SAFETY DATA SHEET

according to Directive 67/548/EC and Regulation 1907/2906/EC as amended.

1. IDENTIFICATION OF THE SUBSTANCE AND OF THE COMPANY

GRAMICIDIN S . 2 HCl Biotika a.s.

976 13 Slovenská Ľupča 566, Slovak Republic

Tel. +421 48 4368 111 Fax +421 48 418 70 60

 contract manufacturing for

Join Stock Company Valenta Pharmeceuticals

(JSC Valenta Pharm)

18/2, Generala Dorokhova street,

Moscow, Russian Fedration

Tel. +7 (495) 933 60 80 Fax +7 (495) 933 60 81

2. HAZARDS IDENTIFICATION

Substance is not classified in Annex I of Directive 67/548/EC.

Prolonged or repeated exposure may cause allergic reactions in certain individuals (antibiotic).

3. COMPOSITION/INFORMATION ON INGREDIENTS

Gramicidin consists of a family of antimicrobial linear polypeptides, usually obtained by
extraction from tyrothricin, the complex isolated from the fermentation broth of Aneurinibacillus
migulanus. The main component is gramicidin S, together with gramicidins A1, A2, Bl, C1 and
C2 in particular.

CAS: 15207-30-4

EC No: Not Available

EC Index: None

NB: Antibiotic.

4. FIRST AID MEASURES

Inhalation: Remove to fresh air. If breathing becomes difficult, call a physician.

Skin contact: Flush with copious amounts of water for at least 15 minutes. Remove
contaminated clothing and shoes.

Eyes contact: Assure adequate flushing by separating the eyelids with fingers. Flush
with copious amounts of water for at least 15 minutes.

Ingestion: Wash out mouth with water provided person is conscious.

In case of reactions described in hazards identification or other severe, immediate or persisting symptoms
seek medical advice and call the nearest poison centre. Show the label and this safety data sheet.

5. FIRE FIGHTING MEASURES

Extinguishing media: Carbon dioxide, dry chemical powder or appropriate foam. Water
spray. This substance may form dust and is sensitive to ignition.

Wear self-contained breathing apparatus and protective clothing to
prevent contact with skin and eyes. Emits toxic fumes under fire
conditions.

Dangerous combustion

products: COx, NOx and other noxious gases or vapours in case of incomplete
combustion.

6. ACCIDENTAL RELEASE MEASURES

Wear respirator, chemical safety goggles, rubber boots and heavy rubber gloves. Sweep up, place
in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site with
soap water after material pick up is complete.

7. HANDLING AND STORAGE

Handling: Do not breathe dust. Avoid contact with eyes, skin or clothing. Avoid
prolonged or repeated exposure. Wash thoroughly after handling.

Storage: Keep unopened in the original container.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Handle small quantities in fume hood. Safety shower and eye bath required.

Respiratory protection: Protection mask (PI)

Hand protection: Compatible chemical-resistant gloves

Eye protection: Chemical safety goggles

9. PHYSICAL AND CHEMICALS PROPERTIES

Appearance: White or almost white, crystalline powder.

Solubility: Practically insoluble in acetone, sparingly soluble in alcohol (1:15).

10. STABILITY AND REACTIVITY

Incompatibilities: Not known.

Hazardous combustion or

decomposition products: Nature of decomposition products not known.
Hazardous polymerisation will not occur.

11. TOXYCOLOGICAL INFORMATION

LD50 (oral-rat): Information not available.

LC50 (inhalation-rat): Information not available.

LC50 (skin-rat): Information not available.

Prolonged or repeated exposure may cause allergic reactions in certain individuals.

Carcinogenicity, Mutagenicity, Reproductive toxicity and Sensitisation: None identified.

12. ECOLOGICAL INFORMATION Not available.

13. DISPOSAL CONSIDERATIONS

Incinerate in an approved facility.

Observe all federal state and local environmental regulations.

14. TRANSPORT INFORMATION Not applicable.