GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 103-84-4
Chemical Name Acetanilide
Substance ID 24A6011
Classification year (FY) FY2012
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) Physical Hazards and Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
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
-
-
- - No data available.
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 530 deg C (CRC (2010)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - 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 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.
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
It was classified in Category 4 based on an LD50 value of 1,959 mg/kg for rats (males and females) (OECD TG401) (SIDS (2001)).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - No data available.
2 Skin corrosion/irritation Not classified
-
-
- - It was classified as "Not classified" because it was not irritating in a skin irritation test with rabbits (OECD TG404, GLP-compliant) (SIDS (2001)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
It was classified in Category 2B because it was slightly irritating in an eye irritation test with rabbits (OECD TG405, GLP-compliant) (SIDS (2001)).
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
4 Skin sensitization Classification not possible
-
-
- - No data available.
5 Germ cell mutagenicity Not classified
-
-
- - It was classified as "Not classified" based on negative results in a micronucleus test with bone marrow cells after intraperitoneal administration to mice (OECD TG474; GLP) (in vivo somatic cell mutagenicity test) and chromosomal aberration tests by intraperitoneal or oral administration to mice (in vivo somatic cell mutagenicity test) (SIDS (2001)). Besides, it is reported that it was positive in a micronucleus test with bone marrow cells after intraperitoneal administration to mice (in vivo somatic cell mutagenicity test) and a chromosomal aberration test with bone marrow cells after intraperitoneal administration to rats (in vivo somatic cell mutagenicity test), but both were not used for classification because the former test gave a weakly positive result, and the micronucleated polychromatic erythrocyte rate in the control group was high, and the latter was considered invalid due to the test condition details unknown (SIDS (2001)). And as for in vitro tests, it is reported that it was all negative in multiple Ames tests and a chromosomal aberration test with CHO cells (SIDS (2001), NTP DB (1983)).
6 Carcinogenicity Classification not possible
-
-
- - No data available. Besides, it is reported that in tests in which this substance was dosed to rats by feeding to investigate effects on the carcinogenicity of the other substances, no hyperplastic or dysplastic changes were observed, or there was no induction of liver tumors (SIDS (2001)), but there are no test data on the carcinogenicity of this substance itself.
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats by oral administration (OECD TG 422; GLP), significant decreases in body weights of pups at or above 200 mg/kg/day and viability on day 4 after birth at 600 mg/kg/day were observed, and as general toxicity in parent animals at the same doses, there is a report on hyperplasia of the spleen and bone marrow, decreases in hemoglobin level and hematocrit values, and death cases at 600 mg/kg (SIDS (2001)). Therefore, it was classified in Category 2. Besides, it is reported that in a reproductive test with mice by diet administration of a 0.1% concentration up to the 4th generation, significant decreases in reproductive capacity and survival were found at the dose that caused general toxicity such as methemoglobin formation and cyanosis (SIDS (2001)), although the details are unknown.
8 Specific target organ toxicity - Single exposure Category 1 (blood), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
It is reported that workers who were engaged in the manufacturing of this substance in a factory in India complained of chest pain and epigastric pain after work hours, there were no clinical signs but a tinge of cyanosis, and hemoglobin values decreased (SIDS (2001)). There are reports on cases of acute poisoning by the use of this substance, and symptoms were characterized by cyanosis, fatigue, vertigo, somnolence, oppression, palpitation, etc. and nausea, gastric pain, visual disturbances, trismus, etc. were reported (SIDS (2001)), and it is described that large doses in acute poisoning produce methemoglobin in humans (SIDS (2001)). On the other hand, as for animal tests, it is described that single oral administration of 200 mg/kg of this substance to dogs caused oxidization of hemoglobin to form methemoglobin (HSDB (2003)). It was classified in Category 1 (blood) from the above knowledge. And in an acute toxicity test in which male and female rats were orally dosed (OECD TG401), an LD50 value was 1,959 mg/kg, indicating lower acute toxicity, but symptoms of lethargy, coma, and abnormal gait were observed after administration (SIDS (2001)), and loss of pain sensation was seen as a result of oral administration 180 mg/kg to rats (IUCLID (2000)). Therefore, it was Category 3 (narcotic effects).
9 Specific target organ toxicity - Repeated exposure Category 1 (hematopoietic system, kidney)


Danger
H372 P260
P264
P270
P314
P501
It is well known to produce cyanosis in humans when taken repeatedly due to the formation of sulfhemoglobin (SIDS (2001)). And it is reported that as human case reports, the continued use leads to chronic poisoning characterized by gastroenteric disturbances, cardiac dysfunctioning, drowsiness, hemolytic anemia, methemoglobinemia, reticulocytosis, cyanosis, and acute renal failure, and advanced degenerative changes of the kidney were the most prominent postmortem findings (SIDS (2001)). On the other hand, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats (OECD TG 422; GLP), decreases in blood parameters such as hemoglobin level and hematocrit values at or above 22 mg/kg/day (converted guidance value: 7.3 mg/kg/day: equivalent to Category 1) and a decrease in erythrocyte count at or above 67 mg/kg/day (converted guidance value: 22.3 mg/kg/day: equivalent to Category 2) were observed, and histopathological examination showed red pulp hyperplasia of the spleen and bone marrow hyperplasia of the femur at or above 22 mg/kg/day, extramedullary hematopoiesis of the liver and thymus atrophy at or above 200 mg/kg/day (converted guidance value: 66.7 mg/kg/day: equivalent to Category 2), and death cases and cyanosis were found at the dose above the upper limit of the guidance values (SIDS (2001)). From the above, it was classified in Category 1 (hematopoietic system) based on findings in case reports in humans and hematological and histopathological findings in the repeated oral administration test with rats. Furthermore, because degenerative changes of the kidney were reported as prominent findings in humans, it was classified in Category 1 (kidney).
10 Aspiration hazard Classification not possible
-
-
- - No data available.

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 3
-
-
H402 P273
P501
It was classified in Category 3 from 72-hour EC50 = 13.5 mg/L for algae (Pseudokirchneriella subcapitata) (SIDS, 2004).
11 Hazardous to the aquatic environment (Long-term) Not classified
-
-
- - Reliable chronic toxicity data were not obtained. It was classified as "Not classified" due to rapid degradability (a degradation rate by BOD: 68.7% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1995)), and a low bioaccumulation estimate (LogKow = 1.16 (PHYSPROP Database, 2009)), although it corresponds to Category 3 in acute toxicity for algae (SIDS, 2004).
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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.

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