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

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GENERAL INFORMATION
 
Item Information
CAS RN 88-73-3
Chemical Name o-Nitrochlorobenzene
Substance ID m-nite-88-73-3_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 Not classified
-
-
- - Classified into Not classified since the substance is classified into Division 6.1 in UNRTDG (UN1578) and is not "Explosives" though it contains chemical groups (N-O) associated with explosive properties present in the molecules. The calculated oxygen balance is -121 (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 (nitro group) 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 487 degC (ICSC (J) (2002)) and the substance does not spontaneously ignite on contact with room temperature air. 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 Not classified (Not applicable)
-
-
- - The substance contains chlorine which is chemically bonded only to carbon. 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 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
LD50 values are 144, 251, 263, 550 mg/kg bw (SIDS (2001)), 270, 510 mg/kg bw (DFGOT vol. 4 (1992)), 219 and 457 mg/kg bw (BUA Report No. 2 (1985)), and five values correspond to Category 3 and three values correspond to Category 4. The substance was classified into Category 3 since 5 of 8 LD50 values are in this category. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
LD50 values of 655 mg/kg bw and 1320 mg/kg bw for rats (SIDS (2001)) for rats correspond to Category 3 and 4, respectively. The category with higher hazard was adopted, the substance was classified into Category 3. 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) Category 3


Danger
H331 P304+P340
P403+P233
P261
P271
P311
P321
P405
P501
Based on a LC50 value (vapour/aerosol mixture) of 495 ppm (3.18 mg/L) for rats (SIDS (2001)), the substance was classified into Category 3. Although there is a report that a vapour/aerosol mixture was used in this inhalation test, it is considered that the test was conducted for vapour mixed with mist since the test concentration (495 ppm) is between saturated vapour pressure concentration of 526 ppm (calculated from the vapour pressure of 0.4 mmHg (25 degC) (NTP TOX No. 33 (1993))) and 90% of saturated vapour pressure concentration (473 ppm). 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 Classification not possible
-
-
- - In rabbit skin irritation tests, although results of "mild irritation" (in one test) and "no irritation" (in two tests) are reported, the administration procedures employed in these tests were not standard. Review of the data indicated "the tests gave no evidence of a skin irritating potential" (SIDS (2001)). Classification was not possible due to lack of data. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
In a rabbit eye irritation test, 1-hour post application slight conjunctival injections (score 1-2/0-3) were noted in the eyes of 6/6 rabbits, and 24-hour post application no irritating effects were observed (SIDS (2001)). In another test, slight redness (score 1/3) was observed in the eye of 1/2 rabbits, which disappeared within 24-hour, and no signs of irritation were observed in cornea on the day of application or during the 7 day post exposure observation period (SIDS (2001)). Based on the reports, the substance was classified into Category 2B. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
4 Respiratory sensitization Classification not possible
-
-
- - Although there is a report that rats exposed via inhalation for 5 months showed positive sensitization reactions (SIDS (2001)), the details are not clear. Classification was not possible due to lack of other data. FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
4 Skin sensitization Classification not possible
-
-
- - No data available. In regard to a positive result in a modified Freunds complete adjuvant test with guinea pigs (SIDS (2001)), there is a comment that "due to the limited and poor quality information available, it cannot be concluded whether or not the chemical has a sensitizing activity" (SIDS (2001)). 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. There is a report of a positive result in an in vivo genotoxicity test, intraperitoneal injection mouse DNA damage test (alkaline elution assay) (liver, kidney) (SIDS (2001)). From in vitro mutagenicity tests, there are reports of weakly positive (with S9) results in a chromosomal aberration test and a sister chromatid exchange test using Chinese hamster ovary cells (NTP TOX No. 33 (1993)), but negative (with and without S9) result in the other chromosomal aberration test using Chinese hamster ovary cells (SIDS (2001)). As relevant information, there are many reports of negative and positive Ames tests (IARC vol. 65 (1996). SIDS (2001) concluded that the substance is suspected of being genotoxic, at least a weak clastogen. 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 liver tumors (hepatocellular adenoma and hepatocellular carcinoma) was observed both in males and females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2006), IARC 123 (2020)).
(2) In a two-year carcinogenicity study with mice dosed by feeding, an increase in the incidence of liver tumors (hepatocellular adenoma, hepatocellular carcinoma and hepatoblastoma) was observed both in males and females (Results from Carcinogenicity Studies (Ministry of Health, Labour and Welfare, 2006), 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 organizations, the IARC changed the category from the previous Group 3 (IARC 123 (2020)) to Group 2B based on the data in (2) and (3) (IARC 123 (2020)). The Japan Society For Occupational Health (JSOH) classified it in Group 2B (Recommendation of Occupational Exposure Limits (2020): Classification in 2019) and the DFG classified it in Category 3 (DFG MAK (2020)).

[Reference Data, etc.]
(5) In a 78-week feeding administration test with rats and mice, an increase in tumors in multiple organs in rats, and an increase in hepatocellular carcinoma in mice were suggested (SIDS (2004), IARC 65 (1996), Environmental Risk Assessment for Chemical Substances vol. 15 (Ministry of the Environment, 2017)).
FY2021 GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7 Reproductive toxicity Classification not possible
-
-
- - In a 13-week inhalation test in rats, decreases in the epididymal weight and spermatid count of males were observed at the high dose (18 ppm) without death. There were no significant changes in females (NTP TOX No. 33 (1993)). In a 13-week inhalation test in mice, sperm motility was significantly decreased in all dose groups (4.5, 9, 18 ppm) and the highest dose level (18 ppm) produced mortality (2/10). There were no significant changes in females (NTP TOX No. 33 (1993)). Based on the data, classification was not possible. In a continuous breeding test in mice (male and female mice received three dose levels by gavage for 7 days prior to cohabitation for 98 days for continuous breeding). Pup weight gain was lower but no effect on fertility was noted (NTP TOX No. 33 (1993)). In an oral test in pregnant rats by gavage, no differences in the number of the litters exhibiting malformations were evident in the treatment groups compared to the control group. Although there is no indication of developmental toxicity, it was reported in SIDS that there is a concern for a reproductive toxicity potential for the substance (SIDS (2001)). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - No data available.

FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
9 Specific target organ toxicity - Repeated exposure Category 1 (blood, liver)


Danger
H372 P260
P264
P270
P314
P501
In a 13-week chronic inhalation (vapour) test in rats, methemoglobin concentrations were elevated at a dose level of 1.1 - 18 ppm (0.007 - 0.12 mg/L), which fall within the guidance value range for Category 1 (NTP TOX No. 33 (1993)). In a 13-week chronic inhalation (vapour) test in mice, liver lesions (hepatocellular necrosis, mineralization, chronic inflammation, hepatocytomegaly) and increased hematopoietic activity of the spleen were observed at 18 ppm (0.12 mg/L), which falls within the guidance value range for Category 1 (NTP TOX No. 33 (1993)). Based on the data, the substance was classified into Category 1 (blood system, liver). 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 3
-
-
H402 P273
P501
Classified into Category 3 from its 48h-EC50 = 21.3 mg/L for Crustacea (Daphnia magna) (SIDS, 2001). FY2009 GHS Classification Guidance by the Japanese Government (March, 2009)
11 Hazardous to the aquatic environment Long term (Chronic) Category 3
-
-
H412 P273
P501
Classified into Category 3 since its acute toxicity is Category 3 and it is not rapidly degradable (BOD degradation rate: 0% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1977)). 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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