NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	736994-63-1
Chemical Name	3-Bromo-1-(3-chloro-2-pyridyl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-1H-pyrazole-5-carboxamide; Cyantraniliprole
Substance ID	m-nite-736994-63-1_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)
Sample SDS by MHLW (External link)
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.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rats (females): > 5,000 mg/kg (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)) (2) LD50 for rats: > 5,000 mg/kg (JMPR (2013), EFSA (2014))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), EFSA (2014)) (2) LD50 for rats: > 2,000 mg/kg (JMPR (2013))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LC50 for rats (4 hours): > 5.2 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), EFSA (2014), JMPR (2013))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in a skin irritation test with rabbits (n = 3) (GLP, semi-occlusive, 4-hour application, 72-hour observation), no skin irritation reactions were seen in any animal (erythema/eschar score: 0/0/0, edema score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 3) (GLP, 72-hour observation), conjunctival redness and discharge were observed after 1 hour in all the animals but disappeared after 24 hours (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0/0/0, chemosis score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in a maximization test with guinea pigs (n = 20) (GLP, intradermal administration: 5% solution), a positive rate was 0% (0/20) at both 24, 48 hours after the removal of challenge patches (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, in a micronucleus test with mouse bone marrow cells (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (2) In a bacterial reverse mutation test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (3) In a chromosomal aberration test using human lymphocytes, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (4) In a gene mutation test using Chinese hamster ovary cells (CHO), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (5) Based on in vivo and in vitro test results, this substance was not considered to have genetic toxicity (or mutagenicity) (JMPR (2013), EFSA (2014), Federal Register Vol. 83, No. 219 (2018)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) As for the classification results by domestic and international organizations, EPA classified this substance in NL (Not Likely to be Carcinogenic to Humans) (EPA Annual Cancer Report 2018 (Accessed Sep. 2020): Classification in 2013). (2) In a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (OECD TG 451, GLP), no evidence of carcinogenicity was observed at doses up to the highest dose where systemic effects were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), JMPR Report (2013)). (3) In an 18-month carcinogenicity study with mice dosed by feeding (OECD TG 453, GLP), no evidence of carcinogenicity was observed at doses up to the highest dose where systemic effects were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), JMPR Report (2013)). (4) In a carcinogenicity study with rats and mice, no increase in the incidence of tumors was observed and there was no mutagenicity concern. Based on these findings, this substance was classified in "NL (Not Likely to be Carcinogenic to Humans)" (Federal Register Vol. 83, No. 219 (2018)). (5) In the test results with rats and mice, there was no evidence of an increase in the incidence of tumors (EFSA (2014)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding (GLP), at doses where reduced body weight gain, weight changes and/or alterations in tissues of organs such as the thymus, thyroid, and liver were observed in parental animals, reduced body weight gain and decreases in the weight, etc. of the thymus and spleen were observed in pups, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017), JMPR (2013)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, day 6 to 20 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017), JMPR (2013)). (3) In a developmental toxicity study with rabbits dosed by gavage (GLP, gestation days 7 to 28), at 250 mg/kg/day, reduced body weight gain, a reduction in food consumption, abortion, premature delivery, diarrhea, and decreases in bowel movements and the amount of feces were observed in parental animals, while only lower body weight was observed in pups. It was reported that no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017), JMPR (2013)). [Reference Data, etc.] (4) This substance exhibited no developmental toxicity in either rats or rabbits, and a two-generation reproduction study with rats showed that this substance had no adverse effect on any reproductive parameters (US Federal Register (2018)). (5) In a multi-generation test with rats, no adverse effect on any reproductive parameters was observed, and in a developmental toxicity study with rats and rabbits, no teratogenic effect was observed (EFSA (2014)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified." [Evidence Data] (1) It was reported that in an acute oral toxicity test (GLP) with rats (females), at 5,000 mg/kg (in the range corresponding to "Not classified"), neither death nor symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (2) It was reported that in an acute oral toxicity test with mice (females), at 5,000 mg/kg (in the range corresponding to "Not classified"), neither death nor symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (3) It was reported that in an acute neurotoxicity test with rats by single-dose oral administration (GLP), no neurotoxicity was observed at 2,000 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), EFSA (2013)). (4) It was reported that in an acute dermal toxicity test with rats (GLP), at 5,000 mg/kg (in the range corresponding to "Not classified"), neither death nor symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (5) It was reported that in an acute (dust) inhalation toxicity test with rats (for 4 hours, GLP), at 5.2 mg/L (in the range corresponding to "Not classified"), there was no death case, and partial eyelid closure was observed in two males and three females just after the exposure (which cleared after one day) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Specific target organ toxicity - Repeated exposure	Category 2 (cardiovascular system, liver)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (4), the target organs were considered to be the artery and liver, and effects were observed within the dosage range for Category 2, therefore, it was classified in Category 2 (cardiovascular system, liver). The thyroid effects observed in (1) were considered to be secondary effects of hypermetabolism of thyroid hormone in the liver because an increase in UDP-GT activity in the liver was observed, and the thyroid was excluded from the target organs. [Evidence Data] (1) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by feeding (GLP), liver effects (an increase in UDP-GT activity, increases in absolute and relative weight, and centrilobular hepatocyte hypertrophy (females)) and thyroid effects (decreases in T3 and T4, an increase in absolute weight, and hypertrophy of follicular cells (females)) were observed at or above 400 ppm (22.4 mg/kg/day (males), 26.6 mg/kg/day (females), within the range for Category 2); and liver effects (centrilobular hepatocyte hypertrophy and an increase in P450 in the liver (males), an increase in liver to brain weight ratio (females)) were observed at or above 3,000 ppm (168 mg/kg/day (males), 202 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), JMPR (2013)). (2) It was reported that in a repeated dose 90-day oral toxicity study with dogs dosed by feeding (GLP), slight liver effects (an increase in weight, an increase in ALP) were observed at or above 1,000 ppm (31.9 mg/kg/day (males), 34.3 mg/kg/day (females), within the range for Category 2); and reduced activity or anorexia, reduced body weight gain, decreases in Chol and Glu, biliary epithelial hyperplasia, polyarteritis and single-cell necrosis of hepatocytes, emaciation, a reduction in food consumption, sinusoidal leukocytosis (males), an increase in ALT, hypertrophy of hepatic Kupffer cells, and granulomatous inflammation (females) were observed at 10,000 ppm (281 mg/kg/day (males), 294 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), JMPR (2013)). (3) It was reported that in a one-year chronic toxicity study with dogs dosed by feeding (GLP), slight liver effects (an increase in weight and an increase in ALP (males)) were observed at or above 200 ppm (5.67 mg/kg/day (males), 6.00 mg/kg/day (females), within the range for Category 1); and apparent liver effects (an increase in ALT and degeneration of hepatocytes (in the centrilobular area), an increase in ALP, increases in absolute and relative weight of the liver/gallbladder, an increase in the relative ratio of liver/gallbladder weight to brain weight, and chronic active inflammation in the portal area (females)) and arteritis (males) were observed at or above 1,000 ppm (27.0 mg/kg/day (males), 27.1 mg/kg/day (females), within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), JMPR (2013)). (4) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (GLP), focus of hepatocellular alterations (clear and eosinophilic) (males) and centrilobular hepatocyte hypertrophy (females) were observed at or above 2,000 ppm (84.8 mg/kg/day (males), 107 mg/kg/day (females), within the range for Category 2 or in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), JMPR (2013)). [Reference Data, etc.] (5) In a repeated dose 90-day oral toxicity study with mice dosed by feeding, at or above 50 ppm (7.2 mg/kg/day (males), 9.7 mg/kg/day (females), within the range for Category 1), micro-vacuolation in fascicular zone cells of the adrenal glands (males) was observed but there was no dose dependency, and in an evaluation study of effects on the adrenal glands, no adrenal insufficiency or morphological abnormalities were observed. It was also reported that an increase in liver weight and centrilobular hepatocyte hypertrophy and an increase in hepatocellular necrosis (females) were observed at 7,000 ppm (1,090 mg/kg/day (males), 1,340 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2013)). (6) It was reported that in an 18-month combined chronic toxicity/carcinogenicity study with mice dosed by feeding (GLP), an increase in liver weight and centrilobular hepatocyte hypertrophy were observed at or above 1,000 ppm (104 mg/kg/day (males), 131 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), JMPR (2013)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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 48-hour EC50 = 0.01827 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. Since data on rapid degradability were not obtained and it was classified in Category 1 in acute toxicity, it was classified in Category 1.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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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