GHS Classification Result

Chemical Name:2,6-xylidine; 2,6-dimethylaniline
CAS:87-62-7

Result:
ID: 20A2144
Classifier: Ministry of Health, Labour and Welfare (MHLW), Ministry of the Environment (MOE)
Year Classified: FY2008
Reference Manual: GHS Classification Guidance by the Japanese Government (Sep, 2008)

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - There are no chemical groups associated with explosive properties present in the molecules.
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 Category 4 - Warning H227: Combustible liquid P370+P378: In case of fire: Use ... for extinction.
P403+P235: Store in a well-ventilated place. Keep cool.
P210: Keep away from heat/sparks/open flames/hot surfaces. ? No smoking.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P501: Dispose of contents/container to ...
Based on its flash point of 91degC (ICSC (2007)), the substance was classified into Category 4.
7 Flammable solid 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 - - - - Its autoignition point is 490degC (IUCLID (2000)), which is above 70degC.
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 - - - - Organic compounds containing no oxygen, fluorine or chlorine
14 Oxidizing solids Not applicable - - - - Liquid (GHS definition)
15 Organic peroxides Not applicable - - - - Organic compounds containing no bivalent -O-O- structure
16 Corrosive to metals Classification not possible - - - - No data available.

HEALTH HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Acute toxicity (Oral) Category 4 Warning H302: Harmful if swallowed P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P330: Rinse mouth.
P501: Dispose of contents/container to ...
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.
1 Acute toxicity (Dermal) Classification not possible - - - - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable - - - - Liquid (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 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).
3 Serious eye damage/eye irritation Category 2 Warning H319: Causes serious eye irritation P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313: If eye irritation persists: Get medical advice/attention.
P264: Wash ... thoroughly after handling.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
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.
4 Respiratory sensitization Classification not possible - - - - No data available.
4 Skin sensitization Classification not possible - - - - No data available.
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)).
6 Carcinogenicity Category 2 Warning H351: Suspected of causing cancer P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
Since the substance is classified into Group 2B in IARC (IARC vol.57 (1993)), it was classified into Category 2.
7 Reproductive toxicity Category 2 Warning H361: Suspected of damaging fertility or the unborn child P308+P313: IF exposed or concerned: Get medical advice/attention.
P201: Obtain special instructions before use.
P202: Do not handle until all safety precautions have been read and understood.
P281: Use personal protective equipment as required.
P405: Store locked up.
P501: Dispose of contents/container to ...
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.
8 Specific target organ toxicity - Single exposure Category 1 (blood), Category 2 (nervous system) Danger
Warning
H370: Causes damage to organs (blood)
H371: May cause damage to organs (nervous system)
P307+P311: IF exposed: Call a POISON CENTER or doctor/physician.
P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P321: Specific treatment (see ... on this label).
P405: Store locked up.
P501: Dispose of contents/container to ...
P309+P311: IF exposed or if you feel unwell: Call a POISON CENTER or doctor/physician.
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".
9 Specific target organ toxicity - Repeated exposure Category 2 (blood, kidney) Warning H373: May cause damage to organs through prolonged or repeated exposure (blood, kidney) P260: Do not breathe dust/fume/gas/mist/vapours/spray.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ...
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).
10 Aspiration hazard Classification not possible - - - - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 3 - - H402: Harmful to aquatic life P273: Avoid release to the environment.
P501: Dispose of contents/container to ...
Based on its 48h-EC50 = 20 mg/L for crustaceans (Daphinia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2002), the substance was classified into Category 3.
11 Hazardous to the aquatic environment (Long-term) Not classified - - - - Its preexisting classification for acute toxicity is Category 3, and it is not rapidly biodegradable (non-biodegradable; BOD degradability, 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2002)). However, its 21-day-NOEC = 2.2 mg/L for crustaceans (Daphinia magna) (Test for the Ecological Effect of Chemical Substances (Ministry of the Environment), 2002). Therefore, the substance was classified into "Not classified".


NOTE:
* 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.

Reference:
Reference Manual

Definitions / Abbreviations

Model Label by MHLW

MHLW Website (in Japanese Only)

Model SDS by MHLW

MHLW Website (in Japanese Only)


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