Safety Data Sheet

According to Regulation (EU) No. 1907/2006 (REACH), Annex II

Version: 2.1/EN Revision date: 21/03/2013

Product name: Terbinafine hydrochloride Printing date: 21/03/2013

Section 1: Identification of the substance/mixture and of the company/undertaking

1.1 Product identifier

Product name: Terbinafine hydrochloride
Trans-N-(6,6-Dimethyl-2-hepten-4-ylyl)-N-methyl-1-
Substance name:
naphthylmethylaminehydrochloride
REACH Reg. No.: This substance except from registration as it is medicine.
CAS No.: 78628-80-5

1.2 Relevant identified uses of the substance or mixture and uses advised against
Identified uses: Antifungal drugs
Uses advised against: No uses advised against.

1.3 Details of the supplier of the SDS

Manufacturer: Qilu Pharmaceutical Co., Ltd.
Address: No. 243 Gongye Bei Road, Jinan, Shandong Province, P. R. China
Postcode: 250100
E-mail: [email protected]
Telephone: +86-531-83126666
Fax: +86-531-83126688

Importer:
Address:
Postcode:
E-mail:
Telephone:
Fax:

1.4 Emergency telephone number：+86-531-83126666

Section 2: Hazards identification

2.1 Classification of the substance or mixture

Classification according to Regulation (EC) No 1272/2008[CLP]
Skin irritation (Category 2)
Eye irritation (Category 2)
Specific target organ toxicity - single exposure (Category 3)
Acute aquatic toxicity (Category 1)
Chronic aquatic toxicity (Category 1)
Classification according to Council Directive 67/548/EEC [DSD]
Irritating to eyes, respiratory system and skin.
Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
Additional information

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 Safety Data Sheet
According to Regulation (EU) No. 1907/2006 (REACH), Annex II

Version: 2.1/EN Revision date: 21/03/2013

Product name: Terbinafine hydrochloride Printing date: 21/03/2013
Full text of R-phrase(s) and H-statement(s): see section 16.

2.2 Label elements

Labelling according to Regulation (EC) No 1272/2008 [CLP]
Substance name: Terbinafine hydrochloride

Hazard pictogram(s):

GHS07
Signal word: Warning.
H315 Causes skin irritation.
H319 Causes serious eye irritation.
Hazard statements:
H335 May cause respiratory irritation.
H412 Harmful to aquatic life with long lasting effects.
Precautionary statements:
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
Prevention:
P273 Avoid release to the environment.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove
Response: contact lenses, if present and easy to do. Continue rinsing.
P501 Dispose of contents/container to an approved waste disposal plant.
Supplemental Hazard information (EUH):
None

2.3 Other hazards

None.

Section 3: Composition/information on ingredients

3.1 Substance information

Substance name CAS No. % (w/w)
Trans-N-(6,6-Dimethyl-2-hepten-4-ylyl)-N-methyl-1-
78628-80-5 >99
naphthylmethylaminehydrochloride
Remark: The rest unspecified ingredients are impurities, and they are not hazard.
Formula : C21H25N ·HCl
Molecular Weight : 327.89 g/mol

Section 4: First aid measures

4.1 Description of first aid measures

General notes: Consult a physician,Show this safety data sheet to the doctor in attendance.
Following inhalation:
If breathed in, move person into fresh air. If not breathing give artificial respiration Consult a physician.
Following skin contact:
Wash off with soap and plenty of water. Consult a physician.

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 Safety Data Sheet
According to Regulation (EU) No. 1907/2006 (REACH), Annex II

Version: 2.1/EN Revision date: 21/03/2013

Product name: Terbinafine hydrochloride Printing date: 21/03/2013

Following eye contact:

Rinse thoroughly with plenty of water for at least 15 minutes and consult a physician.
Following ingestion:
Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.

4.2 Most important symptoms and effects, both acute and delayed
None

Section 5: Fire-fighting measures

5.1 Extinguishing media

Suitable extinguishing media:
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Unsuitable extinguishing media:
For this substance no limitations of extinguishing agents are given.

5.2 Advice for fire-fighters

Wear self contained breathing apparatus for fire fighting if necessary.

Section 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

Use personal protective equipment. Avoid dust formation. Avoid breathing dust. Ensure adequate ventilation.

6.2 Environmental precautions

Prevent further leakage or spillage if safe to do so.
Do not let product enter drains.
Discharge into the environment must be avoided.

6.3 Methods and material for containment and cleaning up

Pick up and arrange disposal without creating dust. Keep in suitable, closed containers for disposal.

6.4 Reference to other sections

See Section 7 for information on safe handling.
See section 8 for information on personal protection equipment.
See Section 13 for information on disposal.

Section 7: Handling and storage

7.1 Precautions for safe handling

Avoid contact with skin and eyes. Avoid formation of dust and aerosols.
Provide appropriate exhaust ventilation at places where dust is formed. Normal measures for preventive fire
protection.

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 Safety Data Sheet
According to Regulation (EU) No. 1907/2006 (REACH), Annex II

Version: 2.1/EN Revision date: 21/03/2013

Product name: Terbinafine hydrochloride Printing date: 21/03/2013

7.2 Conditions for safe storage, including any incompatibilities

Store in Protected from light, preserve in well closed container, up to 30℃.

7.3 Specific end use(s)

Apart from the uses mentioned in section 1.2 no other specific uses are stipulated.

Section 8 : Exposure controls/personal protection

8.1 Control parameters

Occupational exposure limit values:
There are no currently occupational exposure limit values established for the substance.

DNEL(Derived No Effect Level) for workers:

There are no DNEL values for workers established for the substance.

DNEL(Derived No Effect Level) for the general population:

There are no DNEL values for the general population established for the substance.

PNEC(Predicted No Effect Concentration) values:

There are no PNEC values established for the substance.

8.2 Exposure controls

Appropriate engineering controls:
Use adequate general or local exhaust ventilation to keep airborne concentrations below the permissible
exposure limits.
Personal protective equipment:
Respiratory protection Respiratory protection must be worn.
Hand protection Handle with gloves.
Eye and face protection: Wear appropriate protective eyeglasses or chemical safety goggles.
Choose body protection according to the amount and concentration of the
Skin and body protection: dangerous substance at the work place.
Protective shoe covers.
Environmental exposure controls:
Prevent further leakage or spillage if safe to do so.
Do not let product enter drains.
Discharge into the environment must be avoided.
Industrial hygiene:
Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the
end of workday.

Section 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties

Appearance:
Form powder

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 Safety Data Sheet
According to Regulation (EU) No. 1907/2006 (REACH), Annex II

Version: 2.1/EN Revision date: 21/03/2013

Product name: Terbinafine hydrochloride Printing date: 21/03/2013
Colour white
Safety data:
pH no data available.
Melting point no data available.
Boiling point no data available.
Flash point no data available.
Ignition temperature no data available.
Lower explosion limit no data available.
Upper explosion limit no data available.
Water solubility no data available.

9.2 Other information

No data available.

Section 10: Stability and reactivity

10.1 Reactivity
Stable under recommended storage and handling conditions (see section 7, handling and storage).

10.2 Chemical stability

Stable under recommended storage conditions.

10.3 Possibility of hazardous reactions

No hazardous reactions known.

10.4 Conditions to avoid

No data available.

10.5 Incompatible materials

Strong oxidizing agents.

10.6 Hazardous decomposition products

Hazardous decomposition products formed under fire conditions. - Carbon oxides, nitrogen oxides (NOx),
Hydrogen chloride gas.

Section 11: Toxicological information

11.1 Toxicokinetics, metabolism and distribution

No relevant information available.

11.2 Information on toxicological effects

Acute toxicity:
LD50 Dermal - rat - > 2.000 mg/kg

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 Safety Data Sheet
According to Regulation (EU) No. 1907/2006 (REACH), Annex II

Version: 2.1/EN Revision date: 21/03/2013

Product name: Terbinafine hydrochloride Printing date: 21/03/2013

Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and Taste):Eye:Ptosis. Behavioral:Ataxia.
Blood:Changes in spleen.
Skin corrosion/irritation:
No data available.
Serious eye damage/irritation:
No data available.
Respiratory or skin sensitization:
No data available.
Germ cell mutagenicity:
No data available.
STOT-single exposure and repeated exposure:
Inhalation - May cause respiratory irritation.
Additional information:
No data available.

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.

12.4 Mobility in soil

No data available.

12.5 Results of PBT and vPvB assessment

No data available.

12.6 Other adverse effects

Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Section 13: Disposal considerations

13.1 Waste treatment methods

Product:
Observe all federal, state, and local environmental regulations. Contact a licensed professional waste
disposal service to dispose of this material. Dissolve or mix the material with a combustible solvent and
burn in a chemical incinerator equipped with an afterburner and scrubber.

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 Safety Data Sheet
According to Regulation (EU) No. 1907/2006 (REACH), Annex II

Version: 2.1/EN Revision date: 21/03/2013

Product name: Terbinafine hydrochloride Printing date: 21/03/2013

Contaminated packaging:
Dispose of as unused product.

Section 14: Transport information

14.1 Land transport (ADR/RID/GGVSE)

This product is not regulated as a hazardous material or dangerous goods for transportation.

14.2 Sea transport (IMDG-Code/GGVSee)

This product is not regulated as a hazardous material or dangerous goods for transportation.

14.3 Air transport (ICAO-TI/IATA-DGR)

This product is not regulated as a hazardous material or dangerous goods for transportation.

14.4 Additional information

No other information available.

Section 15: Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture
This safety datasheet complies with the requirements of Regulation(EC)No.1907/2006.

15.2 Chemical Safety Assessment

No Chemical Safety Assessment has been carried out for this substance.

Section 16: Other information

16.1 Revision Information:

Date of the previous revision: Not applicable. Date of this revision: 21/03/2013.
Revision summary: The first new SDS

16.2 Abbreviations and acronyms

EU regulation (EC) No 1272/2008 on classification, labelling and packaging of chemical
CLP:
substances and mixtures.
CAS: Chemical Abstracts Service (division of the American Chemical Society).
EINECS: European Inventory of Existing Commercial Chemical Substances.
RID: European Rail Transport.
IMDG: International Maritime Code for Dangerous Goods.
IATA: International Air Transport Association.
OSHA: The United States Occupational Safety and Health Administration.
TSCA: Toxic Substances Control Act, The American chemical inventory.
DSD: Dangerous Substance Directive (67/548/EEC).

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 Safety Data Sheet
According to Regulation (EU) No. 1907/2006 (REACH), Annex II

Version: 2.1/EN Revision date: 21/03/2013

Product name: Terbinafine hydrochloride Printing date: 21/03/2013
IECSC: Inventory of existing chemical substances in China.
DSL: Domestic Substances List, The Canadian chemical inventory.
AICS: The Australian Inventory of Chemical Substances.
ECL: Existing Chemicals List, the Korean chemical inventory.
ENCS: Japanese Existing and New Chemical Substances.

16.3 Key literature references and sources for data

http://www.qilu-pharma.com

16.4 Text of H-code(s) and R-phrase(s) mentioned in Section 3

code and full text:

Aquatic
Acute aquatic toxicity.
Acute:
Aquatic
Chronic aquatic toxicity.
Chronic:
Eye Irrit : Eye irritation.
H315: Causes skin irritation.
H319: Causes serious eye irritation.
H335: May cause respiratory irritation.
H410: Very toxic to aquatic life with long lasting effects.
Skin Irrit: Skin irritation.
N: Dangerous for the environment.
Xi: Irritant.
R36/37/38: Irritating to eyes, respiratory system and skin.
Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic
R50/53:
environment.

16.5 Training advice

Provide adequate information, instruction and training for operators.

16.6 Declare to reader

The information in this Safety Data Sheet (SDS) was obtained from sources which we believe are reliable.
However, the information is provided without any warranty, express or implied, regarding its correctness.
The conditions or methods of handling, storage, use or disposal of the product are beyond our control and
may be beyond our knowledge. For this and other reasons, we do not assume responsibility and expressly
disclaim liability for loss, damage or expense arising out of or in any way connected with the handling,
storage, use or disposal of the product. This SDS was prepared and is to be used only for this product. If
the product is used as a component in another product, this SDS information may not be applicable.
According to REACH Article 31(5), the SDS shall be supplied in an official language of the Member State(s)
where the substance or mixture is placed on the market, unless the recipient Member State(s) concerned
provide otherwise. It should also be noted that this SDS is applicable to the countries with English as an
official language.

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