NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	1194-65-6
Chemical Name	2,6-Dichlorobenzonitrile; Dichlobenil
Substance ID	R01-B-041
Classification year (FY)	FY2019
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	FY2018 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	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2	Flammable gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3	Aerosols	*	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."
4	Oxidizing gases	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5	Gases under pressure	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6	Flammable liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7	Flammable solids	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2005)).
8	Self-reactive substances and mixtures	*	- -	-	-	There are no chemical groups associated with explosive or self-reactive properties present in the molecule. It was classified as "Not classified (Not applicable)."
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2005)).
11	Self-heating substances and mixtures	*	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2005)).
12	Substances and mixtures which, in contact with water, emit flammable gases	*	- -	-	-	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)."
13	Oxidizing liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14	Oxidizing solids	*	- -	-	-	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)."
15	Organic peroxides	*	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16	Corrosive to metals	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	*	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	*	- -	-	-	[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))
1	Acute toxicity (Dermal)	*	- -	-	-	[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))
1	Acute toxicity (Inhalation: Gases)	*	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1	Acute toxicity (Inhalation: Vapours)	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	*	- -	-	-	[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))
2	Skin corrosion/irritation	*	- -	-	-	[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)).
3	Serious eye damage/eye irritation	*	- -	-	-	[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)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	*	- -	-	-	[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)).
5	Germ cell mutagenicity	*	- -	-	-	[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)).
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).
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)).
8	Specific target organ toxicity - Single exposure	*	- -	-	-	[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)).
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)).
10	Aspiration hazard	*	- -	-	-	[Rationale for the Classification] 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 Short term (Acute)	-	- -	-	-	-
11	Hazardous to the aquatic environment Long term (Chronic)	-	- -	-	-	-
12	Hazardous to the ozone layer	-	- -	-	-	-

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.

To GHS Information