General Information
Version
1.0
Revision date
2023-10-12
Product name
PROCAINE HYDROCHLORIDE 4% + ADRENALINE
REACH No
Not
1.2.1 Relevant identified uses
Veterinary medicinal product Professional uses
Emergency telephone
+32 (0) 14 67 20 51
Icons in SDS
Company Information
company name
V.M.D. nv/sa
e-mail address of the competent person responsible for the Safety Data Sheet
info@inovet.be
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H301, H336
Hazard statements
Code
Statements
H301
Toxic if swallowed
Section 2
SECTION 2: Hazards identification
Directive 1999/45/EC: Classification of the substance or mixture
2.3 Other hazards
Of no significance.
Results of PBT and vPvB assessment
no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 (CLP) Medicinal products for human or veterinary use, as defined in Directive 2001/83/EC and EU regulation 2019/6 in their final state and intended for the final user are exempted for both classification and labeling according to EU Directive 1999/45/EC art. 1.5 and Regulation EC 1272/2008 art. 1.5. Additional information According to Regulation EU 1272/2008; Article 1.5: This Regulation shall not apply to substances and mixtures in the following forms, which are in the finished state, intended for the final user: (a) medicinal products as defined in Directive 2001/83/EC; (b) veterinary medicinal products as defined in Directive 2001/82/EC (replaced by regulation 2019/6); (c) cosmetic products as defined in Directive 76/768/EEC; (d) medical devices as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC; (e) food or feeding stuffs as defined in Regulation (EC) No 178/2002 including when they are used: (i) as a food additive in foodstuffs within the scope of Directive 89/107/EEC; (ii) as a flavouring in foodstuffs within the scope of Directive 88/388/EEC and Decision 1999/217/EC; (iii) as an additive in feeding stuffs within the scope of Regulation (EC) No 1831/2003; (iv) in animal nutrition within the scope of Directive 82/471/EEC. Acute toxicity (oral), Category 3 H301 pecific target organ toxicity – Single exposure, Category 3, Narcosis H336 Full text of H- and EUH-statements: see section 16
