GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 108-44-1 |
| Chemical Name | m-Toluidine |
| Substance ID | H29-B-041 |
| 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 |
- |
- | - | 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 |
P370+P378
P403+P235 P210 P280 P501 |
Based on a flash point of 85 deg C (closed cup) (ICSC (J) (2009)), it was classified in Category 4. |
| 7 | Flammable solids | 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 |
- |
- | - | It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 480 deg C (GESTIS (Access on June 2017)). |
| 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 in the molecule |
| 16 | Corrosive to metals | Classification not possible |
- |
- | - | No data available. |
| 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 |
Based on reports of LD50 values for rats of 450 mg/kg (ACGIH (7th, 2001), SIDS (2003)), 974 mg/kg (SIDS (2003), PATTY (6th, 2012)), 1,160 mg/kg (SIDS (2003)), and 1,430 mg/kg (SIDS (2003)), it was classified in Category 4. |
| 1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | Based on a report of an LD50 value of 3,250 mg/kg (SIDS (2003)) for rabbits, it was classified as "Not classified" (Category 5 in UN GHS classification). The category was changed from the previous classification due to the revision of the GHS classification guidance for the Japanese government. |
| 1 | Acute toxicity (Inhalation: Gases) | Not applicable |
- |
- | - | Liquid (GHS definition) |
| 1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 1 | Acute toxicity (Inhalation: Dusts and mists) | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 2 | Skin corrosion/irritation | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
Based on a report that this substance was moderately or slightly irritating in a skin irritation test with rabbits (SIDS (2003)), it was classified in Category 2. |
| 3 | Serious eye damage/eye irritation | Category 2 |
Warning |
H319 |
P305+P351+P338
P337+P313 P264 P280 |
There is a report that this substance showed moderate irritation in an eye irritation test with rabbits (SIDS (2003)). Since there is no information for subcategorization, it was classified in Category 2. |
| 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. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. As for in vivo, there is a report of a negative result in a sister chromatid exchange test with mice, however, the details are unknown (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), BUA 146 (1993)). As for in vitro, bacterial reverse mutation tests and a chromosomal aberration test with mammalian cultured cells were negative (JECDB (Access on June 2017), ACGIH (7th, 2001), NTP DB (Access on June 2017), HSDB (Access on June 2017), BUA 146 (1993)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | In carcinogenicity tests in which m-toluidine hydrochloride was administered by feeding to male rats, and female and male mice for 18 months, no significant increase in the incidence of tumors was observed in rats, and in mice, an increase in the number of animals which developed hepatic tumors was observed in the low-dose group of males (dosed at 16,000 ppm for 5 months, and then at 4,000 ppm for 13 months), but there was no finding of dose-response relationship (ACGIH (7th, 2001), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). From the above, ACGIH classified this substance in A4 since this substance (hydrochloride) showed no carcinogenicity in rats or mice (ACGIH (7th, 2001)). Therefore, it was classified as "Classification not possible." |
| 7 | Reproductive toxicity | Category 2 |
 Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, in the groups of 30 and 100 mg/kg/day, deaths of offspring due to poor delivery and lactation conditions were sporadically observed, and in the group of 100 mg/kg/day, early deaths and resorptions of total implants were observed in 2/10 of maternal animals. In addition, in the group of 300 mg/kg/day, early resorptions of total implants were observed in all maternal animals (11/11), and a birth rate was 0% (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). These reproductive and developmental effects occurred at doses where general toxic effects such as effects on the spleen and kidney at or above 30 mg/kg/day and reduced body weight gain at or above 100 mg/kg/day were observed (JECDB (Access on June 2017), Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006)). Therefore, it was classified in Category 2 for this hazard class. |
| 8 | Specific target organ toxicity - Single exposure | Category 1 (haemal system) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
There is a report that in single oral and dermal administration tests with rats, at 200 mg/kg and 700 mg/kg respectively within a range of Category 1, blood methemoglobin concentrations increased up to above 30%, and severe methemoglobinemia was induced (SIDS (2003)). Therefore, it was classified in Category 1 (haemal system). |
| 9 | Specific target organ toxicity - Repeated exposure | Category 1 (haemal system), Category 2 (kidney) |
Danger Warning |
H372
H373 |
P260
P264 P270 P314 P501 |
As for humans, there is a report that toluidines (isomers not specified) produce the same symptoms as does aniline, and cyanosis is slightly milder than that of aniline, but painful urination and hemoglobinuria appear more strongly, and they cause hypothermia and anemia (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), ACGIH (7th, 2001)). There is a description that this substance causes methemoglobinemia in humans (PATTY (6th, 2012)). As for experimental animals, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) with rats dosed by gavage, pigmentation and extramedullary hematopoiesis of the spleen, kidney lesions (female: vacuolization and necrosis of the proximal tubular epithelial cells, tubular regeneration in the medulla, etc.) at or above 30 mg/kg/day (converted guidance value: 14 mg/kg/day) within a guidance value range for Category 2, and macrocytic anemia, pigmentation and increased extramedullary haematopoiesis of the liver, pigmentation and eosinophilic droplets of the tubular epithelium of the kidneys, brown urine, etc. at or above 100 mg/kg/day (converted guidance value: 47 mg/kg/day) were observed (Environmental Risk Assessment for Chemical Substances Vol.5 (Ministry of the Environment, 2006), JECDB (Access on June 2017)). From the above, anemia was seen in humans, and in experimental animals, damages of the kidney in addition to anemia and findings related to anemia were observed within a guidance value range for Category 2. Therefore, it was classified in Category 1 (haemal system), Category 2 (kidney). Besides, because information on humans was obtained, and as a result of reconfirmation of the information on experimental animals, the effects on the kidney were observed, the classification result was different from the previous classification. |
| 10 | Aspiration hazard | Classification not possible |
- |
- | - | Classification not possible due to lack of data. Besides, the kinematic viscosity is calculated to be 3.343 mm2/sec (25/20 deg C) from the numerical data (viscosity: 3.306 mPa*s (25 deg C), density: 0.9889 g/cm3 (20 deg C)) listed on HSDB (Access on June 2017). |
| Hazard class | Classification |
Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
|---|---|---|---|---|---|---|
| 11 | Hazardous to the aquatic environment (Acute) | Category 1 |
 Warning |
H400 |
P273
P391 P501 |
From 48-hour EC50 (immobile) = 0.73 mg/L for crustacea (Daphnia pulex) (OECD SIDS: 2001), it was classified in Category 1. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 1 |
Warning |
H410 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified in Category 1 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 0.33% (J-CHECK, 1991)), and 21-day NOEC (reproduction inhibition) = 0.01 mg/L for crustacea (Daphnia pulex) (OECD SIDS: 2001). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (non-biodegradable, average degradation rate by BOD: 0.33% (J-CHECK, 1991)), and 72-hour EC50 (biomass) = 17.7 mg/L for algae (Pseudokirchneriella subcapitata) (OECD SIDS: 2001). From the above results, it was classified in Category 1. |
| 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. |