Item | Information |
---|---|
CAS RN | 99-09-2 |
Chemical Name | m-Nitroaniline |
Substance ID | H28-B-069, C-148B |
Classification year (FY) | FY2016 |
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 |
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 |
- |
- | - | It is a nitro compound containing a chemical group associated with explosive properties (N-O), but because it is classified in Division 6.1 PG II (UN 1661) in UNRTDG, it does not correspond to explosives which is 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 | Not classified |
- |
- | - | It is a nitro compound containing a chemical group associated with explosive properties (N-O), but because self-accelerating decomposition temperature is 213 deg C in Bretherick (J) (5th, 1998), it does not correspond to self-reactive substances and mixtures. |
9 | Pyrophoric liquids | Not applicable |
- |
- | - | Solid (GHS definition). |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. |
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 |
- |
- | - | The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded to the element other than carbon or hydrogen (N), but 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 |
Based on the LD50 value of 540 mg/kg for rats (SIDS (2002)), this substance was classified in Category 4. Besides, because the data in SIDS (1995) used in the previous classification cited the data of RTECS (2000) listed in List 3 in the GHS classification guidance for the Japanese Government, and the details were unknown, it was not adopted. |
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, it is described in PATTY (6th, 2012) that the substance is readily absorbed through intact skin and irritates skin. However, because details are unknown, this substance was classified as "Classification not possible." |
3 | Serious eye damage/eye irritation | Classification not possible |
- |
- | - |
Classification not possible due to lack of data. Besides, it is described in PATTY (6th, 2012) that it irritates eyes. However, because no details are available, this substance was classified as "Classification not possible." |
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 | Category 2 |
Warning |
H341 |
P308+P313
P201 P202 P280 P405 P501 |
As for in vivo, a micronucleus test using mouse bone marrow cells was positive (JECDB (Access on October 2016), SIDS (2002)). As for in vitro, bacterial reverse mutation tests and mammalian cell chromosome aberration tests were positive (JECDB (Access on October 2016), SIDS (2002), NTP DB (Access on October 2016)). As described above, this substance was classified in Category 2 according to the GHS classification guidance for the Japanese Government. |
6 | Carcinogenicity | Classification not possible |
- |
- | - | Classification not possible due to lack of data. |
7 | Reproductive toxicity | Category 2 |
Warning |
H361 |
P308+P313
P201 P202 P280 P405 P501 |
In a reproduction/developmental toxicity screening test (OECD TG 421) using rats administered by gavage, infertile females were observed in 1 of 13 cases and maternal animals in which all the pups died were observed in 2 of 12 cases at mid-dose (15 mg/kg/day), where enlargement and dark reddening of the spleen were observed as the general toxic effects. Additionally, deaths during delivery were observed in 1 of 13 females, and maternal animals in which all pups died were observed in 3 of 12 cases at high dose (50 mg/kg/day) where reduced body weight gain was observed in male and female animals. Also, no abnormality was observed in the offspring (Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009), JECDB (Access on October 2016), SIDS (2002)). Although effects on fertility or development were not observed, a death during delivery and deaths of all offspring were observed in the maternal animals. This substance was classified in Category 2 due to concerns of adverse effects on parturition and nursing ability. |
8 | Specific target organ toxicity - Single exposure | Category 1 (haemal system) |
Danger |
H370 |
P308+P311
P260 P264 P270 P321 P405 P501 |
It is described that in humans, this substance indicates strong methemoglobin generated action and hemolytic action (PATTY (6th, 2012), HSDB (Access on October 2016)). As for experimental animals, it is reported that in a single dose test using rats administered orally at 450 mg/kg equivalent to Category 2, the methemoglobin and sulfhemoglobin levels in the blood increased significantly (HSDB (Access on October 2016)). Since the report on the effects in humans is from the assessment report listed in List 1 in the GHS classification guidance for the Japanese government, the category was changed from the previous classification and it was classified in Category 1 (haemal system). |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (haemal system), Category 2 (genetic organs (men)) |
Danger Warning |
H372
H373 |
P260
P264 P270 P314 P501 |
There is no information on humans. As for experimental animals, in a 28-day repeated dose toxicity study using rats administered by gavage, in the groups of not less than 15 mg/kg/day (converted guidance value: 4.7 mg/kg/day) which is equivalent to Category 1, hemolytic anemia, an increase in liver, spleen and kidney weights, hemosiderin deposition in the spleen, an increase in erythroid hematopoiesis in the bone marrow were observed. Also, in the group of not less than 50 mg/kg/day (converted guidance value: 15.6 mg/kg/day) which is equivalent to Category 2, hepatocellular swelling was observed. In addition, in the group of 170 mg/kg/day (converted guidance value: 52.9 mg/kg/day), suppression of weight gain, cyanosis, methemoglobinemia, lipofuscin deposition in the renal tubules, hemosiderin deposition and increased extramedullary hematopoiesis in the liver, testis atrophy and a decrease in spermatogenesis with the appearance of multinucleated giant cells in the testis were observed (Environmental Risk Assessment for Chemical Substances Vol. 7 (Ministry of the Environment, 2009), JECDB (Access on October 2016)). Of the above, the effects on the liver and kidneys were not severe, so they were not adopted as the target organs. Therefore, this substance was classified in Category 1 (haemal system), Category 2 (genetic organs (men)). |
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 EC50 = 9.1 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, 2003)), 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 in Category 2 due to being not rapidly degradable (Non-biodegradable, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1977)), and 21-day NOEC (reproduction) = 0.12 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, 2003)). 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, a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1977)), and 96-hour LC50 = 67 mg/L for fish (Oryzias latipes) (SIDS, 2002). It was classified in Category 2 by drawing a comparison between the above results. |
12 | Hazardous to the ozone layer | Classification not possible |
- |
- | - | No data available. |
* 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. |