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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	67-63-0
Chemical Name	Isopropyl alcohol
Substance ID	25B0016
Classification year (FY)	FY2013
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance by the Japanese Government (July, 2013)
UN GHS document (External link)	UN GHS document
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 Signal word	Hazard statement (code)	Precautionary statement (code)	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	- -	-	-	Liquid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Liquid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Liquid (GHS definition)
6	Flammable liquids	Category 2	Danger	H225	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	It was classified in Category 2 based on a flash point of 12 deg C (closed cup) and a boiling point of 82.3 deg C (HSDB (Access on July 2013)). Besides, it is classified in Class 3, PG II (UN1219) in UNRTDG.
7	Flammable solid	Not applicable	- -	-	-	Liquid (GHS definition)
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 399 deg C (HSDB (Access on July 2013)).
10	Pyrophoric solids	Not applicable	- -	-	-	Liquid (GHS definition)
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available. The classification was revised according to the GHS classification guidance for the Japanese government.
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	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14	Oxidizing solids	Not applicable	- -	-	-	Liquid (GHS definition)
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	No data 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	- -	-	-	It was classified as "Not classified" based on LD50 for rats of 4,384 mg/kg (EPA Pesticides (1995)), 4,396 mg/kg (EHC 103 (1990)), 4,710 mg/kg (EHC 103 (1990), PATTY (6th, 2012), SIDS (2002)), 5,000 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), 5,045 mg/kg (Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), 5,280 mg/kg (EHC 103 (1990), SIDS (2002)), 5,300 mg/kg (PATTY (6th, 2012)), 5,480 mg/kg (EHC 103 (1990), PATTY (6th, 2012)), 5,500 mg/kg (EHC 103 (1990), SIDS (2002)), and 5,840 mg/kg (PATTY (6th, 2012), SIDS (2002)). By adding the information in EPA Pesticides (1995), PATTY (6th, 2012), Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008) obtained in this investigation, the classification was changed from Category 5 to "Not classified" according to the Classification JIS.
1	Acute toxicity (Dermal)	Not classified	- -	-	-	It was classified as "Not classified" based on LD50 of 12,870 mg/kg for rabbits (EHC 103 (1990), PATTY (6th, 2012), SIDS (2002)). Besides, because the precedence of literature was changed, data in PATTY (6th, 2012) obtained in this investigation were used for the rationale.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Liquid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not classified	- -	-	-	It was classified as "Not classified" based on LC50 (4 hours) for rats of 68.5 mg/L (27,908 ppmV) (EPA Pesticides (1995)) and 72.6 mg/L (29,512 ppmV) (EHC 103 (1990), SIDS (2002)). Besides, because the LC50 values were lower than 90% of the saturated vapour pressure concentration (53,762 ppmV (25 deg C)), a reference value in the unit of ppmV as a vapour without mist was applied for the classification. Besides, data in EPA Pesticides (1995) obtained in this investigation were used for the rationale. Data from reliable information sources obtained in this investigation were used.
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	It is reported in EHC 103 (1990), PATTY (6th, 2012), ECETOC TR66 (1995) that there was no or slight irritation in skin irritation tests with rabbits, but it is reported in EHC 103 (1990) that no irritation was shown in humans in skin application tests in volunteers or for the treatment of alcoholics, therefore it was thought to be minimally or slightly irritating. Therefore, it was classified as "Not classified" (Category 3 in UN GHS classification) in JIS classification.
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In EHC (1990), SIDS (2002), PATTY (6th, 2012), ECETOC TR48 (1998), slight to severe irritation is reported in eye irritation tests with rabbits, but severe damage is not described. Therefore, it was classified in Category 2.
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. As for in vivo, negative results are reported in a micronucleus test with mouse bone marrow cells (SIDS (2002)) and a chromosomal aberration test with rat bone marrow cells (EHC 103 (1990)), which are somatic cell mutagenicity tests. As for in vitro, there are no data in a chromosomal aberration test, and it was negative in a bacterial reverse mutation test (SIDS (2002), EHC 103 (1990)) and an hgprt gene mutation test with cultured mammalian cells (SIDS (2002)). Besides, it is described in IARC 71 (1999), Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008) that it is not mutagenic. The category was changed according to the revised GHS classification guidance for the Japanese government.
6	Carcinogenicity	Classification not possible	- -	-	-	It was classified as "Classification not possible" because it is classified in Group 3 in IARC 71 (1999) and A4 in ACGIH (7th, 2001). The category was changed according to the revised GHS classification guidance for the Japanese government.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	It is described that no reproductive or developmental toxicity was observed in a two-generation test with rats by oral administration (IARC 71 (1999), EHC 103 (1990)), but the details of the data are unknown. It is described that in a relatively new two-generation test with rats by oral administration, reduced mating index in paternal animals and lower values of body weights and increased mortality in offspring after birth were found at the dose where parent animals showed general toxicity effects (increased weights of the liver and kidney accompanied by histological changes) (PATTY (6th, 2012), SIDS (2002)). It is difficult to consider reduced mating index in paternal animals and adverse effects in neonates to be secondary/non-specific effects of general toxicity in parent animals. Furthermore, in a developmental toxicity test in which pregnant rats were orally administered, only slight effects (lower values of body weights, skeletal variations) were seen in fetuses, and there were no malformations, but reproductive toxicity effects such as failure of implantation and fully resorbed litters were observed at the dose where maternal toxicity (unsteady gait, narcotization, decreased food consumption and body weight gain) was found (PATTY (6th, 2012)). As a result, it was classified in Category 2 according to the GHS classification guidance for the Japanese government.
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, systemic toxicity), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	From descriptions in SIDS (2002), EHC 103 (1990), Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008), acute poisoning symptoms of this substance in humans include central nervous system depression (lethargy, coma, respiratory depression, etc.), irritation of the gastrointestinal tract (nausea, vomiting), effects on the circulatory system such as hypotension, hypothermia, and arrhythmia, and adverse effects occur in the whole body. And inhalation exposure irritates the nose and throat (cough, pharyngeal pain) (EHC 103 (1990), Environmental Risk Assessment for Chemical Substances vol. 6 (Ministry of the Environment, 2008)), therefore it is irritating to the respiratory tract. From the above, it was classified in Category 1 (central nervous system, systemic toxicity), Category 3 (respiratory tract irritation). Besides, Category 1 (kidney) was adopted in the previous classification, but data for the rationale is a case report in humans from the information source in List 3, and its source was old, which was not adopted in multiple information sources in List 1 and 2. Therefore, the kidney was judged to be inappropriate as the target organ and was removed.
9	Specific target organ toxicity - Repeated exposure	Category 1 (haemal system), Category 2 (respiratory organs, liver, spleen)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	It is described that in a 4-month inhalation test with rats exposed to the vapour of this substance, a decrease in the white blood cell count was observed at or above 100 mg/m3 (converted guidance value concentration: 0.067 mg/L/6 hours), and pathological effects were found in the respiratory organs (lung, bronchus), liver, and spleen in the group of 500 mg/m3 (converted guidance value concentration: 0.33 mg/L/6 hours) (EHC 103 (1990)). Therefore, the target organs were judged to be the blood system, respiratory system, liver, and spleen, Category 1 was given to the blood, and Category 2 was assigned for the respiratory system, liver, and spleen. Besides, in animal tests in the inhalation or oral route, narcotic effects and effects on the blood system were seen at the doses above guidance values for Category 2 (SIDS (2002), PATTY (6th, 2012)).
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data. The classification was revised because data in the previous classification could not be confirmed, and the GHS classification guidance for the Japanese government was revised.

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)	Not classified	- -	-	-	It was classified as "Not classified" from 72-hour ErC50 > 1000 mg/L for algae (Pseudokirchneriella subcapitata), 48-hour EC50 > 1000 mg/L for crustacea (Daphnia magna), and 96-hour LC50 > 100 mg/L for fish (Oryzias latipes) (all from Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)).
11	Hazardous to the aquatic environment (Long-term)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 86% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1993)), and 21-day NOEC > 100 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency) (1997), Environmental Risk Assessment for Chemical Substances Vol. 6 (Ministry of the Environment, 2008)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified as "Not classified" because it was classified as "Not classified" in acute toxicity, and it is not water-insoluble (In water, infinitely soluble at 25 deg C, HSDB, 2013). From the above results, it was classified as "Not classified."
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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