Isotretinoin Safety Data Sheets
SAFETY DATA SHEETS
According to the UN GHS revision 8
SECTION 1: Identification
1.1 GHS Product identifier
| Product name | Isotretinoin |
|---|
1.2 Other means of identification
| Product number | - |
|---|---|
| Other names | cis-retinoic acid; 13-cis-ra; 13-cis-Retinoic acid |
1.3 Recommended use of the chemical and restrictions on use
| Identified uses | Industrial and scientific research uses. |
|---|---|
| Uses advised against | no data available |
1.4 Supplier's details
| Company | Echemi.com |
|---|---|
| Address | Echemi.com |
| Telephone | Echemi.com |
1.5 Emergency phone number
| Emergency phone number | Echemi.com |
|---|---|
| Service hours | Monday to Friday, 9am-5pm (Standard time zone: UTC/GMT +8 hours). |
SECTION 2: Hazard identification
2.1 Classification of the substance or mixture
Reproductive toxicity, Category 1B
Hazardous to the aquatic environment, short-term (Acute) - Category Acute 1
Hazardous to the aquatic environment, long-term (Chronic) - Category Chronic 1
2.2 GHS label elements, including precautionary statements
| Pictogram(s) |   |
|---|---|
| Signal word | Danger |
| Hazard statement(s) | H360 May damage fertility or the unborn child H400 Very toxic to aquatic life H410 Very toxic to aquatic life with long lasting effects |
| Precautionary statement(s) | |
| Prevention | P203 Obtain, read and follow all safety instructions before use. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/... P273 Avoid release to the environment. |
| Response | P318 IF exposed or concerned, get medical advice. P391 Collect spillage. |
| Storage | P405 Store locked up. |
| 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. |
2.3 Other hazards which do not result in classification
no data available
SECTION 3: Composition/information on ingredients
3.1 Substances
| Chemical name | Common names and synonyms | CAS number | EC number | Concentration |
|---|---|---|---|---|
| Isotretinoin | Isotretinoin | 4759-48-2 | 225-296-0 | 100% |
SECTION 4: First-aid measures
4.1 Description 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.
4.2 Most important symptoms/effects, acute and delayed
SYMPTOMS: Symptoms of exposure to this compound may include dryness and itching of the skin and conjunctivitis. It can also cause pruritus, epistaxis, dry nose and mouth, rash, temporary thinning of the hair, cheilitis, fatigue, skin fragility, skeletal hyperstosis, musculoskeletal symptoms and chest pain. Other symptoms, rarely seen, include peeling of the palms and soles, skin infections, nonspecific urogenital findings, nonspecific gastrointestinal symptoms and increased susceptibility to sunburn. This compound has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension) characterized by the following symptoms: headache, papilledema, nausea, vomiting and visual disturbances. It can also cause fetal abnormalities if ingested while pregnant. Other symptoms include ocular irritation, blurred vision, arthralgias, facial dermatitis, xerosis, minor nosebleed inflamed urethral meatus and urethritis. ACUTE/CHRONIC HAZARDS: This compound may cause eye irritation. (NTP, 1992)
4.3 Indication of immediate medical attention and special treatment needed, if necessary
Emergency and supportive measures; Maintain an open airway and assist ventilation if necessary. Treat coma, seizures, hypotension, and arrhythmias if they occur. Treat nausea and vomiting with metoclopramide and fluid loss caused by gastroenteritis with intravenous crystalloid fluids. Bone marrow depression should be treated with the assistance of an experienced hematologist or oncologist. 5. Extravasation. Immediately stop the infusion and withdraw as much fluid as possible by negative pressure on the syringe. Then give the following specific treatment. Dactinomycin, daunorubicin, doxorubicin, idarubicin, mitomycin-C, mitoxantrone, and plicamycin. Apply ice compresses to the extravasation site for 15 minutes 4 times daily for 4 days. Topical application of dimethyl sulfoxide (DMSO) may be beneficial. Mechlorethamine (and concentrated dacarbazine and cisplatin); apply ice compresses for 6-12 hours. Etoposide, paclitaxel, vincristine, or vinblastine. Place a heating pad over the area and apply heat intermittently for 24 hours; elevate the limb. /Antineoplastic Agents, Retnoic acid/.
SECTION 5: Fire-fighting measures
5.1 Suitable extinguishing media
Fires involving this material can be controlled with a carbon dioxide, dry chemical or Halon extinguisher. (NTP, 1992)
5.2 Specific hazards arising from the chemical
Flash point data for this material are not available; however, it is probably combustible. (NTP, 1992)
5.3 Special protective actions for fire-fighters
Wear self-contained breathing apparatus for firefighting if necessary.
SECTION 6: Accidental release measures
6.1 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.
6.2 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.
6.3 Methods and materials for containment and cleaning up
PRECAUTIONS FOR CYTOTOXIC AND HAZARDOUS DRUGS:/ Spills. Emergency procedures to cover spills or inadvertent release of hazardous drugs should be included in the facility's overall heath and safety program. Incidental spills and breakages should be cleaned up immediately by a properly protected person trained in the appropriate procedures.
SECTION 7: Handling and storage
7.1 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.
7.2 Conditions for safe storage, including any incompatibilities
PRECAUTIONS FOR CYTOTOXIC AND HAZARDOUS DRUGS:/ Facilities (eg, shelves, carts, counters, and trays) for storing hazardous drugs are designed to prevent breakage and to limit contamination in the event of leakage. Bins, shelves with barriers at the front, or other design features that reduce the chance of drug containers falling to the floor should be used. Hazardous drugs requiring refrigeration should be stored separately from nonhazardous drugs in individual bins designed to prevent breakage and to contain leakage.
SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure limit values
no data available
Biological limit values
no data available
8.2 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.
8.3 Individual 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 | PHYSICAL DESCRIPTION: Yellow-orange to orange crystalline powder; orange-brown chunky solid. (NTP, 1992) |
|---|---|
| Colour | Reddish-orange plates from isopropyl alcohol |
| Odour | no data available |
| Melting point/freezing point | 175°C(lit.) |
| Boiling point or initial boiling point and boiling range | 106°C/3.5mmHg(lit.) |
| Flammability | no data available |
| Lower and upper explosion limit/flammability limit | no data available |
| Flash point | 117°C(lit.) |
| Auto-ignition temperature | no data available |
| Decomposition temperature | no data available |
| pH | no data available |
| Kinematic viscosity | no data available |
| Solubility | less than 1 mg/mL at 72° F (NTP, 1992) |
| Partition coefficient n-octanol/water | no data available |
| Vapour pressure | 1.0X10-7 mm Hg @ 25 deg C /Estimated/ |
| Density and/or relative density | 1.011 g/cm3 |
| Relative vapour density | no data available |
| Particle characteristics | no data available |
SECTION 10: Stability and reactivity
10.1 Reactivity
no data available
10.2 Chemical stability
no data available
10.3 Possibility of hazardous reactions
An organic acid and unsaturated aliphatic hydrocarbon. Carboxylic acids donate hydrogen ions if a base is present to accept them. They react in this way with all bases, both organic (for example, the amines) and inorganic. Their reactions with bases, called "neutralizations", are accompanied by the evolution of substantial amounts of heat. Neutralization between an acid and a base produces water plus a salt. Insoluble carboxylic acids react with solutions of cyanides to cause the release of gaseous hydrogen cyanide. Flammable and/or toxic gases and heat are generated by the reaction of carboxylic acids with diazo compounds, dithiocarbamates, isocyanates, mercaptans, nitrides, and sulfides. Carboxylic acids, especially in aqueous solution, also react with sulfites, nitrites, thiosulfates (to give H2S and SO3), dithionites (SO2), to generate flammable and/or toxic gases and heat. Their reaction with carbonates and bicarbonates generates a harmless gas (carbon dioxide) but still heat. Like other organic compounds, carboxylic acids can be oxidized by strong oxidizing agents and reduced by strong reducing agents. These reactions generate heat. A wide variety of products is possible. Like other acids, carboxylic acids may initiate polymerization reactions; like other acids, they often catalyze (increase the rate of) chemical reactions.
10.4 Conditions to avoid
no data available
10.5 Incompatible materials
no data available
10.6 Hazardous decomposition products
no data available
SECTION 11: Toxicological information
Acute toxicity
- Oral: LD50 Rat oral greater than 4 g/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
12.1 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
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 Other adverse effects
no data available
SECTION 13: Disposal considerations
13.1 Disposal 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
14.1 UN Number
| ADR/RID: UN1759 (For reference only, please check.) | IMDG: UN1759 (For reference only, please check.) | IATA: UN1759 (For reference only, please check.) |
14.2 UN Proper Shipping Name
| ADR/RID: CORROSIVE SOLID, N.O.S. (For reference only, please check.) | IMDG: CORROSIVE SOLID, N.O.S. (For reference only, please check.) | IATA: CORROSIVE SOLID, N.O.S. (For reference only, please check.) |
14.3 Transport hazard class(es)
| ADR/RID: 8 (For reference only, please check.) | IMDG: 8 (For reference only, please check.) | IATA: 8 (For reference only, please check.) |
14.4 Packing group, if applicable
| ADR/RID: I (For reference only, please check.) | IMDG: I (For reference only, please check.) | IATA: I (For reference only, please check.) |
14.5 Environmental hazards
| ADR/RID: Yes | IMDG: Yes | IATA: Yes |
14.6 Special precautions for user
no data available
14.7 Transport in bulk according to IMO instruments
no data available
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations specific for the product in question
| Chemical name | Common names and synonyms | CAS number | EC number |
|---|---|---|---|
| Isotretinoin | Isotretinoin | 4759-48-2 | 225-296-0 |
| European Inventory of Existing Commercial Chemical Substances (EINECS) | Listed. | ||
| EC Inventory | Listed. | ||
| United States Toxic Substances Control Act (TSCA) Inventory | Listed. | ||
| China Catalog of Hazardous chemicals 2015 | Not Listed. | ||
| New Zealand Inventory of Chemicals (NZIoC) | Listed. | ||
| Philippines Inventory of Chemicals and Chemical Substances (PICCS) | Not Listed. | ||
| Vietnam National Chemical Inventory | Listed. | ||
| Chinese Chemical Inventory of Existing Chemical Substances (China IECSC) | Not Listed. | ||
| Korea Existing Chemicals List (KECL) | 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%
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/
Disclaimer: The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. We as supplier shall not be held liable for any damage resulting from handling or from contact with the above product.
Isotretinoin is included in Anti-sebum category.
Buy Isotretinoin of different grades for your demands from various manufactures and traders.
Related Products
Industry News
More Safety Data Sheets