Safety Data Sheet
Amorolfin hydrochloride
1. Product and Company Identification
Product name Product code Company information Amorolfin hydrochloride 04 1180 9 Manufacturer: F. Hoffmann-La Roche AG Postfach CH-4070 Basel Switzerland Phone Fax +41-61/688 54 80 +41-61/681 72 76 Local representation:
2. Composition/Information on ingredients
Characterization Chemical name Synonyms pharmaceutical active substance from the class of morpholines - 4-{3-[p-(1,1-Dimethylpropyl)phenyl]-2-methylpropyl}-2,6-cisdimethylmorpholine hydrochloride - 4-[3-(4-tert-Amylphenyl)-2-methylpropyl]-2,6dimethylmorpholine hydrochloride - rac-cis-4-{3-[4-(1,1-Dimethylpropyl)-phenyl]-2-methylpropyl}-2,6-dimethylmorpholine monohydrochloride - Amorolfine hydrochloride (INN) - LOCERYL substance - Antimycotic Ro 14-4767/004 - Amorolfine-HCl unmilled (code no. 04 0558 2) 78613-38-4 3077 Ro 14-4767/002 C21H35NO HCl
q
CAS number UN number Roche number Empirical formula Molecular mass
353.98 g/mol
O N
HCl
Date: 14.8.04/CSE (SEISMO)
Replacing edition of:
31.5.02
Page: 1/6
Amorolfin hydrochloride
3. Hazards identification
Most important hazards - Harmful if swallowed. - Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
4. First-aid measures
Eye contact - rinse immediately with tap water for 10 minutes - open eyelids forcibly - consult physician - remove immediately contaminated clothes, wash affected skin with water and soap - do not use any solvents - consult physician - remove the casualty to fresh air and keep him/her calm - get medical treatment - treat symptomatically
Skin contact
Inhalation Note to physician
5. Fire-fighting measures
Suitable extinguishing media Specific hazards - water spray jet, dry powder, foam, carbon dioxide - consider dust explosion hazard - formation of toxic and corrosive combustion gases (nitrous oxide, hydrogen chloride) possible - substance is hazardous for water: contain fire-fighting wastewater - precipitate gases/vapours/mists with water spray
Protection of fire-fighters
6. Accidental release measures
Environmental protection Methods for cleaning up - do not allow to enter drains or waterways - collect solids (avoid dust formation) and hand over to waste removal
7. Handling and storage
Handling Technical measures - processing in closed systems, if possible superposed by inert gas (e.g. nitrogen) - local exhaust ventilation necessary - take precautionary measures against electrostatic charging - avoid dust formation; very high dust explosion hazard - stainless steel, enamel, glass, polyethylene - may corrode stainless steel when water-moist or in solution
Suitable materials Note
Date: 14.8.04/CSE (SEISMO)
Replacing edition of:
31.5.02
Page: 2/6
Amorolfin hydrochloride
Storage Storage conditions Validity Packaging materials - room temperature - store under inert gas - 48 months, at room temperature, under nitrogen - tightly closing; material: coated steel (lined with polyethylene bag)
8. Exposure controls/Personal protection
Engineering Measures Monitoring Analytics
- see 7.
- sampling on glass fibre filter and gravimetric or chemical determination
Personal protective equipment Respiratory protection Hand protection Eye protection - in case of open handling or accidental release: particle mask or respirator with independent air supply - protective gloves (eg made of neoprene, nitrile or butyl rubber) - safety glasses
9. Physical and chemical properties
Colour Form Odour Sieve analysis Solubility white to practically white very fine powder none to faint ≥ 99.5 % through USP standard sieve no. 50 (Ø 300 µm)
2’000 ~ 1’800 ~ 120 mg/kg mg/kg mg/kg (oral, mouse) (oral, rat) (i.v., mouse)
Local effects Sensitization Chronic toxicity Mutagenicity Reproduction toxicity Note
- skin: irritant (several species) - not phototoxic (several species) - not sensitizing (several species) - development of cataracts after several weeks’ oral application (rat) - not mutagenic (various in vivo and in vitro test systems) - not teratogenic (several species) - embryotoxic (10 mg/kg/d) - single doses up to 1000 mg showed no adverse effects - very rapid metabolisation - may cause skin reactions (chapped lips, dryness, peeling, itching, redness) - experience with systemic application in humans is very limited
12. Ecological information
Inherent biodegradability - not inherently biodegradable 1 %, 28 d (MITI Test II, OECD No. 302 C) - barely toxic for microorganisms (activated sludge) NOEC 100 mg/l - strongly toxic for fish (rainbow trout) LC50 (96 h) 2.6 mg/l (OECD No. 203) - observe local/national regulations
Ecotoxicity
Air pollution
13. Disposal considerations
Waste from residues - incinerate in qualified installation with flue gas scrubbing - observe local/national regulations regarding waste disposal
Date: 14.8.04/CSE (SEISMO)
Replacing edition of:
31.5.02
Page: 4/6
Amorolfin hydrochloride
14. Transport information
IATA
Class 9
UN/ID 3077
PG III
PI 911/911
Label 9
IMDG
Class 9
UN 3077
PG III
EmS F-A S-F
PI P002/IBC08
Label 9
Mark
RID/ADR
Class 9
UN 3077
PG III
Haz.no 90
PI P002/IBC08
Label 9
Classif.code M7
Proper shipping name
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (Amorolfine hydrochloride)
15. Regulatory information
Classification and labelling according to EU directives
Xn R22 R38 R51/53 S22 S61 Toxicity class (Switzerland) Water hazard class (Germany)
N
Harmful if swallowed. Irritating to skin. Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Do not breathe dust. Avoid release to the environment. Refer to special instructions/Safety data sheets. 5 2: hazardous for water (own classification according to directive VwVwS of 17.05.1999)
Date: 14.8.04/CSE (SEISMO)
Replacing edition of:
31.5.02
Page: 5/6
Amorolfin hydrochloride
16. Other information
Use Safety-lab number Note - broad-spectrum antimycotic for topical application - BS-3301 - with the exception of particle size, the present safety data sheet is also valid for "Amorolfin hydrochloride unmilled", product code 04 0558 2 - changes from previous version in sections 4, 8, 14, 15
Edition documentation
The information in this safety data sheet is based on current scientific knowledge. It should not be taken as expressing or implying any warranty concerning product characteristics.
Date: 14.8.04/CSE (SEISMO) Replacing edition of: 31.5.02 Page: 6/6