GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 108-42-9
Chemical Name Chloroaniline (3-chloroaniline)/chloroaniline
Substance ID H27-B-06-METI/M-027B_P
Classification year (FY) FY2015
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/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
-
-
- - As for isomers of this substance, please refer to 2-chloroaniline (CAS RN: 95-51-2) and 4-chloroaniline (CAS RN: 108-42-9).

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
-
-
- - Based on a flash point of 118 deg C (closed cup) (ICSC (2000)), it was classified as "Not classified."
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 >= 540 deg C (ICSC (2000)).
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 chlorine (but not fluorine or oxygen) 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) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
Please refer to 2-chloroaniline (CAS RN 95-51-2) and 4-chloroaniline (CAS RN 108-42-9) for the isomers of this substance.

There are two reports of LD50 values of 256 mg/kg (Environmental Risk Assessment for Chemical Substances Vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)) and 1,104 mg/kg (DFGOT Vol.3 (1992)) for rats. One value corresponds to Category 3, and the other value corresponds to Category 4. Since the number of reports corresponding to each category was the same, this substance was classified in Category 3 by adopting the category to which the minimum LD50 value corresponds.
1 Acute toxicity (Dermal) Category 4


Warning
H312 P302+P352
P362+P364
P280
P312
P321
P501
There are three reports of LD50 values of 250 mg/kg (HSDB (Access on November 2015), BUA 57 (1991)), approximately 2,000 mg/kg (males), 1,000-2,000 mg/kg (females) (BUA 57 (1991)). One value corresponds to Category 3, and two values correspond to Category 4. Therefore, it was classified in Category 4 to which the larger number of values corresponds.
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.
1 Acute toxicity (Inhalation: Dusts and mists) Category 3


Danger
H331 P304+P340
P403+P233
P261
P271
P311
P321
P405
P501
Based on a report of an LC50 value (4 hours) of 150 ppm (0.783 mg/L) for rats (Environmental Risk Assessment for Chemical Substances Vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)), this substance was classified in Category 3. Besides, the reference value of mist was applied because the LC50 value was higher than the saturated vapor pressure concentration (0.45 mg/L).
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
There is a description that this substance is an irritant to humans (HSDB (Access on October 2015), BUA 133 (1996)). Also, there is a report that as a result of application of 100-900 mg of this substance to rabbits and cats (application time was unknown), skin inflammation was observed (DFGOT Vol. 3 (1992)). From the above, this substance was classified in Category 2. The classification was changed by addition of the new information.
3 Serious eye damage/eye irritation Category 2A


Warning
H319 P305+P351+P338
P337+P313
P264
P280
There is a report that in an eye irritation test with rabbits, as a result of application of this substance, suppurative conjunctivitis was observed, but this resolved in 5-10 days (DFGOT Vol. 3 (1992)). In addition, there is a description that this substance is an irritant to the mucosa (HSDB (Access on October 2015)). From the above, this substance was classified in Category 2A based on the status of recovery in the test with rabbits.
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
In a maximization test (OECD TG compliant) with guinea pigs, sensitization by this substance (25% solution) (70%, 14/20 animals) was reported (DFGOT MAK Value Documentation (2013)). In addition, in a patch test with 26 humans, skin reaction was observed in 8 people (DFGOT MAK Value Documentation (2013)). It is concluded in DFGOT MAK Value Documentation (2013) that this substance is a sensitizer since sensitization was reported in humans and animals. From the above, it was classified in Category 1.
5 Germ cell mutagenicity Classification not possible
-
-
- - The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. As for in vivo, micronucleus tests with bone marrow cells of mice and rats were negative. As for in vitro, bacterial reverse mutation tests were negative, and a gene mutation test, a mouse lymphoma test, a chromosomal aberration test, and a sister chromatid exchange test with cultured mammalian cells were positive in any case (DFGOT Vol. 3 (1992), NTP DB (Access on November 2015)).
6 Carcinogenicity Classification not possible
-
-
- - Since there are no classification results by other organizations, classification was not possible due to lack of data.
7 Reproductive toxicity Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, there is a description that this substance did not induce sperm head morphological abnormality in mice (BUA 133 (1996)). Also, there is a description that in an oral dose test with pregnant rats during the organogenesis period (Day 6 to 15 of gestation), isomeric o-chloroaniline did not induce teratogenicity (BUA 133 (1996)).
8 Specific target organ toxicity - Single exposure Category 1 (central nervous system, cardiovascular system, haemal system, liver, kidney), Category 3 (respiratory tract irritation)



Danger
Warning
H370
H335
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
This substance is an irritant to the mucosa (DFGOT Vol. 3 (1992)). There is a description that methemoglobinemia, damage of the liver and kidney were caused by human exposure to this substance (Environmental Risk Assessment for Chemical Substances Vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)). As human intoxication cases, in occupational exposure case, in which this substance was spilled on clothing and gloves, headache, cyanosis, dyspnea, rapid pulse, increased urinary white blood cells, and lymphocytosis were observed. In another occupational exposure case, Heinz bodies in 8-28% of red blood cells were observed (DFGOT Vol. 3 (1992)). In addition, as acute exposure symptoms, blackening of the lips, tongue and visible mucosa, graying of the skin, headache, coughing, vomiting, throat dryness, and thirst were reported. Also, as central nervous system symptoms, confusion, ataxia, dizziness, tinnitus, disorientation, weakening, lethargy, and coma were reported. As effects on the heart, heart block, arrhythmia, heart shock, cardiovascular disorders, micturition pain, hematuria, hemoglobinuria renal failure, and acute hemolysis were reported (Environmental Risk Assessment for Chemical Substances Vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)).
As for experimental animals, similar to humans, it is described that the substance caused effects on the haemal system, liver, and kidney (PATTY (6th, 2012)). An increase in the blood methemoglobin concentration was observed by oral administration to cats (32 mg/kg, corresponding to Category 1) (DFGOT Vol. 3 (1992)).
From the above, this substance was classified in Category 1 (central nervous system, cardiovascular system, haemal system, liver, kidney), Category 3 (respiratory tract irritation) since it irritates the respiratory tract, and in addition, affects the central nervous system, cardiovascular system, haemal system, liver, and kidney.
9 Specific target organ toxicity - Repeated exposure Category 1 (haemal system), Category 2 (liver, kidney)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
In humans, there is a description that it causes methemoglobinemia and may cause liver and kidney damage (Environmental Risk Assessment for Chemical Substances Vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003), NTP TOX43 (1998)). Also, there is a report that in human occupational exposure, among male workers who work at the factory for an average of 41.2 months and were exposed to chloroaniline, cyanosis was found in 9 out of 36 workers, Heinz bodies were less than 1% in 28 people, and between 1-4% in 8 people (DFGOT Vol. 3 (1992)). Although effects on the haemal system are clear, there is no detail description on liver and kidney damage, so they are unknown.
As for experimental animals, in a 13-week toxicity test with rats dosed by gavage, an increase in methemoglobin concentration and anemia were observed in the dose group of 10 mg/kg/day (converted guidance value: 7.2 mg/kg/day) within the guidance value range for Category 1. Also, in a 13-week toxicity test with mice dosed by gavage, an increase in methemoglobin concentration, and hemosiderin pigmentation in the spleen and bone marrow were observed in the dose group of 10 mg/kg/day (converted guidance value: 7.2 mg/kg/day) within the guidance value range for Category 1 (Environmental Risk Assessment for Chemical Substances Vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003), NTP TOX43 (1998)). Other than these, in a 8-month toxicity test with rats dosed by oral, as findings other than methemoglobinemia, central nervous system excitatory action at the dose group of 2.5 mg/kg/day within the guidance value range for Category 1, and fatty and granular degeneration of the liver at the dose group of 25 mg/kg/day within the guidance value range for Category 2 were observed (DFGOT Vol. 3 (1992)). In a 2-week inhalation toxicity test with rats, effects were observed in the dose groups of 32-160 mg/m3 (converted guidance value: 0.0040-0.018 mg/L) within the guidance value range for Category 1, and as the findings in the dose group of 160 mg/m3, a decrease in the erythrocyte number, hemoglobin concentration, and hematocrit value, an increase in reticulocyte, cyanosis, an increase in activity of alkaline phosphatase and AST, a decrease in serum creatinine, an increase in spleen weight, hyperemia, an increase in extramedullary hematopoiesis, hemosiderin pigmentation, and atrophy of the white pulp were observed (Environmental Risk Assessment for Chemical Substances Vol. 2, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2003)).
From the above, effects on the haemal system were observed in humans, effects on the haemal system were observed from Category 1 in experimental animals, and effects on the liver and kidney were observed within the range for Category 2. Besides, for the central nervous excitatory effect which was observed in rats, it was not adopted as evidence for the classification because it was only symptoms. Therefore, this substance was classified in Category 1 (haemal system), Category 2 (liver, kidney).
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 48-hour EC50 = 0.35 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), 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 (a degradation rate by 28-day BOD = 1%, a degradation rate by TOC = 3%, a degradation rate by HPLC = 0% (Official Bulletin of Ministry of International Trade and Industry, 1990)), and 21-day NOEC (reproduction) = 0.0032 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 2000), Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)), 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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