NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	95-55-6
Chemical Name	o-Aminophenol
Substance ID	H29-B-016
Classification year (FY)	FY2017
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	FY2010
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	- -	-	-	Solid (GHS definition).
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition).
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition).
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition).
7	Flammable solids	Classification not possible	- -	-	-	It is described that it is combustible (ICSC (J) (2005)), but the classification is not possible due to no data.
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 applicable	- -	-	-	Solid (GHS definition).
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 215 deg C (ICSC (J) (2005)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.
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	- -	-	-	Solid (GHS definition).
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on a report of an LD50 value of 1,300 mg/kg for rats (HSDB (Access on May 2017)), it was classified in Category 4.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on a report that the primary irritation index (PCI) was 0 (maximum value of 8) and no irritation was observed in a test in which 0.5 g of fine powder of this substance was applied occlusively or semi-occlusively to rabbits (Journal of The American College of Toxicology. Vol. 7, p. 279-333 (1988)), it was classified as "Not classified."
3	Serious eye damage/eye irritation	Not classified	- -	-	-	Based on a report that it was slightly irritating and the stimulation index (AOI) after 24 hours was 9.83 (maximum value of 110) in a test in which 100 mg of this substance was applied into the conjunctival sac of rabbits (HSDB (Access on May 2017)), it was classified as "Not classified."
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that it caused bronchial asthma in rare instances (HSDB (Access on May 2017)).
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Based on a description that this substance is contained in hair dye and is a causative substance of contact dermatitis to barbers and consumers (Contact Dermatitis (5th ed., 2011)), it was classified in Category 1.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, it was negative in a micronucleus test and a chromosome aberration test with mouse bone marrow cells, negative in a sister chromatid exchange test with Chinese hamster bone marrow cells, negative in an unscheduled DNA synthesis test with rats (SCCS (2010)). As for in vitro, it was positive or negative in bacterial reverse mutation tests, negative in a chromosome aberration test with cultured mammalian cells and positive in a sister chromatid exchanges test with cultured mammalian cells (SCCS (2010), NTP DB (Access on May 2017)). From the above, it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. Besides, SCCS does not evaluate positive findings of the bone marrow micronucleus test with Chinese hamsters (Wild et al., 1981) because it was an "abstract." It is described in the literature in the previous classification (Journal of the American College of Toxicology. Vol. 7, p. 279-333 (1988)), that this finding was that in mice. The former information was not adopted because it was abstract sourced information and the details were unknown.
6	Carcinogenicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	In a test with pregnant rats dosed by gavage during the organogenesis period (day 6-15 of gestation), only slight effects (lowered body weight and retarded ossification) were seen at the highest dose (250 mg/kg/day) where maternal toxicity was observed (SCCS (2010)). In addition, it is reported that as a result of single intraperitoneal administration of 100-200 mg/kg to pregnant hamsters on gestation day 8, malformations such as neural tube defects (exencephaly, encephalocele, and spina bifida), eye defects, and skeletal defects were seen, however, no malformation was observed in oral administration (PATTY (6th, 2012)). From the above, there is no evidence for developmental toxicity by oral administration, and there is no information on the assessment of the effects on fertility and sexual function, therefore, the classification was not possible due to lack of data.
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. In the previous classification, it was classified in Category 2 (nervous system) based on a report that in an oral acute toxicity test with rats (LD50: 1,300 mg/kg), they became excited 20-30 minutes after administration, and weakness and disappearance of the reflexes on external stimulation were observed (Journal of The American College of Toxicology. Vol. 7, p. 279-333 (1988)). However, this description is not included in the paper mentioned above, and the details cannot be confirmed. Since there is no other information by which the target organ can be identified, it was classified as "Classification not possible." The classification result was revised by examining the information sources.
9	Specific target organ toxicity - Repeated exposure	Category 1 (kidney, urinary bladder), Category 2 (haemal system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	There is no information in humans. As for experimental animals, there is a report that in a 30-day repeated dose toxicity test with rats by gavage, an increase in urinary renal cells and increased vacuolization of the urothelium of the bladder at or above at 20 mg/kg/day (converted guidance value: 7 mg/kg/day) which is within the guidance value range for Category 1, and increased AST (GOT) activities and renal tubular lesions at or above at 80 mg/kg/day (converted guidance value: 27 mg/kg/day) which is within the guidance value range for Category 2, and regenerative macrocytic anemia, an increase in blood urea nitrogen, an increase in urinary proteins, and increases in relative liver and kidney weights at 320 mg/kg/day (converted guidance value: 107 mg/kg/day) which exceeds the range of the guidance value of Category 2 were observed (SCCS (2010)). In addition, it is reported that in another 30-day repeated oral dose toxicity study, at 130 mg/kg/day (converted guidance value: 43 mg/kg/day), which is within the guidance value range for Category 2, a decrease in the erythrocyte count and an increase in the level of methemoglobin were seen (HSDB (Access on May 2017)). Therefore, it was classified in Category 1 (kidney, urinary bladder), Category 2 (haemal system). The classification was changed due to the use of new information sources.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

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)	Category 1	Warning	H400	P273 P391 P501	From 72-hour EC50 (rate method) = 0.15 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, 2017)), it was classified in Category 1.
11	Hazardous to the aquatic environment (Long-term)	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 (BIOWIN), and 72-hour NOEC (rate method) = 0.0018 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, 2017)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (BIOWIN), and 48-hour EC50 = 0.57 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)). From the above results, it was classified in Category 1.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.

NOTE:

* A blank or "-" in a cell of classification denotes that the classification of the hazard class was not conducted.
* Hazard_statement_and/or_Precautionary_statement will show when hovering the mouse over a code of Hazard_statement_and/or_Precautionary_statement.
Hazard_statement_and/or_Precautionary_statement are also provided in the Excel file.
* Classification was conducted by relevant Japanese Ministries in accordance with GHS Classification Guidance for the Japanese Government,
and is intended to provide a reference for preparing GHS labelling and SDS for users.
* This is a provisional English translation of classification results and is subject to revision without notice.
* The responsibility for any resulting GHS labelling and SDS referenced from this site is with users.
* Codes assigned to each of the hazard statements and codes for each of the precautionary statement are
based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) in United Nations.

To GHS Information