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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	165252-70-0
Chemical Name	1-Methyl-2-nitro-3-[(3-tetrahydrofuryl)methyl]guanidine; Dinotefuran
Substance ID	R02-A-033-METI, MOE
Classification year (FY)	FY2020
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 chemical group associated with explosive properties (nitro group) present in the molecule, and the oxygen balance is -142, 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 chemical group associated with explosive properties (nitro group) 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	- -	-	-	Classification is not possible because 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 oxygen (but not fluorine or chlorine), which is chemically bonded to an element (N) other than carbon or hydrogen. 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 chemical group associated with explosive properties (nitro group) 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)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: 2,450 mg/kg (males: 2,804 mg/kg, females: 2,000 mg/kg, OECD TG 401, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), REACH registration dossier (Accessed Sep. 2020), JMPR (2012))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (OECD TG 402, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), REACH registration dossier (Accessed Sep. 2020), JMPR (2012))
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)	Classification not possible	- -	-	-	[Rationale for the Classification] The classification is not possible because effects at a dose near the upper limit for Category 4 are unknown from (1). [Evidence Data] (1) LC50 for rats (4 hours): > 4.09 mg/L (OECD TG 403, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), REACH registration dossier (Accessed Sep. 2020), JMPR (2012))
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 = 6) (OECD TG 404, GLP, 4-hour application, 72-hour observation), very slight erythema was observed in 3 animals at 30 minutes after the removal of patches and one after 24 hours but fully disappeared after 48 hours (erythema/eschar score: 0/0/0/0/0/0.3, edema score: 0/0/0/0/0/0) (JMPR (2012), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2018)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) It is reported that in an eye irritation test with rabbits (n = 9) (OECD TG 405, GLP, 14-day observation), out of 6 animals in the group whose eyes were unwashed, slight to moderate conjunctival redness and chemosis were observed in all, the effects in 4 were reversed within 96 hours, and the effects in the remaining two disappeared within 14 days (in 6 in the unwashed eye group: corneal opacity score: 0/0/0.3/0.3/0.3/1, iritis score: 0/0/0.3/0/0/0.7, conjunctival redness score: 1/1.3/1/1.3/1.7/2, chemosis score: 0.7/1/0.7/0.7/1/2) (JMPR (2012), REACH registration dossier (Accessed Sep. 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2018)). (2) It is reported that in an eye irritation test with rabbits (n = 3), corneal opacity in 2 animals and conjunctival redness in one were found after 1 hour, but all the irritation effects were reversible within 24 hours (JMPR (2012)).
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] It was classified as "Not classified" from (1). [Evidence Data] (1) It is reported that in a maximization test with guinea pigs (n = 20) (OECD TG 406, GLP, intradermal administration: 5% solution), a positive rate was 0% (0/20) at both 24, 48 hours after challenge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2018), REACH registration dossier (Accessed Sep. 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a micronucleus test using the bone marrow cells of mice (GLP, two oral doses), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012), REACH registration dossier (Accessed Sep. 2020)). (2) In a bacterial reverse mutation test (OECD TG471, GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012), REACH registration dossier (Accessed Sep. 2020)). (3) In an in vitro mammalian cell chromosome aberration test (OECD TG473, GLP), negative results were reported (JMPR (2012), REACH registration dossier (Accessed Sep. 2020)). (4) In an in vitro mammalian cell gene mutation test (mouse lymphoma L5178Y cell) (OECD TG476, GLP), negative results were reported (JMPR (2012), REACH registration dossier (Accessed Sep. 2020)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on the classification results and test results of (1) to (3), 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 2004). (2) In a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (OECD TG453, GLP), an increased incidence of thyroid C-cell adenomas was observed in males treated at the highest dose of 20,000 ppm, but no increase in C-cell hyperplasia was observed and the incidence of thyroid C-cell adenomas (17%) was within the historical control data range (1.7 to 24%). Therefore, this finding was considered not to be treatment-related. No carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)). (3) In an 18-month carcinogenicity studies with mice dosed by feeding (OECD TG451, GLP), no treatment-related increase in the incidence of neoplastic lesions was observed. No carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (7), 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, at 20,000 ppm, effects such as reduced body weight gain (males and females) and decreased food consumption (except P males) were observed in P and F1 parental animals and reduced body weight gain and decreases in thymus and/or spleen weight (absolute and/or relative weight) were observed in F1 and F2 offspring, but no effects on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (2) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding, at 20,000 ppm, reduced body weight gain and decreased food consumption were observed P and F1 parental animals but no effects on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (3) In a two-generation reproduction toxicity study with rats dosed by feeding (OECD TG416, GLP), at 10,000 ppm, effects such as reduced body weight gain, decreased food consumption (P and F1 males and females), a decrease in absolute spleen weight (P males and females), and death (one female) were observed in parental animals, and reduced body weight gain, a decrease in absolute spleen weight (F1 and F2 males and females), a decrease in relative spleen weight (F1 females and F2 males and females), and a decrease in absolute thymus weight (F2 males and females) were observed in offspring. It was reported that no effects on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017, REACH registration dossier (Accessed Sep. 2020), JMPR (2012)). (4) It was reported that in a developmental toxicity study with rats dosed by gavage, no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017)). (5) It was reported that in a developmental toxicity study with rabbits dosed by gavage (OECD TG414, GLP, day 6 to 18 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), REACH registration dossier (Accessed Sep. 2020), JMPR (2012)). (6) It was reported that in a developmental toxicity study with rabbits dosed by gavage (OECD TG414, GLP, day 6 to 27 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), REACH registration dossier (Accessed Sep. 2020)). (7) It was reported that in a developmental neurotoxicity study with rats dosed by gavage (OECD TG426, GLP, from day 0 of gestation to day 21 of lactation), no developmental neurotoxicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)).
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." In (2), neurotoxicity symptoms were observed at the upper limit value in Category 2 but the effects were not observed in the acute neurotoxicity study of (1). Therefore, the symptoms were not adopted as evidence of the classification. [Evidence Data] (1) It was reported that in an acute neurotoxicity study with rats (OECD TG 424, GLP), no acute neurotoxicity was observed at 1,500 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)). (2) It was reported that in an acute oral toxicity test with rats (OECD TG 401, GLP), hypoactivity, staggering gait, hunched posture, prostration, red-stained face, miosis, lacrimation, salivation, tachycardia, dyspnea, soft feces, yellow staining of the urogenital area, and tremors were observed at or above 2,000 mg/kg, and tonic convulsions (males) and clonic convulsions (females) were observed at or above 3,000 mg/kg (in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), REACH registration dossier (Accessed Sep. 2020), JMPR (2012)). (3) It was reported that in an acute dermal toxicity test with rats (OECD TG 402, GLP), minor weight loss, erythema, and slight edema were observed at 2,000 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), REACH registration dossier (Accessed Sep. 2020), JMPR (2012)). (4) It was reported that in an acute (dust) inhalation toxicity test with rats (OECD TG 403, GLP), no symptoms and no deaths were observed at 4.09 mg/L (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), REACH registration dossier (Accessed Sep. 2020), JMPR (2012)).
9	Specific target organ toxicity - Repeated exposure	Not classified	- -	-	-	[Rationale for the Classification] In (1) to (8), no target organs were identified in any of the oral, dermal, and/or inhalation routes. Therefore, it was classified as "Not classified." [Evidence Data] (1) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by feeding (OECD TG 408), reduced body weight gain and decreased food consumption (females) were observed at or above 5,000 ppm (336 mg/kg/day (males), 384 mg/kg/day (females), in the range corresponding to “Not classified”), and reduced body weight gain and decreased food consumption (males) were observed at or above 25,000 ppm (1,620 mg/kg/day (males), 1,870 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)). (2) It was reported that in a repeated dose 90-day oral toxicity study with mice dosed by feeding (OECD TG 408), reduced body weight gain was observed at 50,000 ppm (10,600 mg/kg/day (males), 11,600 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)). (3) It was reported that in a repeated dose 90-day oral toxicity study with dogs dosed by feeding (OECD TG 409), reduced body weight gain (females) was observed at or above 1,600 ppm (58 mg/kg/day, within the range for Category 2), and reduced body weight gain (males) was observed at or above 24,000 ppm (862 mg/kg/day (males), 950 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)). (4) It was reported that in a one-year chronic toxicity study with dogs dosed by feeding (OECD TG 452), reduced body weight gain (females) was observed at or above 3,200 ppm (111 mg/kg/day (males),108 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)). (5) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (OECD TG 453), reduced body weight gain was observed at 20,000 ppm (991 mg/kg/day (males),1,330 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)). (6) It was reported that in an 18-month carcinogenicity study with mice dosed by feeding (OECD TG 451), reduced body weight gain was observed at 25,000 ppm (3,690 mg/kg/day (males),4,730 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2017), JMPR (2012)). (7) It was reported that in a repeated dose dermal toxicity: 29-day study with rats (OECD TG 410, 6 to 7 hours/day), local dermal irritation effects (acanthosis/hyperkeratosis) were observed at 1,000 mg/kg/day (converted guidance value: 276 to 322 mg/kg/day, in the range corresponding to “Not classified”) (JMPR (2012), HSDB (Accessed Sep. 2020)). (8) It was reported that in a subacute inhalation toxicity: 29-30 day study with rats (OECD TG 412, 6 hours/day), reduced body weight gain was observed at or above 0.66 mg/L (in the range corresponding to “Not classified”) but there were no effects associated with specific organs in both males and females at any dose up to the highest dose (JMPR (2012), HSDB (Accessed Sep. 2020)).
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 pesticide known to have a specific efficacy profile. By the expert judgment, it was classified in Category 1 from 48-hour EC50 = 0.036 mg/L for crustacea (larvae of Chironomus yoshimatsui) (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).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	This substance is a neonicotinoid pesticide known to have a specific efficacy profile. It is not rapidly degradable (BIOWIN), and by the expert judgment, it was classified in Category 1 from 27-day NOEC = 0.00288 mg/L for crustacea (Chironomus riparius) (REACH registration dossier, 2021).
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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