GHS Classification Result

Chemical Name：4,4'-Methylenedianiline
CAS：101-77-9

Result：
ID: 211
Classifier: Inter-ministerial Committee on GHS
Year Classified: FY2006
Reference Manual: GHS Classification Manual （10 Feb, 2006）

PHYSICAL HAZARDS
Hazard class Classification Symbol Signal word Hazard statement Precautionary statement Rationale for the classification
1 Explosives Not applicable - - - - Containing no chemical groups with explosive properties
2 Flammable gases （including chemically unstable gases） Not applicable - - - - Classified as "solid" according to GHS definition
3 Aerosols Not applicable - - - - Not aerosol products
4 Oxidizing gases Not applicable - - - - Classified as "solid" according to GHS definition
5 Gases under pressure Not applicable - - - - Classified as "solid" according to GHS definition
6 Flammable liquids Not applicable - - - - Classified as "solid" according to GHS definition
7 Flammable solids Not classified - - - - Classified as "flammable" by ICSC (2004). Classified into Division 6.1 (UN#2651) (UN Recommendations on the Transport of Dangerous Goods).
8 Self-reactive substances and mixtures Not applicable - - - - Containing no chemical groups with explosive or self-reactive properties
9 Pyrophoric liquids Not applicable - - - - Classified as "solid" according to GHS definition
10 Pyrophoric solids Not classified - - - - Classified into Division 6.1 (UN#2651) (UN Recommendations on the Transport of Dangerous Goods)
11 Self-heating substances and mixtures Classification not possible - - - - Test methods applicable to liquid substances are not available (melting point: 91.5-92degC (ICSC, 2004), test temperature: 140degC).
12 Substances and mixtures which, in contact with water, emit flammable gases Not applicable - - - - Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At)
13 Oxidizing liquids Not applicable - - - - Classified as "solid" according to GHS definition
14 Oxidizing solids Not applicable - - - - Organic compounds containing no oxygen, fluorine and chlorine
15 Organic peroxides Not applicable - - - - Organic compounds containing no "-O-O-" structure
16 Corrosive to metals Classification not possible - - - - Test methods applicable to solid substances are not 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 ... 		Based on the LD50 value of 335mg/kg calculated from the testing data of rat LD50 (oral route) of 264mg/kg (MOE Risk Assessment vol. 2 (2003)), 355mg/kg, 475mg/kg, 547mg/kg and 830mg/kg (DFGOT vol.7 (1996)).
1 Acute toxicity （Dermal） Category 3 Danger H311: Toxic in contact with skin P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P312: Call a POISON CENTER or doctor/physician if you feel unwell.
P322: Specific treatment （see ... on this label）.
P361: Remove/Take off immediately all contaminated clothing.
P363: Wash contaminated clothing before reuse.
P405: Store locked up.
P501: Dispose of contents/container to ... 		Based on the rat LD50 (dermal route) value of 1,000mg/kg (SIDS (2002)).
1 Acute toxicity （Inhalation: Gases） Not applicable - - - - Due to the fact that the substance is "solid" according to the GHS definition and inhalation of its gas is not expected.
1 Acute toxicity （Inhalation: Vapours） Classification not possible - - - - No data available
1 Acute toxicity （Inhalation: Dusts and mists） Classification not possible - - - - Insufficient data available
2 Skin corrosion/irritation Category 3 - Warning H316: Causes mild skin irritation P332+P313: If skin irritation occurs: Get medical advice/attention. Based on the description in the report on rabbit skin irritation tests (SIDS (2002)): "The substance produced slight irritation of the skin" (though exposure duration is not presented).
3 Serious eye damage/eye irritation Category 2A 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. 		Based on the description in the report on rabbit eye irritation tests (SIDS (2002)): "The substance produced mild to moderate irritation of the eye."
4 Respiratory sensitization Classification not possible - - - - The substance is considered to cause no skin sensitization, based on the results of respiratory sensitization studies in guinea pigs (CERI Hazard Data 97-11 (2002)). However, the test methods are not detailed enough and the available data are insufficient to determine the presence or absence of skin sensitization.
4 Skin sensitization Category 1 Warning H317: May cause an allergic skin reaction P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P333+P313: If skin irritation or rash occurs: Get medical advice/attention.
P261: Avoid breathing dust/fume/gas/mist/vapours/spray.
P272: Contaminated work clothing should not be allowed out of the workplace.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P321: Specific treatment （see ... on this label）.
P363: Wash contaminated clothing before reuse.
P501: Dispose of contents/container to ... 		Due to the fact that the substance is classified as a "Skin Sensitizing Substance" by the ad hoc committee of the Japanese Society of Occupational Allergy. Also based on four cases of sensitization reported in human epidemiological studies (CERI Hazard Data 97-11 (2002) and MOE Risk Assessment vol. 2 (2003)).
5 Germ cell mutagenicity Category 2 Warning H341: Suspected of causing genetic defects 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 ... 		Based on the absence of data on multi-generation mutagenicity tests, germ cell mutagenicity tests in vivo and germ cell genotoxicity tests in vivo, and positive data on somatic cell mutagenicity tests in vivo (micronucleus tests, chromosome aberration tests), described in NTP DB (Access on Mar., 2006), EU-RAR No.9 (2001), SIDS (2002) and ATSDR (1998).
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 ... 		Due to the fact that the substance is classified as Category A3 by ACGIH (2001) and Group 2B by IARC (1987).
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 ... 		Based on the evidence of adverse effects on fetuses at doses causing maternal toxicity, described in DFGOT vol.7 (1996).
8 Specific target organ toxicity - Single exposure Category 1 (liver, kidney, heart, central nervous system, visual organs) Danger H370: Causes damage to organs (liver, kidney, heart, central nervous system, visual organs) 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 ... 		Based on the human evidence including "influenza-like symptoms with fever, jaundice," "blurred vision progressed to a significant decrease in vision; hepatic toxicity was observed," "hepatic toxicity, progression of albuminuria/hematuria," "myalgia and arthralgia" (ATSDR (1998)), "hepatitis observed in 3 days," "hepatitis," "acute hepatic symptoms," "severe pain above the navel, jaundice, electrocardiographic abnormalities suggesting cardiac muscle damage" (EU-RAR No.9 (2001)), and the evidence from animal studies including "necrosis and hemorrhage of the hepatocyte/bile duct" (ATSDR (1998)), "liver and kidney damage," "exophthalmos, hunchback position, rough fur," "indifference, chromodacryorrhea, jaundice" (EU-RAR No. 9 (2001)), "atrophy of the nucleus of rod/cone/outer nuclear layer of the retina" (CERI Hazard Data 97-11 (1998)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for Category 1.
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, heart), Category 2 (thyroid, kidney, blood system) Danger
Warning 		H372: Cause damage to organs through prolonged or repeated exposure (liver, heart)
H373: May cause damage to organs through prolonged or repeated exposure (thyroid, kidney, blood system) 		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.
P314: Get medical advice/attention if you feel unwell.
P501: Dispose of contents/container to ... 		Based on the human evidence: "A man exhibited hepatic toxicity following accidental ingestion of a solution containing 4,4'-methylenedianiline, potassium carbonate and gammabutyrolactone; elevated transaminase and bilirubinemia were detected at clinical examination performed 2 days after exposure. Though the solution contain other substances, the clinical findings were consistent with those reported by Kopelman et al., which were considered to be 4,4'-methylenedianiline-induced toxic effects," "echocardiography revealed evidence of decreased septal motion and hypofunction of the left ventricle" (ATSDR (1998)), "11 patients had jaundice," "exposure to MDA caused hepatitis" (EU-RAR No.9 (2001)). Also based on the evidence from animal studies including "hyperplasia of the bile duct," "hyperplasia of the thyroid gland" (ATSDR (1998)), "anemia, hyperplasia of the small bile duct, hypertrophy of the thyroid gland follicular epitheliocytes, nephrocalcinosis," "hepatic parenchyma was replaced by the proliferative bile duct, leading to portal cirrhosis" (EU-RAR No.9 (2001)). The effects on experimental animals were observed at dosing levels within the guidance value ranges for Category 2.
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 1 Warning H400: Very toxic to aquatic life P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		It was classified into Category 1 from 48 hours EC50=0.105mg/L of the crustacea (Daphnia magna) (CERI Hazard Data, 1997).
11 Hazardous to the aquatic environment （Long-term） Category 1 Warning H410: Very toxic to aquatic life with long lasting effects P273: Avoid release to the environment.
P391: Collect spillage.
P501: Dispose of contents/container to ... 		Although acute toxicity is Category 1 and bio-accumulation is low (BCF=15(Existing Chemical Safety Inspections Data, )), since there was no rapidly degrading (the decomposition by BOD: 0%(Existing Chemical Safety Inspections Data)), it was classified into Category 1.


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 SDS by MHLW

 MHLW Website （in Japanese Only）

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