SAFETY DATA SHEETS

According to the UN GHS revision 10

Version: 1.0

Creation Date: July 15, 2019

Revision Date: July 15, 2019

SECTION 1: Identification

1.1GHS Product identifier

Product name	Niclosamide

1.2Other means of identification

Product number	-
Other names	2',5-Dichloro-4'-nitrosalicylanilide; 5-chloro-N-(2-chloro-4-nitrophenyl)-2-hydroxybenzamide; 2’,5-dichloro-4’-nitrosalicylanilide

1.3Recommended use of the chemical and restrictions on use

Identified uses	Industrial and scientific research use.
Uses advised against	no data available

SECTION 2: Hazard identification

2.1Classification of the substance or mixture

Hazardous to the aquatic environment, short-term (Acute) - Category Acute 1

2.2GHS label elements, including precautionary statements

Pictogram(s)
Signal word	Warning
Hazard statement(s)	H400 Very toxic to aquatic life
Precautionary statement(s)
Prevention	P273 Avoid release to the environment.
Response	P391 Collect spillage.
Storage	none
Disposal	P501 Dispose of contents/container to an appropriate treatment and disposal facility in accordance with applicable laws and regulations, and product characteristics at time of disposal.

2.3Other hazards which do not result in classification

no data available

SECTION 3: Composition/information on ingredients

3.1Substances

Chemical name	Common names and synonyms	CAS number	EC number	Concentration
Niclosamide	Niclosamide	50-65-7	200-056-8	100%

SECTION 4: First-aid measures

4.1Description of necessary first-aid measures

If inhaled

Move the victim into fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration and consult a doctor immediately. Do not use mouth to mouth resuscitation if the victim ingested or inhaled the chemical.

Following skin contact

Take off contaminated clothing immediately. Wash off with soap and plenty of water. Consult a doctor.

Following eye contact

Rinse with pure water for at least 15 minutes. Consult a doctor.

Following ingestion

Rinse mouth with water. Do not induce vomiting. Never give anything by mouth to an unconscious person. Call a doctor or Poison Control Center immediately.

4.2Most important symptoms/effects, acute and delayed

no data available

4.3Indication of immediate medical attention and special treatment needed, if necessary

Absorption, Distribution and Excretion

Niclosamide appears to be minimally absorbed from the gastrointestinal tract--neither the drug nor its metabolites have been recovered from the blood or urine.

SECTION 5: Fire-fighting measures

5.1Suitable extinguishing media

Use dry chemical, carbon dioxide or alcohol-resistant foam.

5.2Specific hazards arising from the chemical

no data available

5.3Special protective actions for fire-fighters

Wear self-contained breathing apparatus for firefighting if necessary.

SECTION 6: Accidental release measures

6.1Personal precautions, protective equipment and emergency procedures

Avoid dust formation. Avoid breathing mist, gas or vapours.Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable gloves. Ensure adequate ventilation.Remove all sources of ignition. Evacuate personnel to safe areas.Keep people away from and upwind of spill/leak.

6.2Environmental precautions

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

6.3Methods and materials for containment and cleaning up

Collect and arrange disposal. Keep the chemical in suitable and closed containers for disposal. Remove all sources of ignition. Use spark-proof tools and explosion-proof equipment. Adhered or collected material should be promptly disposed of, in accordance with appropriate laws and regulations.

SECTION 7: Handling and storage

7.1Precautions for safe handling

Handling in a well ventilated place. Wear suitable protective clothing. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Use non-sparking tools. Prevent fire caused by electrostatic discharge steam.

7.2Conditions for safe storage, including any incompatibilities

stored at a temp less than 30 deg C; freezing of the tablets should be avoided.

SECTION 8: Exposure controls/personal protection

8.1Control parameters

Occupational Exposure limit values

no data available

Biological limit values

no data available

8.2Appropriate engineering controls

Ensure adequate ventilation. Handle in accordance with good industrial hygiene and safety practice. Set up emergency exits and the risk-elimination area.

8.3Individual protection measures, such as personal protective equipment (PPE)

Eye/face protection

Wear tightly fitting safety goggles with side-shields conforming to EN 166(EU) or NIOSH (US).

Skin protection

Wear fire/flame resistant and impervious clothing. Handle with gloves. Gloves must be inspected prior to use. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.

Respiratory protection

If the exposure limits are exceeded, irritation or other symptoms are experienced, use a full-face respirator.

Thermal hazards

no data available

SECTION 9: Physical and chemical properties and safety characteristics

Physical state	Solid
Colour	PALE, YELLOW CRYSTALS
Odour	no data available
Melting point/freezing point	225-230°C
Boiling point or initial boiling point and boiling range	424.5°C at 760 mmHg
Flammability	no data available
Lower and upper explosion limit/flammability limit	no data available
Flash point	210.5°C
Auto-ignition temperature	no data available
Decomposition temperature	no data available
pH	no data available
Kinematic viscosity	no data available
Solubility	no data available
Partition coefficient n-octanol/water	log Kow = 10 @ pH 9.6
Vapour pressure	<9.87X10-9 mm Hg at 20 deg C
Density and/or relative density	1.616g/cm3
Relative vapour density	no data available
Particle characteristics	no data available

SECTION 10: Stability and reactivity

10.1Reactivity

no data available

10.2Chemical stability

Tablets are sensitive to moisture.

10.3Possibility of hazardous reactions

no data available

10.4Conditions to avoid

no data available

10.5Incompatible materials

no data available

10.6Hazardous decomposition products

no data available

SECTION 11: Toxicological information

Acute toxicity

• Oral: no data available
• Inhalation: no data available
• Dermal: no data available

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

Carcinogenicity

no data available

Reproductive toxicity

no data available

STOT-single exposure

no data available

STOT-repeated exposure

no data available

Aspiration hazard

no data available

SECTION 12: Ecological information

12.1Toxicity

• Toxicity to fish: LC50 Rainbow trout, wt 1.4 g, 340 ug/l/96 hr at 13 deg C (95% confidence limit 289-399 ug/l) /wettable powder, 70%
• Toxicity to daphnia and other aquatic invertebrates: no data available
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

12.2Persistence and degradability

A second order microbial transformation rate constant of 2.0X10-14 L/organism-hr was determined for niclosamide in natural pond water; degradation was via microbially mediated hydrolysis of the amide(1). The biodegradability of niclosamide in soil was reported as extremely low(2). Niclosamide degraded rapidly in both pond and river sediments incubated under static conditions with half-lives of 1.1 and 3.9 days, respectively(3). Rapid disappearance of niclosamide from water above the sediment was also observed with half-lives of 3.1 and 0.83 days in water above pond and river sediment, respectively(3); degradation in autoclaved samples occurred at a very slow rate indicating a dependence on microbial activity. Aminoniclosamide is the major degradation product for this reaction, representing more than 50% of the extractable radioactivity(3). 11.3, 7.2, 3.5, and 6.2% of the added 14C-niclosamide was present as CO2 after 32 days for cultures incubated under river sediment/aerobic, river sediment/anaerobic, pond sediment/aerobic, and pond sediment/anaerobic conditions, respectively; by 93 days, 37.7, 9.0, 6.8, and 8.7% of the total radioactivity for the same cultures was present as CO2(3). Aminoniclosamide was again the major degradation product detected in water and sediment extracts from this experiment; more aminoniclosamide was formed under anaerobic than aerobic conditions, especially during the first 64 days of incubation(3).

12.3Bioaccumulative potential

An estimated BCF value of 215 was calculated for niclosamide(SRC), using a water solubility of 6.5 mg/l(1) and a recommended regression-derived equation(2). According to a classification scheme(3), this BCF value suggests that bioconcentration in aquatic organisms may be low(SRC). Depuration occurred within 72 hours for rainbow trout exposed to 14C-labeled niclosamide. Biliary concentration was high, reaching a 10,000:1 bile to water ratio in 24 hours. The metabolite formed was the glucuronide(4,5).

12.4Mobility in soil

The Koc of niclosamide is estimated as approximately 1600(SRC), using a measured water solubility of 6.5 mg/L(1) and a regression-derived equation(2,SRC). According to a recommended classification scheme(3), this estimated Koc value suggests that niclosamide has low mobility in soil(SRC). Adsorption of niclosamide by sediment reached equilibrium after 4-7.5 hours of shaking; an average Koc value of 3111 +/- 1552 was measured using five different sediments (pH range = 6.8-7.8; organic carbon = 1.9-9.2%)(4). Bottom sediment samples from 3 rivers in the Upper Peninsula of Michigan gave Koc values at 20 deg C of 3510, 946, 766, and 77.9 at pH 6.5, 7, 8, and 9 for the Cedar River, 1210, 1570, 828, and 234 at the same pH values for the Ford River, and 1920, 1580, 532, and 131 at the same pH values for the Tahquamenon River(5).

12.5Other adverse effects

no data available

SECTION 13: Disposal considerations

13.1Disposal methods

Product

The material can be disposed of by removal to a licensed chemical destruction plant or by controlled incineration with flue gas scrubbing. Do not contaminate water, foodstuffs, feed or seed by storage or disposal. Do not discharge to sewer systems.

Contaminated packaging

Containers can be triply rinsed (or equivalent) and offered for recycling or reconditioning. Alternatively, the packaging can be punctured to make it unusable for other purposes and then be disposed of in a sanitary landfill. Controlled incineration with flue gas scrubbing is possible for combustible packaging materials.

SECTION 14: Transport information

14.1UN Number

ADR/RID: UN3077 (For reference only, please check.)

IMDG: UN3077 (For reference only, please check.)

IATA: UN3077 (For reference only, please check.)

14.2UN Proper Shipping Name

ADR/RID: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (For reference only, please check.)

IMDG: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (For reference only, please check.)

IATA: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (For reference only, please check.)

14.3Transport hazard class(es)

ADR/RID: 9 (For reference only, please check.)

IMDG: 9 (For reference only, please check.)

IATA: 9 (For reference only, please check.)

14.4Packing group, if applicable

ADR/RID: III (For reference only, please check.)

IMDG: III (For reference only, please check.)

IATA: III (For reference only, please check.)

14.5Environmental hazards

ADR/RID: Yes

IMDG: Yes

IATA: Yes

14.6Special precautions for user

no data available

14.7Transport in bulk according to IMO instruments

no data available

SECTION 15: Regulatory information

15.1Safety, health and environmental regulations specific for the product in question

Chemical name	Common names and synonyms	CAS number	EC number
Niclosamide	Niclosamide	50-65-7	200-056-8
European Inventory of Existing Commercial Chemical Substances (EINECS)			Listed.
EC Inventory			Listed.
United States Toxic Substances Control Act (TSCA) Inventory			Not Listed.
China Catalog of Hazardous chemicals 2015			Not Listed.
New Zealand Inventory of Chemicals (NZIoC)			Listed.
Philippines Inventory of Chemicals and Chemical Substances (PICCS)			Listed.
Vietnam National Chemical Inventory			Listed.
Chinese Chemical Inventory of Existing Chemical Substances (China IECSC)			Not Listed.
Korea Existing Chemicals List (KECL)			Not Listed.

SECTION 16: Other information

Information on revision

Creation Date	July 15, 2019
Revision Date	July 15, 2019

Abbreviations and acronyms

• CAS: Chemical Abstracts Service
• ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
• RID: Regulation concerning the International Carriage of Dangerous Goods by Rail
• IMDG: International Maritime Dangerous Goods
• IATA: International Air Transportation Association
• TWA: Time Weighted Average
• STEL: Short term exposure limit
• LC50: Lethal Concentration 50%
• LD50: Lethal Dose 50%
• EC50: Effective Concentration 50%

 

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