SAFETY DATA SHEET

(in accordance with Regulation (EU) 2015/830)

117410-Docusate sodium USP

Version: 2 Page 1 of 7
Revision date: 20/04/2016 Print date: 20/04/2016

SECTION 1: IDENTIFICATION OF THE SUBSTANCE AND OF THE

COMPANY/UNDERTAKING.

1.1 Product identifier.

Product Name: Docusate sodium USP

Product Code: 117410
Chemical Name: Docusate sodium USP
CAS No: 577-11-7
EC No: 209-406-4
Registration No: 01-2119491296-29-XXXX

1.2 Relevant identified uses of the substance and uses advised against.

For manufacturing, processing, laboratory or repacking use only

Uses advised against:
Uses other than those recommended.

1.3 Details of the supplier of the safety data sheet.

Company: DC FINE CHEMICALS Ltd.

Address: Hill Top, 88
City: NW11 6DY London (United Kingdom)
Telephone: +44 (20) 7586 6800
Fax: +44 (20) 7504 1701
E-mail: info@dcfinechemicals.com
Web: www.dcfinechemicals.com

1.4 Emergency telephone number: (Only available during office hours)

SECTION 2: HAZARDS IDENTIFICATION.

2.1 Classification of the substance.

In accordance with Regulation (EU) No 1272/2008:
Eye Dam. 1 : Causes serious eye damage.
Skin Irrit. 2 : Causes skin irritation.

2.2 Label elements.

.
.

Labelling in accordance with Regulation (EU) No 1272/2008:

Pictograms:

Signal Word:
Danger
H statements:
H315 Causes skin irritation.
H318 Causes serious eye damage.

P statements:
P264 Wash thoroughly after handling.
P280 Wear protective gloves/protective clothing/eye protection/face protection.
P310 Immediately call a POISON CENTER/doctor.
P302+P352 IF ON SKIN: Wash with plenty of water.
P332+P313 If skin irritation occurs: Get medical advice/attention.
P362+P364 Take off contaminated clothing and wash it before reuse.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and
easy to do. Continue rinsing.

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 SAFETY DATA SHEET
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117410-Docusate sodium USP

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Contains:
Docusate sodium USP

2.3 Other hazards.

In normal use conditions and in its original form, the product itself does not involve any other risk for health and the environment.

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS.

3.1 Substances.
Chemical Name: Docusate sodium USP
CAS No: 577-11-7
CE No: 209-406-4
Registration No: 01-2119491296-29-XXXX

3.2 Mixtures.
Not Applicable.

SECTION 4: FIRST AID MEASURES.

IRRITANT PREPARATION. Its repeated or prolonged contact with the skin or mucous membranes can cause
irritant symptoms such as reddening of the skin, blisters, or dermatitis. Some of the symptoms may not
be immediate. They can cause allergic reactions on the skin.

4.1 Description of first aid measures.

In case of doubt or when symptoms of feeling unwell persist, get medical attention. Never administer anything orally to persons
who are unconscious.

Inhalation.
If breathing is irregular or stops, perform artificial respiration. Do not administer anything orally. If unconscious, place them in a
suitable position and seek medical assistance.

Eye contact.
If wearing contact lenses, remove them. Wash eyes with plenty of clean and cool water for at least 10 minutes while pulling
eyelids up, and seek medical assistance.

Skin contact.
Remove contaminated clothing. Wash skin vigorously with water and soap or a suitable skin cleaner. NEVER use solvents or
thinners.

Ingestion.
If accidentally ingested, seek immediate medical attention. Keep calm. NEVER induce vomiting.

4.2 Most important symptoms and effects, both acute and delayed.
Irritant Product, repeated or prolonged contact with skin or mucous membranes can cause redness, blisters or dermatitis,
inhalation of spray mist or particles in suspension may cause irritation of the respiratory tract, some symptoms may not be
immediate. Can cause allergic reactions.

4.3 Indication of any immediate medical attention and special treatment needed.
In case of doubt or when symptoms of feeling unwell persist, get medical attention. Never administer anything orally to persons
who are unconscious.

SECTION 5: FIREFIGHTING MEASURES.

5.1 Extinguishing media.

Recommended extinguishing methods.
Extinguisher powder or CO2. In case of more serious fires, also alcohol-resistant foam and water spray. Do not use a direct
stream of water to extinguish.

5.2 Special hazards arising from the substance.

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117410-Docusate sodium USP

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Special risks.
Fire can cause thick, black smoke. As a result of thermal decomposition, dangerous products can form: carbon monoxide, carbon
dioxide. Exposure to combustion or decomposition products can be harmful to your health.

5.3 Advice for firefighters.

Use water to cool tanks, cisterns, or containers close to the heat source or fire. Take wind direction into account. Prevent the
products used to fight the fire from going into drains, sewers, or waterways.
Fire protection equipment.
According to the size of the fire, it may be necessary to use protective suits against the heat, individual breathing equipment,
gloves, protective goggles or facemasks, and gloves.

SECTION 6: ACCIDENTAL RELEASE MEASURES.

6.1 Personal precautions, protective equipment and emergency procedures.

For exposure control and individual protection measures, see section 8.

6.2 Environmental precautions.

Prevent the contamination of drains, surface or subterranean waters, and the ground.

6.3 Methods and material for containment and cleaning up.

The contaminated area should be immediately cleaned with an appropriate de-contaminator. Pour the decontaminator on the
remains in an opened container and let it act various days until no further reaction is produced.

6.4 Reference to other sections.

For exposure control and individual protection measures, see section 8.
For later elimination of waste, follow the recommendations under section 13.

SECTION 7: HANDLING AND STORAGE.

7.1 Precautions for safe handling.

For personal protection, see section 8. Never use pressure to empty the containers. They are not pressure-resistant containers.
In the application area, smoking, eating, and drinking must be prohibited.
Follow legislation on occupational health and safety.
Keep the product in containers made of a material identical to the original.

7.2 Conditions for safe storage, including any incompatibilities.

Store according to local legislation. Observe indications on the label. Keep far away from ignition points. Keep away from
oxidising agents and from highly acidic or alkaline materials. Do not smoke. Prevent the entry of non-authorised persons. Once
the containers are open, they must be carefully closed and placed vertically to prevent spills.
The product is not affected by Directive 2012/18/EU (SEVESO III).
7.3 Specific end use(s).

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION.

8.1 Control parameters.

The product does NOT contain substances with Professional Exposure Environmental Limit Values.The product does NOT contain
substances with Biological Limit Values.
8.2 Exposure controls.

Measures of a technical nature:

Provide adequate ventilation, which can be achieved by using good local exhaust-ventilation and a good general exhaust system.

Concentration: 100 %
Uses: For manufacturing, processing, laboratory or repacking use only
Breathing protection:
If the recommended technical measures are observed, no individual protection equipment is necessary.
Hand protection:

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If the product is handled correctly, no individual protection equipment is necessary.

Eye protection:
If the product is handled correctly, no individual protection equipment is necessary.
Skin protection:
PPE: Work footwear.
Characteristics: «CE» marking, category II.
CEN standards: EN ISO 13287, EN 20347
This product adapts to the first user's foot shape. That is why, as well as for hygienic reasons, it should
Maintenance:
not be used by other people.
Work footwear for professional use includes protection elements aimed at protecting users against any
Observations:
injury resulting from an accident

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES.

9.1 Information on basic physical and chemical properties.

Appearance:Solid
Colour: N.A./N.A.
Odour:N.A./N.A.
Odour threshold:N.A./N.A.
pH:N.A./N.A.
Melting point:157 ºC
Boiling Point: N.A./N.A.
Flash point: N.A./N.A.
Evaporation rate: N.A./N.A.
Inflammability (solid, gas): N.A./N.A.
Lower Explosive Limit: N.A./N.A.
Upper Explosive Limit: N.A./N.A.
Vapour pressure: N.A./N.A.
Vapour density:N.A./N.A.
Relative density:1,1 g/cm3
Solubility:N.A./N.A.
Liposolubility: N.A./N.A.
Hydrosolubility: N.A./N.A.
Partition coefficient (n-octanol/water): N.A./N.A.
Auto-ignition temperature: N.A./N.A.
Decomposition temperature: N.A./N.A.
Viscosity: N.A./N.A.
Explosive properties: N.A./N.A.
Oxidizing properties: N.A./N.A.
N.A./N.A.= Not Available/Not Applicable due to the nature of the product

9.2. Other information.

SECTION 10: STABILITY AND REACTIVITY.

10.1 Reactivity.
The product does not present hazards by their reactivity.

10.2 Chemical stability.

Stable under the recommended handling and storage conditions (see section 7).

10.3 Possibility of hazardous reactions.

The product does not present possibility of hazardous reactions.

10.4 Conditions to avoid.

Avoid any improper handling.

10.5 Incompatible materials.

Keep away from oxidising agents and from highly alkaline or acidic materials in order to prevent exothermic reactions.

10.6 Hazardous decomposition products.

No decomposition if used for the intended uses.

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117410-Docusate sodium USP

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SECTION 11: TOXICOLOGICAL INFORMATION.

IRRITANT PREPARATION. Its repeated or prolonged contact with the skin or mucous membranes can cause
irritant symptoms such as reddening of the skin, blisters, or dermatitis. Some of the symptoms may not
be immediate. They can cause allergic reactions on the skin.
11.1 Information on toxicological effects.
Repeated or prolonged contact with the product can cause the elimination of oil from the skin, giving rise to non-allergic contact
dermatitis and absorption of the product through the skin.

a) acute toxicity;
Not conclusive data for classification.

b) skin corrosion/irritation;
Product classified:
Skin irritant, Category 2: Causes skin irritation.

c) serious eye damage/irritation;

Product classified:
Serious eye damage, Category 1: Causes serious eye damage.

d) respiratory or skin sensitisation;

Not conclusive data for classification.

e) germ cell mutagenicity;

Not conclusive data for classification.

f) carcinogenicity;
Not conclusive data for classification.

g) reproductive toxicity;
Not conclusive data for classification.

h) STOT-single exposure;
Not conclusive data for classification.

i) STOT-repeated exposure;
Not conclusive data for classification.

j) aspiration hazard;
Not conclusive data for classification.

SECTION 12: ECOLOGICAL INFORMATION.

12.1 Toxicity.
No information is available regarding the ecotoxicity.

12.2 Persistence and degradability.

No information is available about persistence and degradability of the product.

12.3 Bioaccumulative potencial.

No information is available regarding the bioaccumulation.

12.4 Mobility in soil.

No information is available about the mobility in soil.
The product must not be allowed to go into sewers or waterways.
Prevent penetration into the ground.

12.5 Results of PBT and vPvB assessment.

No information is available about the results of PBT and vPvB assessment of the product.

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12.6 Other adverse effects.

No information is available about other adverse effects for the environment.

SECTION 13 DISPOSAL CONSIDERATIONS.

13.1 Waste treatment methods.

Do not dump into sewers or waterways. Waste and empty containers must be handled and eliminated according to current,
local/national legislation.
Follow the provisions of Directive 2008/98/EC regarding waste management.

SECTION 14: TRANSPORT INFORMATION.

Transportation is not dangerous. In case of road accident causing the product’s spillage, proceed in accordance with point 6.
14.1 UN number.
Transportation is not dangerous.

14.2 UN proper shipping name.

Transportation is not dangerous.

14.3 Transport hazard class(es).

Transportation is not dangerous.

14.4 Packing group.

Transportation is not dangerous.

14.5 Environmental hazards.

Transportation is not dangerous.

14.6 Special precautions for user.

Transportation is not dangerous.

14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code.
Transportation is not dangerous.

SECTION 15: REGULATORY INFORMATION.

15.1 Safety, health and environmental regulations/legislation specific for the substance.
The product is not affected by the Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September
2009 on substances that deplete the ozone layer.
See annex I of the Directive 96/82/EC of 9 December 1996 on the control of major-accident hazards involving dangerous
substances and the Regulation (EC) No 689/2008 of the european parliament and of the council of 17 June 2008 concerning the
export and import of dangerous chemicals and its subsequent updates.
The product is not affected by Directive 2012/18/EU (SEVESO III).
The product is not affected by Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal
products.
The product is not affected by the procedure established Regulation (EU) No 649/2012, concerning the export and import of
dangerous chemicals.

15.2 Chemical safety assessment.

There has been no evaluation a chemical safety assessment of the product.

SECTION 16: OTHER INFORMATION.

Classification codes:

Eye Dam. 1 : Serious eye damage, Category 1

Skin Irrit. 2 : Skin irritant, Category 2

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 SAFETY DATA SHEET
(in accordance with Regulation (EU) 2015/830)

117410-Docusate sodium USP

Version: 2 Page 7 of 7
Revision date: 20/04/2016 Print date: 20/04/2016

Sections changed compared with the previous version:

1,2,3,4,8,9,10,11,14,16

It is advisable to carry out basic training with regard to health and safety at work in order to handle this product correctly.

Labelling in accordance with Directive 67/548/EEC:

Symbols:

Xi

Irritant

R Phrases:
R38 Irritating to skin.
R41 Risk of serious damage to eyes.

S Phrases:
S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S39 Wear eye/face protection.

Abbreviations and acronyms used:

CEN: European Committee for Standardization.
PPE: Personal protection equipment.

Key literature references and sources for data:

http://eur-lex.europa.eu/homepage.html
http://echa.europa.eu/
Regulation (EU) 2015/830.
Regulation (EC) No 1907/2006.
Regulation (EU) No 1272/2008.

The information given in this Safety Data Sheet has been drafted in accordance with COMMISSION REGULATION (EU) 2015/830
of 28 May 2015 amending Regulation (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18
December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a
European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC,
93/105/EC and 2000/21/EC.

The information in this Safety Data Sheet on the Preparation is based on current knowledge and on current EC and national
laws, as far as the working conditions of the users is beyond our knowledge and control. The product must not be used for
purposes other than those that are specified without first having written instructions on how to handle. It is always the
responsibility of the user to take the appropriate measures in order to comply with the requirements established by current
legislation. The information contained in this Safety Sheet only states a description of the safety requirements for the
preparation, and it must not be considered as a guarantee of its properties.

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