Chemical Safety Data Sheet MSDS / SDS

Clarithromycin

Revision Date:2026-03-21Revision Number:1

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

Product identifier

Product name: Clarithromycin
CBnumber: CB2225614
CAS: 81103-11-9
EINECS Number: 1806241-263-5
Synonyms: Clarythromycin

Relevant identified uses of the substance or mixture and uses advised against

Relevant identified uses: For R&D use only. Not for medicinal, household or other use.
Uses advised against: none

Company Identification

Company: Chemicalbook
Address: Building 1, Huihuang International, Shangdi 10th Street, Haidian District, Beijing
Telephone: 010-86108875

SECTION 2: Hazards identification

GHS Label elements, including precautionary statements

Symbol(GHS)

Signal wordWarning

Precautionary statements

P501 Dispose of contents/container to..…

P301+P312 IF SWALLOWED: call a POISON CENTER or doctor/physician IF you feel unwell.

P270 Do not eat, drink or smoke when using this product.

P264 Wash skin thouroughly after handling.

Hazard statements

H302 Harmful if swallowed

SECTION 3: Composition/information on ingredients

Substance

Product name: Clarithromycin
Synonyms: Clarythromycin
CAS: 81103-11-9
EC number: 1806241-263-5
MF: C38H69NO13
MW: 747.95

SECTION 4: First aid measures

Most important symptoms and effects, both acute and delayed

The most important known symptoms and effects are described in the labelling (see section 2) and/or in section 11

Protection of first-aiders

For personal protection see section 8.

Notes to physician

No data available

SECTION 5: Firefighting measures

Specific hazards during fire fighting

Combustible.

Hazardous combustion products

Carbon oxides Nitrogen oxides (NOx) Sulphur oxides

Specific extinguishing methods

No data available

Special protective equipment for fire-fighters

No data available

NFPA 704

HEALTH	2	Intense or continued but not chronic exposure could cause temporary incapacitation or possible residual injury (e.g. diethyl ether, ammonium phosphate, iodine)
FIRE	0	Materials that will not burn under typical fire conditions, including intrinsically noncombustible materials such as concrete, stone, and sand. Materials that will not burn in air when exposed to a temperature of 820 °C (1,500 °F) for a period of 5 minutes.(e.g. Carbon tetrachloride)
REACT	0	Normally stable, even under fire exposure conditions, and is not reactive with water (e.g. helium,N2)
SPEC. HAZ.

SECTION 6: Accidental release measures

SECTION 7: Handling and storage

Handling

Avoidance of contact

Acid chlorides Strong acids Strong oxidizing agents Strong reducing agents

Storage

Storage class

10, Combustible liquids

Recommended storage temperature

-20 °C

SECTION 8: Exposure controls/personal protection

control parameter

Hazard composition and occupational exposure limits

Does not contain substances with occupational exposure limits.

Engineering measures

No data available

SECTION 9: Physical and chemical properties

Information on basic physicochemical properties

SolubilitySoluble in DMSO
Physical statepowder
Flash point87 °C
Boiling point/boiling range86℃
Melting point/ rangeNo data available
pHNo data available
Odor ThresholdNo data available
OdorNo data available
Colorcolorless to faint yellow
Appearanceliquid
Particle characteristics Particle sizeNo data available
Oxidizing propertiesNo data available
Explosive propertiesNo data available
Flow timeNo data available
Viscosity, kinematicNo data available
Viscosity, dynamicNo data available
Decomposition temperatureNo data available
Autoignition temperatureNo data available
Partition coefficient: n-octanol/waterNo data available
Water solubility99.48mg/L(20 ºC)
Density1.1334 (rough estimate)
Relative density1.1334 (rough estimate)
Relative vapor densityNo data available
Vapor pressureNo data available
Lower explosion limit / Lower flammability limitNo data available
Upper explosion limit / Upper flammability limitNo data available
Burning rateNo data available
Flammability (liquids)No data available
Flammability (solid, gas)No data available
Evaporation rateNo data available

SECTION 10: Stability and reactivity

Reactivity

No data available

Chemical stability

No data available

Possibility of hazardous reactions

No data available

Conditions to avoid

No data available

Incompatible materials

Acid chlorides Strong acids Strong oxidizing agents Strong reducing agents

Hazardous decomposition products

In the event of fire: see section 5

SECTION 11: Toxicological information

11.1 Information on toxicological effects

Mixture Acute toxicity

Acute toxicity estimate Oral - > 5,000 mg/kg (Calculation method)
Inhalation: No data available
Dermal: No data available

Skin corrosion/irritation

Classified based on available data. For more details, see section 2

Serious eye damage/eye irritation

Classified based on available data. For more details, see section 2

Respiratory or skin sensitization

Classified based on available data. For more details, see section 2

Germ cell mutagenicity

Classified based on available data. For more details, see section 2

Carcinogenicity

Classified based on available data. For more details, see section 2

Reproductive toxicity

Classified based on available data. For more details, see section 2

Specific target organ toxicity - single exposure

Classified based on available data. For more details, see section 2

Specific target organ toxicity - repeated exposure

Classified based on available data. For more details, see section 2

Aspiration hazard

Classified based on available data. For more details, see section 2

11.2 Additional Information

Nausea, Fatigue, Headache, To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.
Hazardous properties cannot be excluded but are unlikely when the product is handled appropriately.

Components dimethyl sulphoxide

Acute toxicity

LD50 Oral - Rat - male and female - 28,300 mg/kg (OECD Test Guideline 401)
LC0 Inhalation - Rat - male and female - 4 h - > 5.33 mg/l - dust/mist (OECD Test Guideline 403)
LD50 Dermal - Rat - male and female - 40,000 mg/kg
Remarks: (ECHA)

Skin corrosion/irritation

Skin - Rabbit
Result: slight irritation - 4 h (OECD Test Guideline 404)

Serious eye damage/eye irritation

Eyes - Rabbit
Result: slight irritation - 24 h (OECD Test Guideline 405)

Respiratory or skin sensitization

Maximisation Test - Guinea pig
Result: negative (OECD Test Guideline 406)
Local lymph node assay (LLNA) - Mouse
Result: negative (OECD Test Guideline 429)

Germ cell mutagenicity

Test Type: Ames test
Test system: Salmonella typhimurium
Result: negative
Test Type: sister chromatid exchange assay
Test system: Chinese hamster ovary cells
Result: negative
Test Type: Mutagenicity (mammal cell test): chromosome aberration.
Test system: Chinese hamster ovary cells
Result: negative
Method: OECD Test Guideline 474
Species: Rat - male and female
Result: negative

Carcinogenicity

Classified based on available data. For more details, see section 2

Reproductive toxicity

Classified based on available data. For more details, see section 2

Specific target organ toxicity - single exposure

Classified based on available data. For more details, see section 2

Specific target organ toxicity - repeated exposure Aspiration hazard

Classified based on available data. For more details, see section 2

Clarithromycin Acute toxicity

LD50 Oral - Rat - 1,270 mg/kg
Remarks: Behavioral:Change in motor activity (specific assay).
Inhalation: No data available
Dermal: No data available

Skin corrosion/irritation

Remarks: No data available

Serious eye damage/eye irritation

Remarks: No data available

Respiratory or skin sensitization

Classified based on available data. For more details, see section 2

Germ cell mutagenicity

Classified based on available data. For more details, see section 2

Carcinogenicity

Classified based on available data. For more details, see section 2

Reproductive toxicity

Classified based on available data. For more details, see section 2

Specific target organ toxicity - single exposure

Classified based on available data. For more details, see section 2

Specific target organ toxicity - repeated exposure

Classified based on available data. For more details, see section 2

Aspiration hazard

Classified based on available data. For more details, see section 2

SECTION 12: Ecological information

Ecotoxicity

Components:

dimethyl sulphoxide:

Toxicity to fish

LC50 (Danio rerio (zebra fish)): > 25,000 mg/l End point: mortality Exposure time: 96 h Test Type: static test Analytical monitoring: yes Method: OECD Test Guideline 203 GLP: yes

Toxicity to daphnia and other aquatic invertebrates

EC50 (Daphnia magna (Water flea)): 24,600 mg/l Exposure time: 48 h Test Type: static test Analytical monitoring: yes Method: OECD Test Guideline 202

Toxicity to algae/aquatic plants

ErC50 (Pseudokirchneriella subcapitata (green algae)): 17,000 mg/l Exposure time: 72 h Test Type: static test Analytical monitoring: yes Method: OECD Test Guideline 201 GLP: yes

Toxicity to microorganisms

EC50 (activated sludge): 10 - 100 mg/l Exposure time: 30 min Method: ISO 8192

Clarithromycin:

Toxicity to fish

LC50 (Oryzias latipes): > 100 mg/l Exposure time: 96 hrs Remarks: No data available

Toxicity to algae/aquatic plants

ErC50 (Pseudokirchneriella subcapitata (algae)): 0.0069 mg/l Exposure time: 72 hrs

M-Factor (Acute aquatic toxicity)

100

M-Factor (Chronic aquatic toxicity)

100

Persistence and degradability

Components:

dimethyl sulphoxide:

Biodegradability

aerobic Concentration: 2 mg/l Result: Not readily biodegradable. Biodegradation: 31 % Exposure time: 28 d Method: OECD Test Guideline 301D GLP: yes

Stability in water

Degradation half life: 0.12 - 1.2 h (30 °C) pH: 7 Remarks: Hydrolyses readily.

Clarithromycin:

Biodegradability

Remarks: No data available

Bioaccumulative potential

Components:

dimethyl sulphoxide:

Partition coefficient: noctanol/water

log Pow: -1.35 (20 °C) Remarks: Bioaccumulation is not expected.

Clarithromycin:

Bioaccumulation

Remarks: No data available

Mobility in soil

Components:

Clarithromycin:

Stability in soil

Remarks: No data available

Other adverse effects

Components:

Clarithromycin:

Additional ecological information

No data available

SECTION 13: Disposal considerations

Disposal methods

SECTION 14: Transport information

International Regulations

IATA-DGR

Not regulated as a dangerous good
UN/ID No. : Not applicable
Proper shipping name : Not applicable
Class : Not applicable
Subsidiary risk : Not applicable
Packing group : Not applicable
Labels : Not applicable
Packing instruction (cargo aircraft) : Not applicable
Packing instruction (passenger aircraft) : Not applicable

IMDG-Code

Not regulated as a dangerous good
UN number : Not applicable
Proper shipping name : Not applicable
Class : Not applicable
Subsidiary risk : Not applicable
Packing group : Not applicable
Labels : Not applicable
EmS Code : Not applicable
Marine pollutant : no

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code

Not applicable for product as supplied.

National Regulations

JT/T 617

UN number : Not applicable
Proper shipping name : Not applicable
Class : Not applicable
Subsidiary risk : Not applicable
Packing group : Not applicable
Labels : Not applicable
Environmentally hazardous : no

Special precautions for user

Not applicable

SECTION 15: Regulatory information

Catalogue of Hazardous Chemicals : This product is not listed in the catalogue of hazardous chemicals, but it meets the definition of hazardous chemicals and its principles of determination.
Downstream users need to comply with the conditions of safe use of the chemical, understand the environmental and health hazard and risk management measures identified on the SDS as well as the local/national regulations concerning the chemical.

National regulatory information

Law on the Prevention and Control of Occupational Diseases

Regulations on Safety Management of Hazardous Chemicals

Identification of Major Hazard Installations for Hazardous Chemicals (GB 18218)

Not listed

Hazardous Chemicals for Priority Management

Not listed under SAWS

Catalogue of Specially Controlled Hazardous

Not listed Chemicals

List of Explosive Precursors

Not listed

Regulations on Labour Protection in Workplaces where Toxic Substances are Used

Catalogue of Highly Toxic Chemicals

Not listed

Regulation of Environmental Management on the First Import of Chemicals and the Import and Export of Toxic Chemicals

China Severely Restricted Toxic Chemicals for Import and Export

Not listed

Measures on the Environmental Administration of New Chemical Substances Registration

Registration/Notification number

B1A222224933

Regulation on the Administration of Precursor Chemicals

Catalogue and Classification of Precursor Chemicals

Not listed

Regulations on the Administration of Controlled Chemicals

List of Controlled Chemicals

Not listed

Regulations of Ozone Depleting Substances Management

List of Controlled Ozone Depleting Substances

Not listed

List of Controlled Ozone Depleting Substances Import and Export

Not listed

Environmental Protection Law

List of Priority Controlled Chemicals

Not listed

List of Key Controlled New Pollutants

Not listed

SECTION 16: Other information

Full text of other abbreviations

GBZ 2.1-2007

Occupational exposure limits for hazardous agents in the workplace - Chemical hazardous agents.

GBZ 2.1-2007 / PC-TWA AIIC - Australian Invent Transport by Land of Bra bw - Body weight; CMR Standard of the German List (Canada); ECx - Conc associated with x% respo Chemical Substances (Jap response; ERG - Emerge GLP - Good Laboratory P cer; IATA - International Construction and Equipm Half maximal inhibitory c tion; IECSC - Inventory o tional Maritime Dangerou Industrial Safety and H Standardisation; KECI - K tration to 50 % of a test (Median Lethal Dose); MA lution from Ships; MERC of Dangerous Goods; n.o. - No Observed (Adverse) fect Level; NOELR - No Norm; NTP - National Toxi icals; OECD - Organisatio fice of Chemical Safety a and Toxic substance; PIC stances; (Q)SAR - (Quant (EC) No 1907/2006 of th Registration, Evaluation, Accelerating Decompositi Chemical Substance Inve Thailand Existing Chemica States); UN - United Nat Transport of Dangerous WHMIS - Workplace Hazar

Permissible concentration - time weighted average ry of Industrial Chemicals
ANTT - National Agency for il
ASTM - American Society for the Testing of Materials
- Carcinogen, Mutagen or Reproductive Toxicant
DIN nstitute for Standardisation
DSL - Domestic Substances ntration associated with x% response
ELx - Loading rate se
EmS - Emergency Schedule
ENCS - Existing and New n)
ErCx - Concentration associated with x% growth rate cy Response Guide
GHS - Globally Harmonised System
actice
IARC - International Agency for Research on Canir Transport Association
IBC - International Code for the nt of Ships carrying Dangerous Chemicals in Bulk
IC50 ncentration
ICAO - International Civil Aviation Organiza- Existing Chemical Substances in China
IMDG - Interna- Goods
IMO - International Maritime Organisation
ISHL alth Law (Japan)
ISO - International Organisation for rea Existing Chemicals Inventory
LC50 - Lethal Concenopulation
LD50 - Lethal Dose to 50% of a test population POL - International Convention for the Prevention of Pol- SUR - The Agreement for the Facilitation of the Transport . - Not Otherwise Specified
Nch - Chilean Norm
NO(A)EC ffect Concentration
NO(A)EL - No Observed (Adverse) Efbservable Effect Loading Rate
NOM - Official Mexican ology Program
NZIoC - New Zealand Inventory of Chemfor Economic Co-operation and Development
OPPTS - Ofd Pollution Prevention
PBT - Persistent, Bioaccumulative S - Philippines Inventory of Chemicals and Chemical Subtative) Structure Activity Relationship
REACH - Regulation European Parliament and of the Council concerning the uthorisation and Restriction of Chemicals
SADT - Selfn Temperature
SDS - Safety Data Sheet
TCSI - Taiwan tory
TDG - Transportation of Dangerous Goods
TECI s Inventory
TSCA - Toxic Substances Control Act (United ons
UNRTDG - United Nations Recommendations on the oods
vPvB - Very Persistent and Very Bioaccumulative
ous Materials Information System

Disclaimer:

The information in this MSDS is only applicable to the specified product, unless otherwise specified, it is not applicable to the mixture of this product and other substances. This MSDS only provides information on the safety of the product for those who have received the appropriate professional training for the user of the product. Users of this MSDS must make independent judgments on the applicability of this SDS. The authors of this MSDS will not be held responsible for any harm caused by the use of this MSDS.