GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 97-52-9 |
| Chemical Name | 4-Nitro-o-anisidine |
| Substance ID | H29-B-017 |
| 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 | FY2012 |
| 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 |
- |
- | - | There is a chemical group associated with explosive properties (nitro group) in the molecule, but the classification is not possible due to no data. |
| 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 |
- |
- | - |
It is described that it is combustible (GESTIS (Access on June 2017)), but the classification is not possible due to no data. |
| 8 | Self-reactive substances and mixtures | Classification not possible |
- |
- | - | There is a chemical group associated with explosive properties (nitro group) in the molecule, but the classification is not possible due to no data. |
| 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 > 360 deg C (GESTIS (Access on June 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 | 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 the element other than carbon or hydrogen (N). However, the classification is not possible due to no data. |
| 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) | Category 4 |
 Warning |
H302 |
P301+P312
P264 P270 P330 P501 |
From the result of a mortality rate of 0% (0/6) at 300 mg/kg and 100% (3/3) at 2,000 mg/kg in an acute toxicity test (OECD TG 423) with rats, the approximate lethal dose is estimated to be 500 mg/kg (JECDB (Access on May 2017)). Therefore, it was classified in Category 4. Besides, there is a report that an oral LD 50 value for rats is 997 mg/kg though this is from an information source listed in List 3 and the details of the test are unknown (GESTIS (Access on May 2017)). |
| 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 | Not classified |
- |
- | - | Based on a report that in a skin irritation test with rabbits, no irritation was observed in the application of 500 mg of this substance (NTP IMM98007 (2011) (Access on May 2017)), it was classified as "Not classified." Besides, there is a description in the information source in List 3 that no irritation tests with rabbits (according to OECD TG 404) (GESTIS (Access on May 2017)). |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | Based on a report that in an eye irritation test with rabbits, no eye irritation was observed in the application of 100 mg of this substance (NTP IMM98007 (2011) (Access on May 2017)), it was classified as "Not classified." Besides, it is described in the information source in List 3 that minor irritation was observed in two eye irritation tests with rabbits (according to OECD TG 405 and Draize method), and that this substance was not irritating (GESTIS (Access on May 2017)). |
| 4 | Respiratory sensitization | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 4 | Skin sensitization | Classification not possible |
- |
- | - | Although it is stated that no sensitization was observed in a skin sensitization test with mice (NTP IMM 98007 (2011) (Access on May 2017)), it was classified as "Classification not possible" because experimental conditions such as the number of animals, the dose condition, etc., were unknown. Besides, in the information source in List 3, there is a description that no sensitization was observed in a test with guinea pigs (GESTIS (Access on May 2017)). |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. There is no in vivo data, and as for in vitro, it was positive in a bacterial reverse mutation test, and a chromosomal aberration test with mammalian cultured cells (JECDB (Access on May 2017), NTP DB (Access on May 2017)). |
| 6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a reproductive toxicity screening test (OECD TG 421) with rats dosed by gavage, even at 200 mg/kg/day where general toxicities such as death (one female), suppression of body weight gain, and decreasing trend in feed consumption were observed in parent animals, no adverse effects on reproduction were observed, and only a minor finding (lower body weight) was found in the pups (JECDB (Access on May 2017)). However, since it was a screening test, it was not possible to classify as "Not classified" based on this result alone, and there are no other data available for classification. Therefore, it was classified as "Classification not possible" due to lack of data. |
| 8 | Specific target organ toxicity - Single exposure | Category 2 (systemic toxicity) |
 Warning |
H371 |
P308+P311
P260 P264 P270 P405 P501 |
There is no information on single exposure to this substance in humans. As for experimental animals, in a single oral administration test with rats, at 300 mg/kg, there were no death cases, and a decrease in locomotor activity, lower body temperature, and yellow urine were observed. However, these rats recovered after 2 hours from the administration and showed a steady weight gain, and no gross changes were observed on necropsy at the end of the observation period. At 2,000 mg/kg, reduced locomotor activity, lateral position, lower body temperature, yellow urine or yellowish brown urine and contamination of the lower abdomen due to urine were observed, and all cases died on the second day of observation, and on necropsy, pleural effusion and swelling of the adrenal gland were observed in 2 out of 3 animals (JECDB (Access on May 2017).) From the results above, although clear toxic effects were observed at the upper limit within the guidance value range for Category 2, it was classified in Category 2 (systemic toxicity) because the target organ could not be identified. |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (haemal system, heart) |
Warning |
H373 |
P260
P314 P501 |
No information on humans is available. As for experimental animals, there is a report that in a 28-day repeated oral dose toxicity test with rats by gavage, at or above 100 mg/kg/day (converted guidance value: 31 mg/kg/day) within a guidance value range for Category 2, reduced locomotor activity, and a decrease in hematocrit value, and at 300 mg/kg/day (converted guidance value: 93 mg/kg/day), death, lower values of erythrocyte count and hemoglobin amount, higher values of the number of platelets and reticulocyte ratio, lower values of mean hemoglobin concentration of erythrocytes, increases in AST, ALT and total bilirubin, reddish brown urine, higher values of urinary glucose and bilirubin, occult blood, increases in weight of the spleen and liver, thickening of the pericardium, retention of pericardial effusion, pleural effusion, myocardial damage and necrosis, extramedullary hematopoiesis and pigmentation of the spleen etc. were observed (JECDB (Access on May 2017)). From the above, it was classified in Category 2 (haemal system, heart). |
| 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. |