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Yichang Sanxia Pharmaceutical Co.

,Ltd
According to Regulation (EC) No. 1907/2006
Version: 2.0 Revision Date: 10.10.2017
Printed Date: 12.10.2017

化学品安全数据表

MATERIAL SAFETY DATA SHEET

第 1 节:物料/混合物与公司/企业标识
SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1 产品标识 Product identifier


产品名称 Product name 硫酸新霉素 Neomycin Sulfate
品牌 Brand 三峡 Sanxia
CAS-No. 1405-10-3
该物质没有注册号。因为根据 REACH 法规(EC) No 1907/2006,
该物质或用途的吨位无需注册。预计将在以后的注册截止日期之
前进行注册。
REACH 注册号 A registration number is not available for this substance as the
REACH Registration number substance or its uses are exempted from registration according to
REACH Regulation (EC) No 1907/2006, the annual tonnage does
not require a registration or the registration is envisaged for a later
registration deadline.
物料或者混合物的相关用途及禁止使用
1.2
Relevant identified uses of the substance or mixture and uses advised against
可用于 药品生产
Identified uses Manufacture of pharmaceutical
安全数据表供应商信息
1.3
Details of the supplier of the safety data sheet
宜昌三峡制药有限公司
公司 Company
YICHANG SANXIA PHARMACEUTICAL CO. LTD.
紫阳路 8 号 No.8 Ziyang Road
湖北宜昌 Yichang ,Hubei
中国 China
电话 Telephone +86-717-6272407
传真 Fax +86-717-6274046
电子邮箱 E-mail address sanxia@renfu.com.cn
1.4 紧急电话 Emergency telephone number
紧急电话
+86-717-6275681
Emergency phone number

第 2 节:危险性概述
SECTION 2: HAZARDS IDENTIFICATION

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Yichang Sanxia Pharmaceutical Co.,Ltd
According to Regulation (EC) No. 1907/2006
Version: 2.0 Revision Date: 10.10.2017
Printed Date: 12.10.2017
2.1 物料分类 Classification of the substance or mixture
根据法规(EC)1272/2008 进行分类 Classification according to Regulation (EC) No 1272/2008
呼吸致敏(类别 1),H334 Respiratory sensitization (Category 1), H334
皮肤过敏(类别 1),H317 Skin sensitization (Category 1), H317
2.2 标签符号 Label elements
标签(法规(EC) No 1272/2008)Labelling (REGULATION (EC) No 1272/2008)
图标 Pictogram

信号表示 Signal word 危险 Danger


危害信息 Hazard statement(s)
H317 可能引起皮肤过敏反应。May cause an allergic skin reaction.
吸入可能引起过敏或哮喘病症状或呼吸困难。May cause allergy
H334
or asthma symptoms or breathing difficulties if inhaled.

防范说明 Precautionary statement(s)


避免吸入粉尘/烟/气体/雾/蒸气/喷雾。
P261
Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
穿戴防护装备。
P280
Wear protective protection.
戴呼吸防护装置。
P284
Wear respiratory protection.

如果吸入:将人员转移到新鲜空气处并保持呼吸舒适。
P304+P311 IF INHALED: Remove person to fresh air and keep comfortable
for breathing.

如果遇到呼吸道症状:呼叫解毒中心/医生。If experiencing
P342+P311
respiratory symptoms: Call a POISON CENTER/ doctor.
危害补充 Supplemental Hazard 无 None
Statements
2.3 其他危害 Other hazards
该物质/混合物不包含被认为具有持久性,生物蓄积性和毒性(PBT)或含量超过 0.1%的具有非常持久性
和生物蓄积性(vPvB)的成分。
This substance/ mixture contains no components considered to be either persistent, bioaccumulative and toxic
(PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

第 3 节:成分/组成信息
SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS
3.1 物质 Substances
化学式 Formula C23H46N6O13, xH2SO4
分子量 Molecular weight 908.88 g/mol
CAS-No. 1405-10-3
EC-No. 215-773-1
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Yichang Sanxia Pharmaceutical Co.,Ltd
According to Regulation (EC) No. 1907/2006
Version: 2.0 Revision Date: 10.10.2017
Printed Date: 12.10.2017
根据(EC)1272/2008 法规的有害成分 Hazardous ingredients according to Regulation (EC) No 1272/2008
成分 Component 分类 Classification 浓度 Concentration
硫酸新霉素 Neomycin sulfate
呼吸 1 类 H334,皮肤过敏 1 类 H317
CAS-No 1405-10-3
Resp. Sens.1; Skin Sens.1; <=100%
EC-No 215-773-1
H334, H317
更多关于危害信息的内容详见第 16 节
For the full text of the H-Statements mentioned in this Section , see Section 16.
第 4 节:急救措施
SECTION 4: FIRST AID MEASURES
4.1 急救措施描述 Description of first aid measures
通用建议 General advice
咨询医生,将该安全数据表出示给就诊医生。
Consult a physician. Show this safety data sheet to the doctor in attendance.
如果吸入 If inhaled
如果吸入,将人转移到空气新鲜场所。如果呼吸停止,立即进行人工呼吸,并就医。
If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.
如果皮肤接触 In case of skin contact
使用肥皂和大量水冲洗,并就医。Wash off with soap and plenty of water. Consult a physician.
如果接触到眼睛 In case of eye contact
用水冲洗眼睛 Flush eyes with water as a precaution.
如果吞入 If swallowed
禁止给患者喂食任何物品,用水冲洗口腔,就医。
Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.
最重要的症状,包括即时及长久的。
4.2
Most important symptoms and effects, both acute and delayed
已知的最重要的症状请参见标签中的 2.2 节或者 11 节。The most important known symptoms and effects are
described in the labelling (see section 2.2) and/ or in section11.
需要立即就医和特殊治疗的指示
4.3
Indication of any immediate medical attention and special treatment needed

无相关信息。No information available.


第 5 节:消防措施
SECTION 5: FIRE FIGHTING MEASURES
5.1 灭火剂 Extinguishing media
适宜的灭火剂 Suitable extinguishing media
使用喷水,抗酒精泡沫,干粉化学药品或二氧化碳。
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
不适用的灭火剂 Unsuitable extinguishing media
对于该物质没有灭火剂的限制。For this substance/mixture no limitations of extinguishing agents are given.
5.2 该物料带来的特殊危害 Special hazards arising from the substance or mixture

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Yichang Sanxia Pharmaceutical Co.,Ltd
According to Regulation (EC) No. 1907/2006
Version: 2.0 Revision Date: 10.10.2017
Printed Date: 12.10.2017
碳氧化物,氮氧化物(NOx),硫氧化物 Carbon oxides, Nitrogen oxides (NOx), Sulphur oxides
5.3 消防建议 Advice for firefighters
必要时,佩戴自给式呼吸器进行消防。Wear self-contained breathing apparatus for firefighting if necessary.

5.4 更多信息 Further information

防止灭火水污染地表水或地下水系统。
Prevent fire extinguishing water from contaminating surface water or the ground water system.

第 6 节:泄露应急处理
SECTION 6: ACCIDENTAL RELEASE MEASURES
个人防护措施,防护装备和应急程序
6.1
Personal precautions, protective equipment and emergency procedures
使用个人防护装备。避免形成灰尘。避免吸入蒸气,雾气或气体。确保足够的通风。将人员疏散到安全
区域。 避免吸入灰尘。
Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate
ventilation. Evacuate personnel to safe areas. Avoid breathing dust.
6.2 环境预防措施 Environmental precautions
防止物质进入下水道。Do not let product enter drains.

6.3 清理污染的方法与材料 Methods and materials for containment and cleaning up

拾起污染物并安排处置,不要产生灰尘。放在合适的密闭容器中进行处置。
Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for
disposal.

6.4 其他参考章节 Reference to other sections

请参考第 13 节。For disposal see section 13.

第 7 节:处理与存放
SECTION 7: HANDLING AND STORAGE
7.1 安全处理的注意事项 Precautions for safe handing
避免与皮肤和眼睛接触。 避免形成灰尘和气溶胶。
Avoid contact with skin and eyes. Avoid formation of dust and aerosols.
在易起灰尘的地方提供适当的排气通风。
Provide appropriate exhaust ventilation at places where dust is formed.
不得在工作场所饮食,吸烟和吸烟; 使用后要洗手,并在进入饮食区之前脱去污染的衣服和防护装备。
Not to eat, drink and smoke in work areas; to wash hands after use and to remove contaminated clothing and
protective equipment before entering eating areas.
预防措施请参考第 2.2 节。For precautions see section 2.2.
7.2 安全存放条件,包括任何不兼容性。Conditions for safe storage, including any incompatibilities

储存条件 Storage conditions


保存在密封,耐光的容器中。Preserve in tight, light resistant containers.
储存温度可达到 25℃。Store at temperatures up to 25℃
7.3 特定最终用途 Specific end use(s)

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Yichang Sanxia Pharmaceutical Co.,Ltd
According to Regulation (EC) No. 1907/2006
Version: 2.0 Revision Date: 10.10.2017
Printed Date: 12.10.2017
除了第 1.2 节中提到的用途外,没有其他规定。Apart from the uses mentioned in section 1.2 no other specific
uses are stipulated.
第8节:暴露控制/个人防护
SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION
8.1 控制参数 Control parameters
8.2 暴露控制 Exposure controls
适当的工程控制 Appropriate engineering controls
按照良好的工业卫生和安全规范进行操作。休息前和当天工作结束时洗手。
Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the
end of workday.
个人防护设备 Personal protective equipment
眼睛/面部防护 Eye/Face protection
防护面具与护目镜。使用经适当的政府标准(例如,NIOSH(US)或 EN 166(EU))测试和批准的护
眼设备。
Face shield and safety glasses. Use equipment for eye protection tested and approved under appropriate
government standards such as NIOSH (US) or EN 166 (EU).
皮肤保护 Skin protection
戴手套处理。使用前必须检查手套。使用适当的技巧脱手套(不接触手套的外表面),以避免皮
肤接触该产品。使用后应根据适用法律和良好的实验室规范处置受污染的手套。
Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without
touching glove’s outer surface) to avoid skin contact with this product. Dispose of contaminated gloves
after use in accordance with applicable laws and good laboratory practices.
清洗烘干双手
Wash and dry hands.
选择的防护手套必须满足欧盟指令 89/686/EEC 的规范以及由此衍生的标准 EN374。
The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the
standard EN 374 derived from it.
手部防护 Hand protection
PVC 或其他塑料材质的防护手套。
PVC or other plastic material gloves.
身体防护 Body protection
全套防化学服,必须根据特定工作场所中危险物质的浓度和数量选择防护设备的类型。
Complete suit protecting against chemicals, the type of protective equipment must be selected according to the
concentration and amount of the dangerous substance at the specific workplace.
呼吸系统防护 Respiratory protection
不得不暴露时,请使用 P95 型(美国)或 P1 型(欧盟 EN143)粒子 r(美国)或 ABEKP2 型(欧盟 EN143)
呼吸器滤芯。使用经适当的政府标准(例如,NIOSH(US)或 CEN(EU))测试和批准的呼吸器和组
件。
For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle r (US) or type ABEKP2
(EU EN 143) respirator cartridges. Use respirators and components tested and approved under appropriate
government standards such as NIOSH (US) or CEN (EU).
环境暴露控制 Control of environmental exposure
不能直接排入下水。

Page 5 of 7
Yichang Sanxia Pharmaceutical Co.,Ltd
According to Regulation (EC) No. 1907/2006
Version: 2.0 Revision Date: 10.10.2017
Printed Date: 12.10.2017
Do not let product enter drains.
第 9 节:物理和化学性质
SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES
9.1 基本理化性质信息 Information on basic physical and chemical properties
固体,白色或黄白色
外观 Appearance
Solid, White or yellow-white
气味 Odour 无臭 Odourless
气味阈值 Odour Threshold 不适用 Not applicable.
pH 5.0 ~ 7.5
熔点/冰点
无可用数据 No data available.
Melting point/ freezing point
初始沸点和沸程 无可用数据 No data available.
Initial boiling point and boiling range
闪点 Flash point 无可用数据 No data available.
蒸发率 Evaporation rate 无可用数据 No data available.
易燃性(固体,气体) 无可用数据 No data available.
Flammability (solid, gas)
爆炸下限 Lower explosion limit 无可用数据 No data available.
爆炸上限 Upper explosion limit 无可用数据 No data available.
蒸汽压力 Vapour pressure 无可用数据 No data available.
蒸气密度 Vapour density 无可用数据 No data available.
相对密度 Relative density 无可用数据 No data available.
溶解性 Solubility 溶于水 soluble in water
分配系数:正辛醇/水
无可用数据 No data available.
Partition coefficient: noctanol/water
自燃温度 Auto-ignition temperature 无可用数据 No data available.
分解温度 Decomposition temperature 无可用数据 No data available.
黏度 Viscosity 无可用数据 No data available.
爆炸特性 Explosive properties 非爆炸性 No classified as explosive.
氧化性 Oxidizing properties 无 None
9.2 其他数据 Other data
无可用数据 No data available.
第 10 节:稳定性和反应性
SECTION 10: STABILITY AND REACTIVITY
10.1 反应性 Reactivity
无可用数据 No data available.
10.2 化学稳定性 Chemical Stability
在推荐的储存条件下可以保持稳定。
Stable under recommended storage conditions.
10.3 危险反应的可能性 Possibility of hazardous reactions
无可用数据。No data available.

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Yichang Sanxia Pharmaceutical Co.,Ltd
According to Regulation (EC) No. 1907/2006
Version: 2.0 Revision Date: 10.10.2017
Printed Date: 12.10.2017
10.4 应避免的条件 Conditions to avoid
无可用数据。No data available.
10.5 不相容物质 Incompatible materials
强氧化剂 Strong oxidizing agents
10.6 危险的分解产物 Hazardous decomposition products
在燃烧条件下形成危险的分解产物。
Hazardous decomposition products formed under fire conditions.
– 碳氧化物,氮氧化物(NOX),硫氧化物 Carbon oxides, Nitrogen oxides(NOX), Sulphur oxides
第 11 节:毒理学信息
SECTION 11: TOXICOLOGICAL INFORMATION
11.1 毒理作用信息 Information on toxicological effects
急性毒性 Acute toxicity
无可用数据。No data available.
皮肤腐蚀/刺激 Skin corrosion/irritation
无可用数据。No data available.
严重眼损伤/眼刺激 Serious eye damage/eye irritation
无可用数据。No data available.
呼吸道或皮肤过敏 Respiratory or skin sensitisation
无可用数据。No data available.
生殖细胞致突变性 Germ cell mutagenicity
无可用数据。No data available.
致癌性 Carcinogenicity
国际癌症研究机构:该产品的任何成分均不能被国际癌症研究机构鉴定为可能,可能或已证实的人类致
癌物,其含量不超过 0.1%。
IARC: No component of this product present at levels greater than or equal to 0.1% is identified as probable,
possible or confirmed human carcinogen by IARC.
生殖毒性 Reproductive toxicity
无可用数据。No data available.
特定目标器官毒性-一次接触
Specific target organ toxicity - single exposure
无可用数据。No data available.
特定目标器官毒性-反复接触
Specific target organ toxicity - repeated exposure
无可用数据。No data available.
吸入危害 Aspiration hazard
无可用数据。No data available.
附加信息 Additional Information
化学物质毒性数据库:无可用数据。
RTECS: Not available
第 12 节:生态信息
SECTION 12: ECOLOGICAL INFORMATION
12.1 毒性 Toxicity

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Yichang Sanxia Pharmaceutical Co.,Ltd
According to Regulation (EC) No. 1907/2006
Version: 2.0 Revision Date: 10.10.2017
Printed Date: 12.10.2017
无可用数据。No data available.
12.2 持久性和降解性 Persistence and degradability
无可用数据。No data available.
12.3 生物蓄积潜力 Bioaccumulative potential
无可用数据。No data available.
12.4 土壤中的流动性 Mobility in soil
无可用数据。No data available.
12.5 PBT 和 vPvB 评估结果 Results of PBT and vPvB assessment
该物质/混合物不包含被认为具有持久性,生物蓄积性和毒性(PBT)或含量超过 0.1%的非常持久且具有
很高生物蓄积性(vPvB)的成分。
This substance/mixture contains no components considered to be either persistent, bioaccumulative and
toxic(PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
12.6 其他不良影响 Other adverse effects
无可用数据。No data available.
第 13 节:废弃处置
SECTION 13: DISPOSAL CONSIDERATIONS
13.1 废弃处理方法 Waste treatment methods
废弃时必须根据《废弃物法规 2008/98 / EC》以及其他国家和地方法规进行处置。将化学品放在原始容
器中。不得与其他废弃物混合。处理未清洁的容器,例如产品本身。
Waste material must be disposed of in accordance with the Directive on waste 2008/98/EC as well as other
national and local regulations. Leave chemicals in original containers. No mixing with other waste. Handle
uncleaned containers like the product itself.
第 14 节:运输信息
SECTION 14: TRANSPORT INFORMATION
14.1 联合国编号 UN number
ADR/RID:None IMDG:None IATA:None
14.2 联合国运输名称 UN proper shipping name
ADR/RID:None IMDG:None IATA:None
14.3 运输危害级别 Transport hazard class(es)
ADR/RID:None IMDG:None IATA:None
14.4 包装组 Packaging group
ADR/RID:None IMDG:None IATA:None
14.5 环境危害 Environmental hazards
ADR/RID:None IMDG Marine pollutant 海洋污染物 IATA:None
14.6 使用者特殊预防措施 Special precautions for user
No data available.
备注:ADR:European Agreement Concerning the International Carriage of Dangerous Goods by Road《关于
危险货物道路国际运输的欧洲协议》。
IMDG:International Maritime Dangerous Goods《国际海上危险货物运输规则》。
ICAO-TI : The International Civil Aviation Organization Technical Instructions on the Safe Transport of
Dangerous Goods by Air《国际空运危险货物规则》;
第 15 节:法规信息
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Yichang Sanxia Pharmaceutical Co.,Ltd
According to Regulation (EC) No. 1907/2006
Version: 2.0 Revision Date: 10.10.2017
Printed Date: 12.10.2017
SECTION 15: REGULATORY INFORMATION
有关物质或混合物的安全,健康和环境法规/法律
15.1
Safety, health and environmental regulations/legislation specific for the substance or mixture
本安全数据表符合法规(EC)No.1907/2006。
This safety datasheet complies with the requirements of Regulation (EC)No. 1907/2006.
化学品安全评估
15.2
Chemical Safety Assessment
对于该产品,未进行化学安全性评估。
For this product a chemical safety assessment was not carried out.
第 16 节:其他信息
SECTION 16:OTHER INFORMATION
培训建议 Training advice:
为操作员提供足够的信息,指导和培训。
provide adequate information, instruction and training for operators.
安全数据表中使用的缩写词和首字母缩略词的关键字或图例:
Key or legend to abbreviations and acronyms used in the safety data sheet:
使用的缩写和首字母缩写可以在 www.wikipedia.org 上查找。
Used abbreviations and acronyms can be looked up at www.wikipedia.org.
以上信息被认为是正确的,但并不意味着包含所有信息,仅应用作指导。本文档中的信息基于我们目前的知识
水平,并且在适当的安全预防措施方面适用于该产品。
The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a
guide. The information in this document is based on the present state of our knowledge and is applicable to the product
with regard to appropriate safety precautions.

宜 昌 三 峡 制 药 有 限 公 司
YICHANG SANXIA PHARMACEUTICAL CO.,LTD

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