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Material Safety Data Sheet in accordance with 1907/2006/EC Articaine hydrochloride Substance key: SXR013151 Version:2.6 (World) Revision Date: 15.12....
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Material Safety Data Sheet in accordance with 1907/2006/EC

Articaine hydrochloride Substance key: SXR013151 Version:2.6 (World) Revision Date: 15.12.2008

1. Identification of the substance/preparation and company Product details Trade name:

Articaine hydrochloride

Synonyms:

Carticaine Hydrochloride

Usage Active Pharmaceutical Ingredient Therapeutic class: local anesthetic Supplier details Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 65926 Frankfurt am Main Telephone no.: +49 (0) 69 305- 0 Information provided by USB - Sicherheit Telephone no.:

+49 (0) 69 305-3963/- 12590

Emergency telephone number:

+49 (0) 69 305-6418

Safety data sheet created by :

USB Produktsicherheit ([email protected])

2. Hazards identification

Physical-, chemical and toxicological hazards

Sanofi-aventis Hygiene Hazard Band

:

Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Harmful if swallowed. Avoid contact with skin and eyes Caution: Through the effect of the product, the eye can become insensitive to pain. Danger of damage to cornea of the eye through mechanical rubbing of the eye. Substance pharmacologically active (Minimum Therapeutic Daily Dose > 10 mg/day). The product may cause dust explosions.

:

OEB 2 Further information see chapter 16.

3. Composition/information on ingredients Chemical characterization

:

4-Methyl-3((1-oxo-2-(propylamino)propyl)amino)-2-thiophenecarboxylic acid methyl ester, monohydrochloride

Empirical formula Molar mass

: :

C13 H20 N2 O3 S * HCl 320,4 g/mol

Date of printing: 19.01.2010

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Material Safety Data Sheet in accordance with 1907/2006/EC

Articaine hydrochloride Substance key: SXR013151 Version:2.6 (World) Revision Date: 15.12.2008

CAS number EINECS number

: :

23964-57-0 245-957-7

General information

:

Remove contaminated clothing immediately and dispose of safely.

After inhalation

:

Take medical treatment.

After contact with skin

:

In case of contact with skin wash off immediately with plenty of water.

After contact with eyes

:

In case of contact with eyes rinse thoroughly with plenty of water and seek medical advice

After ingestion

:

When swallowed seek medical aid immediately and show the physician the packaging or the label of the packaging.

:

Treat symptomatically.

Suitable extinguishing media

:

Water., Foam., Dry powder., Carbon dioxide., Sand.

Special hazards from the substance itself, its combustion products or from its vapours

:

In case of fires, hazardous combustion gases are formed: Carbon monoxide (CO). Carbon dioxide (CO2) Hydrogen chloride (HCl) Nitrogen oxides (NOx) Sulphur dioxide (SO2)

Special protective equipment for firefighting

:

Use self-contained breathing apparatus.

Further information

:

Fire residues and contaminated firefighting water must be disposed of in accordance with the local regulations.

Personal precautions

:

Avoid dust formation. Use personal protective clothing.

Environmental precautions

:

Do not allow to enter drains or waterways.

Methods for cleaning up/taking up

:

Take up mechanically Avoid raising dust When picked up, treat material as prescribed under heading "Disposal".

4. First aid measures

Notes to Physician Treatment

5. Fire-fighting measures

6. Accidental release measures

Date of printing: 19.01.2010

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Material Safety Data Sheet in accordance with 1907/2006/EC

Articaine hydrochloride Substance key: SXR013151 Version:2.6 (World) Revision Date: 15.12.2008

7. Handling and storage Handling Advice on safe handling (industrial scale)

:

Avoid the formation and deposition of dust. Provide exhaust ventilation if dust is formed.

Advice on protection against fire and explosion

:

Take precautionary measures against electrostatic loading. Do not empty containers over cooking vessels containing combustible gas mixtures. Avoid formation of dust Observe the general rules of industrial fire protection

Requirements for storage rooms and vessels

:

Keep only in the original container Keep tightly closed.

Advice on storage compatibility

:

Keep away from chemicals as it is a pharmaceutical substance

Further information on storage conditions

:

Storage: dry Store and transport at 10 °C - 25 °C

Storage

8. Exposure controls/personal protection Personal protective equipment General protective measures

:

Do not inhale dust Avoid contact with eyes and skin. Protective clothing should be selected specifically for the working place, depending on concentration and quantity of the hazardous substances handled. The resistance of the protective clothing to chemicals should be ascertained with the respective supplier. A workplace risk assessment must be carried out in order to determine the correct engineering control measures and personal protective equipment.

Hygiene measures

:

Do not eat or drink during work time. Keep away from foodstuffs and beverages. Wash hands before breaks and after work.

Respiratory protection

:

Particle filter half mask, filter P2.

Date of printing: 19.01.2010

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Material Safety Data Sheet in accordance with 1907/2006/EC

Articaine hydrochloride Substance key: SXR013151 Version:2.6 (World) Revision Date: 15.12.2008

Hand protection

:

Nitrile rubber gloves. Glove material : Layer thickness : Permeation time :

Dermatril® (KCL) 0,11 mm > 480 min

Glove material : Layer thickness : Permeation time :

Nitrile rubber 0,5 mm > 480 min

The protective gloves to be used must comply with the specifications of EC directive 89/686/EEC and the resultant standart EN374. This recommandation applies only to the product stated in this safety data sheet and supplied by us as well as to the purpose specified by us. When dissolving in or mixing with other substances and under conditions deviating from those stated in EN374 please contact the supplier of CE-approved gloves. Eye protection

:

Safety glasses with side protection shield.

Body protection

:

protective clothing

Additional advice on system design

:

Use in closed system.

Concentration limits in air: Occupational Expos. Limit (Sanofi-Aventis): (Year: 2003 World) OEL (Sanofi-Aventis): Sanofi-aventis Hygiene Hazard Band

: :

0,1 mg/m3 OEB 2 Further information see chapter 16.

9. Physical and chemical properties Form

:

Crystalline

Colour

:

white

Odour

:

odourless

Molar mass

:

320,4 g/mol

Melting range

:

168 - 170 °C

Flash point

:

Not applicable.

Ignition temperature

:

not determined

Self-ignition temperature

:

from 200 °C The sample was mixed 1:1 with diatomaceous earth.No autoignition in the absence of diatomaceous earth.

Date of printing: 19.01.2010

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Material Safety Data Sheet in accordance with 1907/2006/EC

Articaine hydrochloride Substance key: SXR013151 Version:2.6 (World) Revision Date: 15.12.2008

Thermal decomposition

:

from 240 °C Heating rate: 3 K/min decomposition energy: 220 kJ/kg Method: DTA

Minimum ingnition energie

:

6 mJ < MIE < 13 mJ Method: Mike 3

Vapour pressure

:

not determined

Bulk density

:

approx. 340 kg/m³

Solubility in water

:

331 g/l at 24 °C

pH value

:

4,2 - 4,9 at 10 g/l, 20 °C

Octanol/water partition coefficient

:

log(Pow): 2,75 Method: Calculation Hansch/Leo

Combustion number

:

BZ1: Does not catch fire

Further information (phys.chem.)

:

The product is capable of dust explosions.

:

Risk of dust explosions.

Acute oral toxicity (LD50)

:

978 mg/kg Species: rat Source: Untersuch. Hoechst

intravenous (i. v.) (LD50)

:

37 mg/kg Species: mouse Source: RTECS (Praktische Anaesthesie 9,135,1974)

Sensitization

:

Non sensitizing. Species: Guinea pig Source: Untersuch. Hoechst

Mutagenicity

:

No experimental evidence available for Genotoxicity in vitro. (Ames test negative). No experimental evidence available for Genotoxicity in vivo. (Micronucleus test negative).

other toxicity data

:

In case of contact with mucous membranes an anaesthetising effect may occur (numbness)

10. Stability and reactivity Hazardous reactions

11. Toxicological information

Date of printing: 19.01.2010

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Material Safety Data Sheet in accordance with 1907/2006/EC

Articaine hydrochloride Substance key: SXR013151 Version:2.6 (World) Revision Date: 15.12.2008

12. Ecological information Information on elimination (peristence and degradability) Biodegradability

:

- 11 % Not readily biodegradable. Duration of test: 28 day Method: OECD 301 F Source: Aventis Pharma Deutschland

Fish toxicity (LC50)

:

70,7 mg/l Species: zebra fish Duration of exposure: 96 h Method: OECD 203 Source: Untersuch. Hoechst

Fish toxicity (LC100)

:

100 mg/l Species: zebra fish Duration of exposure: 96 h Method: OECD 203 Source: Untersuch. Hoechst

Toxicity on invertebrates (EC50)

:

209,4 mg/l Species: Daphnia magna Duration of exposure: 48 h Method: OECD 202 Source: Aventis Pharma Deutschland

Algae toxicity (EC50)

:

> 100 mg/l Species: Pseudokirchneriella subcapitata Duration of exposure: 72 h Endpoint : Biomass Method: OECD 201 Source: Aventis Pharma Deutschland

Bacteria toxicity (EC50)

:

> 1.000 mg/l Species: Activated sludge. Method: OECD 209 Source: Untersuch. Hoechst

:

Do not allow to enter soil, waterways or waste water

:

In accordance with regulations for special waste, must be taken to an authorised special waste incineration plant. Harmful emissions must be removed by flue gas scrubbing

Ecotoxic effect

Further ecological information Remarks

13. Disposal considerations Product

Date of printing: 19.01.2010

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Material Safety Data Sheet in accordance with 1907/2006/EC

Articaine hydrochloride Substance key: SXR013151 Version:2.6 (World) Revision Date: 15.12.2008

Uncleaned packaging

:

Packaging that cannot be cleaned should be disposed off as product waste

14. Transport information Road transport ADR :

Non-hazardous goods

Road transport RID :

Non-hazardous goods

Air transport IATA_P :

Non-hazardous goods

Marine transport IMDG :

Non-hazardous goods

15. Regulatory information Labelling in accordance with

:

The product is classified and labelled in accordance with EC directives/German regulations on dangerous substances.

Hazard symbols Xn: Harmful

R phrases

R22: Harmful if swallowed. R52/53: Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

S phrases

S22: Do not breathe dust. S24/25: Avoid contact with skin and eyes. S46: If swallowed, seek medical advice immediately and show this container or label. S61: Avoid release to the environment. Refer to special instructions/Safety data sheets.

16. Other information

Version : 2.6 Revision date 15.12.2008

Date of printing: 19.01.2010

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Material Safety Data Sheet in accordance with 1907/2006/EC

Articaine hydrochloride Substance key: SXR013151 Version:2.6 (World) Revision Date: 15.12.2008

Explanations due to OEB: OEB is a occupational exposure band with the following levels: Occupational Occupational Exposure Band Exposure Level OEB 1 > 1000 µg/m³ OEB 2 100 - 1000 µg/m³ OEB 3 10 – 100 µg/m³ OEB 4 1 – 10 µg/m³ OEB 5 < 1 µg/m³ Additional notations may be applied as suffixes to the OEL/OEB and are used to communicate additional information that is not directly indicated by the OEL/OEB classifications. This information is necessary to perform an efficient risk assessment and determine the correct exposure controls. The meanings of the suffixes is explained in this way: Notation/Suffixes Risk Reprotoxic Hazard for pregnant women. Exposure below the OEL is G1 acceptable. Hazard for pregnant women. Exposure even below the OEL is not G2 acceptable. Respiratory sensitization hazard with serious potential consequences Sr (anaphylactic reactions). Specific dermal hazard (High dermal absorption / Danger of skin Sk sensitization). Corrosive compound - Important dermal and ocular hazard If Cor corrosive compounds (i.e. R34 or R35).

The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text.

Date of printing: 19.01.2010

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