Latest GHS Classification Results by the Japanese Government (edited by NITE)

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GENERAL INFORMATION
Item Information
CAS RN 89-61-2
Chemical Name 1,4-Dichloro-2-nitrobenzene
Substance ID m-nite-89-61-2_v2
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) To Guidance List
UN GHS document (External link) To UN GHS document
FAQ(GHS classification results by the Japanese Government) To FAQ
List of Information Sources (Excel file) List of Information Sources
List of Definitions/Abbreviations Definitions/Abbreviations
Sample Label by MHLW (External link) MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) To OECD/eChemPortal (External link)

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Explosives Classification not possible
-
-
- - Classification is not possible since no data are available though the substance contains chemical groups (N-O) associated with explosive properties present in the molecules and the calculated oxygen balance is -96 (calculated value). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
7 Flammable solids Classification not possible
-
-
- - No data available. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
8 Self-reactive substances and mixtures Classification not possible
-
-
- - Classification is not possible since no data are available though there are chemical groups (N-O) associated with explosive properties present in the molecules. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
10 Pyrophoric solids Not classified
-
-
- - Auto-ignition point is 465 degC (ICSC (J) (2008)) exceeding 70 degC. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to solid (melting point <= 140 degC) substances are not available. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (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). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
14 Oxidizing solids Classification not possible
-
-
- - Classification is not possible since no data are available though the substance is an organic compound containing oxygen which is chemically bonded to atoms (nitrogen) except carbon or hydrogen. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
17 Desensitized explosives -
-
-
- - - - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Acute toxicity (Oral) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
Based on LD50 values of 1000 mg/kg, 1210 mg/kg (Initial Environmental Risk Assessment of Chemicals (Ministry of Environment) vol. 6 (2008)), 2503 mg/kg (SIDS (1996)) and 1000 - 2503 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)) for rats, the substance was classified into Category 4 since most of the values are in this category. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
1 Acute toxicity (Dermal) Not classified
-
-
- - Based on a LD50 value of >2000 mg/kg for rats (OECD TG402 (GLP)) (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)), the substance was classified as "Not classified" in JIS Classification (correspond to Category 5 or "Not classified" in GHS classification). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - Solid (GHS definition) FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - No data available. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
2 Skin corrosion/irritation Not classified
-
-
- - In a rabbit skin irritation test (4-hour application) (OECD TG404 (GLP)), only dry skin was found, and no irritation was observed (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)). The substance was classified as "Not classified". FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
3 Serious eye damage/eye irritation Not classified
-
-
- - Based on a result of "no irritation" in a rabbit eye irritation test (OECD TG405 (GLP)) (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)) and a report that "the substance was not irritating to rabbit eyes" (SIDS (1996)), the substance was classified as "Not classified". In another rabbit eye irritation test (Draize test), moderate irritation was noted in one animal (disappeared within 72-hour) (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008), BUA No. 65 (1991)). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
4 Respiratory sensitization Classification not possible
-
-
- - No data available. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
4 Skin sensitization Classification not possible
-
-
- - In a patch test of 31 workers of a chemical plant (with a control group of 5 subjects), erythema was observed in 3, 6 and 9 people, respectively at concentrations of 0.1%, 0.5% and 1.0% of the substance (erythema was not observed in control subjects at any concentration). It is not possible to evaluate the sensitizing property of the substance based on this data alone (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)). In a guinea pig maximization test (GLP), a negative result is reported (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)). Classification was not possible. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
5 Germ cell mutagenicity Classification not possible
-
-
- - Classification not possible due to lack of data from in vivo mutagenicity tests. From in vitro mutagenicity tests, there are reports of positive Ames tests ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (access on Oct. 2009), Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)) and negative Chinese hamster V79 cell chromosomal aberration test and HGPRT test (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)). Although there is a positive Chinese hamster cell (CHL/IU) chromosomal aberration test ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (access on Oct. 2009)), there is a report about this result that "the reliability is low since the number of observable cells were far fewer due to severe cytotoxicity" (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) and (2), clear evidence of carcinogenicity including malignant tumors was observed in two animal species, and based on (3), this substance is a target substance in the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act, and emphasizing these, it was classified in Category 1B.

[Evidence Data]
(1) In a two-year carcinogenicity study with rats dosed by feeding, an increase in the incidence of hepatocellular adenoma and hepatocellular adenoma or hepatocellular carcinoma (combined), an increase in the incidence of Zymbal gland adenoma, an increase in kidney tumors (incidence of renal cell adenoma or renal cell carcinoma (combined)), and an increase in skin tumor were observed in males; and uterus tumors (combined incidence of papillary adenoma or adenocarcinoma) and an increase in the incidence of mammary gland adenocarcinoma were also observed in females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2003), IARC 123 (2020)).
(2) In a two-year carcinogenicity study with mice dosed by feeding, an increase in the incidence of hepatocellular carcinoma and hepatoblastoma was observed in males, and an increase in the incidence of hepatocellular adenoma, and hepatocellular carcinoma was observed in females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2003), IARC 123 (2020)).
(3) This substance is a target substance in the public announcement on guidelines in order to prevent the impairment of worker's health caused by the chemical substances decided by the Minister of Health, Labour and Welfare based on paragraph (3) of Article 28 of the Industrial Safety and Health Act (guidelines in order to prevent the impairment of worker's health, announcement No. 27 on February 7, 2020).
(4) As for the carcinogenicity classification results by domestic and international assessment organizations, the IARC classified this substance in Group 2B (IARC 123 (2020)) and the Japan Society For Occupational Health (JSOH) classified it in Group 2B (Recommendation of Occupational Exposure Limits (2020): Classification in 2019).
FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
In a preliminary reproductive/developmental toxicity test in rats by oral administration (OECD TG421 (GLP)), one dam delivered only dead pups at a dose producing general toxicity (such as salivation) in parental animals. There is a report that the finding is considered to be the consequence of effects on dams during the perinatal period ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (access on Oct. 2009)). Based on the data, the substance was classified into Category 2. There were no effects on the estrous cycle, mating index, fertility index, gestation length, number of corpora lutea, number of implantations, implantation index, gestation index, total number of births, delivery index, number of stillbirths, number of live offspring at birth, live birth index, sex ratio, or necropsy findings on day 4 of lactation. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
8 Specific target organ toxicity - Single exposure Category 1 (blood system), Category 3 (narcotic effects)



Danger
Warning
H370
H336
P308+P311
P260
P264
P270
P321
P405
P501
P304+P340
P403+P233
P261
P271
P312
In an oral test in rats, loss of equilibrium was observed at 25.0 mg/kg (LD50 value). In an oral test in cats, methemoglobin formation and mild cyanosis were observed at 25 mg/kg and higher dose levels, and loss of equilibrium and prone position were observed at 250 mg/kg (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)). In a dermal test in rats, reduced spontaneous activity was observed at 2000 mg/kg (BUA No. 65 (1991)). Based on the data, the substance was classified into Category 1 (blood system) and Category 3 (narcotic effects). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
9 Specific target organ toxicity - Repeated exposure Category 1 (blood system), Category 2 (nervous system, liver, kidney)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
In an oral test with rats (preliminary reproductive/developmental toxicity test (OECD TG421 (GLP))), "decrease in locomotor activity, extension of hindlimbs, staggering gait, prone or lateral position, bradypnea and torticollis" were observed at 200 mg/kg (90-day equivalence: 91.1 mg/kg) ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (access on Oct. 2009)). In a 28-day oral test in rats (OECD TG407 (GLP)), "increased hepatic weight and bilirubin value, hepatocellular hypertrophy and testicle damage (necrosis of germ epithelium, azoospermia, depression of spermatogenesis)" were observed at 250 mg/kg (90-day equivalence: 77.8 mg/kg) (SIDS (1996)). In a 21-day oral test in rabbits, "moderate effects in the kidney (cloudy swelling and congestion)" were observed at 50 mg/kg (90-day equivalence: 11.7 mg/kg) (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008), Initial Environmental Risk Assessment of Chemicals (Ministry of the Environment) vol. 6 (2008)). In a 15-day dermal test in rabbits, "decreases in erythrocyte count and hemoglobin, increased extramedullary hematopoiesis and deposition of iron pigment in the spleen" were observed at 100 mg/kg (90-day equivalence: 16.7 mg/kg) and higher concentrations (Initial Risk Assessment Report (NITE, CERI, NEDO) No. 46 (2008)). Based on the data, the nervous system, liver, kidney and blood system are considered to be target organs. Since the findings in animals were noted at dose levels within the guidance value range for Category 2 (nervous system, liver, kidney) and Category1 (blood system), the substance was classified into Category 1 (blood system) and Category 2 (nervous system, liver, kidney). In a 28-day oral test in rats (OECD TG407 (GLP)), "testicle damage (necrosis of germ epithelium, azoospermia, depression of spermatogenesis)" was observed at 250 mg/kg (90-day equivalence: 77.8 mg/kg) (SIDS (1996)). This data corresponds to Category 2 for reproductive toxicity, and was not used in this classification. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
10 Aspiration hazard Classification not possible
-
-
- - No data available. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
11 Hazardous to the aquatic environment Short term (Acute) Category 1


Warning
H400 P273
P391
P501
Classified into Category 1 from its 96h-LC50 = 0.118 mg/L for fish (Cyprinus carpio) (Initial Risk Assessment Report (NITE, CERI, NEDO), 2008). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
11 Hazardous to the aquatic environment Long term (Chronic) Category 1


Warning
H410 P273
P391
P501
Classified into Category 1 since its acute toxicity is Category 1 and it is not rapidly degradable (BOD degradation rate: 4% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1995)). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in Annexes to the Montreal Protocol. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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