1 PRODUCT NAME AND COMPANY IDENTIFICATION
| PRODUCT IDENTIFICATION | ||
|---|---|---|
| PRODUCT NAME | : | HYDROXOCOBALAMIN base |
| CHEMICAL FAMILY | : | Cobalamins |
| KIND OF USE | : | Active ingredient for medical use. : hematopoietic vitamin . |
| COMPANY IDENTIFICATION | ||
| SUPPLIER | : | Aventis Pharma S.A. |
| ADDRESS | : | 20, avenue Raymond Aron 92160 Antony |
| TELEPHONE NUMBER | : | Tel : 33-1-55-71-71-71 |
| TELEX NUMBER/TELEFAX NUMBER | : | Fax : 33-1-47-02-50-14 |
| EMERGENCY TELEPHONE NUMBER | ||
| Tel : 33-1-45-42-59-59 | ||
2 COMPOSITION / INFORMATION ON INGREDIENTS
SUBSTANCE
| COMMON CHEMICAL NAME / GENERIC NAME | : | Alpha-(5,6-dimethyl-benzimidazolyl) hydroxocobamide |
| SYNONYMS | : |
Vitamin B12 A |
| MOLECULAR MASS | : | 1346.41 |
| FORMULA | : | C62 H89 Co N13 O15 P |
| CAS NUMBER | : | 13422-51-0 |
| EINECS NUMBER | : | 236-533-2 |
| INGREDIENTS CONTRIBUTING TO THE HAZARD |
| CONTENT | CAS | EC LABELLING | ||
|---|---|---|---|---|
| Hydroxocobalamin | #100% | 13422-51-0 | No label |
3 HAZARDS IDENTIFICATION
MOST IMPORTANT HAZARDS
| SPECIFIC HAZARDS | : Crystallized solid . Substance pharmacologically active at low dose : hematopoietic vitamin . |
4 FIRST-AID MEASURES
INFORMATIONS ON DIFFERENT EXPOSURE ROUTES
INHALATION : Make the victim blow his nose.
SKIN CONTACT: Rinse immediately with plenty of water for at least 15 minutes.
EYE CONTACT : Rinse immediately with plenty of water for at least 15 minutes. Seek medical advice.
INGESTION : Do not make the victim vomit. Seek medical advice.
5 FIRE-FIGHTING MEASURES EXTINGUISHING MEDIA
SUITABLE : All means.
NOT SUITABLE : Jet of water from a fire hose.
SPECIFIC HAZARDS : In case of fire, the product emits toxic fumes
PROTECTION OF FIREFIGHTERS : Wear a self-contained respiratory apparatus.
6 ACCIDENTAL RELEASE MEASURES
METHODS FOR CLEANING UP
RECOVERY : Collect thoroughly into a plastic bag
NEUTRALIZATION : Rinse the polluted area with plenty of water.
7 HANDLING AND STORAGE
HANDLING
TECHNICAL MEASURES : The protective equipments indicated in chapter 8 may be adaptedaccording to the local conditions based upon the worplace riskassessment. Mechanical removal ventilation at source of formation of dust. Containment level regarding OEB 1/2 (Aventis) (provisional)
STORAGE
| TECHNICAL MEASURES | : Sensitivity to damp | : | Very hygroscopic. |
| : Sensitivity to light | : | Sensitive to light. (bright) | |
| : Sensitivity to oxidation | : | Not observed. | |
| STORAGE CONDITIONS (SUITABLE) | : | Keep at temperature not exceeding 46 °F (8°C.) | |
| STORAGE CONDITIONS (TO BE AVOIDED) | : | None. | |
| INCOMPATIBLE PRODUCTS | Unknown | ||
| PACKAGING MATERIALS RECOMMENDED | Stainless steel, polythene, white iron, aluminium | ||
| SUPPLIER PACKAGING | Metal box, inner double polythene sack. | ||
| PACKAGING MATERIALS NOT SUITABLE | Unknown | ||
| STORAGE CONDITIONS | Keep away from heat. Keep in a well closed container, away from | ||
8 EXPOSURE CONTROLS / PERSONAL PROTECTION
ENGINEERING MEASURES (see also chapter 7)
CONTROL PARAMETERS : STEL: Not determined. : TWA : Not determined.
PROTECTIVE EQUIPMENTS-WORKSHOP
RESPIRATORY PROTECTION : Dust respirator. HAND PROTECTION : Suitable gloves. EYE PROTECTION : Safety glasses.
PROTECTIVE EQUIPMENTS-LABORATORY
RESPIRATORY PROTECTION : Dust respirator. HAND PROTECTION : Suitable gloves. EYE PROTECTION : Safety glasses.
9 PHYSICAL AND CHEMICAL PROPERTIES
APPEARANCE
PHYSICAL STATE : Solid FORM : Crystallized COLOUR : Red (dark) ODOUR : Odourless
PH : Aqueous solution at 2% : 8-10 FLASHPOINT : Not applicable. AUTOIGNITION TEMPERATURE : Not determined. SOLUBILITY : Soluble in water and alcohol.
Practically insoluble in acetone, chloroform. OTHER DATA : Bulk density: 0.36. Melting point: >300°C
10 STABILITY AND REACTIVITY
POSSIBLE HAZARDOUS REACTIONS :Unknown.
HAZARDOUS DECOMPOSITION PRODUCTS : Unknown
11 TOXICOLOGICAL INFORMATION
| ACUTE TOXICITY | |
| OTHER DATA | : LD 50 intraveinous route / mouse : >50 mg/kg. |
| PHARMACOLOGICAL ACTIVITY | : Substance pharmacologically active at low dose : hematopoietic vitamin.Therapeutic dose : 5mg/d (intraveinous or intramuscular route). |
| COMMENTS AND SYMPTOMS | : Possible adverse effects in case of treatment: Rare cases of allergicreaction which could be severe.Risk of acnea. Cellular proliferation effect (risk of rapid changes and development ofmalignant tumours)Possible discolouration of urine. |
| RECOMMENDATIONS | : The handling is not advisable to people who are known to be allergic tocobalamins. |
12 ECOLOGICAL INFORMATION
COMMENTS : Ecological data not available. Do not release material and undilutedcleaning waters into the environment.
13 DISPOSAL CONSIDERATIONS
| WASTE FROM RESIDUES | |
| NEUTRALIZATION OF THE PRODUCT /WASTE | : The recycling of this product is possible during manufacture. |
| CONTAMINATED PACKAGING | |
| DESTRUCTION SOILED PACKAGING | : Empty and rinse well |
14 TRANSPORT INFORMATION
| INTERNATIONAL REGULATIONS | |
| LAND (RID/ADR) | |
| SEA (IMDG) | : Not regulated |
| AIR (IATA) | : Not regulated |
| ADDITIONNAL REGULATIONS | |
| LAND FRANCE (RID/ADR) | : Not regulated |
15 REGULATORY INFORMATION
REGULATIONS
LABELLING EC NUMBER : Labelling according to EC regulations of dangerous substances(67/548/EEC)
PHRASES : S7/8-22-24-47, 8°C.
SAFETY ADVICES: Keep container tightly closed and dry. Do not breathe dust. Avoid contactwith skin. Keep at temperature not exceeding 46°F (+8°C).
ADDITIONAL LABELLING : Hygroscopic. Storage : 36° F to 46° F (+2° C to +8° C).
16 OTHER INFORMATION
| All the regulatory instructions mentioned are intended to help the addressee to comply with his obligations when using the product. This listcannot be considered as exhaustive and does not discharge the addressee from his duty to enquire about all otherregulatory provisions which may apply to the possession and handling of the product for which he bears sole liability. |
| The information given in this sheet has been introduced in accordance with the guidelines established by directives 91/155 EEC and 92/32EEC, in compliance with international standard ISO 11014-1.This data sheet complements the user's instructions, but does not replace them.Users are further reminded of the possible riscks of using a product for purposes other than those for which it was intended.The required informations complies with current EC legislation. Addressees are requested to applied any additional national requirement. |