GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 95-51-2
Chemical Name o-Chloroaniline
Substance ID H28-B-01-METI, M-001B
Classification year (FY) FY2016
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
-
-
- -  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 108 degC (ICSC (2000)), it was classified as "Not classified."
7 Flammable solids Not applicable
-
-
- -  Liquid (GHS definition)
8 Self-reactive substances and mixtures Type G
-
-
- -  There is haloaniline as a chemical group associated with self-reactive properties present in the molecule. However, because it is classified in Division 6.1 (Toxic substances), Packing group II (UN2019, chloroanilines, liquid) in UNRTDG, it is thought that it does not correspond to self-reactive substances and mixtures which is hazard class with the highest precedence.
9 Pyrophoric liquids Not classified
-
-
- -  It is estimated that it does not ignite at normal temperatures from an ignition point of >500 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 4


Warning
H302 P301+P312
P264
P270
P330
P501
 On the basis of a reported LD50 value for rats of 1,016 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)), this substance was classified in Category 4.
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
 On the basis of a reported LD50 value for rats of 1,016 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)), this substance was classified in Category 4.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- -  On the basis of a reported LD50 value for rats of 1,016 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)), this substance was classified in Category 4.
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- -  On the basis of a reported LD50 value for rats of 1,016 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)), this substance was classified in Category 4.
1 Acute toxicity (Inhalation: Dusts and mists) Category 4


Warning
H332 P304+P340
P261
P271
P312
 Five LC50 values (4 hours) for rats of 4,000 - 6,000 mg/m3 (PATTY (6th, 2012)), 4,160 mg/m3 (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)), 4,100 mg/m3, 6,000 mg/m3, and > 4,406 mg/m3 (BUA 57 (1991)) are reported, and these values correspond to Category 4 to "Not classified." By adopting the category with higher hazard, the substance was classified in Category 4. Besides, the reference value of mist was applied because the LC50 values are higher than the saturated vapor pressure concentration (1.17 mg/L).
2 Skin corrosion/irritation Not classified
-
-
- -  In a skin irritation test using rabbits (OECD TG 404), there is a report that application of 0.1 mL of this substance resulted in no irritation (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)). Therefore, it was classified as "Not classified."
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
 It is reported that in an eye irritation test (OECD TG 405) using rabbits, after applying 0.1 mL of this substance to the conjunctival sac, conjunctival hyperemia and corneal opacity were observed, but resolved within 3 ? 7 days (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)). From the above, this substance was classified in Category 2B.
4 Respiratory sensitization Classification not possible
-
-
- -  Classification not possible due to lack of data.
4 Skin sensitization Classification not possible
-
-
- -  Negative result is reported in a maximization test using guinea pigs (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), BUA 57 (1991)). However, this substance was classified as "Classification not possible" because details of the test conditions and results are unknown.
5 Germ cell mutagenicity Classification not possible
-
-
- -  As for in vivo, one weak positive result was observed in a mouse micronucleus test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)), however, it is described micronucleus tests using bone marrow cells or peripheral blood of mice (including the data without the description of examinaton site) were all negative according to another information sources (NTP TOX43 (1998), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), DFGOT vol. 21 (2003)). A positive result in a micronucleus test using bone marrow cells of rats was observed (NTP TOX43 (1998)). But as for the positive result of the micronucleus test in bone marrow cell of rats, its reproducibility is not confirmed, therefore it is difficult to judge definitely to be positive (NTP TOX43 (1998)). As for in vitro, results are a negative in a bacterial reverse mutation test, positive in a mouse lymphoma test and a gene mutation test using mammalian cultured cells, a positive or a negative in a chromosome aberration test and a sister chromatid exchange test (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), NTP TOX43 (1998), DFGOT vol. 21 (2003)). From the above, there are positive in vitro results, but the positive in vivo result was difficult to judge clearly as the positive one. Therefore, this substance was classified as "Classification not possible" in accordance with the GHS Classification Guidance for the Japanese Government, although the former classification was Category 2.
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 the reproduction/development toxicity screening test using pregnant rats given this substance by gavage administration on an organogenesis period, in maternal animals, effects on spleen (weight gain, hyperemia, increased extramedullary hematopoiesis) and necrosis of the placental membrane at or above 50 mg/kg/day, tremors, reduced body weight gain, decreased food consumption at 250 mg/kg/day were observed, and in fetuses, increased embryo absorption, decreased survival rate, increased spontaneous malformations (details unknown) at 250 mg/kg/day were observed (Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011), Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). Besides, because fetotoxicity and spontaneous malformations were observed at the dose with apparent maternal toxicity, the substance was classified in Category 2.
8 Specific target organ toxicity - Single exposure Category 1 (haemal system), Category 2 (central nervous system, heart)


Danger
Warning
H370
H371
P308+P311
P260
P264
P270
P321
P405
P501
 In humans, there is a report methemoglobin is formed by acute exposure to this substance (PATTY (6th, 2012)). As effects on the central nervous system, occurrences of confusion, ataxia, vertigo, tinnitus, disorientation, weakness, lethargy, and coma are noted; and as effects on the heart, heart blocks, arrhythmias, and shock are noted (HSDB, Access on October 2016). In experimental animals, cyanosis, dyspnea, muscle weakness, coma, tremor, spasm and so on are observed due to the formed methemoglobin in oral, inhalation and dermal administration tests using rats and mice at dose equivalent to Category 1 or 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), DFGOT vol. 3 (1990), BUA 57 (1991)). From the above, this substance was classified in Category 1 (haemal system), Category 2 (central nervous system, heart). Because HSDB is the source of information on humans, is on List 2, the substance was classified in Category 2 for the central nervous system and heart. The liver and kidney were target organs in the previous classification. Upon checking the original literature of its classification rationale, which is cited in Environmental Risk Assessment for Chemical Substances Vol.3 (Ministry of the Environment, 2004), the effects on the liver and kidney in humans are not described in it. Therefore, the category was changed.
9 Specific target organ toxicity - Repeated exposure Category 1 (haemal system, central nervous system)


Danger
H372 P260
P264
P270
P314
P501
 In humans, though epidemiological studies and cases involving exposure only to this substance have not been obtained, symptoms such as cyanosis and anemia are reported in factory employees exposed to nitro compounds and amino compounds including this substance. Between 1961 ? 1980 in UK, cyanosis in 325 factory employees exposed to nitro compounds or amino compounds were reported. It is presumed that this was caused by chloroaniline (details unknown regarding isomers) in not less than 60 people. Headache, fatigue, dizziness and nausea occurred in 87% of the cases during the exposure period, and were observed in 13% of the cases even after exposure. In addition, from 1956 to 1965 in US, cyanosis and anemia were observed in 187 factory employees exposed to not less than 20 kinds of nitro compounds and amino compounds including m- chloroaniline and this substance. It is presumed this was mainly caused by dermal absorption (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)).
 In experimental animal, in a 4-week (6hr/day, 5days/week) inhalation toxicity test using rats, decreased hematocrit values, increased Heinz body and methemoglobin concentration, increased spleen weight and so on were observed at or above 7.37 ppm (converted guidance value: 0.008 mg/L), which corresponds to Category 1. Cyanosis, decreased hemoglobin concentration, increased reticulocytes, hemosiderin deposition in the spleen and so on were observed at or above 41.0 ppm (0.048 mg/L). Tremors etc. were confirmed at 167.5 ppm (converted guidance value: 0.197 mg/L) (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005)). In 13-week repeated-dose toxicity tests in rats or mice by the oral route, increased methemoglobin concentration is also observed at 10 mg/kg/day (converted guidance value: 7.4 mg/kg/day), which corresponds to Category 1. Cyanosis, tremors, increased hematopoiesis in the spleen, etc. were observed at doses corresponding to Category 2 (Initial Risk Assessment Report (NITE, CERI, NEDO, 2005), NTP TOX43 (1998), Environmental Risk Assessment for Chemical Substances Vol.9 (Ministry of the Environment, 2011)). Therefore, this substance was classified in Category 1 (haemal system, central nervous system).
10 Aspiration hazard Classification not possible
-
-
- -  Classification not possible due to lack of data. Besides, kinematic viscosity is calculated to be 2.407 mm2/sec (20/22 degC) from the numerical data (viscosity: 2.9157 mPa*s (20 degC), density (specific gravity): 1.2114 (22/4 degC)) listed on HSDB (Access on September 2016).

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 LC50 = 0.13 mg/L for crustacea (Daphnia magna) (Initial Risk Assessment (NITE, CERI, NEDO, 2005)), it was classified in Category 1.
11 Hazardous to the aquatic environment (Long-term) Category 1


Warning
H410 P273
P391
P501
 Because it is not rapidly degradable (BOD degradability: 2.7% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1977)), and its 21-day NOEC (reproduction) is 0.032 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. 2 (2003), vol. 3 (2004) and vol.9 (2011) (Ministry of the Environment), Initial Risk Assessment (NITE, CERI, NEDO, 2005), ECETOC TR91 (2003)), 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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