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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	100-02-7
Chemical Name	p-Nitrophenol
Substance ID	R01-B-010
Classification year (FY)	FY2019
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	FY2018 FY2006
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	*	- -	-	-	There is a nitro group, a chemical group associated with explosive properties, present in the molecule, but because it is classified in Division 6.1 (toxic substances), PG III in UNRTDG (UN3443), and it is considered to be not applicable to explosives, hazards of the highest precedence, it was classified as "Not classified."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	There is information that it is combustible (ICSC (1998)), but the classification is not possible due to no data.
8	Self-reactive substances and mixtures	*	- -	-	-	There is a nitro group, a chemical group associated with explosive properties, present in the molecule, but because it is classified in Division 6.1 (toxic substances), PG III in UNRTDG (UN3443), and it is considered to be not applicable to self-reactive substances and mixtures, hazards of the highest precedence, it was classified as "Not classified."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 490 deg C (ICSC (1998)).
11	Self-heating substances and mixtures	*	- -	-	-	Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to an element (N) other than carbon or hydrogen. However, the classification is not possible due to no data.
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	It was classified as "Not classified" because it is not desensitized by wetting, dilution, etc.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 3. [Evidence Data] (1) LD50 for rats: 202 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)) (2) LD50 for rats: 230 mg/kg (ATSDR (1992)) [Reference Data, etc.] (3) LD50 for rats: 220-620 mg/kg (CICAD 20 (2000)) (4) LD50 for rats: 616 mg/kg (PATTY (6th, 2012))
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 1,024 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)) [Reference Data, etc.] (2) LD50 for rats and guinea pigs: > 1,000 mg/kg (CICAD 20 (2000)) (3) LD50 for guinea pigs: > 1,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)) (4) LD50 for rabbits: >5,000 mg/kg (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014), ATSDR (1992))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." Besides, since data on a 24 hour application was adopted as evidence of the classification in the previous classification, the category was changed. [Evidence Data] (1) It is reported that no irritation was shown in a skin irritation test with rabbits comparable to OECD TG 404 (CICAD 20 (2000), BUA 75 (1992)). [Reference Data, etc.] (2) It is reported to be slightly irritating in a skin irritation test with rabbits according to FDA guidelines (24-hour application) (CICAD 20 (2000), BUA 75 (1992)). (3) No effects were observed after the application of 147 mg/kg in a skin irritation test with rabbits for 4 hours (ATSDR (1992)).
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1. [Evidence Data] (1) It is reported to be strongly irritating in an eye irritation test with rabbits in which the nondissolved substance was administered according to FDA guidelines (CICAD 20 (2000)). (2) It is reported that it was corrosive, and persistent severe conjunctival irritation, irritation to the iris, and corneal opacity were observed in an eye irritation test with rabbits in which the undiluted substance was administered (EPA Pesticide (1996)). [Reference Data, etc.] (3) It was reported to be slightly irritating in an eye irritation test with rabbits in which the nondissolved substance was administered (CICAD 20 (2000), BUA 75 (1992)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), though this substance may show slight skin sensitization, it was judged not to be classified in Category 1. [Evidence Data] (1) In a skin sensitization test with guinea pigs (maximization test comparable to OECD TG 406), the positive rate was 25% (5/20) (CICAD 20 (2000), BUA 75 (1992)). (2) In a patch test conducted on workers exposed to multiple substances, positive reactions were observed in some of them, but cross-sensitization with 2-amino-4-chlorophenol was suggested (Environmental Risk Assessment for Chemical Substances Vol.4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified" in accordance with the expert judgment. [Evidence Data] (1) As for in vivo, there are reports of negative results in a dominant lethal test and a micronucleus test with mice (ATSDR (1992), CICAD 20 (2000), Kirkland et al., Regul. Tox. Pharm., 55, 33-42 (2009)). (2) As for in vitro, there are reports of negative results in a mouse lymphoma test and a bacterial reverse mutation test, and a positive result in a chromosomal aberration test with cultured mammalian cells (ATSDR (1992), NTP TR417 (1993), EPA Pesticide (1996), CICAD 20 (2000), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014), NTP DB (Access on May 2019)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Based on the classification results by other organizations in (1), it was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) It was classified in Group D by EPA (1996) in the classification results by domestic and international organizations. [Reference Data, etc.] (2) In a carcinogenicity test in which this substance was dermally applied to mice for 18 months, no increased incidence of tumors was observed (NTP TR417 (1993), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Since there was not enough information for evaluation and classification regarding the reproductive and developmental toxicity of this substance, the classification was not possible. Besides, evidence of the classification data was reviewed, and the category was changed. [Reference Data, etc.] (1) In a two-generation reproduction toxicity study in which rats were dermally applied, no reproductive and developmental effects were observed (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014), CICAD 20 (2000), EPA Pesticide (1996), ATSDR (1992)). However, this finding was considered tentative due to several study deficiencies (EPA Pesticide (1996)). (2) In a developmental toxicity test in which pregnant rats on Day 11 of gestation were dosed by gavage, an increased mortality of dams and a trend of a decreased survival rate of pups were observed (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014), CICAD 20 (2000)). However, it is described that there were some deficiencies such as not conducting an examination of visceral malformations in the pups in this study (CICAD 20 (2000)). (3) In a developmental toxicity test in which pregnant rats were dosed at one dose (400 mg/kg/day) on Day 7-14 of gestation by gavage, though an increased mortality of maternal animals and a slightly decreased average number of live pups per litter were observed, no teratogenicity was observed (Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014), CICAD 20 (2000)). However, it is described that this study used only one dose, and that there were some deficiencies such as not conducting an examination for visceral malformations in the pups (CICAD 20 (2000)).
8	Specific target organ toxicity - Single exposure	Category 1 (blood system), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	[Rationale for the Classification] Since it was considered that effects on the blood system and central nervous system depression occurred at a single exposure in humans as described in (1), it was classified in Category 1 (blood system), Category 3 (narcotic effects). The classification result was changed from the previous classification due to reviewed information. [Evidence Data] (1) As for humans, there is a description that inhalation, ingestion, or absorption through the skin causes headaches, drowsiness, nausea and respiratory depression with blue color to the lips, ears, and fingernails (cyanosis), indicative of methemoglobinemia (NTP TR417 (1993)). [Reference Data, etc.] (2) The oral LD50 value for rats was in the range of 220-620 mg/kg in an acute oral dose test. In addition, tachypnoea and cramps as toxic symptoms, and discoloration with dark red patches of the lungs in the macroscopic examination were observed (CICAD 20 (2000)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system), Category 2 (systemic)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 1 (blood system), Category 2 (systemic toxicity). [Evidence Data] (1) When rats were exposed to the dust of this substance at concentrations of 1-30 mg/m3 (converted guidance value: 0.0002-0.0067 mg/L, within the range for Category 1) for 4 weeks by inhalation (6 hours/day, 5 days/week), methemoglobinemia was observed (ATSDR (1992), CICAD 20 (2000), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)). (2) When rats were dosed at 25-140 mg/kg/day for 13 weeks by gavage, treatment-related death was observed at or above 25 mg/kg/day (within the range for Category 2) in males and females. Wheezing, dyspnea, pale appearance, prostration, and languid behavior were observed in dead animals, and the necropsy revealed congestion in the liver, kidney, lung and adrenal cortex (ATSDR (1992), EPA Pesticide (1996), CICAD 20 (2000), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)). [Reference Data, etc.] (3) When rats were orally dosed for 28 days, fatty degeneration in the liver at 70 mg/kg/day (converted guidance value: 22 mg/kg/day, within the range for Category 2), death in one male and fatty degeneration in the liver at 210 mg/kg/day (converted guidance value: 65 mg/kg/day, within the range for Category 2), locomotion inhibition and an increased leukocyte count at or above 210 mg/kg/day (converted guidance value: 65 mg/kg/day, within the range for Category 2), and death and hydropic liver cell swelling at 630 mg/kg/day (converted guidance value: 196 mg/kg/day, within the range for Category 2) were observed. It is described that because of unclear effects in the liver, a NOAEL cannot be deduced (CICAD 20 (2000), Environmental Risk Assessment for Chemical Substances Vol.12 (Ministry of the Environment, 2014)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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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