GHS Classification Result
GENERAL INFORMATION
REFERENCE INFORMATION
PHYSICAL HAZARDS
HEALTH HAZARDS
ENVIRONMENTAL HAZARDS
NOTE:
GENERAL INFORMATION
| Item | Information |
|---|---|
| CAS RN | 89-63-4 |
| Chemical Name | 4-Chloro-2-nitroaniline |
| Substance ID | H29-B-024 |
| 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 | FY2010 |
| 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 classified |
- |
- | - | There is a chemical group associated with explosive properties (nitro group) in the molecule, but because it is classified in Division 6.1, PGIII in UNRTDG (UN 2237), it does not correspond to explosives, hazard class with the highest precedence. |
| 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 |
- |
- | - | No data available. |
| 8 | Self-reactive substances and mixtures | Type G |
- |
- | - | There is a chemical group associated with explosive properties (nitro group) in the molecule, but because it is classified in Division 6.1, PGIII in UNRTDG (UN 2237), it does not correspond to self-reactive substances and mixtures, hazard class with the highest precedence. |
| 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 518 deg C (GESTIS (Access on June 2016)). |
| 11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Test methods applicable to solid (melting point <= 140 deg C) 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 |
- |
- | - | 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 (P). 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 |
There are two reports of LD50 values of 400 mg kg (HSDB (Access on June 2017)), >5,000 mg/kg (BUA 235 (2002)) for rats, one corresponds to Category 4, and the other corresponds to "Not classified." There is a report of an LD50 value of 800 mg/kg (HSDB (Access on June 2017)) for mice, and it corresponds to Category 4. The category with more cases was adopted, and it was classified in Category 4. The classification was reviewed based on the information obtained in this survey. |
| 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 | Category 2 |
Warning |
H315 |
P302+P352
P332+P313 P362+P364 P264 P280 P321 |
There is a report that it was not irritating in a skin irritation test with rabbits (BUA 235 (2002)), but for humans, there are reports that it caused moderate to severe erythema (redness) and moderate edema (HSDB (Access on June 2017)). From the above, it was classified in Category 2. The classification was reviewed based on the information obtained in this survey. |
| 3 | Serious eye damage/eye irritation | Not classified |
- |
- | - |
Based on a report that it caused temporary yellowing of the sclera or partially of the cornea in an eye irritation test with rabbits (according to FDA guideline), however, it was not irritating to the conjunctiva (BUA 235 (2002)), it was classified as "Not classified." |
| 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, in a skin sensitization test with guinea pigs, there is a report that 4 out of 4 animals showed a positive reaction (BUA 235 (2002)), but it was not adopted because details of the testing method and the test result were unknown. |
| 5 | Germ cell mutagenicity | Classification not possible |
- |
- | - | The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. Besides, as for in vivo, it was negative in a micronucleus test using mouse bone marrow cells (BUA 235 (2002)), and as for in vitro, it was positive in a bacterial reverse mutation test, and a mouse lymphoma test, a chromosome aberration test, and a sister chromatid exchange test with mammalian cultured cells (JECDB (Access on June 2017), NTP DB (Access on June 2017), BUA 235 (2002)). |
| 6 | Carcinogenicity | Not classified |
- |
- | - | In a carcinogenicity study with rats and mice dosed by feeding, no increase in tumor incidence was observed in both sexes of rats and mice (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on June 2017)). There was no classification result by other organization, but the negative results of carcinogenicity were seen in two species of experimental animals. Therefore, it was classified as "Not classified." |
| 7 | Reproductive toxicity | Classification not possible |
- |
- | - | In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422), no reproductive/developmental effect was observed at up to 300 mg/kg/day at which effects on the blood and spleen, etc. were noticed (Safety Test (Ministry of Economy, Trade and Industry (METI)) (Access on June 2017)). However, it is impossible to classify it as "Not classified" with only this result since this test is a screening test, and there are no other available data. Therefore, classification was 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. There is no information on single exposure of this substance in humans. For experimental animals, there is a description that deep narcosis lasted for 24 hours after a single non-lethal oral administration of this substance to guinea pigs in results from a test conducted in 1935 (BUA 235 (2002)), however, since the details are unknown and the original literature is also unavailable and cannot be confirmed, it was not adopted as evidence of classification. Though there is a report that temporal prone position, yellow skin and yellow urine were noted in rats (BUA 235 (2002)), it is impossible to identify the target organs with this information alone. Therefore, it was classified as "Classification not possible." |
| 9 | Specific target organ toxicity - Repeated exposure | Category 2 (haemal system) |
 Warning |
H373 |
P260
P314 P501 |
No information on humans is available. As for experimental animals, in a 13-week repeated oral dose toxicity study with rats dosed by feeding, increased liver weights and increases in total cholesterol, phospholipid, and albumin were shown at or above 640 ppm (male: 38 mg/kg/day, female: 44 mg/kg/day) which is within the guidance value range for Category 2, and a decrease in hemoglobin concentration, an increase in a reticulocyte ratio, an increase in total bilirubin and total protein were found at or above 1600 ppm (male: 94 mg/kg/day, female: 106 mg/kg/day) which is near the upper limit of the guidance value range for Category 2. In a two-year repeated dose toxicity study with rats dosed by feeding, males at or above 1400 ppm (65 mg/kg/day) which is within the guidance value range for Category 2 showed decreases in erythrocyte count, hemoglobin concentration, hematocrit value, increases in total cholesterol, triglyceride, phospholipid, blood urea nitrogen, creatinine, calcium, inorganic phosphorus, a granular change of the kidney, increases in absolute and relative weights of the lung, liver, and kidney, chronic nephropathy, urothelial hyperplasia of the renal pelvis, etc., and females at 800 ppm (46 mg/kg/day) or more showed increases in platelet count, calcium, increased relative weight of the liver, chronic nephropathy, etc. (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare) (Access on June 2017)). In addition, in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats dosed by gavage (OECD TG 422), there is a report of a decreased hematocrit value and extramedullary hematopoiesis in the spleen (Safety Test (Ministry of Economy, Trade and Industry (METI)) (Access on June 2017)). Besides this, it is reported in a 13-week repeated oral dose toxicity study with rats and mice given by gavage that in rats, hemosiderosis of the spleen and increased liver weight at or above 50 mg/kg/day which is within the guidance value range for Category 2, and eosinophilic hyaline droplets and regeneration of the renal proximal tubule, which are specific to male rats, at or above 100 mg/kg/day were observed, and in mice, hemosiderosis in the spleen was noted at 75 mg/kg/day which is within the guidance value for Category 2 (BUA 235 (2002)). From the above, within the guidance value range for Category 2, effects on the haemal system, findings accompanying the effects on the haemal system, effects on the kidney (findings specific to male rats, chronic nephropathy seen in males and females in the 2-year study) were observed, but the kidney was not adopted as the target organ because of the finding specific to male rats and the age-related change. Therefore, it was classified in Category 2 (haemal system). |
| 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) | Category 2 |
- |
H401 |
P273
P501 |
From 48-hour LC50 = 4.2 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)), it was classified in Category 2. |
| 11 | Hazardous to the aquatic environment (Long-term) | Category 2 |
 - |
H411 |
P273
P391 P501 |
If chronic toxicity data are used, then it is classified as "Not classified" due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0%) (J-CHECK: 1977), and 72-hour NOEC (rate method) = 2.1 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (non-biodegradable, a degradation rate by BOD: 0%) (J-CHECK: 1977), and 48-hour EC50 = 4.2 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2017)). From the above results, it was classified in Category 2. |
| 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. |