Note: Ingredients listed on restricted chemical lists
EC/CAS
200-673-2/67-97-0
Name of the chemical
Ergocalciferol (INN) and cholecalciferol (vitamins D2 and D3)
Concentration
>=0,025-<
General Information
Version
6.0
Revision date
2023-09-26
Product name
Alendronate / Vitamin D Formulation
1.2.1 Relevant identified uses
Pharmaceutical
Emergency telephone
+1-551-430-6000, +1-215-631-6999
Icons in SDS
Company Information
company name
Organon & Co
e-mail address of the competent person responsible for the Safety Data Sheet
EHSSTEWARD@organon.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H302, H315, H318, H335, H361d, H373
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Signal word
Danger
Hazard statements
H302 Harmful if swallowed. H315 Causes skin irritation. H318 Causes serious eye damage. H335 May cause respiratory irritation. H361d Suspected of damaging the unborn child. H373 May cause damage to organs through prolonged or repeated exposure.
Prevention
P201 Obtain special instructions before use. P260 Do not breathe dust. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.
Response
P304 + P340 + P312 IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/ doctor if you feel unwell. P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if pre- sent and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor. P308 + P313 IF exposed or concerned: Get medical advice/ attention.
Hazardous Ingredients
Alendronate
Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumula- tive and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher. May form explosive dust-air mixture during processing, handling or other means
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Acute toxicity, Category 4 H302: Harmful if swallowed. Skin irritation, Category 2 H315: Causes skin irritation. Serious eye damage, Category 1 H318: Causes serious eye damage. Reproductive toxicity, Category 2 H361d: Suspected of damaging the unborn child. Specific target organ toxicity - single ex- H335: May cause respiratory irritation. posure, Category 3 Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2 longed or repeated exposure.
