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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	123-30-8
Chemical Name	p-Aminophenol
Substance ID	H29-B-012
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	FY2016 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	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 (GESTIS (Access on June 2017)), 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 > 250 deg C (GESTIS (Access on June 2017)).
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
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 671mg/kg for rats (SIDS (2010)), it was classified in Category 4.
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."
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. 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.
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).
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.
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.
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.
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.
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."
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.
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."
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.
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 (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.
11	Hazardous to the aquatic environment (Long-term)	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.
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.

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