NITE - Chemical Management Field

GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	142-04-1
Chemical Name	anilinium chloride
Substance ID	H28-B-025, C-036B
Classification year (FY)	FY2016
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	- -	-	-	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	- -	-	-	It is combustible, but the classification is not possible due to no data.
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	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data 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	Classification not possible	- -	-	-	The substance is an organic compound containing chlorine, but the classification is not possible due to no data.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule
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	Based on reports that the LD50 values of this substance for rats were 840 - 1,070 mg/kg (CEPA (1994)), it was classified in Category 4. Please see also the related substance, aniline (CAS RN 62-53-3) for the following health hazards.
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data.
2	Skin corrosion/irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, GESTIS (Access on May 2016) adopted in the previous classification is an information source in List 3, and the exposure time is longer than that of the test guidelines; ICSC (2001) is also an information source in List 3, and the original literature is not described, so these were not used for classification.
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, GESTIS (Access on May 2016), which was adopted in the previous classification, is an information source in List 3. The original document is RTECS in List 3, and the reliability of its data cannot be confirmed. ICSC (2001) is likewise in List 3, and the original literature is not described. Therefore, these were not used for classification.
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
5	Germ cell mutagenicity	Category 2	Warning	H341	P308+P313 P201 P202 P280 P405 P501	Data on aniline (CAS RN 62-53-3) are also used in the classification of this substance. As for in vivo, several test results on genotoxicity were reported: negative or equivocal results in a dominant lethal test by intraperitoneal administration to rats, positive or negative results in bone marrow cell micronucleus tests by intraperitoneal or oral administration to mice or oral administration to rats, positive in a micronucleus test of peripheral blood by feeding to mice, negative in a chromosomal aberration test in bone marrow cells by intraperitoneal administration to mice, positive or negative results in bone marrow cell chromosomal aberration tests by oral administration to rats, positive in a sister chromatid exchanging test using bone marrow cells by intraperitoneal administration to mice, and positive or negative results in DNA strand break tests and Comet Assays using the liver, kidneys, spleen and so on by intraperitoneal administration to mice or rats (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EU-RAR (2004), CEPA (1994), DFGOT Vol. 26 (2010), IRIS (1990), NTP DB (Access on June 2016)). As for in vitro, negative in bacterial reverse mutation tests, positive in many of gene mutation tests using mammalian cultured cells and mouse lymphoma tests, and positive in many of micronucleus tests, chromosomal aberration tests and sister chromatid exchange tests on mammalian cultured cells were noted (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), EU-RAR (2004), IRIS (1990), ACGIH (7th, 2001), DFGOT Vol. 26 (2010), CEPA (1994), NTP DB (Access on June 2016)). From the above, this substance was classified in Category 2 according to the GHS Classification Guidance for the Japanese Government.
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	In three experiments where this substance was administered to rats or mice in the diet for 2 years, spleen tumors (sarcoma, fibrosarcoma, hemangiosarcoma, etc.) increased in males in the two experiments using rats. However, no increased tumor incidence was seen in either female rats or male and female mice (EU-RAR (2004), IRIS (1990)). After intake of this substance into the body, it is considered that this substance exerts the same action as aniline (CAS RN 62-53-3) on the living body. As for classifications by other organizations, IARC classified aniline in Group 3 (IARC Suppl. 7 (1987)), the EPA in B2 (IRIS (1990)), ACGIH in A3 (ACGIH (7th, 2001)), and the EU in Carc 2 (Carc. 3 of DSD-classification by EU-RAR (2004)). From the above, this substance was classified in Category 2 like aniline.
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	There was no data on reproductive effects in humans. In experimental animals, in a study in which this substance was administered to pregnant rats by gavage on gestational days 7-20, in the dams, decreased weight gain and an increase in relative spleen weight were observed at 10 mg/kg/day or above; an increase in blood methaemoglobin concentration, reduction in red blood cell count, and an increase of reticulocytes at 100 mg/kg/day were observed. In the fetuses, however, only a mild increase in relative liver weight and slight change in blood parameters were observed at 100 mg/kg/day; no fetal toxicity or malformations were observed (EU-RAR (2004)). In addition, dams were dosed similarly from gestational day 7 to postnatal day 0, and the animals were allowed to spontaneously deliver. The dams and pups were examined up till Postnatal day 30 and Postnatal day 60, respectively, and then they were necropsied. As a result, the dams which had received 100 mg/kg/ day showed increased relative spleen weight, increased blood methemoglobin concentration, and increased MCV, but pups revealed no clear toxic effects up to 100 mg/kg/day (EU-RAR (2004)). On the other hand, with regard to the same data, according to the Ministry of Health, Labor and Welfare, increased relative liver weight and increased mean corpuscular volume (MCV) were seen in fetuses at 100 mg/kg/day; and an increase in MCV on Postnatal day 0 and weight loss in females on Postnatal day 2 were seen in the offspring at 100 mg/kg/day. These were deemed developmental effects (Hazards evaluation report by the Ministry of Health, Labor and Welfare (Access on August 2016)). Also, in a test in which this substance was administered subcutaneously at 195 mg/kg/ day in rats, methemoglobinemia (25-42% methemoglobin) in dams, and cleft palate and malformations in heart and ribs in fetuses, were observed. The frequency of heart abnormalities and cleft palates was decreased by the administration of methylene blue, so it is considered that the effect on the fetuses is due to hypoxia caused by methemoglobin formation (Hazards evaluation report on Aniline by the Ministry of Health, Labor and Welfare (Access on August 2016)). Based on the effects of developmental toxicity on laboratory animals described in the Hazards Evaluation Report on Aniline by the Ministry of Health, Labor and Welfare, it was judged as appropriate to classify this substance in Category 2 for this hazard class.
8	Specific target organ toxicity - Single exposure	Category 1 (haemal system, nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	There is no data on single exposure to this substance. It is stated that acute poisoning of this substance is caused by methemoglobin formation and causes cyanosis, disturbance of consciousness, dyspnea, and convulsions, possibly leading to death (ACGIH (7th, 2001), EU-RAR (2004), Risk Assessment Report (NITE, CERI, NEDO, 2007)). In humans, symptoms such as dizziness, coma, confusion, pallor, cyanosis, dyspnea, etc. have actually been reported due to accidental ingestion, suicidal intake, or occupational exposure; and it is described that its symptoms depend on the amount of methemoglobin in the total hemoglobin (EU-RAR (2004)), Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). From the above, it is considered that this substance may have the same toxicological effect as aniline, so this substance was classified in Category 1 (haemal system, nervous system). Besides, in the previous classification, this substance was classified in Category 3 (respiratory tract irritation) based on the descriptions in ICSC (2001) and HSFS (2003) that this substance is irritating to the respiratory tract in humans, but since these are information sources in the current GHS Classification Guidance for the Japanese Government, the category was revised.
9	Specific target organ toxicity - Repeated exposure	Category 1 (haemal system, nervous system)	Danger	H372	P260 P264 P270 P314 P501	This substance is considered to have the same effect as aniline. In humans, many workers at aniline manufacturing factories revealed cyanosis as well as headaches, dizziness, dysphasia, nausea, vomiting, chest and abdominal pains or convulsions, weakness, palpitations, irregular respiration, pupillary constriction (reactivity to light), abnormal body temperature, aniline odor on the breath and in the sweat and dark urine were seen. Also pulmonary edema and involuntary urination and defecation were noted in severe cases (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007)). In experimental animals, multiple tests have been conducted for both the oral and inhalation routes, and in both of these routes, effects on the haemal system (methemoglobinemia, hemolysis) and secondary effects related to them in the range of Category 1 were observed. As mentioned above, the haemal system and the nervous system were mainly affected (Initial Risk Assessment Report (NITE, CERI, NEDO, 2007), DFGOT vol.26 (2010)). Therefore, this substance was classified in Category 1 (haemal system, nervous 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)	Classification not possible	- -	-	-	No data available.
11	Hazardous to the aquatic environment (Long-term)	Classification not possible	- -	-	-	No data available.
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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