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 |
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 |
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. |
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. |
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. |
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