable
Explosive Not Applicable, the mixture have no Explosive
properties
Oxidizing Not applicable, the mixture have no oxidation
properties

9.2. Other information

Not Applicable
SECTION 10: Stability and reactivity
10.1. Reactivity
Not Applicable
10.2. Chemical stability
Stable under normal conditions of use.
10.3. Possibility of hazardous reactions
Not Applicable
10.4. Conditions to avoid
Avoid Frozen, high temperature , sun of light. Store containers in a cool, dry location

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 Security Classification: Secret Z-0041-015-SJ-5.0

away from direct sunlight at 2-8 ℃

10.5. Incompatible materials
Not Applicable
10.6. Hazardous decomposition products
Not Applicable
SECTION 11: Toxicological information
11.1. Information on toxicological effects

Toxicokinetics,
metabolism and Not Applicable
distribution
Acute toxicity Not Applicable
Skin
May cause skin irritation
corrosion/irritation;
Serious eye
May cause eye irritation.
Damage/irritation
Respiratory or skin
May cause respiratory tract irritation.
Sensitisation
Germ cell
Not applicable
mutagenicity
Carcinogenicity Not applicable
Reproductive
Not applicable
toxicity
STOT-single
Not applicable
exposure
STOT-repeated
Not applicable
exposure
May cause irritation to mouth, throat and stomach with
effects including mucous build up, irritation to the
Aspiration hazard
tongue and lips and pains in the stomach, which may
lead to nausea, vomiting and diarrhoea.

SECTION 12: Ecological information

12.1. Toxicity
Not Applicable

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 Security Classification: Secret Z-0041-015-SJ-5.0

12.2. Persistence and degradability

Not Applicable
12.3. Bioaccumulative potential
Not Applicable
12.4. Mobility in soil
Not Applicable
12.5. Results of PBT and vPvB assessment
Not Applicable
12.6. Other adverse effects
Not Applicable
SECTION 13: Disposal considerations
13.1. Waste treatment methods
Dispose of waste product, unused product in accordance with local requirements.
SECTION 14: Transport information
14.1. UN number
Not Applicable
14.2. UN proper shipping name
Not Applicable
14.3. Transport hazard class(es)
Not Applicable
14.4. Packing group
Not Applicable
14.5. Environmental hazards
This product is not designated as a marine pollutant by the Department of
Transportation
14.6. Special precautions for user
See chapter 7 and chapter 8 for information
14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code
Not Applicable
SECTION 15: Regulatory information
15.1. Safety, health and environmental regulations/legislation specific for the substance

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 Security Classification: Secret Z-0041-015-SJ-5.0

or mixture
Not Applicable
15.2. Chemical safety assessment
No Chemical Safety Assessment has been carried out for this mixture by the
supplier.
SECTION 16: Other information
Date of last revision:2015-5-20
Information of this Safety Data Sheet represents the today’s state of our knowledge.
The purpose is to characterise the product regarding safety precautions having to be
kept. This document will not be a certification of features and will not be the basis of a
legal contract.
The primary changes in 5.0 as follows：
1: Add “ E-mail Address” in SECTION 1;
2: Add the items of “Pictograms”,”signal words” and “PBT or vPvB” in SECTION 2;
3:Add the Percentage of the mixture in SECTION 3;
4: Add the items of “Acute symptoms”,” Delayed symptoms” and “Immediate medical
attention and special treatment needed” in SECTION 4;
5: Add the items of “Extinguishing media”,” Special hazards arising from the substance
or mixture” in SECTION 5;
6: Add the items of “Specific end use(s) ” and modify the items of” Conditions for safe
storage”in SECTION 7;
7: renew the SECTION 9 and 13;
8: Add the items of “Reactivity” , “Possibility of hazardous reactions” in SECTION 10.

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