GHS Classification Result

Chemical Name：ephedrine
CAS：299-42-3

Result：
ID: 20A2203
Classifier: Ministry of Health, Labour and Welfare （MHLW）, Ministry of the Environment （MOE）
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government （Sep, 2008）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Solid (GHS definition)
3 Aerosols Not applicable - - - - Not aerosol products.
4 Oxidizing gases Not applicable - - - - Solid (GHS definition)
5 Gases under pressure Not applicable - - - - Solid (GHS definition)
6 Flammable liquids Not applicable - - - - Solid (GHS definition)
7 Flammable solid Classification not possible - - - - No data available.
8 Self-reactive substances and mixtures Not applicable - - - - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable - - - - Solid (GHS definition)
10 Pyrophoric solids Classification not possible - - - - No data available.
11 Self-heating substances and mixtures Classification not possible - - - - Its melting point is 33degC-39degC (Ullmanns (E) 6th, 2003). Test methods applicable to solid (melting point <= 140degC) substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - - Solid (GHS definition)
14 Oxidizing solids Not applicable - - - - The substance contains oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity （Oral） Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ... 		Based on its rat LD50 value of 600 mg/kg bw (RTECS, 2008: original literature, Psychotropic Drugs and Related Compounds, 2nd ed., Usdin, E., and D.H. Efron, Washington, DC, 341,1972), the substance was classified into Category 4. Its mouse LD50 value of 689 mg/kg bw (RTECS, 2008: original literature, Japanese Journal of Toxicology. 4,143,1991) also indicated Category 4. In humans, the overdose of a drug containing ephedrine was associated with tachycardia and difficulty in breathing, as well as documented cases of death due to heart failure and asphyxiation (HSDB, 2007). With ephedrine sulfate, the mouse LD50 values were 812 mg/kg bw (male) and 1072 mg/kg bw (female) (HSDB, 2007), which also fall into Category 4.
1 Acute toxicity （Dermal） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Solid (GHS definition)
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available.
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - No data available.
2 Skin corrosion/irritation Classification not possible - - - - No data available.
3 Serious eye damage/eye irritation Classification not possible - - - - No data available.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
5 Germ cell mutagenicity Not classified - - - - Since negative results were obtained from in vivo mutagenicity tests using somatic cells (micronucleus tests using mouse erythrocytes) (HSDB, 2007), the substance was classified into "Not classified". In addition, three Ames tests also yielded negative results (NTP DB, accessed in November 2008; HSDB, 2007).
6 Carcinogenicity Classification not possible - - - - No data available.
7 Reproductive toxicity Category 1A, Additional category: Effects on or via lactation Danger H360: May damage fertility or the unborn child
H362: May cause harm to breast-fed children 		P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P263: Avoid contact during pregnancy/while nursing.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product. 		In humans, specific deformation was reliably observed in infants among 373 pregnant women who took ephedrine within 4 months of pregnancy (Birth Defects 3rd. Ed, 2000; Teratogenic 12th Ed, 2007). Based on this document, the substance was classified into Category 1A. In addition, it is documented that ingested ephedrine is distributed into breast milk and thus use by nursing mothers is not recommended because of the higher than usual risks for infants (HSDB, 2007). Thus, in addition to its classification into Category 1A, the substance was also classified into the additonal category indicating adverse effects on or via lactation.
8 Specific target organ toxicity - Single exposure Category 2 (heart, nervous system) Warning H371: May cause damage to organs (heart, nervous system) P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P405: Store locked up.
P501: Dispose of contents/container to ... 		In humans, an overdose of ephedrine or Ma-huang (a Chinese herbal medicine used as an ingredient of ephedrine) intake is associated with toxicity to the nervous system such as nausea, vomiting, chills, sweating, fever, convulsions, dilated pupils, irritability, hypertension, and suicidal behavior (HSDB, 2007). Furthermore, heart-related symptoms such as tachycardia, difficulty in breathing, and cyanosis were observed. This description is consistent with the documented case in which a 36-year-old healthy male pilot suffered from cardiac arrest after taking an over-the-counter supplement that included Ma-huang. In this document, Ma-huang is described to increase the risk of cardiac infarction and central nervous system dysfunctions (HSDB, 2007). Therefore, the substance was classified into Category 2 (heart, nervous system).
9 Specific target organ toxicity - Repeated exposure Category 2 (heart, nervous system) Warning H373: May cause damage to organs through prolonged or repeated exposure (heart, nervous system) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		In humans, the following cases have been documented: a reservist produced increase in blood pressure after taking large doses of Ephedra sinica, or ma huang, a Chinese herbal supplement (both are ingredients of ephedrine) for bodybuilding, a 39-year-old man developed vasculitis and hypersensitivity myocarditis after taking a Ma-huang product for 3 weeks, a 23-year-old body builder died after taking a bodybuilder supplement containing Ma-huang for more than six weeks (myocardial necrosis, mild fibrosis, moderate myocyte hypertrophy, and vascular congestion were observed), and a 45-year-old woman died of cardiovascular collapse after taking Ephedra (HSDB, 2007). Since these are heart-related symptoms, the substance was classified into Category 2 (heart). Moreover, because ephedrine addiction (paranoid psychosis, delusions and hallucinations) has been observed by its long-term use (overdose) (HSDB, 2007), it was classified into Category 2 (nervous system). Also, supplements containing Ephedra sinica or Ma-huang are documented to have side effects such as urinary disorder, gastrointestinal effects, and hepatitis (HSDB, 2007). However, since the information is insufficient and these symptoms could be secondary effects, we did not use these study results as grounds for classification.
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment （Acute） Classification not possible - - - - No data available.
11 Hazardous to the aquatic environment （Long-term） Classification not possible - - - - No data available.


NOTE:
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government, and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.

Reference：
Reference Manual
Definitions / Abbreviations
Model Label by MHLW

 MHLW Website （in Japanese Only）
Model SDS by MHLW

 MHLW Website （in Japanese Only）

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