according to the Hazardous Products Regulations

SECTION 1. IDENTIFICATION
Product name Other means of identification : : Betamethasone Injection Formulation No data available

SECTION 2. HAZARDS IDENTIFICATION
GHS classification in accordance with the Hazardous Products Regulations Reproductive toxicity :   Category 1B Specific target organ toxicity - repeated exposure :    Category 1 (Pituitary gland, Immune system, muscle, thymus gland, Blood, Adrenal gland) GHS label elements Hazard pictograms Signal Word
Storage: P405 Store locked up. Disposal: P501 Dispose of contents and container to an approved waste disposal plant. Other hazards None known.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture : Mixture

SECTION 4. FIRST AID MEASURES

according to the Hazardous Products Regulations
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according to the Hazardous Products Regulations
SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Information on likely routes of exposure Inhalation Skin contact Ingestion Eye contact Acute toxicity Not classified based on available information.
according to the Hazardous Products Regulations
Skin corrosion/irritation Not classified based on available information. Components:
: : :
Serious eye damage/eye irritation Not classified based on available information. Components: Benzyl alcohol: Species Result Method Rabbit : Irritation to eyes, reversing within 21 days : OECD Test Guideline 405 : Betamethasone: | Species Rabbit ..
| Result .. No eye irritation Respiratory or skin sensitization Skin sensitization Not classified based on available information. Respiratory sensitization Not classified based on available information. Components: Benzyl alcohol:
Germ cell mutagenicity Not classified based on available information. Components:
Carcinogenicity Not classified based on available information. Components: Benzyl alcohol:
Reproductive toxicity May damage the unborn child.

ll
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. Components: Betamethasone:
Pituitary gland, Immune system, muscle, thymus gland, Blood, .. Adrenal gland :    Causes damage to organs through prolonged or repeated exposure. Repeated dose toxicity Components: Benzyl alcohol: Species NOAEL Application Route Exposure time Method Betamethasone: Species LOAEL Application Route Exposure time Target Organs
Rat .. 1.072 mg/l : inhalation (dust/mist/fume) .. 28 Days : OECD Test Guideline 412 :
: Pituitary gland, Immune system, muscle
Aspiration toxicity Not classified based on available information. Experience with human exposure Components:
SECTION 12. ECOLOGICAL INFORMATION
SAFETY DATA SHEET according to the Hazardous Products Regulations RGANON
SECTION 13. DISPOSAL CONSIDERATIONS
International Regulations
NON
UNRTDG UN number Proper shipping name : .. UN 3082 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (betamethasone)
.. 9 ==
9 Environmentally hazardous ..
IATA-DGR UN/ID No. Proper shipping name
IMDG-Code UN number Proper shipping name : UN 3082 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, . N.O.S. (Betamethasone)
Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Not applicable for product as supplied. Domestic regulation TDG UN number Proper shipping name .. .. UN 3082 ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S. (Betamethasone)
= 9
171 yes(Betamethasone) 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 variations in regional or country regulations.
NON
SECTION 15. REGULATORY INFORMATION The ingredients of this product are reported in the following inventories: AICS : not determined
SECTION 16. OTHER INFORMATION 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 Level; 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, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Tempera- ture; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transporta- tion 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 Sources of key data used to compile the Material Safety Data Sheet . Internal technical data, data from raw material SDSs, OECD eChem Portal search results and European Chemicals Agen- cy, http://echa.europa.eu/ Revision Date 04/06/2024 :
Items where changes have been made to the previous version are highlighted in the body of this document by two vertical lines. The information provided in this Safety Data Sheet is correct to the best of our knowledge, information 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 material 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 appropriateness of the SDS material in the user's end product, if applicable. CA / Z8