GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 99-55-8 |
| Chemical Name | 2-Methyl-5-nitroaniline [5-nitro-o-toluidine] |
| Substance ID | H27-B-026/C-047B_P |
| Classification year (FY) | FY2015 |
| 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 | FY2008 |
| 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 | Classification not possible |
- |
- | - | It contains a chemical group associated with explosive properties (N-O), and the oxygen balance of -168.42 is higher than criteria of -200. However, the classification is not possible due to no explosiveness test data. |
| 2 | Flammable gases (including chemically unstable gases) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 3 | Aerosols | Not applicable |
- |
- | - | Not an aerosol product. |
| 4 | Oxidizing gases | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 5 | Gases under pressure | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 6 | Flammable liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 7 | Flammable solids | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group present in the molecule associated with explosive properties (N-O), but the classification is not possible due to no data. |
| 9 | Pyrophoric liquids | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 10 | Pyrophoric solids | Classification not possible |
- |
- | - | Due to no data, the classification is not possible. |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No established test method suitable for solid substances with a melting point of 140 degrees C or lower. |
| 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 |
- |
- | - | "Solids" according to GHS definition. |
| 14 | Oxidizing solids | Classification not possible |
- |
- | - | It is an organic compound which does not contain fluorine or chlorine but contains oxygen, and the oxygen is chemically bonded to an element (N) other than carbon or hydrogen, but the classification is not possible due to no data. |
| 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 |
- |
- | - | No established test method suitable for solid substances. |
| Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 1 | Acute toxicity (Oral) | Category 4 |
 Warning |
H302 | P301+P312 P264 P270 P330 P501 |
From an LD50 value of 574 mg/kg for rats (DFGOT vol. 6 (1994); DFGOT vol. 21 (2005)), it was classified in Category 4. Based on DFGOT vol. 6 (1994), DFGOT vol. 21 (2005), the Category was revised. |
| 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. |
| 1 | Acute toxicity (Inhalation: Vapours) | Not applicable |
- |
- | - | "Solids" according to GHS definition. |
| 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 not detailed information, but it is written that this substance may be irritating to skin (NTP TR107 (1978); DFGOT vol.6 (1994)). |
| 3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 5 | Germ cell mutagenicity | Category 2 |
 Warning |
H341 | P308+P313 P201 P202 P280 P405 P501 |
It is reported that as for in vivo, a micronucleus test in mouse bone marrow cells after oral administration was negative (DFGOT vol. 6 (1994)), and as for in vitro, a bacterial reverse mutation test, a chromosomal aberration test and a sister chromatid exchange test in cultured mammalian cells were positive (IARC 48 (1990); ACGIH (7th, 2007); PATTY (6th, 2012); DFGOT vol. 6 (1994); NTP DB (Access on August 2015)), therefore, it was classified in Category 2 in accordance with the GHS classification guidance for the Japanese government. |
| 6 | Carcinogenicity | Category 2 |
Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
There is no carcinogenicity information in humans. As for experimental animals, when necropsy was conducted after a period of 30 weeks in rats or 20 weeks in mice that followed 78-week diet administration, rats showed only an increased trend of hepatocellular carcinoma in high-dose males. However, in mice, a dose-dependent increase of hepatocellular carcinoma was observed in both males and females (ACGIH (7th, 2007); NTP TR107 (1978); IARC vol. 48 (1990)). Moreover, it is written that also in a 2-year diet administration test using transgenic mice carrying the C-Ha-ras gene, dose-dependent malignant liver tumor formation was observed (ACGIH (7th, 2007)). As the carcinogenicity classification results by other organizations, IARC classified in Group 3 in early times (IARC vol. 48 (1990)) whereas the substance was classified in A3 by ACGIH (ACGIH (7th, 2007)), Category 2 by DFG (DFGOT vol. 21 (2005)), and in Carc. 2 in EU CLP classification (ECHA CL Inventory (Access on June 2015)). Therefore, based on the classification results in carcinogenicity by ACGIH and EU, the substance was classified in "Category 2" in accordance with the GHS classification guidance for the Japanese government. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | Due to lack of data, the classification is not possible. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (haemal system) |
Danger |
H370 | P308+P311 P260 P264 P270 P321 P405 P501 |
Although there is little information on this substance, as for humans, the main effect of this substance is methemoglobinemia, and bluish lips and fingernails, headache, nausea, and a sense of fatigue are listed. As for experimental animals, methemoglobinemia was observed after intraperitoneal administration in cats and guinea pigs (at 5-10 mg/kg, 600-700 mg/kg respectively), but rabbits did not show this sign (ACGIH (7th, 2007)). This exposure route (intraperitoneal) was not targeted for the classification in accordance with Classification Guidance. From the above, because this substance has effects on blood system, it was classified in Category 1 (blood system). By adding new information, the Category was revised. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver) |
Danger |
H372 | P260 P264 P270 P314 P501 |
In exposure cases in the work environment, three out of 15 people were hospitalized with acute liver dysfunction, and seven showed liver dysfunction in blood tests. Besides, it is written that histological findings from biopsies during recovery by treatment were similar to acute hepatitis (ACGIH (7th, 2007)). Therefore, it was classified in Category 1 (liver). |
| 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) | Category 3 |
- |
H402 | P273 P501 |
From 96-hour EC50 = 101.5 uM for algae (Pseudokirchneriella subcapitata) (AQUIRE, 2016; HSDB, 2009), it was classified in Category 3. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 3 |
- |
H412 | P273 P501 |
Reliable chronic toxicity data were not obtained. Due to being not rapidly degradable (BioWin), and acute toxicity Category 3, it was classified in Category 3. |
| 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. |