GHS Classification Result

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GENERAL INFORMATION

Item Information
CAS number 57-47-6
Chemical name Physostigmine
Substance ID 23A5114
Fiscal year of classification conducted FY2011
Classifier(s) (Ministries) Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
New/Revised New
Download in Excel format Excel file

REFERENCE INFORMATION

Item Information
Guidance used for classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010)
Environmental Hazards: UN GHS Document (4th revised edition)
Definitions / Abbreviations (Excel file) Definitions / Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Explosives Not applicable - - - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable - - - "Solids" according to GHS definition.
3 Aerosols Not applicable - - - Not an aerosol product.
4 Oxidizing gases Not applicable - - - "Solids" according to GHS definition.
5 Gases under pressure Not applicable - - - "Solids" according to GHS definition.
6 Flammable liquids Not applicable - - - "Solids" according to GHS definition.
7 Flammable solids Classification not possible - - - No data.
8 Self-reactive substances and mixtures Not applicable - - - Containing neither chemical groups related to explosibility nor those related to self-reactivity.
9 Pyrophoric liquids Not applicable - - - "Solids" according to GHS definition.
10 Pyrophoric solids Classification not possible - - - No data.
11 Self-heating substances and mixtures Classification not possible - - - No established test method suitable for solid substances with a melting point of 140 degrees C or lower.
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13 Oxidizing liquids Not applicable - - - "Solids" according to GHS definition.
14 Oxidizing solids Not applicable - - - An organic compound contains oxygen which is not chemically bonded to elements other than carbon.
15 Organic peroxides Not applicable - - - An organic compound that does not contain -O-O- structure.
16 Corrosive to metals Classification not possible - - - No data.

HEALTH HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
1 Acute toxicity (Oral) Category 1

Danger
H300
P301+P310
P264
P270
P321
P330
P405
P501
On the basis that an LD50 value of 4.5 mg/kg for rats (RTECS (2010); original literature; United States Patent Document: #5302593) in List 3 information is an already published data (TOXICOLOGY AND APPLIED PHARMACOLOGY, 21, 153-165 (1972)), it was classified in Category 1.
Besides, it is classified in T+; R26/28 in EU classification (EC-JRC (ESIS) (Access on July. 2011)).
1 Acute toxicity (Dermal) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - "Solids" according to GHS definition.
1 Acute toxicity (Inhalation: Vapours) Classification not possible - - - No data.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible - - - No data.
Besides, it is classified in T+; R26/28 in EU classification (EC-JRC (ESIS) (Access on July. 2011)).
2 Skin corrosion/irritation Classification not possible - - - No data.
3 Serious eye damage/eye irritation Classification not possible - - - No data.
4 Respiratory sensitization Classification not possible - - - No data.
4 Skin sensitization Classification not possible - - - No data.
5 Germ cell mutagenicity Classification not possible - - - No data.
6 Carcinogenicity Classification not possible - - - No data.
7 Reproductive toxicity Classification not possible - - - Lack of data.
Besides, details of the information that this substance induced a low incidence of skeletal defects following a single subcutaneous injection to pregnant mice (Birth Defects (3rd, 2000), corresponding to List 2) were unknown.
8 Specific target organ toxicity - Single exposure Category 2 (nervous system)

Warning
H371
P309+P311
P260
P264
P270
P405
P501
This substance is "an indirect-acting parasympathomimetic drug that promotes accumulation and potentiation of the actions of endogenous acetylcholine via a temporary inactivation of cholinesterase." (HSDB (2002))
Anticholinesterase syndrome shows central nervous and peripheral system symptoms such as mental confusion, disorientation, hallucination, hyperkinetic disorder, tachycardia, dilated pupils, vasodilation, anuria, impaired gastrointestinal motility, decreased secretion of saliva and sweat (NLM DailyMed, (Access on Nov. 2001)).
Because the above information is not from List 1 data, it was classified in Category 2 (nervous system).
9 Specific target organ toxicity - Repeated exposure Category 2 (nervous system)

Warning
H373
P260
P314
P501
This substance is "an indirect-acting parasympathomimetic drug that promotes accumulation and potentiation of the actions of endogenous acetylcholine via a temporary inactivation of cholinesterase." (HSDB (2002))
Anticholinesterase syndrome shows central nervous and peripheral system symptoms such as mental confusion, disorientation, hallucination, hyperkinetic disorder, tachycardia, dilated pupils, vasodilation, anuria, impaired gastrointestinal motility, decreased secretion of saliva and sweat (NLM DailyMed, (Access on Nov. 2001)).
Because overdose and long-term administration may cause the above symptoms, and the information is not from List 1 data, it was classified in Category 2 (nervous system).
10 Aspiration hazard Classification not possible - - - No data.

ENVIRONMENTAL HAZARDS

Hazard class Classification Pictogram
(Code: symbol)
Signal word
Code
(Hazard statement)
Code
(Precautionary statement)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Classification not possible - - - No data.
11 Hazardous to the aquatic environment (Long-term) Classification not possible - - - No data.
12 Hazardous to the ozone layer Classification not possible - - - This substance is not listed in Annexes to the Montreal Protocol.


NOTES:
* 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.



Updated date:
2016/8/17 Addition of Rationale for the classification

List of GHS Classification Results