SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

SECTION 1: IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING

1.1. Product identifier
Trade name: Potassium guaiacolsulfonate
Substance name: Sulfogaiacol
EC number: 215-314-5
CAS number: 1321-14-8 (anhydrous substance)
CAS number: 78247-49-1 (hemihydrate)
Synonyms: Sulfoguaiacol
1.2. Relevant identified uses of the substance or mixture and uses advised against
Active Pharmaceutical Ingredient (API) used in the manufacture of medicinal products. Acts as
expectorant reducing viscosity of bronchial secretions as mild disinfectant.
1.3. Details of the supplier of the safety data sheet
FSP GALENA
Krucza 62
50-984 Wrocaw, Poland
tel.: (48) 71 7106316, (48) 71 7106205
email: info@galena.pl
1.4. Emergency telephone number
112

SECTION 2: HAZARDS IDENTIFICATION

2.1. Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008:
Acute toxicity, category 4 (Acute Tox. 4)
Skin corrosion/irritation, category 2 (Skin Irrit. 2)
Eye damage/irritation, category 2 (Eye Irrit. 2)
Specific target organ toxicity, single exposure, category 3 (STOT Se 3)
Classification according to Directive 67/548/EEC:
Harmful, Xn
Harmful if swallowed, R22
Irritating to eyes, respiratory system and skin, R36/37/38
Full text of each classification is given in Section 16.

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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

2.2. Label elements

Pictogram

Signal word:

Warning

Hazard statements:
H302

Harmful if swallowed

H315
H319
H335

Causes skin irritation

Causes serious eye irritation
May cause respiratory irritation

Precautionary statements:
P261
Avoid breathing dust
P280
Wear protective gloves/protective clothing/eye protection/face protection.
P301+P312
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P302+P352
IF ON SKIN: Wash with plenty of soap and water.
P304+P340

IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable
for breathing.

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing.
2.3. Other hazards
The substance does not meet the criteria for PBT or vPvB.
No other hazards.

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

3.1. Substances
Ingredient

Sulfogaiacol

Content

> 99%

EC
number
215-314-8

CAS
number

Molecular
formula

78247-49-1

C7H7KO5S,
H 2O

(hemihydrate)

Molecular
weight
251.3

Classification
Acute Tox. 4, Skin
Irrit. 2; Eye Irrit. 2,
STOT Se 3;
Xn, R22, R36/37/38

Full text of each classification is given in Section 16.

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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

SECTION 4: FIRST AID MEASURES

4.1. Description of first aid measures
If inhaled:
Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical advice.
In case of skin contact:
Wash with plenty of soap and water. If skin irritation occurs get medical advice.
In case of eye contact:
Rinse cautiously with water for several minutes. If eye irritation occurs get medical advice.
If swallowed:
Rinse mouth with water. Do not induce vomiting. Get medical advice.
4.2. Most important symptoms and effects, both acute and delayed
If inhaled:
Dust may cause allergy and/or irritation of mucous membrane.
In case of skin contact:
Prolonged contact with skin may cause irritation.
In case of eye contact:
Direct contact with eyes may cause irritation.
If swallowed:
Swallowing may cause irritation of oral cavity and upper alimentary tract and sickness.
4.3. Indication of any immediate medical attention and special treatment needed
Not available.

SECTION 5: FIREFIGHTING MEASURES

5.1. Extinguishing media
Suitable extinguishing media: water, dry chemical powder, foam, carbon dioxide.
5.2. Special hazards arising from the substance or mixture
Non-flammable substance. Under fire conditions it emits toxic fumes (CO, SO2).
5.3. Advice for firefighters
Wear self contained breathing apparatus for fire fighting if necessary.

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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

SECTION 6: ACCIDENTAL RELEASE MEASURES

6.1. Personal precautions, protective equipment and emergency procedures
For non-emergency personnel
Wear suitable protective equipment as described in Section 8. Avoid dust formation. Avoid breathing
dust. Handle and store in a well-ventilated area.
For emergency personnel
Wear suitable protective equipment as described in Section 8.
Suitable fabric for personal protective clothing: cotton, polyester.
6.2. Environmental precautions
Do not allow to enter ground waters and sewage. Collect substance into appropriate container, dispose
according to local regulations.
6.3. Methods and material for containment and cleaning up
Avoid dust formation during collecting and disposal. Wash contaminated area with water. During
cleaning wear suitable protective equipment as described in Section 8.
6.4. Reference to other sections
For description of suitable protective equipment refer to Section 8. For disposal considerations refer to
Section 13.

SECTION 7: HANDLING AND STORAGE

7.1. Precautions for safe handling
Handle with care. Avoid dust formation. Handle and store in a well-ventilated area.
Do not allow to enter ground waters and sewage.
Do not eat, drink or smoke when handling the substance.
Do not get in eyes, on skin, or on clothing.
Wash hands and face thoroughly after handling. Contaminated work clothing should not be allowed out
of the workplace. Take off contaminated clothing and wash before reuse.
7.2. Conditions for safe storage, including any incompatibilities
Store indoors at 15 25 C in tightly closed original containers. Store in a well-ventilated area. Protect
from light and moisture.
Incompatibilities: iron salts.
7.3. Specific end use(s)
When using the substance for manufacture of medicinal products according to the specific end use
described in subsection 1.2 ensure appropriate transportation, storage, sampling and usage according to
the rules of Good Manufacturing Practice (GMP).
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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1. Control parameters
Occupational exposure limit values are not defined for the substance.
8.2. Exposure controls
Appropriate engineering controls
Store and handle indoors. Store in a well-ventilated area. Protect from light and moisture.
Appropriate personal protective equipment
Eye/face protection:
use safety glasses
Skin protection:

use latex protective gloves of minimal thickness 0.20 mm. Use work
clothing made of cotton or polyester

Respiratory protection:

use dust masks such as two-layer medical masks.

Environmental exposure controls

Do not allow to enter ground waters and sewage. Collect substance into appropriate container, dispose
according to local regulations.

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

9.1. Information on basic physical and chemical properties
a)
b)
c)
d)
e)

Appearance:
Odour:
Odour threshold:
pH:
Melting point/freezing point:

solid substance, white crystalline powder

no odour
does not apply
6,0 8,5 (5% w/v solution in water)
no data available

f)
g)
h)
i)
j)

Initial boiling point and boiling range:

Flash point:
Evaporation rate:
Flammability (solid, gas):
Upper/lower flammability or explosive limits:

no data available
no data available
no data available
non-flammable
no data available

k)
l)
m)

Vapour pressure:
Vapour density:
Relative density:

no data available
no data available
no data available

n)

Solubility(ies):

o)
p)

Partition coefficient: n-octanol/water:

Auto-ignition temperature:

freely soluble in water, very slightly soluble in

ethanol, practically insoluble in diethyl ether.
no data available
no data available

q)
r)

Decomposition temperature:
Viscosity:

no data available
no data available

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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

s)
t)

Explosive properties:
Oxidising properties:

not classified as explosive

not classified as oxidising

9.2. Other information

No other information

SECTION 10: STABILITY AND REACTIVITY

10.1. Reactivity
No reactivity hazards of the substance are known.
10.2. Chemical stability
The substance is stable under storage and handle conditions described on Section 7.
10.3. Possibility of hazardous reactions
No hazardous reactions of the substance are known.
10.4. Conditions to avoid
Avoid dust formation. Use personal protective equipment specified in Section 8.
10.5. Incompatible materials
Iron salts may cause discoloration of the substance from white to yellow. This reaction is not dangerous.
10.6. Hazardous decomposition products
No data available.

SECTION 11: TOXICOLOGICAL INFORMATION

11.1. Information on toxicological effects
a)
b)

acute toxicity:
skin corrosion/irritation:

no data available
no data available

c)
d)
e)
f)
g)

serious eye damage/irritation:

respiratory or skin sensitisation:
germ cell mutagenicity:
carcinogenicity:
reproductive toxicity:

no data available
no data available
no data available
no data available
no data available

h)
i)

STOT-single exposure:
STOT-repeated exposure:

no data available
no data available

j)

aspiration hazard:

no data available

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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

Absence of specific data

Due to absence of specific data on toxicological effects of sulfogaiacol, the classification described in
Section 2 was based on toxicological data for guaiacol (CAS: 90-05-1), as sulfogaiacol is quickly
decomposed to guaiacol after ingestion, thus acting harmfully.
Toxicological data for guaiacol (CAS: 90-05-1):
Acute toxicity:

rat, oral, LD50: 520 mg/kg (source: Folia Medica Cracoviensia. Vol. 32, Pg. 309, 1991)

mouse, oral, LD50: 621 mg/kg (source Drugs of the Future. Vol. 5, Pg. 539, 1980)

Skin irritation:

rabbit, serious irritation (source: TOXNET)

Eye irritation:

rabbit, mild irritation (10% solution in glycerin) (source: TOXNET)

rabbit, damage to cornea and conjunctiva (source: TOXNET)

Information on likely routes of exposure / Symptoms related to the physical, chemical and toxicological
characteristics
If inhaled:
Dust may cause allergy and/or irritation of mucous membrane.
In case of skin contact:
Prolonged contact with skin may cause irritation.
In case of eye contact:
Direct contact with eyes may cause irritation.
If swallowed:
Swallowing may cause irritation of oral cavity and upper alimentary tract and sickness.

SECTION 12: ECOLOGICAL INFORMATION

12.1. Toxicity
No data available.
12.2. Persistence and degradability
No data available.
12.3. Bioaccumulative potential
No data available.
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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

12.4. Mobility in soil

No data available.
12.5. Results of PBT and vPvB assessment
No data available.
12.6. Other adverse effects
No data available.

SECTION 13: DISPOSAL CONSIDERATIONS

13.1. Waste treatment methods
Observe all national and local environmental regulations.
Do not allow to enter ground waters and sewage. Avoid dust formation during collecting and disposal.
Wash contaminated area with water.
Product packaging must be emptied prior to disposal. Product packaging may be recycled after being
thoroughly washed. If recycling of product packaging is not possible, it must be disposed of in
compliance with the respective national regulations.

SECTION 14: TRANSPORT INFORMATION

14.1. UN number
Does not apply not dangerous goods.
14.2. UN proper shipping name
Does not apply not dangerous goods.
14.3. Transport hazard class(es)
Does not apply not dangerous goods.
14.4. Packing group
Does not apply not dangerous goods.
14.5. Environmental hazards
Does not apply not dangerous goods.
14.6. Special precautions for user
Transport by sheltered vehicle is recommended.
14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code
Does not apply not dangerous goods.
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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

SECTION 15: REGULATORY INFORMATION

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture
International regulations that apply:
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, as amended.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008
on classification, labelling and packaging of substances and mixtures, amending and repealing
Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
Commission Regulation (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No
1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH).
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and
administrative provisions relating to the classification, packaging and labelling of dangerous
substances, as amended.
15.2. Chemical safety assessment
Chemical safety assessment has not been carried out.

SECTION 16: OTHER INFORMATION

Information about revision of Safety Data Sheet
Edition IV of Safety Data Sheet from 01.12.2010. Changes to edition III form 15.09.2009 include:
new format of the Safety Data Sheet according to Commission Regulation (EU) No 453/2010 of 20
May 2010,
new classification and labeling according to Regulation (EC) No 1272/2008 of the European
Parliament and of the Council of 16 December 2008.
Full text of the classification according to Regulation (EC) No 1272/2008:
Acute toxicity, category 4 (Acute Tox. 4)
Skin corrosion/irritation, category 2 (Skin Irrit. 2)
Eye damage/irritation, category 2 (Eye Irrit. 2)
Specific target organ toxicity, single exposure, category 3 (STOT Se 3)

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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

Pictogram

Signal word:

Warning

Hazard statements:
H302
Harmful if swallowed
H315
Causes skin irritation
H319
H335

Causes serious eye irritation

May cause respiratory irritation

Precautionary statements:
P261
Avoid breathing dust
P280
Wear protective gloves/protective clothing/eye protection/face protection.
P301+P312
IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P302+P352
IF ON SKIN: Wash with plenty of soap and water.
P304+P340

IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable
for breathing.

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing.
Full text of classification according to Directive 67/548/EEC:
Danger symbol: Xn harmful

Xn

Risk phrases:
R22

Harmful if swallowed

R36/37/38

Irritating to eyes, respiratory system and skin

Safety phrases:
S22
Do not breathe dust
S24/25
Avoid contact with skin and eyes
S26
In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
S36/37/39 Wear suitable protective clothing, gloves and eye/face protection
S46
If swallowed, seek medical advice immediately and show this container or label
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SAFETY DATA SHEET

Potassium guaiacolsulfonate
Edition: IV
Revision: 01.12.2010

S36/37
S46

Wear suitable protective clothing and gloves

If swallowed, seek medical advice immediately and show this container or label

Disclaimer
The above information is based on the present state of our knowledge. The information presented in this
document relate solely to the product and cannot be applied after the product has been processed.

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