NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	156-43-4
Chemical Name	p-Phenetidine
Substance ID	m-nite-156-43-4_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)	- -	-	-	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	Not classified	- -	-	-	A flash point is 120 deg C (closed cup) (ICSC (J) (2008)).	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 425 deg C (GESTIS (Access on June 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)	- -	-	-	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))
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	- -	-	-	No data 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)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, the data from Chemical Substance Hazard Data (CERI, 2001) used in the previous classification was not adopted because it was from the information source of List 3, and the details were unknown.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, the data from Chemical Substance Hazard Data (CERI, 2001) used in the previous classification was not adopted because it was from the information source of List 3, and the details were unknown.	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)	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, the data from IUCLID (2000) used in the previous classification was not adopted because it could not be obtained, and the details were unknown.	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	Not classified	- -	-	-	Based on results of slight irritation or no irritation in skin irritation tests with rabbits (SIDS (2002)), and on a description that this substance is slightly irritating to the skin (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)), 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 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Based on reports that in eye irritation tests with rabbits, severe irritation was observed (SIDS (2002)), and on a description that this substance is severely irritating to the eyes (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)), it was classified in Category 2A. Besides, this substance was classified as "Eye Irrit. 2" in the EU CLP classification (ECHA CL Inventory (Access on June 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	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	As for humans, it is described that in a patch test with this substance at the concentration of 0.3-10%, 2 out of 50 people showed significant positive reaction at all concentrations examined, and 10 out of 50 people showed moderate to significant reaction at a 10% concentration (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). Therefore, it was classified in Category 1. Besides, this substance was classified as "Skin Sens. 1" in the EU CLP classification (ECHA CL Inventory (Access on June 2017)).	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, mouse bone marrow micronucleus tests were positive (JECDB (Access on June 2017), SIDS (2002)). As for in vitro, a bacterial reverse mutation test and a chromosomal aberration test with mammalian cultured cells were positive (SIDS (2002), NTP DB (Access on June 2017)). From the above, it was classified in Category 2 according to the GHS classification guidance for the Japanese government.	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	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a reproduction/developmental toxicity screening test with rats dosed by gavage, salivation, cyanosis and delayed parturition were observed in maternal animals at a high dose of 200 mg/kg/day, normal delivery was found only in 1/12 cases, the case of perinatal death which is the total of deaths without delivery or death cases immediately after delivery were observed in 9/12, the remaining 2 cases were also urgently slaughtered on gestational day 25 without delivery. In the newborns, a decrease in birth rate and increases in stillborn pups and dead fetuses were observed at 200 mg/kg/day (JECDB (Access on June 2017), SIDS (2002), Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). From the above, since abnormal deliveries and increases in fetal and neonatal death occurred at the dose where general toxicity effects were observed, 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.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system)	Danger	H372	P260 P264 P270 P314 P501	As for humans, it is reported that this substance is a metabolite of the medical drug phenacetin, and it is a causative substance of a blood disorder (methemoglobinemia) on administration of phenacetin (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). As for experimental animals, in a 28-day repeated toxicity study with rats dosed by gavage, a decrease in the erythrocyte count, an increase in the reticulocyte count, an increase in the urinary urobilinogen, an increase in the spleen weight, hemosiderin deposition, increased extramedullary hematopoiesis and congestion in the spleen erythroblast hyperplasia in the bone marrow at or above 40 mg/kg/day (converted guidance value: 12 mg/kg/day), and methemoglobinemia, slight hemosiderin deposition and increased extramedullary hematopoiesis in the liver at 160 mg/kg/day (converted guidance value: 50 mg/kg/day) were observed (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). In a 4-week repeated inhalation toxicity study with rats (6 hours/day, 5 days/week), an increase in the reticulocyte count, decreases in the hemoglobin concentration, the erythrocyte count and hematocrit value, an increase in the hematopoietic cells in the bone marrow, and hemosiderin deposition in the spleen at or above 86 mg/m3 (converted guidance value: 0.02 mg/L) within the guidance value range (vapour) for Category 1, and decreased body weight gain, an increase in the spleen weight and hemosiderin deposition in the liver, etc. at 883 mg/m3 (converted guidance value: 0.2 mg/L) within the guidance value range (mist) for Category 2 were observed (Environmental Risk Assessment for Chemical Substances Vol.8, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2010)). From the above, effects on the haemal system and the findings related to them were observed. Therefore, it was classified in Category 1 (haemal system).	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 2	- -	H401	P273 P501	From 72-hour EC50 (unknown calculation method) = 5.1 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 2002), it was classified in Category 2.	FY2017	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 1977)), and 21-day NOEL = 0.19 mg/L for crustacea (Daphnia magna) (OECD SIDS: 2002). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0% (J-CHECK, 1977)), and 72-hour EC50 (unknown calculation method) = 5.1 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 2002). From the above results, it was classified in Category 2.	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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