NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	75-31-0
Chemical Name	Isopropylamine
Substance ID	m-nite-75-31-0_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 (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Category 1	Danger	H224	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Based on a flash point of -37 deg C (closed cup), and a boiling point of 31.7 deg C (ICSC (J) (2015)), it was classified in Category 1. Besides, it is classified in Class 3, Subsidiary risk 8, PGI in UNRTDG (UN 1221).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 400 deg C (GESTIS (Access on September 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to low-temperature-boiling liquids are not available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	There are three reports of the LD50 values of 122 mg/kg, 552mg/kg (SIDS (2016)) and 820 mg/kg (PATTY (6th, 2012)) for rats, and one of the data corresponds to Category 3, two data correspond to Category 4. It was classified in Category 4 to which the largest number of data corresponds. The category was revised from the previous classification by use of a new information source.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Category 3	Danger	H311	P302+P352 P361+P364 P280 P312 P321 P405 P501	There are two reports of the LD50 values of 0.55 mL/kg (385 mg/kg) (PATTY (6th, 2012)), > 400 mg/kg (according to OECD TG 402) (SIDS (2016)) for rabbits. One corresponds to Category 3. Another corresponds to Category 4 or "Not classified," however, the classification could not be determined. The category with higher hazard was adopted, and it was classified in Category 3. Besides, when the assessment reports were confirmed, the LD50 value for rats described in PATTY (5th, 2001) which was adopted as the evidence of classification in the previous classification was the same rabbit data as in PATTY (6th, 2012).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Category 4	Warning	H332	P304+P340 P261 P271 P312	The LC50 value of 11.5 mg/L (4,761 ppm) (converted 4-hour equivalent value: 5.75 mg/L (2,381 ppm)) for rats in a 1-hour inhalation exposure test and the LC50 value of 8.7 mg/L (3,602 ppm) for rats in a 4-hour inhalation exposure test were reported (both from SIDS (2016)), one data corresponds to Category 3, and another corresponds to Category 4. According to the GHS classification guidance for the Japanese Government, the data of 4-hour inhalation exposure test was adopted, and this substance was classified in Category 4. Besides, since the exposure concentrations are lower than 90% of the saturated vapor pressure concentration (764,957 ppm), the reference values in the unit of ppm was applied as vapour with little mist.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 1A	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	Based on the description that in a skin irritation test with rabbits (equivalent to OECD TG 404), necrosis, followed by eschar, occurred within 24 hours after 3-minute application of this substance, and a description that corrosion was seen in both of other two tests with rabbits (application time: 1, 5, 15 minutes or 24 hours) (both from SIDS (2016)), this substance was classified in Category 1A. Besides, this substance is classified as "Skin Irrit. 2, H315" in EU CLP classification (ECHA CL Inventory (Access on August 2017)). Based on the information obtained in this investigation, the category was changed.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	This substance is classified Category 1A for skin corrosion/irritation. There is a description that in an eye irritation test with rabbits (equivalent to OECD TG 405), it showed corrosivity, by causing severe conjunctival irritation (erythema, chemosis, discharge, and necrosis), corneal opacity, and ulceration 24 hours after the application of this substance, and a description that in other two tests with rabbits, it showed corrosivity in both cases (SIDS (2016)). Therefore, this substance was classified in Category 1. Besides, this substance is classified as "Eye Irrit. 2, H319" in EU CLP classification (ECHA CL Inventory (Access on August 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	There are descriptions that no skin sensitization was found in a maximization test with guinea pigs (according to OECD TG 406) and that there was no skin sensitization in a LLNA test with mice (both by SIDS (2016)). This substance was classified as "Classification not possible" because no humans data was available.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data. No in vivo data was available, and as for in vitro, bacterial reverse mutation tests, in vitro mammalian cell mouse lymphoma tests and chromosome aberration tests were negative (SIDS (2016), HSDB (Access on August 2017), NTP DB (Access on September 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	In a one-generation reproduction toxicity study with rats exposed by inhalation, reproductive and developmental effects were not observed in the parental animals of males and females at up to the highest dose (499 mg/m3) at which 2/20 death cases were observed in paternal animals (SIDS (2016)). In addition, in a developmental toxicity study with pregnant rats exposed by inhalation during the period of organogenesis (gestation day 6-15), skeletal abnormalities (reduced ossification of the 13th rib, curved ribs) were observed in pups at the highest dose (1,000 mg/m3) where maternal toxicity (symptoms such as decreased weight gain, nasal discharge, rales, and labored breathing) was observed, but they were not statistically significant changes (SIDS (2016)). From the above, no findings which suggested reproductive and developmental effects were observed by inhalation route, however, no toxicity information by oral route was available. Therefore, this substance was classified as "Classification not possible" due to lack of data.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system, respiratory organs), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	As for humans, in a test with volunteers, complaints of irritation of the nose and throat by the subjects were reported after brief inhalation exposures at 10-20 ppm (ACGIH (7th, 2001), PATTY (6th, 2012)). As for experimental animals, it is reported that in 3 single dose oral administration studies with rats, decreased activity, staining around the nose and mouth, and labored breathing were observed at 118 mg/kg corresponding to Category 1; lethargy, labored breathing, piloerection and prostration were observed at about 173 mg/kg corresponding to Category 1; and intermittent respiration, blood crusts around the nose and ruffled fur were observed at 346 mg/kg corresponding to Category 2 (all reports from SIDS (2016)). As for dermal route, there is a report that in a single dermal exposure test with rats, dyspnea, apathy, staggering, spastic gait, tremor, piloerection, exophthalmos and poor general state were observed at 400 mg/kg corresponding to Category 1, but there were no mortalities (SIDS (2016)). As for inhalation route, there is a report that in a 4-hour single inhalation exposure test with rats, labored breathing, lacrimation, nasal discharge, reduced activity, closed eyes and moist and dry rales were observed at 2.8-6.5 mg/L corresponding to Category 1, and there was no description on cases of survival or death in gross findings at necropsy, however, a few cases of lung emphysema as well as reddening and swelling of the lungs were observed (SIDS (2016)). In addition, there is a report that in a 1-hour inhalation exposure study with rats, gasping, labored breath and rales were observed at or above 6.6 mg/L, a converted 4-hour equivalent value of which is 3.3 mg/L and corresponding to Category 1. By combining the above information in humans and experimental animals, this substance was classified in Category 1 (central nervous system, respiratory organs), Category 3 (narcotic effects). The classification result was changed from the previous classification due to the use of a new information source.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (respiratory organs)	Warning	H373	P260 P314 P501	As for humans, there are reports on acute eye and respiratory effects, but no information is available for chronic effects (ACGIH (7th, 2001), PATTY (6th, 2012)). As for experimental animals, there is a report that in a 1-month inhalation toxicity test (6 hours/day, 5 days/week, 20 applications) with rats, decreased body weight, inflammatory changes and degeneration of the eyes and nose at or above 0.5 mg/L (converted guidance value: 0.1 mg/L), which is within a guidance value range (vapor) for Category 1, and at 1.35 mg/L (converted guidance value: 0.3 mg/L), which is within a guidance value range (vapor) for Category 2, general conditions (ocular opacity, nasal crust etc.) which indicated eye and nose irritation were observed (HSDB (Access on August 2017)). In addition, in a 13-week inhalation toxicity test (6 hours/day, 5 days/week) with rats, at 499 mg/m3 (converted guidance value: 0.36 mg/L), which is within a guidance value range (vapor) for Category 2, nasal inflammation in females was reported (SIDS (2016)). From the above, although there are reports of the effects of irritation on the eyes and nose, the effects on the eyes were considered to be the result of eye irritation, thus, they were not adopted as target organ for this hazard class. Furthermore, the information source of the test in which the effects were seen within a guidance value range for Category 1 is listed in List 2. Therefore, this substance was classified in Category 2 (respiratory organs). Besides, SITTIG (47th, 2002) which was used for the previous classification was not adopted because this information source is currently listed in List 3, and the effects on the eyes which were considered to be due to the eye irritation were not adopted as the evidence of the classification, thus, the classification result was different from the previous one.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, in the previous classification, this substance was classified in Category 2 by using the information source listed in List 3, however, the evidence was not from a report based on humans cases etc., but from a general attention remark. Additionally, according to the Japan Industrial Standard (JIS) on the GHS classification (JIS Z 7252:2014) published after the previous classification, a substance can be allocated only to Category 1, not to Category 2, for this hazard class.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	From 48-hour EC50 (immobile) = 91.6 mg/L for crustacea (Daphnia magna) (EPA AQUIRE: 2017, Chester, N. A. et al. (1992)), it was classified in Category 3.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Chronic toxicity data were not obtained. Due to being rapidly degradable (BioWin), and no bioaccumulation (LogPow: 0.26 (SRC PhysProp Database: 2017)), it was classified as "Not classified."	FY2017	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.	FY2017	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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