NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	103-90-2
Chemical Name	N-(4-Hydroxyphenyl)acetamide
Substance ID	m-nite-103-90-2_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 molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Even if it contacts the normal temperature air, it does not ignite spontaneously (ignition temperature 540degC (Merck KGaA data from March 2009)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Although it is an organic compound including oxygen, not fluorine and chlorine, this oxygen has not chemically bound to any elements other than carbon and hydrogen.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	The organic compound not including peroxy group in molecule.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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)	Not classified	- -	-	-	LD50 value 3,700 mg/kg of the oral administration test employing a rat (IARC 73 (1999)), which corresponded to the U.N. GHS acute toxicity Category 5, fell under unadopted category in Japan and was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Although "not irritating" is described for the skin irritation/corrosion test using rabbits (OECD TG 404, GLP) in IUCLID that is the information source of List 2, classification is not possible due to insufficient data, because there is no information in List 1 nor other negative study results I available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Although, in IUCLID (2000) which is the resource of List 2, there is a description of "not irritating" in the eyes irritation/corrosion test employing the rabbit (OECD TG 405, GLP), since there is no information in List 1and no other negative test result is obtained, classification is not possible due to insufficient data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification is not possible since there is no data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	Classification is not possible since there is no data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	There are descriptions of "negative" (IARC 73 (1999)) in the productive cell in vivo mutagenicity test (chromosome aberration test employing the spermatocyte of a mouse), "positive" (IARC 73 (1999))NTP TR394 (1993)) as body cell in vivo mutagenicity test in the chromosome aberration test employing human peripherals lymphocytes, " positive" (IARC 73 (1999), NTP TR394 (1993)) in the micronucleus test using human buccal mucosa cells, "positive" (IARC 73 (1999)) in the chromosome aberration test employing the bone marrow cell of a mouse, "negative" (IARC 73 (1999)) in the micronucleus test using the bone marrow cell of a mouse, and "positive" (IARC 73 (1999)) in the body cell in vivo genotoxicity test (SCE test employing human blood). As mentioned above, although there was data of two or more body cell in vivo mutagenicity tests, since there was no positive data of a productive cell in vivo genotoxicity test, it was classified into Category 2. In addition, there are descriptions of "negative" (IARC 73 (1999) (IUCLID (2000)) in the reverse mutation test employing Salmonella typhimurium as an in vitro mutagenicity test and "negative" (IUCLID (2000)) in the reverse mutation test employing coli bacteria.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Not classified	- -	-	-	Since it was estimated the group 3 (IARC 73 (1999)) by IARC, according to guidance, it was classified into "Not classified". In addition, the two-year oral administration test employing male and female rats and male and female mice shows a description that "No carcinogenicity findings was acknowledged in male and female mice and male rats, however, the increase in a development-of-symptoms rate of mononuclear cell leukemia was seen in the high-dose group of female rats" (IARC 73 (1999), NTP TR 394 (1993)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Classification not possible	- -	-	-	There is a description about humans based on a large scale cohort study and case study as follows, "There is no report on teratogenicity caused by this substance" (IARC 73 (1999)). Moreover, there is a description as follows, "Although low body weight and body weight decrease in the child animals in the administered group were observed at birth and increase in the development ratio of sperm abnormality in the group with high level administration was observed, there is no effect on reproductive functions" in the reproduction evaluation study based on a continuous reproduction study via oral administration using mice (NTP TR394 (1993)). On the other hand, since there is also a description as follows, "The number of cleft palates, skeletal deformation and development of hydronephrosis increased depending on dose levels" (IUCLID (2000)) in the oral administration study with female mice during 6-15 days of pregnancy, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 1 (liver, kidney, central nervous system, heart, gastrointestinal system), Category 2 (respiratory system, testis)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	IARC73 (1999) and NTP TR394 (1993) have a report that "hepatotoxicity and nephrotoxicity were foreseen" in the oral administration test which used multiple human cases and animals (rats, mice, dogs). Moreover, HSDB (2007) has descriptions that "confusion, a temperature fall, inactivity, shallow respiration, arrhythmia, a blood-pressure fall, and inadequate circulations may occur followed by excitement and mental confusions, " as a symptoms, that "symptom advances in four steps: The 1st step - loss of appetite, nausea, vomit, sense of discomfort, diaphoresis, the 2nd step - an abdominal pain, tenderness, enlarged liver, a bilirubin elevation, increasing liver enzymes concentrations, prolonged prothrombin time, oliguria depending on the case, the 3rd step - loss of appetite, nausea, vomit, the recurrence of sense of discomfort, liver failures, kidney failures, cardiomyopathy, and the 4th step - recovery or liver failures that results fatality", and that "excessive dosage may cause the increase of gastrointestinal ulcers and bleeding risk by epidemiological study". In animal studies, on the other hand, there is a description that "the necrosis was looked at by the bronchial epithelium and the testis in addition to the effect on liver and kidney" in the oral administration test employing a mouse (IARC 73 (1999)), and such symptoms were foreseen within the limits of the guidance value of Category 2. As mentioned above, it was classified into Category 1 (liver, the kidney, a central nervous system, the heart, digestive system) and Category 2 (the respiratory system, testis). In addition, HSDB (2007) has a warning reporting that "skin reactions including the spots-like papular eruption accompanied by pruritus and hives occurs" by dosing it, and a description that "the reaction pharynx part dropsy, blood vessel nature dropsy, and like an anaphylaxis may occur rarely." as a sensitivity reaction.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, kidney, blood system), Category 2 (thyroid)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	For humans, there is a report that "chronic active hepatitis accompanies chronic ingestion and chronic kidney disease accompanies prolonged use" (NTP TR394 (1993)). There are also reports from human epidemiological studies that "toxicity was shown" (IARC 73 (1999)), "an increase in kidney lipofuscinosis, chronic kidney disease and hemolytic anemia through excessive long-term ingestion were observed" (Patty (5th, 2001)) and "neutropenic and thrombocytopenic disorders were observed" (HSDB (2007)). Therefore the liver, kidney and blood system are considered to be target organs. Furthermore, in a 2-year oral administration study in rats and mice (21 CFR Part 58, GLP) there is a report that "increased severity of nephropathy in male and female rats, increased frequency of localized kidney tubule hyperplasia and kidney hyperparathyroidism in male rats, and increased thyroid follicular epithelial hyperplasia in male and female mice were observed" (NTP TR394 (1993)), and these effects are seen to be within the range of guidance values for Category 2. For the reasons stated above, we classified it as Category 1 (liver, kidney and blood system) and Category 2 (thyroid). As for observed effects which are outside the range of guidance values for Category 2, there is a report that "at 12,500 ppm (corresponding value: 625 mg/kg) testis atrophy and at 25,000 ppm (corresponding value: 1,250 mg/kg) ovarian and uterine atrophy were observed" in a 13-week oral administration study in rats (NTP TR 394 (1993)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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	It was classified in Category 2 from 48-hour EC50 (immobile) = 3.5 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, 2018)).	FY2018	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	It was classified in Category 2 due to being not rapidly degradable and 21-day NOEC (reproduction inhibition) = 0.46 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, 2018)).	FY2018	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.	FY2018	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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