GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 25214-70-4 |
| Chemical Name | Aniline, polymer with formaldehyde |
| Substance ID | H27-A-026/C-056A_P |
| Classification year (FY) | FY2015 |
| Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE) |
| New/Revised | New |
| Classification result in other fiscal year | |
| 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 |
| 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 present in the molecule associated with explosive properties. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Liquids" or "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Liquids" or "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Liquids" or "Solids" according to GHS definition. |
| 6 | Flammable liquids | Category 4 (when it is judged to be liquid) |
Warning |
H227 | P370+P378 P403+P235 P210 P280 P501 |
There is a flash point data of 70 degrees C (unknown method) (MOLBASE (Access on September 2015)), and it is estimated that it corresponds to Category 4 in a prescribed test. |
| 7 | Flammable solids | Classification not possible (when it is judged to be solid) |
- |
- | - | Due to no data, the classification is not possible. |
| 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 | Classification not possible (when it is judged to be liquid) |
- |
- | - | Due to no data, the classification is not possible. |
| 10 | Pyrophoric solids | Classification not possible (when it is judged to be solid) |
- |
- | - | Due to no data, the classification is not possible. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | For liquids and solids with a melting point of 140 degrees C or lower, the classification is not possible due to no established test method suitable for liquid substances (a test temperature 140 degrees C). For substances with a melting point of above 140 degrees C, the classification is not possible due to no data. |
| 12 | Substances and mixtures which, in contact with water, emit flammable gases | Not applicable |
- |
- | - | Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). |
| 13 | Oxidizing liquids | Not applicable (when it is judged to be liquid) |
- |
- | - | It is an organic compound that hardly contains oxygen, fluorine, or chlorine (it is estimated that oxygen from formaldehyde will be removed during a condensation process). |
| 14 | Oxidizing solids | Not applicable (when it is judged to be solid) |
- |
- | - | It is an organic compound that hardly contains oxygen, fluorine, or chlorine (it is estimated that oxygen from formaldehyde will be removed during a condensation process). |
| 15 | Organic peroxides | Not applicable |
- |
- | - | It is an organic compound that does not contain bivalent -O-O- structure in the molecule. |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | This substance has another name of technical grade methylenedianiline (MDA) and is a UVCB substance (Substances of Unknown or Variable composition, Complex reaction products or Biological materials) consisting of a variable content of variable components: tri- and polynuclear amine (so-called "polymers"). According to an EU survey, a typical standard product of this substance containing 4,4'-methylenedianiline (4,4'-MDA: CAS number: 101-77-9) of between ca. 47 and < 65% is liquid at room temperature and contains followings as other components: 2,4'-MDA (1.4 to ca. 10%), 2,2'-MDA (ca. 0.2 to 3%), oligomers of MDA (ca. 38.4 to <65%) and so on (ECHA SVC Support Document (2011), EU-RAR (2001)). The classification is not possible due to lack of data. |
| 1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. (in case of solids) "Liquids" according to GHS definition. (in case of liquids) |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable (when it is solid), Classification not possible (when it is liquid) |
- |
- | - | "Solids" according to GHS definition. (in case of solids) Due to lack of data, the classification is not possible. (in case of liquids) |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 2 | Skin corrosion/irritation | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is reported that only slight erythema was observed in a skin irritation test in which 500 mg of 4,4'-MDA (CAS number: 101-77-9), a major component of this substance was applied to rabbit skin for 24 hours (EU-RAR (2001)). |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is reported that after 100mg of 4,4'-methylenedianiline (4,4'-MDA: CAS number: 101-77-9), a major component of this substance was applied to conjunctival sac of rabbits, mild to moderate irritation was shown but resolved within seven days (EU-RAR (2001)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | The classification is not possible due to lack of data. Besides, it is reported that in a maximization test in which 4,4'-methylenedianiline (4,4'-MDA: CAS number: 101-77-9), a major component of this substance was applied to guinea pigs, sensitization was not found. However, because there are many reports that it caused sensitization in a human patch test, the EU considered that there is the comment that 4,4'-MDA could be sensitizing in humans (EU-RAR (2001)). |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
There are no data on this substance. This substance is a polymer and that of standard technical grade consists of 4,4'-methylenedianiline (4,4'-MDA: CAS number: 101-77-9) between ca. 47 and < 65%, 2,4'-MDA (1.4 to ca. 10%), 2,2'-MDA (ca. 0.2 to 3%), oligomers of MDA (ca. 38.4 to <65%) and on (ECHA SVC Support Document (2011), EU-RAR (2001)). Among components with a content of 1% or higher, data on germ cell mutagenicity was obtained for 4,4'-MDA, but could not be obtained for 2,4'-MDA and 2,2'-MDA. Therefore, germ cell mutagenicity of 4,4'-MDA, a major component of this substance is described below: As for in vivo, for 4,4'-MDA, a somatic cell mutagenicity test (a micronucleus test, a chromosomal aberration test) was positive (NTP DB (Access on March 2006), EU-RAR (2001), SIDS (2002)). As for in vitro, a bacterial reverse mutation test, a mouse lymphoma test, a chromosomal aberration test, and a sister chromatid exchange test in cultured mammalian cells were all positive (Initial Risk Assessment, NITE (2007); EU-RAR (2001); SIDS (2002)). Because this substance contains 1.0% of 4,4'-MDA or more, this substance was classified in Category 2. |
| 6 | Carcinogenicity | Category 1B |
Danger |
H350 | P308+P313 P201 P202 P280 P405 P501 |
This substance is a mixture containing 4,4'-methylenedianiline (4,4'-MDA: CAS number: 101-77-9), and classification results of 4,4'-MDA can be applied. As for classification results of 4,4'-MDA by other organizations, it was classified as follow: Group 2B by IARC (IARC 39 Sup.7 (1987)), A3 by ACGIH (ACGIH (7th, 2001)), R by NTP (NTP RoC (13th, 2014)), 2B by Japan Society for Occupational Health (The Recommendation of Acceptable Concentration (2015)), and Carc. 1B by EU (ECHA CL Inventory (Access on August 2015)) respectively. Among these, according to Classification Guidance, EU classification corresponds to Category 1B, and it corresponds to Category 2 except EU and NTP. In EU-RAR (2001) assessment, in a carcinogenicity test of 4,4'-MDA in rats and mice in an oral route, significantly increased incidences of tumors in the thyroid and liver were observed, and rat showed bladder transitional epithelial papillomas although in a lower frequency. Because they are rare tumors, there is the comment that association of administrating this substance cannot be excluded. Namely, it was concluded that there is sufficient evidence in experimental animals (EU-RAR (2001)). On the other hand, it was suggested that bladder cancer might be associated with occupational exposure to this substance in humans, but it was concluded that no clear conclusion could be drawn for carcinogenicity from epidemiological knowledge. From these, 4,4'-MDA is a carcinogen in experimental animals, but there is insufficient information on human carcinogenicity. Therefore, 4,4'-MDA was classified in Category 2 (corresponding to Carc. 1B in the current CLP classification) according to the criteria of the Directive 67/548/EEC (EU-RAR (2001)). As above, by adopting the carcinogenicity classification results of 4,4'-MDA which EU conducted after IARC evaluation (consistent with the 2014 NTP assessment) and because it is also applicable to this substance, this substance was classified in Category 1B in this hazard class. Besides, by applying the results of 4,4'-MDA in carcinogenicity evaluation of this substance, this substance will be classified in Category 1B. Therefore, EU classed this compound in SVHC (ECHA SVHC Support Document (2011)). |
| 7 | Reproductive toxicity | Category 2 |
Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
This substance is a mixture containing 4,4'-methylenedianiline (4,4'-MDA: CAS number: 101-77-9), and classification results of 4,4'-MDA can be applied. Information on reproductive effects of 4,4'-MDA is very limited. There is the only description that pregnant rats were administered by gavage with hydrochloride of 4,4'-MDA at 50 mg/kg/day on day 14 to 20 of gestation and had a Caesarean section on day 21 of gestation, and effects on the liver in maternal animals (discoloration, proliferation in the bile ducts, and proliferation and initial signs of fibrosis in the portal region) and histological changes in the liver in fetuses (fatty infiltration of liver parenchyma (too severe to distinguish the bile ducts and portal area)) were observed (DFGOT vol. 7 (1996)). Besides, it is written that pregnant rats or rabbits were administered by gavage of a preparation containing about 30% 4,4'-MDA (EMP IV) during an organogenetic period in teratogenicity tests, both of which did not observe fetal toxicity and malformations in fetuses even administered up to the doses where maternal animals died. (Result of the initial environmental risk assessment of chemicals, Vol. 10, Ministry of the Environment in Japan (2012)) From the above, it is judged that Category 2 classification is valid for 4,4'-MDA from the data described in DFGOT similarly to the previous classification. Because the classification results of 4,4'-MDA are also applicable to this substance, this substance was classified in Category 2 in this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (central nervous system, visual organs, heart, liver, kidney) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
There are no data on this substance. This substance is a polymer and that of standard technical grade consists of 4,4'-methylenedianiline (4,4'-MDA: CAS number: 101-77-9) between ca. 47 and < 65%, 2,4'-MDA (1.4 to ca. 10%), 2,2'-MDA (ca. 0.2 to 3%), oligomers of MDA (ca. 38.4 to <65%) and on (ECHA SVC Support Document (2011), EU-RAR (2001)). Among components of 1% or higher, data on single exposure toxicity was obtained for 4,4'-MDA, but could not be obtained for 2,4'-MDA and 2,2'-MDA. Therefore, single exposure toxicity of 4,4'-MDA, a major component of this substance is described below. As for humans, the following is reported as acute toxic signs of 4,4'-MDA reported in oral, inhalation, and dermal routes: acute hepatitis with nausea, vomiting, fever, chill, right upper quadrant pain, and jaundice, hepatic enlargement, cholangitis, inflammation and congestion of bile in the portal region, necrosis and degeneration of hepatocytes, myocardial disorder, ECG abnormalities suggesting myocardial injury, and retinal disorder (Initial Risk Assessment, NITE (2007); Result of the initial environmental risk assessment of chemicals, Vol. 10, Ministry of the Environment in Japan (2012); EU-RAR (2001); ACGIH (7th, 2001)). As for experimental animals (rats, mice and so on), the following was reported: necrosis of hepatocytes with hemorrhage, multifocal cholangiolar hepatitis, necrosis of bile ducts, liver and kidney damage, and blindness due to retinal atrophy in oral administration of 4,4'-MDA (at the dose corresponding to Category 1); and tremor, hunched posture, and exophthalmos in inhalation exposure (at the dose corresponding to Category 1) (Initial Risk Assessment, NITE (2007); ACGIH (7th, 2001); EU-RAR (2001); ATSDR (1998)). As above, effects of 4,4'-MDA were observed in the central nervous system, visual organs, heart, liver, and kidney. Because this substance contains 10% of 4,4'-MDA or more, this substance was classified in Category 1 (central nervous system, visual organs, heart, liver, kidney). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver, heart, thyroid, kidney), Category 2 (haemal system) |
Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
There are no data on this substance. However, this substance is a polymer and that of standard technical grade consists of 4,4'-methylenedianiline (4,4'-MDA: CAS number: 101-77-9) between ca. 47 and < 65%, 2,4'-MDA (1.4 to ca. 10%), 2,2'-MDA (ca. 0.2 to 3%), oligomers of MDA (ca. 38.4 to <65%) and on (ECHA SVC Support Document (2011), EU-RAR (2001)). Among components of 1% or higher, data on repeated toxicity was obtained for 4,4'-methylenedianiline (4,4'-MDA: CAS number: 101-77-9). Data on repeated dose toxicity could not be obtained for 2,4'-MDA (CAS number: 1208-52-2) and 2,2'-MDA (CAS number: 6582-52-1). Repeated toxicity of 4,4'-MDA (CAS number: 101-77-9), a major component of this substance is described below. As for humans, in a single exposure and short-term exposure for two weeks or shorter, acute hepatitis was mainly reported, and cases with ECG abnormalities were also reported (Initial Risk Assessment, NITE (2007); ATSDR (1998); EU-RAR (2001)). As for experimental animals, as repeated dose toxicity, in a 103-week toxicity test using rats in drinking water administration, fatty liver, cysts and hyperplasia of thyroid follicular epithelial cells were observed at 150 ppm (9 to 10 mg/kg/day) or higher, and kidney mineralization (males) at 300 ppm (16 mg/kg/day). In a 3-month toxicity test using rats in drinking water administration, the following was observed: nephrocalcinosis and degeneration of thyroid follicular epithelial cells at 80 ppm (males: 7.5 mg/kg/day, females: 8 mg/kg/day) or higher; decreases in food and water consumption, reduced weight gain, anemia, increases in ALP, ALT, AST, urea nitrogen, bile pigments, and cholesterol, focal nodular hyperplasia of thyroid follicular epithelial cells at 400 ppm (males: 22 mg/kg/day, females: 23 mg/kg/day) or above; and increases in white blood cells and neutrophils, prolonged prothrombin time, hyperplasia of small bile ducts of the liver, hyperplasia of thyroid follicular epithelial cells at 800 ppm (males: 31 mg/kg/day, females: 32 mg/kg/day) (Initial Risk Assessment, NITE (2007)). Among these effects, effects on liver, thyroid, and kidney were observed in the range of Category 1, and effects on blood were found in the range of Category 2. As above, effects of 4,4'-MDA were observed in liver and heart in humans, and effects on liver, thyroid, and kidney were observed in the range of Category 1, and effects on blood were found in the range of Category 2 in experimental animals. Because this substance contains 10% of 4,4'-MDA or more, this substance was classified in Category 1 (liver, heart, thyroid, and kidney), Category 2 (blood system). |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 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. |
| 11 | Hazardous to the aquatic environment (Long-term) | Classification not possible |
- |
- | - | No data. |
| 12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data. |
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. |