1. PRODUCT AND COMPANY IDENTIFICATION
Product name :    Betamethasone Liquid Formulation Manufacturer or supplier's details Company : Organon & Co.
： +1-551-430-6000 Emergency telephone number  :    +1-215-631-6999 E-mail address :  EHSSTEWARD@organon.com Recommended use of the chemical and restrictions on use Recommended use Pharmaceutical : Restrictions on use Not applicable ..
2. HAZARDS IDENTIFICATION
GHS Classification Reproductive toxicity .. Category 1B Specific target organ toxicity -    : repeated exposure Category 1 (Pituitary gland, Immune system, muscle, thymus gland, Blood, Adrenal gland) Long-term (chronic) aquatic hazard .. Category 1 GHS label elements Hazard pictograms Signal word : Hazard statements : H360D May damage the unborn child. H372 Causes damage to organs (Pituitary gland, Immune sys- tem, muscle, thymus gland, Blood, Adrenal gland) through pro- longed or repeated exposure. H410 Very toxic to aquatic life with long lasting effects. Precautionary statements : Prevention:
Other hazards which do not result in classification None known. 3. COMPOSITION/INFORMATION ON INGREDIENTS Substance / Mixture : Mixture

4. FIRST AID MEASURES

posal of this material, as well as those materials and items employed in the cleanup of releases. You will need to deter- mine which regulations are applicable. Sections 13 and 15 of this SDS provide information regarding certain local or national requirements.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

10. STABILITY AND REACTIVITY

11. TOXICOLOGICAL INFORMATION

Acute toxicity Not classified based on available information. Product:
Skin corrosion/irritation Not classified based on available information. Components: betamethasone: Species Result : Rabbit Mild skin irritation : Benzalkonium chloride: Species Human Result : : Corrosive after 4 hours or less of exposure
Serious eye damage/eye irritation Not classified based on available information. Components: betamethasone: Species Result .. : Rabbit No eye irritation Benzalkonium chloride: Species Result ..
.. Respiratory or skin sensitisation Skin sensitisation Not classified based on available information. Respiratory sensitisation Not classified based on available information. Components: betamethasone: Exposure routes Species Result
: Benzalkonium chloride:
Germ cell mutagenicity Not classified based on available information. Components: betamethasone: Genotoxicity in vitro : Test Type: Bacterial reverse mutation assay (AMES) Result: negative Test Type: In vitro mammalian cell gene mutation test Result: negative Test Type: Chromosome aberration test in vitro Result: positive
Carcinogenicity Not classified based on available information. Components:
: 90 weeks : negative Reproductive toxicity May damage the unborn child.
STOT - single exposure Not classified based on available information. STOT - repeated exposure Causes damage to organs (Pituitary gland, Immune system, muscle, thymus gland, Blood, Ad- renal gland) through prolonged or repeated exposure.
ORGANON
Components: betamethasone: Target Organs Assessment Pituitary gland, Immune system, muscle, thymus gland, Blood, .. Adrenal gland : Causes damage to organs through prolonged or repeated exposure. Benzalkonium chloride: Assessment No significant health effects observed in animals at concentra- : tions of 100 mg/kg bw or less. Repeated dose toxicity Components: betamethasone: : Rabbit : 0.05 % : : Skin contact 10 - 30 d Pituitary gland, Immune system, muscle : Species LOAEL Application Route Exposure time Target Organs
Benzalkonium chloride:
Aspiration toxicity Not classified based on available information.
Experience with human exposure Components:
: :
Ecotoxicity
ORGANON
Persistence and degradability Components: Benzalkonium chloride: Biodegradability
Bioaccumulative potential Components:
Mobility in soil No data available Other adverse effects No data available 13. DISPOSAL CONSIDERATIONS
International Regulations
ORGANON
UNRTDG UN number Proper shipping name UN 3082 .. : N.O.S. (betamethasone)
IATA-DGR
UN 3082 .. .. N.O.S. (betamethasone) .. 9 .. == .. 9
F-A, S-F .. : yes Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable for product as supplied. Special precautions for user The transport classification(s) provided herein are for informational purposes only, and solely based upon the properties of the unpackaged material as it is described within this Safety Data Sheet. Transportation classifications may vary by mode of transportation, package sizes, and var- iations in regional or country regulations. 15. REGULATORY INFORMATION Safety, health and environmental regulations/legislation specific for the substance or mix- ture
Minister of Industry Regulation No. 23/M-IND/PER/4/2013 concerning the Revision of Minis- ter of Industry Regulation No. 87/M-IND/PER/9/2009 concerning Globally Harmonized Sys- tem of Classification and Labelling of Chemicals. Regulation of the Minister of Health No. 472 of 1996 on the Safeguarding of Substances Hazardous to Health Hazardous substances that must be registered : Not applicable Government Regulation No. 74 of 2001 on the Management of Hazardous and Toxic Sub- stances Hazardous substances approved for use .
:
..
Regulation of the Ministry of Trade No. 7 of 2022 on Distribution and Control of Hazardous Materials Type of hazardous materials subject to distribution and   :    Not applicable control, Annex I Type of hazardous materials subject to distribution and   :    Not applicable control, Annex II The components of this product are reported in the following inventories: AICS :    not determined
not determined : 16. OTHER INFORMATION
Date format ： yyy/mm/dd Full text of other abbreviations AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport by Land of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute for Standardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized Sys- tem; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA - International Air Transport Association; IBC - International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory con- centration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemi- cal Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Or- ganisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Con- centration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Leve!; NOELR - No Observable Effect Loading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Develop- ment; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumu- lative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substanc- es; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evalua- tion, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Tem- perature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Trans- portation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Sub- stances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recom- mendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumu- lative; WHMIS - Workplace Hazardous Materials Information System The information provided in this Safety Data Sheet is correct to the best of our knowledge, infor- mation and belief at the date of its publication. The information is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and shall not be considered a warranty or quality specification of any type. The information provided relates only to the specific material identified at the top of this SDS and may not be valid when the SDS mate- rial is used in combination with any other materials or in any process, unless specified in the text. Material users should review the information and recommendations in the specific context of their intended manner of handling, use, processing and storage, including an assessment of the ap- propriateness of the SDS material in the user's end product, if applicable. ID / EN