GHS Classification Result

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GENERAL INFORMATION
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

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

PHYSICAL HAZARDS
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.

HEALTH HAZARDS
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.

ENVIRONMENTAL HAZARDS
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.


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.

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