msds isotreitonina

ACCUTANE(R) Capsules (40 mg)Material Safety Data Sheet

1. Product and Company Identification

Product name ACCUTANE(R) Capsules (40 mg)Product code SAP-10052693

Use - oral treatment of severe acne, resistant against other therapiesEnquiries:Hoffmann-La Roche Inc.340 Kingsland StreetUSA-Nutley, N.J. 07110-1199United States of America

Phone 001-973/235 50 00E-Mail [email protected]

US Emergency phone: (800)-827-6243US Chemtrec phone: (800)-424-9300

Company information

Synonyms - ACCUTANE Capsules (soft) 40 mg- Isotretinoin capsules

2. Hazards identification

Emergency Overview

Form gelatin capsule soft

Color yellow

Hazard Overview - Can cause birth defects

Page: 1/7Replacing edition of: 11.1.10Date: 26.6.10/CSE (SEISMO)

ACCUTANE(R) Capsules (40 mg)

Potential Health Effects - Exposure: Ingestion, Skin contact, Eye contact- Target Organs: eye, skin, liver, respiratory tract, gastrointestinal

system, Central nervous system, Female reproductive system,Skeletal system

- Acute Effects: May cause excessive drying of the eyes., Maycause conjunctivitis., This material has not been tested as awhole; therefore, the information described below is based on oneor more of its ingredients., May cause drying and/or irritation of themucous membrane., May cause skin reactions such as cracks inlips and around mouth, dry skin, skin peeling, itching and rednessof the skin., May cause central nervous system effects., Signs andsymptoms may include headache, dizziness, drowsiness, fatigueand lack of muscular coordination., May cause hepatic (liver)system effects., Signs and symptoms may include elevation ofliver enzyme levels and jaundice (yellowing of the skin and eyes).,May cause musculoskeletal effects., Signs and symptoms mayinclude muscle weakness or pain and skeletal abnormalities.

- Chronic Effects: May cause elevation of liver enzyme andtriglyceride levels., May cause enlargement of the liver., Maycause bronchitis., May cause muscle weakness and pain.

- Carcinogenicity: formulation not listed by NTP, IARC or OSHA

Additional Health Information - Reproductive Toxicity: Can cause birth defects.- Conditions Aggravated: Liver conditions and /or impaired liver

function, diabetes, heart conditions, depression and pseudotumorcerebri.

- Additional Health Hazard Information: Individuals taking Vitamin Aas a nutritional supplement should avoid exposure to this material.

Note - women of childbearing potential must not be engaged in any workwhere dust exposure might occur. In case of doubt a riskassessment is advised.

- women of childbearing potential have to avoid any overexposure(limit values see chapter 8)

3. Composition/Information on ingredients

Characterization pharmaceutical active substance in the class of retinoids *1

Vegetable oil CAS: 68334-00-9

82 - 96 %

Ingredients Concentration

Isotretinoin CAS: 4759-48-2

3.2 - 12.7 %

*1 Isotretinoinreferring to:



4. First-aid measures

Eye contact - rinse immediately with tap water for 10 minutes - open eyelidsforcibly

- consult a physician

Skin contact - remove immediately contaminated clothes, wash affected skinwith water and soap - do not use any solvents

Inhalation - remove the casualty to fresh air and keep him/her calm- in the event of symptoms get medical treatment

Note to physician - treat symptomatically

5. Fire-fighting measures

Suitable extinguishing media - adapt extinguishing media to surrounding fire conditions

Flash point (liquid) not applicableSpecific hazards - substance is hazardous for water: contain fire-fighting wastewater

6. Accidental release measures

Personal precautions - ensure adequate ventilation

Environmental protection - do not allow to enter drains or waterways- if the substance reaches waters or the sewer system, inform the

competent authority

Methods for cleaning up - collect spilled material (avoid dust formation) and hand over towaste removal in sealed containers

7. Handling and storage

Handling

Technical measures - processing in closed systems, if possible superposed by inert gas(e.g. nitrogen)

- provide suitable exhaust ventilation at the processing machines- take precautionary measures against electrostatic charging- avoid formation and deposition of dust

Storage

Storage conditions - 15 - 30 C- protected from light

Validity - see "best use before" date stated on the label



8. Exposure controls/Personal protection

Engineering Measures - see 7.

Monitoring

Threshold value (USA) air - ACGIH-TLV: 10 mg/m3 *2- OSHA-PEL: 5 mg/m3 (respirable fraction) *2- OSHA-PEL: 15 mg/m3 *2

Threshold value (Roche) air - IOEL (Internal Occupational Exposure Limit): 0.05 mg/m3 (InternalOccupational Exposure Limit, men) *1

- IOEL (Internal Occupational Exposure Limit): 0.005 mg/m3(Internal Occupational Exposure Limit, women of childbearing age)*1

Analytics - sampling on glassfiber filter and chemical determination of theactive compound (eg HPLC) *1

Personal protective equipment

Respiratory protection - Respiratory protection is recommended as a precaution tominimze exposure. Effective engineering controls are consideredto be the primary means to control worker exposure. Respiratoryprotection should not substitute for feasible engineering controls.

- in case of open handling or accidental release:particle mask or respirator with independent air supply

Hand protection - protective gloves (eg made of neoprene, nitrile or butyl rubber)Eye protection - safety glasses

General protective andhygiene measures

- instruction of employees mandatory- shower after work recommended

*1*2

IsotretinoinVegetable oil

referring to: referring to:

9. Physical and chemical properties

Color yellow

Form gelatin capsule soft

Solubility < 100 mg/l, water (25 C) *13000 mg/l, peanut oil (25 C) *112000 mg/l, ethanol (25 C) *115000 mg/l, n-octanol (25 C) *124000 mg/l, acetone (25 C) *1

Partition coefficient log Pow 6.6 (octanol/waterC) *1




10. Stability and reactivity

Conditions to avoid - light (gradual decomposition) *1- warming (gradual decomposition) *1*1


11. Toxicological information

Acute toxicity LD50 > 4000 mg/kg (oral, rat) *1-Mutagenicity not mutagenic (various test systems) *1-Carcinogenicity not cancerogenic *1-

Reproduction toxicity - teratogenic (human and animal) *1Note - dosage: daily 0.5 - 1.0 mg/kg (oral) *1

- half-life of elimination: between 7 - 39 hours (average approx. 20hours) *1

- systemic symptoms: signs of vitamin A hypervitaminosis (drynessof mucous membranes, exanthems, pruritus; high doses: signs ofintracranial pressure like headache, vomiting, etc.) *1


12. Ecological information

Inherent biodegradability - inherently biodegradable59 %, 28 days(MITI Test II, OECD No. 302 C) *1

Ecotoxicity strongly toxic for planktonic crustaceans (Daphnia magna)EC50 (48 h) 2.06 mg/l(FDA Technical Assistance Document No. 4.08) *1

-

highly toxic for fish (rainbow trout)LC100 (96 h) 0.61 mg/lLC50 (96 h) 0.52 mg/lLC0 (96 h) 0.45 mg/lNOEC (96 h) 0.05 mg/l(OECD No. 203) *1

-

barely toxic for microorganisms (activated sludge)LC50 (3 h) > 100 mg/l(Activated Sludge Respir. Inhib. Test, OECD No. 209) *1

-

Note - the substance shows a potential of bioaccumulation *1




13. Disposal considerations

Waste from residues - incinerate in qualified installation with flue gas scrubbing- observe local/national regulations regarding waste disposal- DO NOT FLUSH unused medications or POUR them down a sink

or drain. If available in your area, use takeback programs run byhousehold hazardous waste collection programs or communitypharmacies to dispose of unused and expired medicines. If youdont have access to a takeback program, dispose of thesemedicines in the household trash by removing them from theiroriginal containers and mixing them with an undesirablesubstance, such as used coffee grounds or kitty litter.

Contaminated packaging - incinerate contaminated packaging material in qualified installationwith flue gas scrubbing

RCRA waste - not regulated under RCRA

14. Transport information

UN/ID PG

9 3077 9III 911/911

IATA Class LabelPI

UN EmS

9 9

IMDG

3077 marine pollutant

Class Label MarkPG

III

PI

P002/IBC08F-A S-F

9 9

RID/ADR Class

90

Haz.no LabelUN

3077

PG

III

PI

P002/IBC08

Classif.code

M7

PI

9

DOT

- NON-REGULATED IN NON-BULK PACKAGINGSTRANSPORTED BY MOTOR VEHICLES, RAIL CARS ORAIRCRAFT (49CFR 171.4(c)).

DOT Remark:

Class

III3077

PI RQUN/ID PG Label

9

Haz.no

Proper shipping name ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S.

Technical name Isotretinoin mixture



15. Regulatory information

US Regulations- Law: safe drinking water and toxic enforcement act of 1986- Ident_No: Proposition 65- Common name: Prop 65- Agency: California Environmental Protection Agency- Authority: California- Criteria met: contains a chemical known to the state to cause

reproductive toxicity- Law: hazardous chemical reporting: community right-to know- Ident_No: 40CFR370- Common name: SARA title 312- Agency: Environmental Protection Agency EPA- Authority: USA- Criteria met: acute

TSCA Status - FDA Exemption - not on inventory

Reporting Requirements - The United States Environmental Protection Agency (USEPA) hasnot established a Reportable Quantity (RQ) for releases of thismaterial.

- In New Jersey, report all releases which are likely to endanger thepublic health, harm the environment or cause a complaint to theNJDEPE Hotline (1-609-292-5560) and to local officials.

- State and local regulations vary and may impose additionalreporting requirements.

16. Other information

Safety-lab number - BS-2435 *1- BS-7164 *1- BS-9093 *1

Edition documentation - changes from previous version in sections 13


The information in this safety data sheet is based on current scientific knowledge. It should not betaken as expressing or implying any warranty concerning product characteristics.


msds isotreitonina

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