NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	78-59-1
Chemical Name	Isophorone
Substance ID	m-nite-78-59-1_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	- -	-	-	Classification not possible due to lack of data, though the substance contains unsaturated C-C bonds as chemical groups associated with explosive properties present.	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	Although flash point by open cup measuring device was 96.1 degC, it adopted 84 degC of flash point by a closed cup flash point analyzer device, and was classified as Category 4 (GHS standards: flash point being more than 60 degC and 93 degC or less).	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	Classification not possible due to lack of data, though the substance contains unsaturated C-C bonds as chemical groups with self-reactive properties present.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified	- -	-	-	The ignition points is 460 - 462 degC (ICSC (J) (2000), pocket book books (1997))	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available	FY2006	GHS Classification Manual （10 Feb, 2006）
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 metaloids(B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing oxygen (but not chlorine and fluorine) chemically bonded only to carbon (but not to other elements).	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no -0-0- structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
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	It was set as Category 4 based on rat LD50 =1843mg/kg: calculated by the technical guideline using seven data of rat (SIDS (2003), EHC 174 (1995)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	LD50 = 1265mg/kg calculated by the technical guideline using 4 examination of rabbits (SIDS (2003), PATTY (5th, 2001)). And LD50 = 1700mg/kg (SIDS (2003)) of a rat examination. It was set as Category 4 based on the lower value.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	-	- Warning	-	-	It done by higher concentrations than the saturated vapor pressure pressures concentrations, and based on LC50 = 7mg/L (SIDS (2003)) of the rat inhalation test considered to be mist tests. So it was set as Category 5	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Category 3	- Warning	-	-	Based on the report that in test of less than 4 hours on rabbits or guinea pigs, there was mild skin irritation or no stimulativeness observed (SIDS (2003), EHC 174 (1995), PATTY (5th, 2001)), it was classified as Category 3.	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	There is the statement that humans had eye irritationt (ACGIH (2001), SIDS (2003)), and that there was moderate or mild eye irritation (SIDS(2003), EHC 174 (1995)), and that although moderate to severe impairment was produced, it recovered within 14 days in rabbit test (SIDS (2003)). So it was set as Category 2A-2B.	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Skin sensitization	Not classified	- -	-	-	Based on the statements that sensitization was not identified in guinea pigs tests [ SIDS (2003) and EHC 174 (1995)] and that there is no sensitization in humans(SIDS (2003), ECETOC JACC 10 (1989)), it was put outside of the Category.	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Germ cell mutagenicity	Not classified	- -	-	-	The lack of results for human over generation epidemiology, the over generation mutagenicity test, and the productive cell in vivo mutagenicity test, and based on the statement that it gave negative by two in vivo somatic mutagenicity examinations (mouse bone marrow cells micronucleus test) (SIDS (2003), EHC 174 (1995), ECETOC JACC 10 (1989)). So we classified it as Out Of Category by the technical guideline.	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	It was set as 2. Based on being classified into A3 according to ACGIH (ACGIH (2001)), and being classified into a category 3 by EU and R40 being given (EU-Annex I (2005)).	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Reproductive toxicity	Not classified	- -	-	-	Since it is not observed that adverse effects on genital tract and fetal development in the rat or mouse test (SIDS (2003), EHC 174 (1995), PATTY (5th, 2001)) and the dog study (SIDS (2003)), it is considered as on the outside of Categry.	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Specific target organ toxicity - Single exposure	Category 3 (respiratory tract irritation, narcotic effects)	Warning	H335 H336	P304+P340 P403+P233 P261 P271 P312 P405 P501	There is the respiratory irritation (irritation of nose and throat) and anesthetic action (nausea, headache, dizziness, faint, choking sensation) (ACGIH (2001), EHC 174 (1995)) in human exposure report. And there is the description that there is respiratory irritation also in rat and rabbit (EHC 174 (1995)) and there are symptoms which indicate anesthetic action such as ataxia, suppression state and coma (EHC 174 (1995), SIDS (2003)). So it is classified into Category 3 (respiratory irritation and anesthetic action)	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In the example of exposure in the humans mentioned of SIDS (2003), effects to specific organ is not admitted, but only fatigue and malaise are reported. In an animal examination, serious effects on specific organ is not admitted by oral dosage higher than the guidance value of Category 2 (SIDS (2003), EHC 174 (1995)). However, the affect (bleeding,edema,inflammatory,changes in the tissue) on lungs and the affect (changes in the tissues) on the kidney are mentioned with higher dosage than the guidance value of 2 in the inhalation test of the animal (EHC 174 (1995), PATTY (5th, 2001)). In order that there might be no data which serves as a conclusive factor of a classification among the above informations, it was presupposed that it cannot be classified.	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

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)	Not classified	- -	-	-	It was classified as "Not classified" from 72-hour EC50 (growth rate) = 230 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2018)), 48-hour EC50 (immobile) = 117 mg/L for crustacea (Daphnia magna) (WHO/IPCS EHC: 1995), and 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2018)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	It was classified as "Not classified" from 32-day NOEC (body weight) = 4.15 mg/L for fish (Pimephales promelas) (EPA AQUIRE: 2018, Lemke, A. E. (1983)) although it is not rapidly degradable (not readily degradable, a degradation rate by BOD: 1.5% (J-CHECK, 1975)).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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