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BRITISH PHARMACOPOEIA CHEMICAL REFERENCE SUBSTANCE
MATERIAL SAFETY DATA SHEET

The substance to which this Safety Data Sheet relates is supplied exclusively as a British Pharmacopoeia Chemical Reference Substance
(BPCRS) for chemical test and assay purposes. It is not intended to be used for any other purpose and is not for human consumption.
The BPCRS is supplied in accordance with the Terms of Trade and Supply as set out in the catalogue. The information set out in this sheet
is applicable solely to the substance when used as a BPCRS and is not intended to apply to any other use or preparation of the substance
(e.g. at different concentrations, in drug dosage form or in bulk quantities).
The information which follows has been assembled from sources considered reliable, in particular from material provided in the ordinary
way by the manufacturer or supplier. It has not been independently verified by the British Pharmacopoeia. The accuracy of the information
cannot therefore be guaranteed, nor does it constitute any expression of opinion by the British Pharmacopoeia concerning the substance.
This information is not to be regarded as a representation or statement concerning the quality or safety of the substance except that of use
as a BPCRS by professional persons having technical skill and at their own discretion and risk.
All persons using BPCRS materials must determine the risks associated with the substance depending on the actual conditions of use and
should take appropriate measures.
Information given in sections 2, 3, 4, 5, 6, 9, 10, 11, 12 and 13 relates to the bulk substance and is not necessarily relevant to the BPCRS
regarding the small quantities contained in vials. Information in sections 1, 7, 8 and 14 applies only to the BPCRS.
1. IDENTIFICATION OF THE SUBSTANCE AND OF THE COMPANY

CHLORTETRACYCLINE HYDROCHLORIDE BPCRS
This substance is a mixture of antibiotics. Information given in this MSDS refers to the main component; chlortetracycline hydrochloride.
British Pharmacopoeia Commission
Secretariat

Telephone: +44 (0)20 70840 2561 (office hours)
Emergency telephone: +44 (0)20 70840 2561 (office hours)
Reference standard for laboratory use
2. HAZARDS IDENTIFICATION
Irritating to eyes, respiratory system and skin. Possible risk of harm to the unborn child. May cause harm to breastfed babies. May cause
an allergic reaction, especially in case of pre-existing sensitivity to similar substances. May be harmful to the environment.
Symbol: Xn
R phrases: R36/37/38, R63, R64
3. COMPOSITION/INFORMATION ON INGREDIENTS

C22H24Cl2N2O8
4. FIRST AID MEASURES

Inhalation: Remove to fresh air. If breathing becomes difficult, call a physician.
Skin contact: Flush with copious amounts of water and soap for at least 15 minutes. Remove contaminated clothing and shoes.
Eye contact: Assure adequate flushing by separating the eyelids with fingers. Flush with copious amounts of water for at least 15 minutes.
Ingestion: Wash out mouth with water and administer fresh water provided that the person is conscious.
In any case seek medical advice and call the nearest poison centre. Show the label and this safety data sheet.

5. FIRE FIGHTING MEASURES

Extinguishing media: Water spray. Carbon dioxide, dry chemical powder or appropriate foam. Avoid overspills into drains, surface and
groundwater and soil.
Dust may form explosive mixture in air. Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and
eyes. Emits toxic fumes under fire conditions.
Dangerous combustion products: COx, NOx, HCl and other noxious gases or vapours in case of incomplete combustion.

6. ACCIDENTAL RELEASE MEASURES

Wear self-contained breathing apparatus, rubber boots and heavy rubber gloves. Switch off sources of ignition and intense heat. Collect
residues manually, wipe with sodium hypochlorite solution until residues have been removed, place in a bag and hold for waste disposal.
Avoid raising dust or mist. Ventilate area and wash spill site with sodium hypochlorite after material pick up is complete. Keep away from
drains, surface and groundwater and soil.
7. HANDLING AND STORAGE

Handling: Handle small quantities in fume hood. Avoid inhalation. Avoid contact with eyes, skin and clothing. Avoid prolonged or repeated
exposure.
Storage: Keep unopened in the original container at about 2-8 °C. Protect from heat, direct sunlight and moisture.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Respiratory protection: Protecting mask (filter P1).
Hand protection: Compatible chemical-resistant gloves.
Eye protection: Wear protective chemical safety goggles.
9. PHYSICAL AND CHEMICAL PROPERTIES

Appearance: Yellow powder.
Solubility: Slightly soluble in water and in alcohol. It dissolves in solutions of alkali hydroxides and carbonates.
10. STABILITY AND REACTIVITY
Materials to avoid: Strong oxidizing agents.
Dangerous decomposition products: COx, NOx, HCl and other substances in case of incomplete decomposition.

11. TOXICOLOGICAL INFORMATION

RTECS No: QI7800000 (chlortetracycline hydrochloride) and Q1910000 (tetracycline hydrochloride)
LD50 (oral-mouse): 2314 mg/kg
Reproductive toxicity (development of foetus) has been reported in humans with tetracycline hydrochloride. Toxicity to fertility and
reproduction has been reported in animal studies.
See actual entry in RTECS for complete information.
CMR Classification: Repr. Cat. 3
12. ECOLOGICAL INFORMATION
PBT index (Janus) 5 (tetracycline hydrochloride). Biodegradation is uncertain, may bioaccumulate or have direct ecotoxic effects. The
substance may have inhibitory effects on the activity of micro-organisms and an impact on sewage treatment plants and environment,
including risk of introducing antimicrobial resistance. Information on the mobility, biodegradability and persistence in nature is not available.
13. DISPOSAL CONSIDERATIONS

Incinerate in an approved facility.
Observe all federal state and local environmental regulations.

14. TRANSPORT INFORMATION

Not classified.
15. REGULATORY INFORMATION

Symbol: Xn
Risk phrases: R36/37/38, R63, R64
Safety phrases: S36/S37
CMR Classification: Repr. Cat. 3
16. OTHER INFORMATION

R36/37/38: Irritating to eyes, respiratory system and skin.
R63: Possible risk of harm to the unborn child.
R64: May cause harm to breastfed babies.
S36/37: Wear suitable protective clothing and gloves.

Source: https://www.pharmacopoeia.gov.uk/custom/files/MSDS/MSDS_Chlortetracycline%20hydrochloride_Cat783.pdf