NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	54-85-3
Chemical Name	Isoniazid
Substance ID	m-nite-54-85-3_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Classification not possible	- -	-	-	The substance contains a chemical group associated with an explosive property (neighboring nitrogen atoms), but the classification is not possible due to no data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	The substance contains a chemical group associated with an explosive property (neighboring nitrogen atoms), but the classification is not possible due to no data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	An organic compound that contains oxygen which is not chemically bonded to elements other than carbon or hydrogen.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	From an LD50 value of 650 mg/kg bw for rats (PIM 288 (1999), corresponding to List 1), it was classified in Category 4.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	A negative in a dominant lethal test using mice (in vivo heritable germ cell mutagenicity test) (IARC Suppl. 7 (1987)) and negatives in both of the chromosomal aberration test using human lymphocytes treated with this substance and the chromosomal aberration test using rodents (in vivo mutagenicity test) (IARC Suppl. 7 (1987)) were reported. Therefore, it was classified as "Not classified." Besides, a sister chromatid exchange test and a DNA damage test using rodents (in vivo genotoxicity test) also resulted in negatives. (IARC Suppl. 7 (1987)) But, positives in an Ames test and a chromosomal aberration test using cultured rodent cells were reported as in vitro tests. (IARC Suppl. 7 (1987))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" based on the Group 3 classification in an IARC carcinogenicity evaluation (IARC Suppl. 7 (1987)). Besides, as animal test data on oral administration via diet or drinking water, a dose-dependent increase in the incidence of lung tumors in mice, but no clear increase in the tumor in rats, and no significant effects in hamsters were found. (IARC 4 (1974)) Besides, as a result of a large-scale epidemiological survey in humans, neither a statistically significant increase in deaths from lung tumors and incidence in lung tumors, nor an increase in a frequency of deaths from cancers were observed. (IARC 4 (1974))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	From some reports on adverse effects on the development of the offspring in humans such as an increase in a malformation rate and severe encephalopathies in infants of mothers exposed during the first 3 to 4 months of pregnancy, a stillborn baby with the arthrogryposis multiple congenital syndromes from a mother taken a large dose in a suicide attempt (Birth Defects (3rd, 2000), corresponding to List 2), and births of 10 malformed infants from 85 mothers (Teratogenic (12th, 2007), corresponding to List 2) from List 2 information, it was classified in Category 2. Besides, there is the information that no dosing in pregnant women or women anticipating pregnancy is desirable (development disorders of fetuses were found in mice) (Ethical pharmaceuticals (2010), corresponding to List 1). Furthermore, though this substance is excreted in breast milk, effects on or via lactation were not used as a basis for classification due to its low concentration in milk (HSDB (2005)).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	From a description of acute effects of exposure such as seizures found at doses of 30 to 40 mg/kg, even at a low dose of 14 mg/kg in adults with prior seizure disorders (PIM 288 (1999)), and a description of initial symptoms such as vision disorders, dizziness, and slurred speech in addition to nausea and vomiting followed by severe grand mal seizures, respiratory distress, and coma and so on in the second stage (PIM 288 (1999)), it was classified in Category 1 (nervous system).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system, liver, blood)	Danger	H372	P260 P264 P270 P314 P501	In chronic use of this substance which is used as a tuberculosis chemotherapeutic medicine, peripheral neuropathy and hepatotoxicity are described as the most common adverse effects. (PIM 288 (1999)) (Ethical pharmaceuticals (2010), corresponding to List 1) From the information that peripheral neuropathy, whose predisposing factors are alcohol, malnutrition, pregnancy and so on, manifests dose-dependently and is uncommon at 5 mg/kg/day and frequent at 300 mg/kg/day (PIM 288 (1999)), it was classified in Category 1 (nervous system). On the other hand, from a description of an asymptomatic elevation of serum GOT shown in 10 to 20% of patients and a possibility of hepatitis with jaundice (0.5%) which occurs within the 3 months following the onset of the treatment (PIM 288 (1999)), it was classified in Category 1 (liver). Furthermore, it was classified in Category 1 (blood) because disseminated intravascular coagulation syndrome, granulocytosis, anemia, thrombocytopenia, and so on are listed as other main adverse effects (PIM 288 (1999)). From the above, the classification resulted in Category 1 (nervous system, liver, blood).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 24-hour EC50 = 84.6 mg/L for crustacea (Daphnia magna) (AQUIRE, 2012).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Reliable chronic toxicity data were not obtained. Due to lack of rapid degradability (BIOWIN), and acute toxicity Category 3, it was classified in Category 3.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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