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

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 1194-65-6
Chemical Name 2,6-Dichlorobenzonitrile; Dichlobenil
Substance ID m-nite-1194-65-6_v1
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 (Not applicable)
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Flammable solids Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (ICSC (2005)). FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Self-reactive substances and mixtures Not classified (Not applicable)
-
-
- - There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Pyrophoric solids Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (ICSC (2005)). FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Self-heating substances and mixtures Not classified
-
-
- - It was classified as "Not classified" from information that it is not combustible (ICSC (2005)). FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14 Oxidizing solids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing chlorine (but not fluorine or oxygen) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16 Corrosive to metals Classification not possible
-
-
- - Classification is not possible because test methods applicable to solid substances are not available. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17 Desensitized explosives Not classified
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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) Not classified
-
-
- - [Rationale for the Classification]
Based on (1)-(5), it was classified as "Not classified." The category was changed from the previous classification by the use of new information sources.
Besides, they were adopted by putting an emphasis on GLP tests.

[Evidence Data]
(1) LD50 for rats: >2,000 mg/kg (JMPR (2014))
(2) LD50 for rats: 3,160 mg/kg (HSDB (Access on July 2019))
(3) LD50 for rats: >2,150 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))
(4) LD50 for rats: 4,250 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))
(5) LD50 for rats: male: 4,540 mg/kg, female: 3,930 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))

[Reference Data, etc.]
(6) LD50 for rats: male: 1,680 mg/kg, female: 1,330 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
Based on (1)-(3), it was classified as "Not classified."
Besides, they were adopted by putting an emphasis on GLP tests.

[Evidence Data]
(1) LD50 for rabbits: >2,000 mg/kg (JMPR (2014))
(2) LD50 for rabbits: >5,000 mg/kg (HSDB (Access on July 2019))
(3) LD50 for rabbits: >5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))

[Reference Data, etc.]
(4) LD50 for rabbits: 1,350 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified (Not applicable)."
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1)-(4), since neither data can identify any category, it was classified as "Classification not possible."

[Evidence Data]
(1) LD50 (4 hours) for rats: >0.25 mg/L (HSDB (Access on July 2019))
(2) LD50 (4 hours) for rats: >3.3 mg/L (JMPR (2014), HSDB (Access on July 2019))
(3) LD50 (dust, 4 hours) for rats: >0.045 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))
(4) LD50 (dust, 4 hours) for rats: >3.2 mg/L (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015))
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
Based on (1)-(4), it was classified as "Not classified."

[Evidence Data]
(1) In a skin irritation test in which this substance (85.3% formulation) was administered to rabbits according to EPA TG81-5 (corresponding to OECD TG 404), it is reported not to be a dermal irritant (EPA Pesticide (1998), REACH registration dossier (Access on August 2019)).
(2) In a skin irritation test with rabbits, no irritation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
(3) In a skin irritation test with rabbits (4-hour application), the scores 30-60 minutes after application and 24/48/72 hours after were all 0 and no irritation was observed (Agricultural Chemicals Times supplement Vol.10 (Japan Crop Protection Association, 1991)).
(4) This substance was not irritating to the skin of rabbits (JMPR (2014)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
Base on (1), it was classified as "Not classified."

[Evidence Data]
(1) In an eye irritation test in which this substance (85.3% formulation) was administered to rabbits according to EPA TG81-4 (corresponding to OECD TG 405), it is reported not to be irritating (EPA Pesticide (1998), REACH registration dossier (Access on August 2019)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) In a skin sensitization test with guinea pigs according to EPA TG81-6 (corresponding to OECD TG 406), this substance (not specified as active ingredient) did not show sensitization to the skin of rabbits (EPA Pesticide (1998), REACH registration dossier (Access on August 2019)).
(2) In a skin sensitization test of this substance (not specified as active ingredient) with guinea pigs (maximization method), it was judged to be negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2014)).

[Reference Data, etc.]
(3) In a Buehler test on the wet powder of this substance with guinea pigs and a skin sensitization test (maximization method) on the granules of the substance with guinea pigs, it was judged to be negative and positive (moderately sensitizing), respectively (Agricultural Chemicals Times supplement Vol.10 (Japan Crop Protection Association, 1991)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), since the results of all standard combination tests, including in vivo and in vitro tests, were negative, it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, there is a report of a negative result in a micronucleus test with mouse bone marrow (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
(2) As for in vitro, there are reports of negative results in a bacterial reverse mutation test, and a chromosome aberration test and a mouse lymphoma test with cultured mammalian cells (EPA Pesticide (1998)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on the classification results by other organizations in (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) In the classification results by domestic and international organizations, it was classified as "C (Possible human carcinogen)" by EPA (EPA Cancer Annual Report (2018): classified in FY 1995).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1), since external or visceral malformations were observed in fetuses at the dose where maternal toxicity was observed, it was classified in Category 2.
Besides, the classification result was changed from the previous classification by the use of new information sources.

[Evidence Data]
(1) In a developmental toxicity test in which female rabbits were dosed by gavage on gestational days 7-19, decreased body weight, external and visceral abnormalities were observed in fetuses at the dose where maternal toxicity (decreased body weight gain, decreased feed consumption) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). Besides, in JMPR (2014), it is reported that an increased number of total resorptions, increased post-implantation loss, and increased incidences of external, visceral and skeletal malformations (open eyes, major fusion of sternebrae, cleft palate, etc.) were observed in embryos/fetuses (JMPR (2014)).

[Reference Data, etc.]
(2) In a two-generation reproduction toxicity study with rats by feeding, though decreased body weight gain and decreased food consumption were observed in parental animals, and decreased body weight gain was observed in pups, no effects on fertility were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), EPA Pesticide (1998)). Besides, it is reported in JMPR (2014) that a decreased number of implantations was observed in F1 maternal animals as effects on fertility (JMPR (2014)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Specific target organ toxicity - Single exposure Not classified
-
-
- - [Rationale for the Classification]
There are no reports of single exposure to this substance in humans. As for experimental animals, based on (1)-(3), no findings which would enable the identification of target organs were obtained from tests through any of the oral, dermal, and inhalation routes. Therefore, it was classified as "Not classified." The classification result was changed from the previous classification by the use of new information sources.

[Evidence Data]
(1) In a single oral dose test with rats, hypolocomotion, ptosis, salivation, irregular respiration, piloerection and abnormal gait were observed at or above 2,253 mg/kg (exceeding Category 2). In addition, reddish tear, hematuria, sedation and declined body temperature were observed in high-dose groups (though there was no description of doses, it was considered to be 5,500 mg/kg, the highest dose, and 4,400 mg/kg, one step below that). Deaths were observed from 3,520 mg/kg. As necropsy findings, discoloring of the liver, gastric distention, reddish-darkening and atrophy of the thymus, and discoloring of the kidney, etc. were observed only in dead animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(2) In a single dermal administration test with rabbits, at 2,000 mg/kg (upper limit of Category 2), there were neither findings of effects nor deaths related to treatment, and also, no abnormality was observed in necropsy findings (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(3) In a 4-hour single inhalation exposure test with rats, salivation and hypolocomotion were observed after exposure to the dust of this substance at 3.2 mg/L (corresponding to Category 2, described that it was the highest reachable concentration as the dust). However, there were no deaths, and also no striking changes observed in macroscopic pathology (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Specific target organ toxicity - Repeated exposure Category 1 (blood system, liver), Category 2 (kidney)


Danger
Warning
H372
H373
P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1)-(3), in oral administration to rats and mice, effects on the liver and kidney were observed within the range of Category 2. Based on (4) and (5), in oral administration to dogs, effects on the blood system and liver were observed within the range of Category 1. Therefore, it was classified in Category 1 (blood system, liver), Category 2 (kidney). The previous classification was changed by the use of new information sources.

[Evidence Data]
(1) As a result of administration to rats by feeding for 90 days, hepatocyte hypertrophy, etc. were observed at or above 140 ppm (male: 10.2 mg/kg/day, female: 13.4 mg/kg/day, within the range of Category 2). At 480 ppm (male: 34.5 mg/kg/day, female: 41.3 mg/kg/day, within the range of Category 2), increased eosinophilic body and hyaline droplet degeneration in the renal tubular epithelial cells, etc. in males and increased reticulocytes, etc. in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
(2) As a result of administration to mice by feeding for 13 weeks, at or above 625 ppm (95 mg/kg/day, within the range of Category 2), hepatocyte hypertrophy was observed in both sexes, and pyelonephritis, etc. were observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2014), EPA Pesticide (1998)).
(3) As a result of a combined repeated toxicity test with the carcinogenicity test with rats for 2 years, increased weight of the liver, an increased incidence of chronic nephropathy, etc. were observed in both sexes at or above 400 ppm (male/female: 29.0/26.3 mg/kg/day, within the range of Category 2), and decreased values of hemoglobin and hematocrit. etc. were observed at 3,200 ppm (male/female: 241/248 mg/kg/day, exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2014)).
(4) As a result of a 1-year chronic toxicity test (oral administration of capsules) with dogs, decreased hemoglobin and erythrocyte counts, increased weight of the liver, hepatocyte hypertrophy, etc. were observed at or above 6 mg/kg/day (within the range of Category 1), and increased weight of the thyroid and kidney, adrenal cortex vacuolation, decreased weight of the uterus and thymus (females), etc. were observed at 36 mg/kg (within the range of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2014)).
(5) As a result of a 2-year chronic toxicity test (feeding) with dogs, hepatocyte hypertrophy with glycogen storage and slight inflammation in the liver, and increased weight of the liver and thyroid, etc. were observed at 350 ppm (converted guidance value: 9.0 mg/kg/day, within the range of Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2014)).

[Reference Data, etc.]
(6) As a result of transdermal administration to rabbits at 100-1,000 mg/kg/day (exceeding Category 2) for 21 days, no effects due to administration were observed (EPA Pesticide (1998)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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
It was classified in Category 1 from 7-day EC50 (growth rate) = 0.1295261655 mg/L for higher aquatic plants (Lemna aequinoctialis) (EPA AQUIRE: 2018, Michel, A. et al. (2004)). FY2018 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Hazardous to the aquatic environment Long term (Chronic) Category 1


Warning
H410 P273
P391
P501
It was classified in Category 1 due to being not rapidly degradable and 14-day NOEC (growth) = 0.006 mg/L for higher aquatic plants (Lemna gibba) (EPA RED: 1998). FY2018 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Hazardous to the ozone layer Classification not possible
-
-
- - No data available. FY2018 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))


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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