NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	150824-47-8
Chemical Name	(E)-N-[(6-Chloro-3-pyridyl)methyl]-N-ethyl-N'-methyl-2-nitroethene-1,1-diamine (synonym: Nitenpyram)
Substance ID	R03-A-022-METI, MOE
Classification year (FY)	FY2021
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised	New
Classification result in other fiscal year
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)
Model SDS by MHLW (External link)
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	Classification not possible	- -	-	-	There is a nitro group, a chemical group associated with explosive properties, present in the molecule, and the calculated oxygen balance is -162, higher than the criteria: -200. But the classification is not possible due to no data.
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a nitro group, a chemical group associated with explosive properties, present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.
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).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Classification not possible	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which is chemically bonded to the element other than carbon or hydrogen (N). However, the classification is not possible due to no data.
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Classification not possible	- -	-	-	There is a nitro group, a chemical group associated with explosive properties, present in the molecule, but the classification is not possible due to no data.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 4. [Evidence Data] (1) LD50 for rats (males): 1,680 mg/kg (GLP) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)) (2) LD50 for rats (females): 1,580 mg/kg (GLP) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats (males): > 2,000 mg/kg (GLP) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)) (2) LD50 for rats (females): > 2,000 mg/kg (GLP) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LC50 (4 hours) for rats: > 5.8 mg/L (GLP) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)).
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in a skin irritation test (GLP, occlusive, 4-hour application, 72-hour observation) with rabbits (n=6), no skin irritation reactions were observed in any animals (erythema and scab score：0/0/0/0/0/0, edema score: 0/0/0/0/0/0) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) In an eye irritation test (GLP, 72-hour observation) with rabbits (n=9), among 3 animals of a group with eye washing, slight corneal opacity was observed in 1 animal after 24 hours, but the effect disappeared within 72 hours. It was reported that, among 6 animals of a group without eye washing, slight corneal opacity in 2 animals, slight conjunctival redness in all animals, and slight chemosis in 2 animals were observed after 24 hours, but the effects disappeared within 72 hours (corneal opacity score: 0/0/0/0/0.7/0.3, iritis score: 0/0/0/0/0/0, conjunctival redness score: 0.3/0.3/0.3/0.3/0.3/0.3, chemosis score: 0.3/0/0/0/0/0.3) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in a Buehler test (GLP, topical administration: 25% solution) with guinea pigs (n=15), the positive rate was 0% at 24 and 48 hours after challenge (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow cells of mice (up to 500 mg/kg, single-dose intraperitoneal injection), negative results were reported (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (2) In a bacterial reverse mutation test, negative results were reported (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), Japanese Journal of Pesticide Science Vol. 23, No. 1 (Pesticide Science Society of Japan)). (3) In a chromosomal aberration test using the cultured mammalian cells (CHL), negative results were reported (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), Japanese Journal of Pesticide Science Vol. 23, No. 1 (Pesticide Science Society of Japan)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." Also for the information on human carcinogenicity, there were no classification results, but in a carcinogenicity study, results were negative in 2 species of animals. [Evidence Data] (1) In a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, at doses up to the highest dose of 9,000 ppm (males/females: 403/529 mg/kg/day), there were no neoplastic lesions for which the incidences increased due to the administration of the test substance, and no carcinogenicity was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), (Japanese Journal of Pesticide Science Vol. 23, No. 1 (Pesticide Science Society of Japan, Accessed May 2021)). (2) In an 18-month carcinogenicity study with mice dosed by feeding, at doses up to the highest dose of 3,000 ppm (males/females: 440/551 mg/kg/day), there were no neoplastic lesions for which the incidences increased due to the administration of the test substance, and no carcinogenicity was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), (Japanese Journal of Pesticide Science Vol. 23, No. 1 (Pesticide Science Society of Japan, Accessed May 2021)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 2. At a dose exceeding the limit level at which general toxic effects were observed in parent animals, effects on fertility (a reduced number of implantations, and a reduced number of liveborn pups) were observed. [Evidence Data] (1) It was reported that, in a two-generation reproduction toxicity study (GLP) with rats dosed by feeding, at 20,000 ppm (1,400 to 2,040 mg/kg/day), at a range of dose at which general toxic effects (reduced body weight gain, and a decrease in food consumption) were observed in parent animals, a reduced number of implantations (P, F1 females), and a reduced number of liveborn pups were observed; and low body weight at birth, and reduced body weight gain during the lactation period were observed in F1 and F2 offspring (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), Japan Crop Protection Association, 1997)). It was considered that the reduced number of liveborn pups, and the low body weight at birth in F2 offspring were not significant effects, but were effects of the administration of the test substance (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)). (2) It was reported that, in a developmental toxicity study (GLP, days 6-15 of gestation) with rats dosed by gavage, no teratogenicity was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), Japan Crop Protection Association, 1997)). (3) It was reported that, in a developmental toxicity study (GLP, days 6-19 of gestation) with rabbits dosed by gavage, no teratogenicity was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015), Japan Crop Protection Association, 1997)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 2 (nervous system). [Evidence Data] (1) It was reported that, in an acute oral toxicity test with rats (GLP), death, spasms, staggering gait, a decrease in locomotor activity, and salivation (males) were observed at 1,250 mg/kg (within the range for Category 2), and hemorrhages and congestion in the lungs, erosion and petechiae of the glandular stomach were observed at necropsy of the dead animals (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (2) It was reported that, in an acute oral toxicity test with mice (GLP), a decrease in locomotor activity at 500 mg/kg (within the range for Category 2), death at 650 mg/kg (within the range for Category 2), spasms, and sedation (males) at 850 mg/kg (within the range for Category 2), and staggering gait, and spasms (females) at 1,100 mg/kg (within the range for Category 2) were observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)). (3) It was reported that, in an acute dermal toxicity test (GLP) with rats, no effects were observed at 2,000 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)). (4) It was reported that, in an acute inhalation (dust) exposure test (GLP, 4 hours) with rats, at 5.8 mg/L (in the range corresponding to "Not classified"), dyspnea, gasping, salivation, decreased activity, and white matter attached on the fur were observed during the exposure period, and lacrimation, nasal mucosa discharge, staining in the anogenital area, and dry brown matter attached on the face were observed after the exposure period (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)). [Reference Data, etc.] (5) It was reported that nitenpyram was a neonicotinoid insecticide, and was considered to show insecticidal effects by blocking the excitation transmission due to the action to acetylcholine receptors of the postsynaptic membrane (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (5), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was not sufficient information available for classification in other routes. [Evidence Data] (1) It was reported that, in a 90-day oral toxicity study (GLP) with rats dosed by feeding, reduced body weight gain and a decrease in food consumption were observed at 10,000 ppm (617 mg/kg/day (males), 733 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (2) It was reported that, in a 90-day oral toxicity study with mice dosed by feeding, labored respiration, subnormal temperature / leaning / decreased activity (females), reduced feces (females), and death (5/10 animals) (females) were observed at 12,000 ppm (2,030 mg/kg/day (males), 2,640 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)). (3) It was reported that, in a 1-year oral toxicity study with dogs dosed by gavage, no effects were observed at 60 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016)). (4) It was reported that, in a 2-year oral toxicity test (GLP) with rats dosed by feeding, reduced body weight gain (males) was observed at 3,000 ppm (129 mg/kg/day (males), 164 mg/kg/day (females), in the range corresponding to "Not classified"), and reduced body weight gain (females) was observed at 9,000 ppm (403 mg/kg/day (males), 529 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)). (5) It was reported that, in an 18-month oral toxicity test (GLP) with mice dosed by feeding, no effects were observed at 3,000 ppm (440 mg/kg/day (males), 551 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2015)).
10	Aspiration hazard	Classification not possible	- -	-	-	[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)	Category 1	Warning	H400	P273 P391 P501	This substance is a neonicotinoid insecticide and is known to have a specific sensitivity distribution. Based on expert judgment, it was classified in Category 1 from 48-hour EC50 = 0.11 mg a.i./L for Chironomus yoshimatsui (larva) (Document for registration standards for agricultural chemicals set by the Minister of Environment to prevent harm to animals and plants in areas of public waters, 2017). (a.i.: active ingredient)
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	This substance is a neonicotinoid insecticide and is known to have a specific sensitivity distribution. Reliable chronic toxicity data were not obtained. Based on expert judgment, it was classified in Category 1 because it is not rapidly degradable (BIOWIN), and due to 48-hour EC50 = 0.11 mg a.i./L for Chironomus yoshimatsui (larva) (Document for registration standards for agricultural chemicals set by the Minister of Environment to prevent harm to animals and plants in areas of public waters, 2017). (a.i.: active ingredient)
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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