GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 59-66-5
Chemical Name Acetazolamide
Substance ID H29-A-007
Classification year (FY) FY2017
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link)  
Model SDS by MHLW (External link)  
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- - It is a thiadiazol compound which contains neighboring nitrogen atoms, but does not correspond to azides, hydrazines, aliphatic azo compounds, diazonium salts, or sulfonyl hydrazides. Therefore, it does not correspond to explosives.
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 solids Classification not possible
-
-
- - No data available.
8 Self-reactive substances and mixtures Not applicable
-
-
- - It is a thiadiazol compound which contains neighboring nitrogen atoms, but does not correspond to azides, hydrazines, aliphatic azo compounds, diazonium salts, or sulfonyl hydrazides. Therefore, it does not correspond to self-reactive substances and mixtures.
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
-
-
- - No data 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 Classification not possible
-
-
- - It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to the element other than carbon or hydrogen (S). However, the classification is not possible due to no data.
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 Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - There is a report of an LD50 value of 3,000-6,000 mg/kg for mice (IPCS, PIM 005 (1995)), and it corresponds to "Not classified" (Category 5 in UN GHS classification) or "Not classified." By adopting the category with higher hazard, this substance was classified as "Not classified" (Category 5 in UN GHS classification).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
2 Skin corrosion/irritation Classification not possible
-
-
- - Classification not possible due to lack of data.
3 Serious eye damage/eye irritation Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there are no in vivo data. As for in vitro, it was negative in a bacterial reverse mutation test (Brambilla and Martelli, Mutation Res., 209-229, 2009). However, this information is from PDR (Physicians' Desk Reference).
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
This substance is a therapeutic drug for glaucoma, epilepsy, etc., and it is considered desirable not to administer it to women in early pregnancy or women suspected of being pregnant from the findings in animal experiments (described later) (Ethical Pharmaceuticals 2017 (2016)). In the experimental animals, this substance crosses the placenta, and it is reported that in a study in which 0.60% of this substance was administered by feeding to pregnant rats and pregnant mice during gestation periods, defects of the fourth and fifth digits from the right forelimb mainly occurred in fetuses (IPCS, PIM 005 (1995), HSDB (Access on August 2017)), and that in a test with pregnant rabbits orally dosed (50-150 mg/kg/day) during the organogenesis period (gestational day 6-18), increased incidence of skeletal malformations (increased incidence of malformations of the thoracic and lumbar vertebrae, defects of the vertebrae) were seen at doses where the maternal toxicity (decreased body weight gain, acidosis, electrolyte change) was manifested (HSDB (Access on August 2017)). From the above, since the application to pregnant women or women who may be pregnant is restricted based on the findings such as induction of the malformations in experimental animals, it was classified in Category 1B.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Category 1 (nervous system, liver, hematopoietic system, kidney)


Danger
H372 P260
P264
P270
P314
P501
As for humans, there are reports of a case of a person who died due to cholestatic jaundice, a case which showed lethal bone marrow depression with leukopenia, thrombocytopenia, and anemia, and a case with renal failure (anuria), etc. (IPCS, PIM 005 (1995)). In addition, headache, confusion, depression, irritability, nervousness, dizziness and ataxia are reported (IPCS, PIM 005 (1995)).
From the above, it was classified in Category 1 (nervous system, liver, hematopoietic system, kidney).
10 Aspiration hazard Classification not possible
-
-
- - Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
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.
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available.


NOTE:
* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* 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.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

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