NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	16051-77-7
Chemical Name	Isosorbide mononitrate
Substance ID	m-nite-16051-77-7_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	Not classified	- -	-	-	It contains chemical groups (nitrates) associated with explosive properties. However, since it is defined as UN3251, Division 4.1, packing group III, and not Class 1 or Division 4.1, packing group I, the substance was classified into the "Not classified" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
7	Flammable solids	Category 2	Warning	H228	P370+P378 P210 P240 P241 P280	Since it is defined as Division 4.1, packing group III (UN 3251) by the UNRTDG, the substance was classified into Category 2 for flammable solids.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
8	Self-reactive substances and mixtures	Type G	- -	-	-	It contains chemical groups (nitrates) associated with explosive properties. However, since it is defined as UN3251, Division 4.1, packing group III, and not Division 4.1, packing group I, the substance was rated as Type G.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
14	Oxidizing solids	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Containing no bivalent -O-O- structure in the molecule	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
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)	-	- Warning	-	-	Based on its rat LD50 of 2010 mg/kg (RTECS (accessed in August 2007)), the substance was classified into Category 5.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
5	Germ cell mutagenicity	Not classified	- -	-	-	Negative results were obtained in an Ames test, mutation test using cultured mouse lymphoma cells, chromosomal aberration test using human lymphocytes, and in vivo mouse micronucleus test (HSDB (2005)). Based on these negative results, the substance was classified into the "Not classified" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
6	Carcinogenicity	Classification not possible	- -	-	-	No evidence of carcinogenicity was observed in rats exposed to this substance in their diets at doses of up to 900 mg/kg/day for the first 6 months and 500 mg/kg/day for the remaining duration of a study in which males were dosed for up to 121 weeks and females were dosed for up to 137 weeks (HSDB (2005)). However, due to no other test results available, the substance was classified into the "Classification not possible" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
7	Reproductive toxicity	Classification not possible	- -	-	-	In both a test in which rats received administration before mating, and in tests in which rats or rabbits received administration during the embryonic development, no toxic effects of the compound administered were detected (HSDB (2005)). In addition, in a test in which rats were treated during late gestation and lactation, effects on neonatal survival and development were noted only at a high dose (750 mg/kg/day) and the NOEL was found to be 300 mg/kg/day. However, since neither presence/absence of maternal toxicity nor details in reproductive toxicity are provided, the substance was classified into the "Classification not possible" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
8	Specific target organ toxicity - Single exposure	Category 1 (circulatory organ, central nervous system, gastrointestinal tract, liver, skin)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	This substance has vasodilation effects and it is clinically used to treat angina pectoris. Regarding this substance used as oral agents (tablets), the following side effects (shown in more than 0.1% of the subjects) are listed: cardiovascular symptoms such as dizziness/lightheadedness and palpitation, neuropsychiatric symptoms such as headache, a heavy-headed sensation, and malaise, hypersensitivity reactions such as rash and itching, digestive symptoms such as stomachache, nausea, and loss of appetite, effects to the liver such as elevated GOT/GPT/LDH levels and jaundice with increased gamma-GTP, and elevated CPK, BUN, and creatinine levels (2007 Drugs in Japan, 1083-1084; Jiho (2006); Pharmaceuticals and Medical Devices Agency/Approved products/Package inserts (2007)). Based on this information, the substance was classified into Category 1 for its toxic effects on the cardiovascular system, central nervous system, gastrointestinal tract, liver, and skin.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 3-month repeated oral administration test using rats, the TDLo and NOEL are reported to be 500 mg/kg/day and 125 mg/kg/day, respectively (Konishi, Koji et al. Pharmacometrics, 30, p. 1079-1111 (1985)). Because the NOEL is above the upper limit of Category 2 guidance values, the substance was classified into the "Not classified" category. No information is available on side effects of the substance in a repeated administration to humans. However, based on a report that tolerance may develop as this substance or other nitrate- or nitrite-group drugs are repeatedly administered and activities of these drugs may recede (2007 Drugs in Japan, 1083-1084, Jiho (2006); Pharmaceuticals and Medical Devices Agency/Approved products/Package inserts (2007)). These reports indicate that both repeated and single administrations presumably induce similar side effects. However, due to lack of test results, it was classified into the "Classification not possible" category.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）

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)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	FY2007	GHS Classification Manual （10 Feb, 2006）/Technical Guidance Document on the GHS Classification （6 Dec, 2005）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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