Promethazine hydrochloride SDS
SECTION 1: Identification of the substance/mixture and of the company/undertaking
Product identifier
- Product name： Promethazine hydrochloride
- CAS： 58-33-3
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.in
- Address：5 vasavi Layout Basaveswara Nilayam Pragathi Nagar Hyderabad, India -500090
- Telephone：+91 9550333722
SECTION 2: Hazards identification
Classification of the substance or mixture
Acute toxicity - Category 4, Oral
Skin irritation, Category 2
Skin sensitization, Category 1
Eye irritation, Category 2
Acute toxicity - Category 4, Inhalation
Specific target organ toxicity – single exposure, Category 3
Hazardous to the aquatic environment, long-term (Chronic) - Category Chronic 2
GHS label elements, including precautionary statements
-
Pictogram(s)
- Signal word Warning
H302 Harmful if swallowed
H315 Causes skin irritation
H317 May cause an allergic skin reaction
H319 Causes serious eye irritation
H332 Harmful if inhaled
H335 May cause respiratory irritation
H411 Toxic to aquatic life with long lasting effects
P264 Wash ... thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
P261 Avoid breathing dust/fume/gas/mist/vapours/spray.
P272 Contaminated work clothing should not be allowed out of the workplace.
P271 Use only outdoors or in a well-ventilated area.
P273 Avoid release to the environment.
P301+P317 IF SWALLOWED: Get medical help.
P330 Rinse mouth.
P302+P352 IF ON SKIN: Wash with plenty of water/...
P321 Specific treatment (see ... on this label).
P332+P317 If skin irritation occurs: Get medical help.
P362+P364 Take off contaminated clothing and wash it before reuse.
P333+P317 If skin irritation or rash occurs: Get medical help.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P317 Get medical help.
P319 Get medical help if you feel unwell.
P391 Collect spillage.
P403+P233 Store in a well-ventilated place. Keep container tightly closed.
P405 Store locked up.
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.
Other hazards which do not result in classification
no data available
SECTION 3: Composition/information on ingredients
Substance
- Chemical name: Promethazine hydrochloride
- Common names and synonyms: Promethazine hydrochloride
- CAS number: 58-33-3
- EC number: 200-375-2
- Concentration: 100%
SECTION 4: First aid measures
Description of necessary first-aid measures
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.
Take off contaminated clothing immediately. Wash off with soap and plenty of water. Consult a doctor.
Rinse with pure water for at least 15 minutes. Consult a doctor.
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.
Most important symptoms/effects, acute and delayed
SYMPTOMS: Symptoms of exposure to this compound include excitement, sleepiness, convulsions and rigidity. Other symptoms include leukopenia, agranulocytosis, drowsiness, confusion and stupor. Acute transitory myopia may occur. Central nervous system effects may also occur. It may cause an increase in blood pressure, mild hypotension, jaundice, extra-pyramidal reactions and photosensitivity. It may also cause dizziness, central nervous system depression, vomiting, local anesthesia, abdominal pain, diarrhea and dryness of the mouth, throat and nose. Symptoms of exposure to this type of compound include muscular weakness, tachycardia, nausea, sedation, tinnitus, lassitude, incoordination, fatigue, blurred vision, diplopia, euphoria, nervousness, insomnia, tremors, loss of appetite, epigastric distress, constipation, cough, urinary retention or frequency, dysuria, palpitation, headache, tightness of the chest, tingling, heaviness and weakness of the hands, allergic dermatitis, fever, hemolytic anemia (rare), fixed and dilated pupils, and flushing. In children, exposure can cause hallucinations, excitement, ataxia, incoordination, athetosis and convulsions. ACUTE/CHRONIC HAZARDS: When heated to decomposition this compound emits toxic fumes of hydrochloric acid, sulfur oxides and nitrogen oxides. (NTP, 1992)
Indication of immediate medical attention and special treatment needed, if necessary
Treatment of phenothiazine overdosage generally involves symptomatic and supportive care. There is no specific antidote for phenothiazine intoxication; however, anticholinergic antiparkinsonian drugs may be useful in controlling extrapyramidal reactions associated with phenothiazine overdosage. Following acute ingestion of the drugs, the stomach should be emptied by gastric lavage and consideration also should be given to repeated doses of activated charcoal. If the patient is comatose, having seizures or a dystonic reaction, or lacks the gag reflex, gastric lavage may be performed if an endotracheal tube with cuff inflated is in place to prevent aspiration of gastric contents. Gastric lavage may be useful even several hours after the drug has been ingested, since GI motility may be greatly reduced following overdosage of phenothiazines. Induction of emesis should generally not be attempted, since a phenothiazine-induced dystonic reaction of the head or neck may result in aspiration of vomitus during emesis. Administration of a saline cathartic may be beneficial in enhancing evacuation of the drug from the GI tract, especially following ingestion of extended-release preparations (eg, Spansules). Phenothiazine General Statement
SECTION 5: Firefighting measures
Suitable extinguishing media
Water spray, dry chemical, carbon dioxide or foam as appropriate for surrounding fire and materials.
Specific hazards arising from the chemical
Flash point data for this chemical are not available; however, it is probably combustible. (NTP, 1992)
Special protective actions for fire-fighters
Wear self-contained breathing apparatus for firefighting if necessary.
SECTION 6: Accidental release measures
Personal 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.
Environmental 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.
Methods and materials for containment and cleaning up
Wear approved respiratory protection, chemically compatible gloves and protective clothing. Wipe up spillage or collect spillage using a high efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately labeled container for disposal. Wash spill site.
SECTION 7: Handling and storage
Precautions 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.
Conditions for safe storage, including any incompatibilities
Promethazine hydrochloride preparations should be protected from light. Promethazine hydrochloride oral solution and tablets should be stored in tight, light-resistant containers at 15-30 and 20-25 deg C, respectively, while the rectal suppositories should be stored in well-closed containers at 2-8 deg C. Freezing of the oral solution should be avoided. Following the date of manufacture, commercially available promethazine preparations have expiration dates of 2-5 years depending on the dosage form and manufacturer.
SECTION 8: Exposure controls/personal protection
Control parameters
no data available
no data available
Appropriate engineering controls
Ensure adequate ventilation. Handle in accordance with good industrial hygiene and safety practice. Set up emergency exits and the risk-elimination area.
Individual protection measures, such as personal protective equipment (PPE)
Wear tightly fitting safety goggles with side-shields conforming to EN 166(EU) or NIOSH (US).
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.
If the exposure limits are exceeded, irritation or other symptoms are experienced, use a full-face respirator.
no data available
SECTION 9: Physical and chemical properties and safety characteristics
-
Physical state：
PHYSICAL DESCRIPTION: Odorless white to faint yellow crystalline powder. Bitter taste. A 10% solution in water has a pH of 3.5-5.0. (NTP, 1992)
-
Colour：
Crystals
-
Odour：
no data available
-
Melting point/freezing point：
-23°C(lit.)
-
Boiling point or initial boiling point and boiling range：
82°C/7mmHg(lit.)
-
Flammability：
no data available
-
Lower and upper explosion limit/flammability limit：
no data available
-
Flash point：
84°C(lit.)
-
Auto-ignition temperature：
no data available
-
Decomposition temperature：
no data available
-
pH：
no data available
-
Kinematic viscosity：
no data available
-
Solubility：
greater than or equal to 100 mg/mL at 72° F (NTP, 1992)
-
Partition coefficient n-octanol/water：
log Kow = 4.81
-
Vapour pressure：
1.03X10-5 mm Hg at 25 deg C (est)
-
Density and/or relative density：
1.131 g/cm3
-
Relative vapour density：
no data available
-
Particle characteristics：
no data available
SECTION 10: Stability and reactivity
Reactivity
Slowly oxidizes in air, acquiring a blue color. Also turns blue on exposure to moisture. Water soluble.
Chemical stability
In general, promethazine HCl exhibits increasing stability with decreasing pH. Promethazine HCl
Possibility of hazardous reactions
PROMETHAZINE HYDROCHLORIDE is sensitive to light. In aqueous solution, it is degraded by heat and light (more rapidly in air or oxygen). Incompatible with alkalis and alkaline solutions such as those of aminophylline, soluble barbiturates and phenytoin sodium. Iron(III) and copper(III) accelerate the degradation (NTP, 1992).
Conditions to avoid
no data available
Incompatible materials
Promethazine hydrochloride injection has been reported to be chemically incompatible with several drugs, especially those with an alkaline pH. However, the compatibility depends on several factors (eg, concentration of the drugs, specific diluents used, resulting pH, temperature).
Hazardous decomposition products
When heated to decomposition it emits very toxic fumes of /nitrogen oxides and sulfur oxides/.
SECTION 11: Toxicological information
Acute toxicity
- Oral: LD50 Rabbit oral 580 mg/kg
- 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
Toxicity
- Toxicity to fish: no data available
- Toxicity to daphnia and other aquatic invertebrates: no data available
- Toxicity to algae: no data available
- Toxicity to microorganisms: no data available
Persistence and degradability
no data available
Bioaccumulative potential
no data available
Mobility in soil
The distribution coefficient, Kd, was found to be from 206 to 1,575 L/kg for promethazine in 12 soils and sediments collected in Australia; organic content in soils and sediments ranged from 0.08% to 8.6%(1).
Other adverse effects
no data available
SECTION 13: Disposal considerations
Disposal methods
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.
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
UN Number
ADR/RID: UN3077 (For reference only, please check.)
IMDG: UN3077 (For reference only, please check.)
IATA: UN3077 (For reference only, please check.)
UN 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.)
Transport 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.)
Packing 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.)
Environmental hazards
ADR/RID: Yes
IMDG: Yes
IATA: Yes
Special precautions for user
no data available
Transport in bulk according to IMO instruments
no data available
SECTION 15: Regulatory information
Safety, health and environmental regulations specific for the product in question
SECTION 16: Other information
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%
References
- IPCS - The International Chemical Safety Cards (ICSC), website: http://www.ilo.org/dyn/icsc/showcard.home
- HSDB - Hazardous Substances Data Bank, website: https://toxnet.nlm.nih.gov/newtoxnet/hsdb.htm
- IARC - International Agency for Research on Cancer, website: http://www.iarc.fr/
- eChemPortal - The Global Portal to Information on Chemical Substances by OECD, website: http://www.echemportal.org/echemportal/index?pageID=0&request_locale=en
- CAMEO Chemicals, website: http://cameochemicals.noaa.gov/search/simple
- ChemIDplus, website: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
- ERG - Emergency Response Guidebook by U.S. Department of Transportation, website: http://www.phmsa.dot.gov/hazmat/library/erg
- Germany GESTIS-database on hazard substance, website: http://www.dguv.de/ifa/gestis/gestis-stoffdatenbank/index-2.jsp
- ECHA - European Chemicals Agency, website: https://echa.europa.eu/