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ERMA200009 Salvia Decision Vfinal DETERMINATION ON WHETHER A SUBSTANCE IS A HAZARDOUS SUBSTANCE PURSUANT TO SECTION 26 OF THE HSNO ACT 29 October 2009 Application Code ERMA200009 Application Type To determine whether a substance is hazardous under Section 26 of the Hazardous Substances and New Organisms Act 1996 (“the Act”). Applicant Ministry of Health Date Application Received 24 July 2009 Consideration Date 29 October 2009 Considered by A Committee of the Authority (“the Committee”) Purpose of the Application To determine whether preparations of Salvia Divinorum are hazardous. 1 Application process 1.1 The Agency received an application requesting a formal determination on whether preparations of Salvia Divinorum are hazardous substances under section 26 of the HSNO Act. 1.2 The application was formally received on 24 July 2009. 1.3 The evaluation of the application was undertaken by the ERMA New Zealand project team (“the Agency”) which comprised the following staff members: Matthew Allen Advisor (Hazardous Substances) Tonderai Kaitano Advisor (Hazardous Substances) 1.4 The report was reviewed and signed out by: Lynne Waterson Applications Manager (Hazardous Substances). 1.5 No external experts were used in the consideration of this application. 1.6 The following members of the Authority considered the application: Helen Atkins (Chair) and Shaun Ogilvie. 1.7 The information available to the Committee comprised: the application; and this report. 2 Background to the application Purpose of the application 2.1 To determine whether preparations of Salvia Divinorum (i.e. preparations of Salvia Divinorum that contain the substance salvinorin-A) are hazardous. Identification of Salvinorin-A 2.2 Salvia Divinorum is a perennial herb of the mint family native to Mexico which is now also grown in many countries (Drug Enforcement Administration, 2008). It has gained popularity as a widely-available substance of abuse (Butelman et al., 2009). 2.3 Salvia Divinorum produces several closely related neoclerodane diterpenes, with salvinorin A being the psychoactive compound that can be extracted from Salvia Divinorum. 2.4 Salvinorin A is a potent naturally occurring hallucinogen and has been described as “the most potent naturally occurring hallucinogen known, rivalling the synthetic hallucinogen lysergic acid diethylamide in potency” (Sheffler and Roth, 2003). 2.5 Fresh leaves of this plant may be chewed, prepared as an aqueous infusion (possibly to be inhaled or injected), or dried and smoked (Valdes, 1994). 2.6 The structural formula of and general information on salvinorin-A can be found below in Table 2.1 and Figure 1. Table 2.1: Identification of Salvinorin-A. CAS number: 83729-01-5 IUPAC name 2H-Naphtho(2,1-c)pyran-7-carboxylic acid, 9- (acetyloxy)-2- (3-furanyl)dodecahydro-6a,10b- dimethyl-4,10-dioxo-, methyl ester, (2S- (2alpha,4aalpha,6abeta,7beta,9beta,10aalpha,10bbeta))- Common name Salvinorin-A Synonyms Divinorin A Salvinorin Molecular formula C23H28O8 Molecular weight 432.47 Known uses Used as an illicit hallucinogen. Being investigated for use in treatment of certain psychiatric disorders such as schizophrenia and Alzheimer‟s disease, as well as various mood disorders (Vortherms and Roth, 2006). HSNO classification 6.9A ERMA New Zealand Section 26 Determination - ERMA200009 Page 2 of 19 Figure 1: Structural formula of Salvinorin-A 3 Hazardous property assessment Hazard classification 3.1 The Agency has based its assessment of preparations of Salvia Divinorum on the ingredient salvinorin-A, and has not taken into consideration the toxicity of possible additional components e.g. solvents, co-formulants in preparations. 3.2 The Agency does not have information on amounts likely to be present in preparations and thus our classifications are based on whether there is sufficient evidence to suggest that salvinorin-A has the intrinsic potential to trigger any of the HSNO least degrees of hazard. The Agency notes that salvinorin-A is found in the leaves of Salvia Divinorum at concentrations ranging from 0.89 to 3.7 mg/g and up to about 0.15 mg/g in the stems (Siebert, 2004). 3.3 Using information contained in the referenced literature (Appendix 1), the Agency has classified Salvinorin-A (refer to Appendix 2). The summary of this classification is detailed in Table 3.1: Table 3.1: Summary of the Agency’s classifications of Salvinorin-A Hazardous Property Agency’s Classificati Component(s) Classification on Method driving classification Explosiveness No data# N/A No data Flammability No data# N/A No data Physical Oxidising No data# N/A No data Metal corrosive No data# N/A No data 6.1 oral No data# N/A No data 6.1 dermal No data# N/A No data 6.1 inhalation No data# N/A No data Toxicity 6.3/8.2 Skin irritation/corrosion No data# N/A No data 6.4/8.2 Eye irritation/corrosion No data# N/A No data 6.5 Respiratory sensitization No data# N/A No data ERMA New Zealand Section 26 Determination - ERMA200009 Page 3 of 19 Hazardous Property Agency’s Classificati Component(s) Classification on Method driving classification # 6.5 Contact sensitisation No data N/A No data # 6.6 Mutagenicity No data N/A No data # 6.7 Carcinogenicity No data N/A No data # 6.8 Reproductive developmental toxicity No data N/A No data 6.9 Target organ systemic toxicity 6.9A Test data Salvinorin A # 9.1 Aquatic ecotoxicity No data N/A No data # Aquatic Persistence No data N/A No data # Bioaccumulative No data N/A No data # Ecotoxicity 9.2 Soil ecotoxicity No data N/A No data # Soil Persistence No data N/A No data # 9.3 Terrestrial vertebrate ecotoxicity No data N/A No data # 9.4 Terrestrial invertebrate ecotoxicity No data N/A No data # No data represents insufficient data or lack of data for this endpoint. 3.4 A summary of the hazardous property assessment is provided below. Refer to Appendix 2 for further information. Class 1: Substances with Explosive Properties 3.5 No information was located to determine whether salvinorin-A is explosive. It is therefore considered there is no information to classify salvinorin-A for explosivity. Classes 2-4: Flammability 3.6 No information was located to determine whether salvinorin-A is flammable. It is therefore considered there is no information to classify salvinorin-A for flammability. Class 5: Oxidisers/Organic Peroxides 3.7 No information was located to determine whether salvinorin-A has oxidising properties. It is therefore considered there is no information to classify salvinorin-A for oxidising properties. Sub-class 8.1: Metal Corrosiveness 3.8 No information was located to determine whether salvinorin-A is corrosive to metals. It is therefore considered there is no information to classify salvinorin-A for corrosivity to metals. ERMA New Zealand Section 26 Determination - ERMA200009 Page 4 of 19 Class 6: Toxicity Sub-class 6.1 – Acute toxicity 3.9 No information was located to determine whether salvinorin-A is an acute oral, dermal or inhalation toxicant (6.1). It is therefore considered there is no information to classify salvinorin-A for acute toxicity. Sub-class 6.3 – Skin Irritation 3.10 No information was located to determine whether salvinorin-A is a skin irritant (6.3A). It is therefore considered there is no information to classify salvinorin-A for skin irritancy. Sub-class 6.4 – Eye Irritation 3.11 No information was located to determine whether salvinorin-A is an eye irritant (6.4A). It is therefore considered there is no information to classify salvinorin-A for eye irritancy. Sub-class 6.5 – Respiratory (6.5A) and Contact (6.5B) Sensitisation 3.12 No information was located to determine whether salvinorin-A is a respiratory sensitiser (6.5A). It is therefore considered there is no information to classify salvinorin-A for respiratory sensitisation. 3.13 No information was located to determine whether salvinorin-A is a contact sensitiser (6.5B). It is therefore considered there is no information to classify salvinorin-A for contact sensitisation. Sub-class 6.6 – Mutagenicity 3.14 No information was located to determine whether salvinorin-A is a mutagenic toxicant (6.6). It is therefore considered there is no information to classify salvinorin-A for mutagenicity. Sub-class 6.7 – Carcinogenicity 3.15 No information was located to determine whether salvinorin-A is a carcinogenic toxicant (6.7). It is therefore considered there is no information to classify salvinorin-A for carcinogenicity. Sub-class 6.8 – Reproductive/Developmental Toxicity 3.16 No information was located to determine whether salvinorin-A is a reproductive or developmental toxicant (6.8). It is therefore considered there is no information to classify salvinorin-A for Reproductive/Developmental Toxicity. Sub-class 6.9 – Target Organ Toxicity ERMA New Zealand Section 26 Determination - ERMA200009 Page 5 of 19 3.17 A number of literature studies and reviews have been sourced investigating the effects of preparations of Salvia Divinorum and salvinorin-A: 3.17.1 Salvinorin-A targets the central nervous system in non-human primates, consistent with observations in humans; 3.17.2 Very low doses of salvinorin-A exert target organ effects in non-human primates, supporting a classification of 6.9A, rather than 6.9B; 3.17.3 A decrease in locomotor activity over a 30 minute time period was observed in rats for salvinorin-A administered by intraperitoneal injection. Although the exposure route is not relevant to humans, these findings are consistent with observations in humans and are supportive of a 6.9A classification; 3.17.4 Salvinorin-A targets specific receptors (κ1-opioidreceptor and κ2-opioidreceptor (weak interaction)), supporting classification of salvinorin-A as a target organ toxicant; 3.17.5 Information contained in a US Drug Enforcement Agency review indicates that absorption of salvinorin-A across the oral mucosa, or smoking pure salvinorin-A affects the central nervous system, causing psychic effects and adverse physical effects, supporting a target organ toxicant classification (6.9A), specifically affecting the central nervous system.
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