0491632.20051005.6763 by msds


									Safety Data Sheet

Fluocinolone acetonide

1. Product and Company Identification
Product name Product code Company information Fluocinolone acetonide 04 9163 2 Enquiries: 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 in the class of corticosteroids - 6α,9α-Difluoro-11β,21-dihydroxy-16α,17α-isopropylidenedioxypregna-1,4-diene-3,20-dione - RS-1610-007 - SYNALAR® substance - Fluocinolone acetonide crude 67-73-2 200 668 5 Ro0077706-000 C24H30F2O6 452.50 g/mol

CAS number EINECS number Roche number Empirical formula Molecular mass




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3. Hazards identification
Most important hazards - Harmful if swallowed.

4. First-aid measures
Eye contact - rinse immediately with tap water for 10 minutes - open eyelids forcibly - consult a physician if irritation persists - remove immediately contaminated clothes, wash affected skin with water and soap - do not use any solvents - remove the casualty to fresh air and keep him/her calm - in the event of symptoms get medical treatment - treat symptomatically

Skin contact Inhalation Note to physician

5. Fire-fighting measures
Suitable extinguishing media Protection of fire-fighters - water spray jet, dry powder, foam, carbon dioxide - precipitate gases/vapours/mists with water spray - use self-contained breathing apparatus

6. Accidental release measures
Methods for cleaning up - collect solids (avoid dust formation) and hand over to waste removal - collect spilled solutions with inert adsorbent and hand over to waste removal - clean contaminated areas with little ethanol

7. Handling and storage

Handling Technical measures - processing in closed systems, if possible superposed by inert gas (e.g. nitrogen) - avoid dust formation; consider dust explosion hazard - local exhaust ventilation necessary - take precautionary measures against electrostatic charging

Storage Storage conditions - dry, cool and ventilated place

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8. Exposure controls/Personal protection

Engineering Measures Monitoring Threshold value (Roche) air

- see 7.

- IOEL (Internal Occupational Exposure Limit): 1 µg/m3 (skin resorption)

Personal protective equipment Respiratory protection Hand protection Eye protection General protective and hygiene measures - 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 - instruction of employees recommended

9. Physical and chemical properties
Colour Form Solubility white crystalline powder virtually insoluble, water soluble, chloroform soluble, diethyl ether ≤ 8.4 mg/l, aquatic ecotoxicity media (20 °C, HPLC) log Pow 2.48 (n-octanol/water) (citation from literature) 265 to 266 °C

Partition coefficient Melting temperature

10. Stability and reactivity
Stability Materials to avoid - stable under normal conditions - strong oxidizing agents

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11. Toxicological information
Acute toxicity Local effects - LD50 400 to 1’200 mg/kg (oral, rat)

- eye: non-irritant - skin: non-irritant; on exposure to large quantities or over prolonged time skin whitening (depigmentation) or thinning (atrophy) may occur - may lead to malformations at dose levels that cause maternal toxicity - prolonged exposition or high dosing may cause: impairment of the suprarenal gland function, bone demineralisation, impairment of immune defense, hyperglycaemia - risk of skin resorption - through damaged skin, corticosteroids may directly enter the bloodstream in amounts high enough to produce systemic effects

Reproduction toxicity Note

12. Ecological information
Inherent biodegradability - not inherently biodegradable 7 %, 28 d (MITI Test II, OECD No. 302 C) - barely toxic for algae (nominal concentration = 100 mg/l), test performed with water accommodated fractions (Selenastrum capricornutum) EC50 (72 h) > 100 mg/l (nominal concentration) NOEC (72 h) 2.7 mg/l (saturation concentration) (OECD No. 201) - barely toxic for planktonic crustaceans (nominal concentration = 100 mg/l), test performed with water accommodated fractions (Daphnia magna) EC50 (48 h) > 100 mg/l (nominal concentration) NOEC (48 h) 2.9 mg/l (saturation concentration) (OECD No. 202) - barely toxic for fish (nominal concentration = 100 mg/l), test performed with water accommodated fractions (zebrafish) LC50 (96 h) > 100 mg/l (nominal concentration) NOEC (96 h) 8.4 mg/l (saturation concentration) (OECD No. 203) - strong adsorption (water-activated sludge, 3 h, ~25 °C)



13. Disposal considerations
Waste from residues - observe local/national regulations regarding waste disposal - incinerate in qualified installation with flue gas scrubbing

14. Transport information
Note - not classified by transport regulations

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15. Regulatory information
Classification and labelling according to EU directives

Xn R22 S22 Water hazard class (Germany) Harmful if swallowed. Do not breathe dust. 1: weakly hazardous for water (own classification according to directive VwVwS of 17.05.1999)

16. Other information
Use Edition documentation - pharmaceutical active substance (corticosteroid) - changes from previous version in sections 2, 3, 4, 6, 11, 15

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: 5.10.05/CSE (SEISMO) Replacing edition of: 8.2.05 Page: 5/5

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