MRSZ/R01N01.04.02(3.

0)

文 件 类 机 密 等
技 术 文 件 机 密
型 级
文 件 编 工 艺 代
Z-0030-070-SJ 0030
号 号
作
孟 祥 平
者

M-30 系 列 血 液 细 胞 分 析 仪 用 试 剂

物 质 安 全 数 据 表 （ 英 文 版 ）

参 考 资 料

文 件 编 号 说 明

修 订 记 录

版本 ECN/PCN 修 改 内 容 概 述 编 写 者

1.0 / 新建 周 志 德

更新技术文件模板，产品编码、规格型号补充及修改；
制造商信息联系方式更改, 紧急联系电话修改；

2.0 EY105 CO2 更改为CO2 ；文档内标点符号修正；pH和密度项内容 郑 文 兵

修改，对应温度写到前一栏， ml改为mL，字母大小写修

改。

M-30D Diluent 、 M-30CFL LYSE 和 M-30R Rinse 增

3.0 EY125 孟 祥 平
加适用机型“BC-3300/BC-3600 Hematology Analyzer”

文件使用部门 国际检验市场部、国际检验销售部、国际用户服务部

（工装、夹具文件必填

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项）

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 Z-0030-070-SJ-3.0

Safety Data Sheet

Data of issue: 2011-01-13

Part I M-30D Diluent

1 Identification of the substance / mixture and of the company/undertaking
Information of the product
Product code A12-000047---(20L), A12-000042---(5.5L×2), A12-000196---(5.5L)
Product name M-30D DILUENT
Use of the For use on Mindray BC-3000PLUS/BC-3200/BC-3000CT/BC-3300/BC-3600
substance/mixture Hematology Analyzer.
Manufacturer / supplier information
Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. ， LTD

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.
China, 518057

Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500

Emergency Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500 (Mon-Fri: 08:30-18:00
telephone No. Beijng Time)

2 Hazards identification
Classification for This preparation is not dangerous under 1999/45/EC regulations and subsequent
supply amendments.
Health hazards See Section 11 for more information.
Environmental See Section 12 for more information.
hazards
Physico-chemical No information available.
hazards
Other hazards No information available.

3 Composition / information on ingredients

Components Components Concentration CAS No.
Sodium Sulphate Anhydrous 7.5-11.5g/L 7757-82-6
Sodium Chloride 3.5-5.5g/L 7647-14-5
Buffering Agents 1.0-3.0g/L
Anti-fungal and Anti-bacterial Agents 0.8-2.5g/L

4 First-aid measures
Skin contact Rinse immediately with plenty of water.

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 Z-0030-070-SJ-3.0

Eye contact Rinse immediately with plenty of water and seek medical advice.
Ingestion Drink lots of water, induce vomiting. Seek medical advice immediately.
Inhalation Not applicable.

5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media CO2, extinguishing powder or water spray.
Special exposure None.
hazards
Protective equipment Fire fighters should wear an approved self-contained breathing apparatus and
for fire-fighters full protective clothing.

6 Accidental release measures

Personal Wear gloves and laboratory coat. Prevent skin and eye contacting.
precautions
environmental Keeping away from drains, surface- and ground-water and soil.
precautions
Methods for Use of absorbent material which should be disposed of in a dustbin. Clean
cleaning up with plenty of water.

7 Handling and storage

Handling No special precautions are necessary if used correctly.
Storage Store at 2-30℃, keep container closed.

8 Exposure controls / personal protection

Exposure limits None established.
Exposure Controls Not necessary.
Personal exposure Standard laboratory latex or rubber gloves recommended.
equipment
Environmental Not necessary.
exposure controls

9 Physico-chemical properties
Appearance Colourless liquid.
Odour Odourless.
pH(25±1°C ) 7.05±0.20
Melting point 0 °C.

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 Z-0030-070-SJ-3.0

Boiling point 100 °C.

Flash point Not applicable.
Explosive properties Not explosive.
Oxidizing properties Not applicable.
Autoignition Not applicable.
temperature
Vapour pressure No information available.
Relative density 1.000 - 1.023
Specific gravity (20 1.000 - 1.023 g/mL.
°C )
Solubility in water Soluble.
Solubility in solvents No information available.
Partition coefficient Not applicable.
Viscosity No information available.
Vapour density Not applicable.
Evaporation rate Not applicable.
Corrosivity to metal Not corrosive.

10 Stability and reactivity

Stability This product is stable.
Conditions to avoid Frozen, high temperature （above 30℃ ）.
Materials to avoid No information available.
Hazardous No information available.
decomposition
products

11 Toxicological information
Toxicokinetics, No experimental data for this preparation available.
metabolism and
distribution
Acute toxicity No experimental data for this preparation available.
Corrosivity/ No corrosive/irritant effect.
irritation
Sensitisation No experimental data for this preparation available.
Repeated-dose No experimental data for this preparation available.
toxicity
Carcinogenicity/ No experimental data for this preparation available.
Mutagenicity/

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Reproducitive
toxicity

12 Ecological information
Ecotoxicity No information available.
Mobility No information available.
Persistence/ No information available.
degradability
Bioaccumulation No information available.
potential
Results of PBT No information available.
assessment
Other adverse No information available.
effects

13 Disposal considerations
Product Dispose of waste product, unused product in accordance with governmental
requirements.

Packing Dispose of contaminated packaging in accordance with governmental

requirements.

14 Transport information
Transport / This substance is not dangerous under current provisions of the Code of
further International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID),
information of the International Maritime Dangerous Goods Code (IMDG), and of the
International Air Transport Association (IATA) regulations.

15 Regulations
Classification Preparation not classified.
and labelling DIRECTIVE 1999/45/EC
according to EC
REGULATION (EC) No 1907/2006 REACH
Directives
DIRECTIVE 2001/59/EC
DIRECTIVE 67/548/EEC

16 Other information
Revisions:3.0
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

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 Z-0030-070-SJ-3.0

certification of features and will not be the basis of a legal contract.

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Part II M-30E E-Z CLEANSER& M-30R RINSE

1 Identification of the substance / preparation and of the company
Information of the product
Product code M-30R RINSE ： A12-000048---(20L), A12-000043---(5.5×2), A12-000197---
(5.5L)
M-30E E-Z CLEANSER ：A12-000045---(100mL)
Trade name M-30E E-Z CLEANSER
M-30R RINSE
Use of the M-30R RINSE ：For use on Mindray BC-3000PLUS/BC-3200/BC-3000CT/
substance/mixture BC-3300/BC-3600 Hematology Analyzer. For use as a cleaning reagent for
cleaning hematology analyzer.
M-30E E-Z CLEANSER ：For use on Mindray BC-3000PLUS/BC-3200/
BC-3000CT Hematology Analyzer. For use as a cleaning reagent for cleaning
hematology analyzer.
Manufacturer / supplier information
Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. ， LTD

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.
China, 518057

Tel:+86 755 26582479 ， 26582888 / Fax:+86 755 26582934 ， 26582500

Emergency Tel:+86 755 26582479 ， 26582888 / Fax:+86 755 26582934 ， 26582500 (Mon-Fri: 08:30-
telephone No. 18:00 Beijng Time)

2 Hazards identification
Classification for The preparation is not dangerous under 1999/45/EC regulations and subsequent
supply amendments.
Health hazards See Section 11 for more information.
Environmental See Section 12 for more information.
hazards
Physico-chemical No information available.
hazards
Other hazards No information available.

3 Composition / information on ingredients

M-30E E-Z Components Concentration CAS No.
CLEANSER Proteolytic Enzyme 3.0-10g/L
Surfactant 0.3-1.5g/L
Sodium Chloride 3.0-5.0g/L 7647-14-5

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Anti-fungal and Anti-bacterial Agents 0.5-2.5g/L

Buffering Agents 1.0-4.0g/L
M-30R RINSE Components Concentration CAS No.
Sodium Sulfate Anhydrous 3.5-5.5g/L 7757-82-6
Sodium Chloride 7.5-11.5g/L 7647-14-5
Anti-fungal and Anti-bacterial Agents 1.0-3.0 g/L
Polyoxyethylene Ester 0.3-1.5g/L

4 First-aid measures
Skin contact Rinse immediately with plenty of water.
Eye contact Rinse immediately with plenty of water and seek medical advice.
Ingestion Drink lots of water, induce vomiting. Seek medical advice immediately.
Inhalation Not applicable.

5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media CO2, extinguishing powder or water spray.
Special exposure None.
hazards
Protective equipment Fire fighters should wear an approved self-contained breathing apparatus and
for fire-fighters full protective clothing.

6 Accidental release measures

Personal Wear gloves and laboratory coat. Prevent skin and eye contacting.
precautions
environmental Keeping away from drains, surface- and ground-water and soil.
precautions
Methods for Use of absorbent material which should be disposed of in a dustbin. Clean
cleaning up with plenty of water.

7 Handling and storage

Handling No special precautions are necessary if used correctly.
Storage Store at 2-30℃, keep container closed.

8 Exposure controls / personal protection

Exposure limits None established.

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Exposure Controls Not necessary.

Personal exposure Standard laboratory latex or rubber gloves recommended.
equipment
Environmental Not necessary.
exposure controls

9 Physico-chemical properties
Appearance M-30E E-Z CLEANSER Blue liquid.
M-30R RINSE Colourless liquid.
Odour Odourless.
pH (25±1°C) M-30R RINSE ≥7.0
M-30E E-Z CLEANSER 6.2±0.5
Melting point 0 °C.
Boiling point 100 °C.
Flash point Not applicable.
Explosive properties Not explosive.
Oxidizing properties Not applicable.
Autoignition Not applicable.
temperature
Vapour pressure No information available.
Relative density 1.000 - 1.023
Specific gravity (20 1.000 - 1.023 g/mL.
°C )
Solubility in water Soluble.
Solubility in solvents No information available.
Partition coefficient Not applicable.
Viscosity No information available.
Vapour density Not applicable.
Evaporation rate Not applicable.
Corrosivity to metal Not corrosive.

10 Stability and reactivity

Stability This product is stable.
Conditions to avoid Frozen, high temperature （above 30℃ ）.
Materials to avoid No information available.
Hazardous No information available.
decomposition

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products

11 Toxicological information
Toxicokinetics, No experimental data for this preparation available.
metabolism and
distribution
Acute toxicity No experimental data for this preparation available.
Corrosivity/ No corrosive/irritant effect.
irritation
Sensitisation No experimental data for this preparation available.
Repeated-dose No experimental data for this preparation available.
toxicity
Carcinogenicity/ No experimental data for this preparation available.
Mutagenicity/
Reproducitive
toxicity

12 Ecological information
Ecotoxicity No information available.
Mobility No information available.
Persistence/ No information available.
degradability
Bioaccumulation No information available.
potential
Results of PBT No information available.
assessment
Other adverse No information available.
effects

13 Disposal considerations
Product Dispose of waste product, unused product in accordance with governmental
requirements.

Packing Dispose of contaminated packaging in accordance with governmental

requirements.

14 Transport information
Transport / This substance is not dangerous under current provisions of the Code of
further International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID),
information of the International Maritime Dangerous Goods Code (IMDG), and of the

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 Z-0030-070-SJ-3.0

International Air Transport Association (IATA) regulations.

15 Regulations
Classification Preparation not classified.
and labelling DIRECTIVE 1999/45/EC
according to EC
REGULATION (EC) No 1907/2006 REACH
Directives
DIRECTIVE 2001/59/EC
DIRECTIVE 67/548/EEC

16 Other information
Revisions:3.0
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.

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Part III M-30CFL LYSE

1 Identification of the substance / preparation and of the company
Information of the product
Product code A12-000084---(500mL), A12-000083--- (250mL)
Product name M-30CFL LYSE
Use of the For use on Mindray BC-3000PLUS/BC-3200/BC-3000CT/BC-3300/BC-3600
substance/mixture Hematology Analyzer.
Manufacturer / supplier information
Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. ， LTD

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.
China, 518057

Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500

Emergency Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500 (Mon-Fri: 08:30-18:00
telephone No. Beijng Time)

2 Hazards identification
Classification for This preparation is not dangerous under 1999/45/EC regulations and subsequent
supply amendments.
Health hazards See Section 11 for more information.
Environmental See Section 12 for more information.
hazards
Physico-chemical No information available.
hazards
Other hazards No information available.

3 Composition / information on ingredients

M-30CFL LYSE Components Concentration CAS No.
Quaternary Ammonium Salts <50g/L
Nonionic Surfactant <15g/L
Isopropanol 0.1-1.5mL/L
Ethanol <1.5mL/L

4 First-aid measures
Skin contact Rinse immediately with plenty of water.
Eye contact Rinse immediately with plenty of water and seek medical advice.
Ingestion Drink lots of water, induce vomiting. Seek medical advice immediately.
Inhalation Not applicable.

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Skin contact Rinse immediately with plenty of water.

5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media CO2, extinguishing powder or water spray.
Special exposure None.
hazards
Protective equipment Fire fighters should wear an approved self-contained breathing apparatus and
for fire-fighters full protective clothing.

6 Accidental release measures

Personal Wear gloves and laboratory coat. Prevent skin and eye contacting.
precautions
environmental Keeping away from drains, surface- and ground-water and soil.
precautions
Methods for Use of absorbent material which should be disposed of in a dustbin. Clean
cleaning up with plenty of water.

7 Handling and storage

Handling No special precautions are necessary if used correctly.
Storage Store at 2-30℃, keep container closed.

8 Exposure controls / personal protection

Exposure limits None established.
Exposure Controls Not necessary.
Personal exposure Standard laboratory latex or rubber gloves recommended.
equipment
Environmental Not necessary.
exposure controls

9 Physico-chemical properties
Appearance Colourless liquid.
Odour Slight odour.
pH(25±1 °C ) 7.50±0.50
Melting point 0 °C.
Boiling point 100 °C.
Flash point Not applicable.

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Explosive properties Not explosive.

Oxidizing properties Not applicable.
Autoignition Not applicable.
temperature
Vapour pressure No information available.
Relative density 1.00-1.25
Specific gravity (20 1.00 - 1.25 g/mL.
°C )
Solubility in water Soluble.
Solubility in solvents Soluble.
Partition coefficient Not applicable.
Viscosity No information available.
Vapour density Not applicable.
Evaporation rate Not applicable.
Corrosivity to metal Not corrosive.

10 Stability and reactivity

Stability This product is stable.
Conditions to avoid Frozen, high temperature （above 30℃ ）.
Materials to avoid No information available.
Hazardous No information available.
decomposition
products

11 Toxicological information
Toxicokinetics, No experimental data for this preparation available.
metabolism and
distribution
Acute toxicity No experimental data for this preparation available.
Corrosivity/ No corrosive/irritant effect.
irritation
Sensitisation No experimental data for this preparation available.
Repeated-dose No experimental data for this preparation available.
toxicity
Carcinogenicity/ No experimental data for this preparation available.
Mutagenicity/
Reproducitive
toxicity

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12 Ecological information
Ecotoxicity No information available.
Mobility No information available.
Persistence/ No information available.
degradability
Bioaccumulation No information available.
potential
Results of PBT No information available.
assessment
Other adverse No information available.
effects

13 Disposal considerations
Product Dispose of waste product, unused product in accordance with governmental
requirements.

Packing Dispose of contaminated packaging in accordance with governmental

requirements.

14 Transport information
Transport / This substance is not dangerous under current provisions of the Code of
further International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID),
information of the International Maritime Dangerous Goods Code (IMDG), and of the
International Air Transport Association (IATA) regulations.

15 Regulations
Classification Preparation not classified.
and labelling DIRECTIVE 1999/45/EC
according to EC
REGULATION (EC) No 1907/2006 REACH
Directives
DIRECTIVE 2001/59/EC
DIRECTIVE 67/548/EEC

16 Other information
Revisions:3.0
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.

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Part IV M-30P PROBE CLEANSER

1 Identification of the substance / preparation and of the company
Information of the product
Product code A12-000046---(17mL), 105-001656-00(17mL×12)
Product name M-30P PROBE CLEANSER
Use of the For use on Mindray BC-3000PLUS/BC-3200/BC-3000CT Hematology
substance/mixture Analyzer. For use as a cleaning reagent for cleaning hematology analyzer.
Manufacturer / supplier information
Manufacturer SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. ， LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.
China, 518057

Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500

Emergency Tel:+86 755 26582479, 26582888 / Fax:+86 755 26582934, 26582500 (Mon-Fri: 08:30-18:00
telephone No. Beijng Time)

2 Hazards identification
Classification for This preparation is irritant under 67/548/EEC and 1999/45/EC regulations and
supply subsequent amendments.
Classification:Xi Phrases R:31-36/38
Health hazards The product is irritant to skin and eye.
Environmental See Section 12 for more information.
hazards
Physico-chemical No information available.
hazards
Other hazards Contact with acids liberates toxic gas.

3 Composition / information on ingredients

M-30P PROBE Components Concentration CAS No.
CLEANSER Surfactant <2.0g/L
Sodium hypochlorous <100 g/L
Sodium hydroxide <100 g/L

4 First-aid measures
Skin contact Rinse immediately with plenty of water.
Eye contact Rinse immediately with plenty of water and seek medical advice.
Ingestion Drink lemon juice, vinegar, or eggs in milk, avoid vomiting. Contact a physician
immediately.
Inhalation Remove to fresh air. If symptoms persist contact a physician.

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5 Fire-fighting measures
Fire and explosive The product is water based, and not flammable or explosive.
properties
Extinguishing media CO2, extinguishing powder or water spray.
Special exposure None.
hazards
Protective equipment Fire fighters should wear an approved self-contained breathing apparatus and
for fire-fighters full protective clothing.

6 Accidental release measures

Personal Wear gloves and laboratory coat. Prevent skin and eye contacting.
precautions
environmental Keeping away from drains, surface- and ground-water and soil.
precautions
Methods for Use of absorbent material which should be disposed of in a dustbin. Clean
cleaning up with plenty of water.

7 Handling and storage

Handling Prevent skin and eye contacting.
Storage Store at 2-30℃, keep container closed in a dark and cool place.

8 Exposure controls / personal protection

Exposure limits None established.
Exposure Controls Necessary, if vapours / aerosols are released.
Personal exposure Standard laboratory latex or rubber gloves recommended.
equipment
Environmental Not necessary.
exposure controls

9 Physico-chemical properties
Appearance Yellowish-green liquid.
Odour Slightly pungent.
pH( 25±1°C ) 10.0-13.8
Melting point 0 °C.
Boiling point 100 °C.
Flash point Not applicable.
Explosive properties Not explosive.

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Oxidizing properties Oxide.

Autoignition Not applicable.
temperature
Vapour pressure No information available.
Relative density 1.00 - 1. 25
Specific gravity (20 1.00 - 1. 25 g/mL.
°C )
Solubility in water Soluble.
Solubility in solvents Not soluble.
Partition coefficient Not applicable.
Viscosity No information available.
Vapour density Not applicable.
Evaporation rate Not applicable.
Corrosivity to metal Not corrosive.

10 Stability and reactivity

Stability This product is decomposable on high temperature.
Conditions to avoid High temperature （above 30℃ ）.
Materials to avoid Acids, ammonia, reducing agents.
Hazardous Chlorine.
decomposition
products

11 Toxicological information
Toxicokinetics, No experimental data for this preparation available.
metabolism and
distribution
Acute toxicity No experimental data for this preparation available.
Corrosivity/ It is irritation of mucous membranes, after inhalation ,can cause cough,
irritation difficulty in breathing, irritatent for skin and eye contact.
Sensitisation No experimental data for this preparation available.
Repeated-dose No experimental data for this preparation available.
toxicity
Carcinogenicity/ No experimental data for this preparation available.
Mutagenicity/
Reproducitive
toxicity

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12 Ecological information
Ecotoxicity No information available.
Mobility No information available.
Persistence/ No information available.
degradability
Bioaccumulation No information available.
potential
Results of PBT No information available.
assessment
Other adverse Do not discard to inshore waters, sink or ground.
effects

13 Disposal considerations
Product Dispose of waste product, unused product in accordance with governmental
requirements.

Packing Dispose of contaminated packaging in accordance with governmental

requirements.

14 Transport information
Transport / This substance is not dangerous under current provisions of the Code of
further International Carriage of Dangerous Goods by Road (ADR) and by Rail (RID),
information of the International Maritime Dangerous Goods Code (IMDG), and of the
International Air Transport Association (IATA) regulations.

15 Regulations
Classification and Preparation is classified Xi.
labelling according
to EC Directives

DIRECTIVE 1999/45/EC
REGULATION (EC) No 1907/2006 REACH
DIRECTIVE 2001/59/EC
DIRECTIVE 67/548/EEC
R-phrases 31-36/38
Contact with acids liberates toxic gas. Irritating to eyes and skin.
S-phrases 26-28-36/37-38
In case of contact with eyes, rinse immediately with plenty of water and seek
medical advice. After contact with skin, wash immediately with plenty of water.

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 Z-0030-070-SJ-3.0

Wear suitable protective clothes, gloves, and eye protection. In case of

insufficient ventilation wear suitable respiratory equipment.

16 Other information
Revisions:3.0
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.

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