NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	123-30-8
Chemical Name	p-Aminophenol
Substance ID	m-nite-123-30-8_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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)	- -	-	-	Solid (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)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	It is described that it is combustible (GESTIS (Access on June 2017)), but the classification is not possible due to no data.	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 (Not applicable)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of > 250 deg C (GESTIS (Access on June 2017)).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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)	- -	-	-	Solid (GHS definition).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	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	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 solid substances 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	Based on a report of an LD50 value of 671mg/kg for rats (SIDS (2010)), it was classified in Category 4.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on a report of an LD50 value of >8000 mg/kg for rabbits (HSDB (Access on May 2017)), it was classified as "Not classified."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	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. There is a report that an LC50 value for rats in 1-hour inhalation was >5.91mg/L (converted 4-hour equivalent value: >1.478 mg/L) (HSDB (Access on May 2017)), however, since the category cannot be specified only with this data, the classification was not possible. Besides, the data of IUCLID (2000), which was used in the previous classification, is not available, and the details are unknown. Therefore, it was not adopted. Due to the use of a new information source, the classification result was changed from the previous classification.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	Based on a report that in a skin irritation test with rabbits, mild edema was induced 24 hours after the application and resolved within 72 hours (primary irritation score 0.2 (maximum value 8)) (SIAP (2010), HSDB (2010) Access on May 2017), it was considered to have a mild irritation, and it was classified as "Not classified" (Category 3 in UN GHS classification).	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Based on the reports that it is irritating to human eyes (HSDB (Access on May 2017)) and that mild irritation was seen in an eye irritation test with rabbits (SIAP (2010), HSDB (Access on May 2017)), it was classified in Category 2B.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Category 1	Danger	H334	P304+P340 P342+P311 P261 P284 P501	Based on the report that this substance caused bronchial asthma (HSDB (Access on May 2017)), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	Based on the description that this substance is contained in hair coloring agents and is a causal substance of contact dermatitis for barbers and consumers (Contact Dermatitis (5th ed., 2011)), and the report of multiple cases where this substance had skin sensitizing potential (SCCS (2011)), it was classified in Category 1.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	As for in vivo, it was negative in a dominant lethal test with rats, positive in a mouse bone marrow micronucleus test (JECDB (Access on May 2017), SIDS (2010)). As for in vitro, it was positive or negative in bacterial reverse mutation tests, positive in a mouse lymphoma test with mammalian cultured cells, negative in gene mutation tests, positive in chromosome aberration tests, positive or negative in sister chromatid exchanging tests (JECDB (Access on May 2017), SIDS (2010), PATTY (6th, 2012), NTP DB (Access on May 2017)). From the above, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. The category was revised based on the new information.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	In a test in which this substance was administered by gavage to rats at doses of up to 30 mg/kg/day for 2 years, no carcinogenicity was observed (SCCS (2011)). Also, it is described that derivatives of this substance (such as phenacetin) have carcinogenicity, but there is no evidence that this substance is carcinogenic (PATTY (6th, 2012)). It is considered that this substance does not show carcinogenicity, however, it was judged that the data were insufficient to classify it as "Not classified," and it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In the reproductive/developmental toxicity screening test with rats dosed by gavage, stopping of a return of estrus cycle, prolonged gestation length, and poor parturition and nursing activity in dams, and an increased stillborn index, lowered delivery and viability indices on postnatal day 4 in pups were observed at 500 mg/kg/day at which deaths (males; 4/12, females; 2/12) and reduced body weight gain were observed in parental animals (JECDB (Access on May 2017), SIDS (2010), SCCS (2011)). On the other hand, in a developmental toxicity test with pregnant rats dosed by feeding on day 0-20 of gestation, there was an increase in postimplantation loss from the lower dose than the dose at which dams showed reduced body weight gain, but in the fetuses, no increase in occurrence of malformations was observed although there were skeletal variations and undeveloped renal papilla due growth retardation (SIDS (2010), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment) Vol. 5: Tentative Hazard Assessment Sheet (2006)). However, as a result of gavage administration during the organogenesis period (day 6-15 of gestation) to pregnant rats, reduced maternal body weight gain was observed at 85 mg/kg/day or more, and malformations (skeletal malformations, anophthalmia and hydrocephalus) were observed in the fetuses at 250 mg/kg/day (SCCS (2011)). In addition, in a test with pregnant rats dosed by gavage on day 11 of gestation, tail abnormalities were observed at doses where reduced body weight gain in maternal animals was observed (SIDS (2010), Environmental Risk Assessment for Chemical Substances Vol. 5: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). Besides, there is a report that external malformations (encephalocele, eye/tail malformations) were observed in the intraperitoneal or intravenous administration test with pregnant hamsters, but no malformations were observed by oral administration (SIDS (2010), PATTY (6th, 2012), SCCS (2011), Environmental Risk Assessment for Chemical Substances Vol. 5: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). As described above, reproductive and developmental effects were observed at the lethal dose for maternal animals in the reproductive/developmental toxicity screening test with rats. On the other hand, in one of three developmental toxicity tests with pregnant rats dosed orally, fetal toxicities occurred from the lower dose than the dose of maternal toxicity expression, and in the other two tests, skeletal and external malformations were observed at the dose for maternal toxicity expression. Since the effects on developmental toxicity in experimental animals were generally seen at the maternal toxicity expression dose, it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. In the previous classification, the haemal system was adopted as the target organ based on the information that this substance caused methemoglobinemia in humans (PATTY (4th, 1999)), but as a result of this confirmation, it was described that it was considered to cause methemoglobinemia, and this information is not described in PATTY (6th, 2012). In addition, it is stated in the Environmental Risk Assessment for Chemical Substances Volume 5: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006), that if this substance is absorbed in large amounts, it causes methemoglobinemia (Source: Goto, et al., Supplementary Edition for Industrial Poisoning Manual (1992)), but after checking the original document, details of the exposure conditions and the number of cases were not described, and there was no information of the original source, so details were not possible to be confirmed. Therefore, the above information was not adopted as the rationale for the classification. In experimental animals, there was a report that lethargy and piloerection were observed and that in some animals, edemas in the salivary glands were observed in a single oral exposure test with rats (SIDS (2010)), but target organs cannot be identified by these symptoms alone. Since there is no other information available for the evidence, the classification result was changed, and it was classified as "Classification not possible."	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney)	Warning	H373	P260 P314 P501	There is no clear report on humans. For experimental animals, there is a report that in a repeated dose toxicity study with rats dosed by gavage, brown urine, increased epithelial cell expression in urine sediment, higher absolute and relative kidney weights, basophilic renal tubules were seen at or above 100 mg/kg/day (converted guidance value: 31 mg/kg/day) which is within the guidance value range for Category 2, and lower values in red blood cell count, lower values in hematocrit/hemoglobin concentration, high reticulocytes count, an increase in liver weight, white streaks at the renal corticomedullary junction, an increase of extramedullary hematopoiesis in the spleen, an increase of hemosiderin pigments in the spleen were observed at 500 mg/kg/day (converted guidance value: 156 mg/kg/day) exceeding the guidance value range for Category 2 (JECDB (Access on May 2017), SIDS (2010), Environmental Risk Assessment for Chemical Substances Volume 5: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006)). In addition, in the 6-month repeated dose toxicity test with rats given by feeding, nephrosis occurred at or above 35 mg/kg/day within the guidance value range for Category 2, and suppressed body weight gain, decreases in the red blood cell count and hemoglobin concentration were observed at 350 mg/kg exceeding the guidance value for Category 2 (Environmental Risk Assessment for Chemical Substances Volume 5: Tentative Hazard Assessment Sheet (Ministry of the Environment, 2006), PATTY (6th, 2012)). As described above, although effects on the haemal system and kidney were observed, since the effects were seen only in the kidney within the guidance value range for Category 2, it was classified in Category 2 (kidney). In addition, it is described in the previous classification that it caused renal toxicity in humans and caused methemoglobinemia (PATTY (4th, 1999)). However, as a result of the confirmation, it was the description that this substance was considered to cause these, and such a description was not included in PATTY (6th, 2012). Therefore, the classification was changed because it was not adopted as the rationale for the classification.	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.	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 1	Warning	H400	P273 P391 P501	From 72-hour EC50 (growth rate) = 0.10 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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 6% (J-CHECK, 1997)), and 72-hour NOEC (growth rate) = 0.025 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.	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.

To GHS Information