Note: Ingredients listed on restricted chemical lists
EC/CAS
13463-67-7
Name of the chemical
Reaction mass of titanium dioxide and silver chloride
Concentration
>=0.1-<1
General Information
Version
3.3
Revision date
2026-01-07
Product name
Ofev , Vargatef , Cyendiv Capsules
Product Synonyms
Ofev® Capsules 25 mg, 100 mg and 150 mg; Cyendiv® Cap- sules 25 mg, 100 mg and 150 mg; Vargatef® Capsules 25
1.2.1 Relevant identified uses
Pharmaceutical
1.2.2. Uses advised against
Safety Data Sheet only for the professional user
supplier name
Boehringer Ingelheim Pharmaceuticals Inc
Emergency telephone
+1 703-527-3887, +1 703-741-5970
Icons in SDS
Company Information
company name
Boehringer Ingelheim Pharmaceuticals Inc
e-mail address of the competent person responsible for the Safety Data Sheet
EHS-Services@Boehringer-Ingelheim.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H360, H372
Hazard statements
Code
Statements
H360
May damage fertility or the unborn child
Section 2
SECTION 2: Hazards identification
Other hazards
The pharmacological effect of the medicament has to be considered (see package leaflet) This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) Hazards associated with a change in physical form: This product does not contain titanium dioxide in its respirable form and would not be considered carcinogenic; however, upon crushing, grinding or other processing that could result in the gener- ation of respirable particulates, the Category 2 carcinogenic classification would apply.
Signal word
Danger
Hazard statements
H360 May damage fertility or the unborn child. H372 Causes damage to organs (Gastro-intestinal system, Liv- er) through prolonged or repeated exposure.
Prevention
P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.
Response
P308 + P313 IF exposed or concerned: Get medical advice/ attention.
Storage
P405 Store locked up.
Disposal
P501 Dispose of contents/ container to an approved waste dis- posal plant.
2.1 Classification of the substance or mixture
1910.1200) Hazards for the product as supplied Reproductive toxicity : Category 1B Specific target organ toxicity : Category 1 (Gastro-intestinal system, Liver) - repeated exposure Other hazards The pharmacological effect of the medicament has to be considered (see package leaflet). This drug is not subject to the labelling requirements under the Globally Harmonized System (GHS) Hazards associated with a change in physical form: This product does not contain titanium dioxide in its respirable form and would not be considered carcinogenic; however, upon crushing, grinding or other processing that could result in the gener- ation of respirable particulates, the Category 2 carcinogenic classification would apply.
