NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	87-62-7
Chemical Name	2,6-xylidine; 2,6-dimethylaniline
Substance ID	m-nite-87-62-7_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	Based on its flash point of 91degC (ICSC (2007)), the substance was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified	- -	-	-	Its autoignition point is 490degC (IUCLID (2000)), which is above 70degC.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Since its rat LD50 values of 1230 mg/kg bw (DFGOT 21 (2005) 1 (2003)), 630, 1550, 840 mg/kg bw (IARC 57 (1993)), and 705 - 840 mg/kg (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (2008)) were within the guidance values of Category 4, the substance was classified into Category 4.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	It is reported that in tests using rabbits (OECD TG 404), the substance was either not irritating or slightly irritating (with slight erythema 24 - 72 hours after removal of the patch), irritating (slight to clear visible erythema and slight to severe edema 4 - 72 hours after application) and both were reversible within 8 days) (IUCLID (2000)). The substance is rated Xi; R37/38 in the EU classification. Therefore, it was classified into "Not classified" in JIS classification (Category 3 in UN classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2	Warning	H319	P305+P351+P338 P337+P313 P264 P280	It is reported that in tests using rabbits (OECD TG 405), application of the substance for 4 hours caused either no irritation, irritation, or moderate irritation. Regarding the moderate irritation cases, conjunctival erythema, slight iridal edemas, and corneal opacity healed 7 days after application, and conjunctival erythema and severe cases of iridal infiltration healed 8 days after application. Based on these results, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on negative results in a micronucleus assay using mouse sperm cells (DFGOT vol. 19 (2003)) (germ cell in vivo mutagenicity test) and a cytogenetic assay using bone marrow of mice and rats (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (accessed in September 2008)) (in vivo mutagenicity tests using somatic cells), the substance was classified into "Not classified". As relevant information, the substance was negative in an unscheduled DNA synthesis test (in vivo genotoxicity tests using somatic cells), positive in in vitro mutagenicity tests including an Ames test (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (accessed in September 2008)), a chromosomal aberration test (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (accessed in September 2008)), and a mouse lymphoma assay (IUCLID (2000)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	Since the substance is classified into Group 2B in IARC (IARC vol.57 (1993)), it was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In an oral administration test by gavage using rats (OECD TG 422), the tendency of reduced number of corpcera lutea and significantly low level of implantation were noted in parental animals and the tendency of reduced total offspring number and significantly low level of neonate survival were observed in fetuses (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (accessed in September 2008)). Therefore, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 1 (blood), Category 2 (nervous system)	Danger Warning	H370 H371	P308+P311 P260 P264 P270 P321 P405 P501	It is documented that administration of lidocaine in humans caused methemoglobinemia, and since 2,6-dimethylaniline is a metabolite of lidocaine, 2,6-dimethylaniline is considered to have caused methemoglobinemia (IARC vol. 57 (1993)). Also, it is reported that exposure at high levels may result in the formation of methaemoglobin (ICSC (2007)). Therefore, the substance was classified into Category 1 (blood). As relevant information, in an oral administration test by gavage using rats, at the dose of 300 mg/kg, slight hypolocomotion with ptosis was observed, but it was reversible from three hours after administration. At the dose of 2000 mg/kg, immediately after administration, severe hypolocomotion, lateral position, abnormal gait, flaccidity, and slightly deep respiration were observed, and treated animals died within 24 hours after administration. In the urinary bladders of dead animals, reddish urine was seen, and it was considered to be hematotoxicity on the kidneys or by hemolysis (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (accessed in September 2008)). Also, it is reported that in an oral administration test by gavage using rats, groups administered 620 mg/kg or more had reddened renal papillae (NTP TR278 (1990)), and in another oral administration test by gavage using rats, mottling of the kidney was the most notable lesion seen in survivors (NTP TR278 (1990)). They suggested effects on the kidney. However, since both lacked distinct pathological descriptions, and due to a lack of data, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood, kidney)	Warning	H373	P260 P314 P501	In an oral administration test using rats (dose, 2, 10, 50, and 250 mg/kg), at the dose of 250 mg/kg (90-day conversion, 83 mg/kg), which is equivalent to the guidance value of Category 2, transient salivation, hypolocomotion, ptosis, reduced hand grip and locomotion, increased methemoglobin level, in males reduced erythrocyte count and hemoglobin concentration, and increased reticulocyte count were noted, and in males and females hypertrophy of hepatocytes, increasing trend of basophilic tubules of the kidneys, papillary necrosis, in males increased hyaline droplet and protein cast in proximal tubular epithelium, in females diffuse dilation of tubules, in males and females increased hemosiderosis, in males increased tendency of extramedullary hematopoiesis were noted (Toxicity Testing Reports of Environmental Chemicals (Chemicals Investigation Promoting Council) (accessed in September 2008)) were noted. In addition, in an oral administration test by gavage using rats for 13 weeks (dose, 20, 40, 80, 160, and 310 mg/kg), at the dose of 40 mg/kg, which is equivalent to the guidance value of Category 2 or more, reduced body weight gain, increased relative weights of the brain and the kidneys, reduced leukocyte count, at doses of 80 mg/kg or more, reduced lymphocyte count and increased segmented neutrophil count were observed, and at the dose of 160 mg/kg, which is equivalent to the guidance value of "Not classified", reduced hemoglobin level, and at the dose of 310 mg/kg, reduced hematocrit level were observed (IUCLID (2000)). Furthermore, in an oral administration test by gavage using mice for 13 weeks (dose, 20, 40, 80, 160, and 310 mg/kg), at the dose of 310 mg/kg above the guidance value of Category 2, reduced body weight, increased weight of liver in males, changes in nasal cavity were noted, and in females, at the dose of 20 mg/kg equivalent to the guidance value of Category 2, changes in leukocytes were observed (IUCLID (2000)). Based on above, the substance was classified into Category 2 (blood, kidneys).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 3	- -	H402	P273 P501	It was classified in Category 3 from 48-hour EC50 = 20 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002), SIAP, 2012, SIDS, 2013, Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2009)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (BIOWIN) and 21-day NOEC = 2.2 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002), SIDS, 2013, Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2009)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (fish), then it is classified as "Not classified" due to being not rapidly degradable and 96-hour LC50 > 98 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002), SIAP, 2012, SIDS, 2013, Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2009)). From the above results, it was classified as "Not classified."	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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