GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 838-88-0 |
| Chemical Name | 4,4'-Diamino-3,3'-dimethyldiphenylmethane [4,4'-Methylenedi-o-toluidine, 4,4'-Methylene bis(2-methylaniline)] |
| Substance ID | H29-B-114 |
| Classification year (FY) | FY2017 |
| 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) | |
| 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 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 |
- |
- | - | There is the information that it is combustible (GESTIS (Access on September 2017)), 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 | Not classified |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 455 deg C (GESTIS (Access on August 2017)). |
| 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 | Not applicable |
- |
- | - | Organic compounds containing no oxygen, fluorine or chlorine |
| 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. |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Based on the information of 1,784 mg/kg as the average value of three LD50 values for rats, it was classified in Category 4 in the previous classification. However, this cannot be confirmed since no information source is described. Therefore, the classification result was changed from the previous classification, and it was classified as "Classification not possible." |
| 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, although it is not a test in compliance with the guidelines, there is a description that even when 0.5 mL of a 15% solution of this substance was repeatedly applied to rabbit skin for 10-30 days, no skin irritation was observed (DFGOT Vol. 18 (2002)). In addition, since the IUCLID (2000) used as evidence of the classification in the previous classification is currently unavailable, the classification result was changed. |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, although it is not a test in compliance with the guideline, there is a description that in an eye irritation test with rabbits, slight redness was observed when 0.1 g of this substance was applied, but this resolved after 24 hours (ECHA registration dossier (Access on November 2017)). In addition, since IUCLID (2000) used as evidence of the classification in the previous classification is currently unavailable, the classification result was changed. |
| 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. Besides, there is a report that in a sensitization test with rabbits in which 0.5 mL of a 15% solution of this substance was applied daily to the right flank for 10-30 days, and 0.5 mL of a 25% solution of this substance was applied to the left flank after 10 days from the application end, swelling with hyperaemia was caused. However, there is a description that the possibility of irritation cannot be excluded, so it is not possible to evaluate (DFGOT Vol. 18 (2002)). Since IUCLID (2000) used in the previous classification is currently unavailable, it was not used. The category was changed based on the information obtained in this research. Besides, this substance was classified as "Skin Sens. 1, H317" in EU CLP classification (ECHA CL Inventory (Access on August 2017)). |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. As for in vitro, a positive result in a bacterial reverse mutation test is described (CPDB (Access on January 2018)). However, since details are unknown, it was not used for the classification. Besides, since IUCLID (2000) described in the previous classification is currently unavailable, it was not adopted. |
| 6 | Carcinogenicity | Category 1B |
 Danger |
H350 |
P308+P313
P201 P202 P280 P405 P501 |
There is a description that in workers exposed to this substance and other substances (including o-toluidine) in a dye production process, an increase in the risk of the urinary bladder cancer was shown (PATTY (6th, 2012), IARC Suppl. 7 (1987)). As for experimental animals, there are reports that in studies with rats dosed by gavage or feeding, an increase in tumors of the lung, skin, and mammary gland in addition to liver tumors (malignant tumors) was observed (IARC 4 (1974), IARC Suppl. 7 (1987)), and that an increase in hepatocellular carcinoma and lung tumors was also observed in an oral administration to dogs (IARC Suppl. 7 (1987)). IARC classified it in Group 2B since the evidence for carcinogenicity was insufficient in humans and sufficient in experimental animals (IARC Suppl. 7 (1987)). Other than that, EU classified it in Carc. 1B (ECHA CL Inventory (Access on August 2017)), and Japan Society For Occupational Health (JSOH) in 2B (Recommendation of Occupational Exposure Limits (2016): proposal in 1991). From the above, based on tumor incidence including liver tumors observed in multiple organs in two species of experimental animals and the classification result by EU, it was classified in Category 1B for this hazard class. Besides, the category was changed from the previous classification. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 9 | Specific target organ toxicity - Repeated exposure | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 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:
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* 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. |