GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 156-43-4
Chemical Name p-Phenetidine
Substance ID H29-B-059
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 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
-
-
- - Liquid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Liquid (GHS definition)
6 Flammable liquids Not classified
-
-
- - A flash point is 120 deg C (closed cup) (ICSC (J) (2008)).
7 Flammable solids Not applicable
-
-
- - Liquid (GHS definition)
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 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)).
10 Pyrophoric solids Not applicable
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid substances are not 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
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
14 Oxidizing solids Not applicable
-
-
- - Liquid (GHS definition)
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule
16 Corrosive to metals Classification not possible
-
-
- - No data available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
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.
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.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Liquid (GHS definition)
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.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data.
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)."
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)).
4 Respiratory sensitization Classification not possible
-
-
- - Classification not possible due to lack of data.
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)).
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.
6 Carcinogenicity Classification not possible
-
-
- - Classification not possible due to lack of data.
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.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - Classification not possible due to lack of data.
9 Specific target organ toxicity - Repeated exposure Category 1 (haemal 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).
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 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.
11 Hazardous to the aquatic environment (Long-term) 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.
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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