NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	591-27-5
Chemical Name	m-Aminophenol
Substance ID	m-nite-591-27-5_v2
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	There is the information that it is combustible (Hommel (1996)), but the classification is not possible due to no data in the prescribed test method.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	This substance was classified as "Not classified" because it is classified in Division 6.1, PG III (UN2512), not applicable to hazards of the highest precedence, pyrophoric solids.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.	FY2012	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)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2012	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	It was classified in Category 4 based on LD50 values of 693 mg/kg (males) and 856 mg/kg (females) in an acute toxicity test with male and female rats (OECD TG 401, GLP) (JECDB (Access on Apr. 2012)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Data are lacking. Besides, there is a description of an LD50 value of 1,000 mg/kg for rats (Chemical Substance Hazard Data (CERI, 2001)) as List 3 data, but the details are unknown.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	There is a report on an LC50 value of 1,162 mg/m3 for rats (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)), but because the exposure time is unknown, the classification is not possible. Besides, because the LC50 value (1,162 mg/L) was higher than the saturated vapour pressure concentration (0.01 mg/L), it was regarded as a test on dust.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	A volume of 0.5 mL of a 3% solution of this substance was applied to the back skin of rabbits and the skin reactions were scored after 24 hours, this procedure was repeated three times in 4 days, and no erythema or edema was observed during the test period (HSDB (2011)). And in another test with rabbits, the primary skin irritation index after 72 hours was 0.2, and it was assessed as mildly irritating (HSDB (2011)), and it is described that the substance is a mild irritant to the rabbit skin (HSDB (2011)). Therefore, it was classified as "Not classified" in the Classification JIS (corresponding to Category 3 in UN GHS classification).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Data are lacking. Besides, it is reported that there was moderate irritation in a test in which 100 mg was applied to the rabbit eye (RTECS (2010)), it is described that it was irritating in an experiment in which 2.5% of this substance was applied (application amount unknown) to the rabbit eye (Chemical Substance Hazard Data (CERI, 2001)), and the above is the List 3 information.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1A. Also, based on the new findings, the classification result was changed. [Evidence Data] (1) It was reported that, in a Local Lymph Node Assay (LLNA) (OECD TG 429, GLP) using mice (n=4/group), the first stimulation indices (SI values) were 7.62 (1%), 12.57 (2.5%), 10.38 (5%), 7.19 (10%), and 6.00 (25%); the second SI values were 1.04 (0.05%), 1.41 (0.1%), 5.88 (0.5%), and 9.00 (1%); and the EC3 value was calculated to be 0.24% (DFG MAK (2013), AICIS IMAP (2016), REACH registration dossier (Accessed Dec. 2021)). (2) It was reported that, in a maximization test (intradermal injection: 1% solution) with guinea pigs, sensitization reaction was observed in all animals (DFG MAK (2013), REACH registration dossier (Accessed Dec. 2021)). [Reference Data, etc.] (3) It was reported that four Local Lymph Node Assays (LLNA) (OECD TG 429) using mice (n=4/group) were conducted, and the stimulation indices (SI values) were 2.8, 3.1, 2.8, and 3.3 at the concentration of 2.5%; 3.5, 7.6, 6.1, and 7.1 at the concentration of 5%; and 5.7, 9.7, 8.1, and 6.7 at the concentration of 10% (DFG MAK (2013), AICIS IMAP (2016), REACH registration dossier (Accessed Dec. 2021)). (4) Two semi-occlusive repeat insult patch tests with 98 and 99 test subjects were conducted. In the first study with 98 subjects, no reactions to the challenge patches were observed. In the second study with 99 subjects, additional rechallenge patches on different parts of the body were applied and 2 subjects showed reactions following the challenge patches (AICIS IMAP (2016)). (5) 2,939 consecutive eczema patients attending 12 dermatology clinics were patch tested with this substance. As a result, 1% of the tested patients developed positive reactions and this substance was considered to be sensitizing to skin of human patients (REACH registration dossier (Accessed Dec. 2021)). (6) In the DFG, it was classified in Sh.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	It was classified as "Not classified" based on a negative result in a dominant lethal test by diet administration to male rats for 19 weeks before mating (in vivo heritable germ cell mutagenicity test) (HSDB (2011)). Furthermore, as for in vivo tests, it was reported to be negative in a sister chromatid exchange test with bone marrow cells after intraperitoneal administration to Chinese hamsters (in vivo somatic cell genotoxicity test) (HSDB (2011)). Besides, as for in vitro tests, it is reported that it was mostly negative in Ames tests (JECDB (2000)) and positive in a chromosomal aberration test with cultured Chinese hamster cells (CHL cells) (JECDB (2000)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	Data are lacking. Besides, in 2-year carcinogenicity tests with rats and mice by drinking water, in rats, no increased incidence of tumors was observed in females, there was a tendency toward increases in the incidence of follicular adenocarcinoma and the combined incidence of follicular adenoma and adenocarcinoma in the thyroid in males, but it was insufficient evidence of carcinogenicity. In mice, it is reported that no increased incidence of tumors was found in either males or females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2012)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In a test by diet administration to female rats from 90 days before mating by gestational day 20, no adverse effects were observed on fertility and the survival or development of offspring (HSDB (2011)). Furthermore, in a test in which a hair dye formulation containing 0.7% of this substance was dermally administered to rats over three generations, no treatment-related effects were found on general status, fertility, gestation, survival, and live birth indices in parent animals or the development of offspring in any generation (HSDB (2011)). On the other hand, it is reported that in a test in which a hair dye formulation containing 0.7% of this substance was dermally administered to rabbits for four weeks before mating and through mating to gestational day 30, the treated group had a slightly lower fetal survival, its percentage of resorbed fetuses was more than twice that of the control group, and the unusually low sex ratio was shown in the treated group (males/females = 0.7) (HSDB (2011)). However, the report was from the results of the test on a hair dye formulation containing this substance, and it was impossible to attribute the effects to this substance. Therefore, the classification is not possible due to lack of data.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 2 (blood system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In an acute oral administration toxicity test with rats (OECD TG401, GLP), deaths occurred in the group at or above 700 mg/kg, and tremors, salivation, brown urine, prone position, lateral position, pale skin in the forelimb, hindlimb, and auricle, etc. were observed on the day of administration at or above 500 mg/kg. Necropsy revealed swelling due to congestion of the spleen in dead animals, dark red discoloration of the spleen, dark brown discoloration of the kidney, etc. in surviving animals at 700 and 1,000 mg/kg. On histopathological examination, congestion in the spleen in males and females, focal necrosis in the liver, a slight deposit of brown pigment in Kupffer cells in the liver and the proximal tubular epithelium in the kidney in males were found in dead animals, and also in surviving animals, a deposit of brown pigment in Kupffer cells in the liver, the proximal tubular epithelium in the kidney and in the spleen were seen in females (JECDB (Access on Apr. 2012)). From the above results, swelling of the spleen was regarded as a change due to elevated processing function from erythroid disorders, and pale skin in the forelimb, hindlimb, and auricle, and dark purple discoloration of the tail tip in general status could be changes reflecting anemic conditions from hemolysis. And it is described that brown pigment deposited in the liver and kidney was estimated to be pigment derived from erythrocytes including hemosiderin, and the administration of this substance probably caused hemolysis (JECDB (Access on Apr. 2012)). Because all the test doses were within the guidance value range for Category 2, it was classified Category 2 (blood system). Besides, the findings in the liver above were not dose-dependent, most of them were observed in dead animals, and effects on the nervous system such as tremors were found at or above 500 mg/kg, which was high and close to the LD50 value. Therefore, these were judged as non-specific findings, and neither the liver nor nervous system was adopted as the target organ.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system)	Warning	H373	P260 P314 P501	After 90-day diet administration (concentrations 0, 0.1, 0.25, 1%) to female rats, hemosiderin deposit in the spleen, liver, and kidney with decreases in erythrocyte counts and hemoglobin levels and an increase in mean corpuscular volume were observed in the 1% group (about 500 mg/kg/day), and hemolytic effects were shown (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)). And in a 28-day repeated oral administration toxicity test with rats (Guidelines specified by the Chemical Substances Control Law, GLP), in the 720 mg/kg/day group (converted guidance value: 224 mg/kg/day), there were signs of tremors and salivation, anemia, and necropsy revealed dark brown discoloration of the liver, dark red discoloration of the spleen, and dark brown discoloration of the kidney. On histopathological examination, a deposit of brown pigment in the proximal tubular epithelium in the kidney, hemosiderin deposit in the spleen, a deposit of brown pigment in Kupffer cells in the liver, and hypertrophy of follicular cells in the thyroid were found (JECDB (Access on Apr. 2012)). From the above test results, blood effects were seen at higher doses above the guidance values for Category 2 in both the test, but adverse blood effects were also shown after acute exposure to this substance and in the isomers, and it is described that inhalation of large amounts causes methemoglobinemia in humans (Environmental Risk Assessment for Chemical Substances vol. 5 (Ministry of the Environment, 2006)). Therefore, it was classified in Category 2 (blood system).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2012	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 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour EC50 = 0.447 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 2 (Ministry of the Environment, 2003)).	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (not readily degradable (a 4-week degradation rate by BOD: 0%) (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1978)), and 21-day NOEC = 0.050 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances Vol. 2 (Ministry of the Environment, 2003)). 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" due to 96-hour LC50 = 120 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, 1995)). By drawing a comparison between the above results, it was classified in Category 1.	FY2012	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2012	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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