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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	105827-78-9
Chemical Name	1-(6-Chloro-3-pyridylmethyl)-N-nitroimidazolidin-2-ylidenamine; Imidacloprid
Substance ID	R01-B-074
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 neighboring nitrogen and an N-O bond, chemical groups associated with explosive properties, present in the molecule, and the calculated oxygen balance is -131, higher than the criteria: -200. However, the classification is not possible due to no data on the onset temperature and decomposition energy.
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	*	- -	-	-	No data available.
8	Self-reactive substances and mixtures	*	- -	-	-	There are neighboring nitrogen and an N-O bond, chemical groups associated with explosive properties, present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	*	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10	Pyrophoric solids	*	- -	-	-	No data available.
11	Self-heating substances and mixtures	*	- -	-	-	No data available.
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 and oxygen (but not fluorine), and the oxygen is chemically bonded to bonded to an element (N) other than carbon or hydrogen. However, the classification is not possible due to no data.
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	*	- -	-	-	It was classified as "Not classified" because it is not desensitized by wetting, dilution, etc.

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: male: 440 mg/kg, female: 410 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)) (2) LD50 for rats: male: 424 mg/kg, female: 450-475 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)) (2) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
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] Classification not possible due to lack of data. Besides, since the particle size in (1) was as large as 20 mm, it was not adopted. [Reference Data, etc.] (1) LC50 for rats (dust, 4 hours): >5.32 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) The mean scores at 24/48/72 hours were all 0 in a skin irritation test with rabbits according to OECD TG 404, and it was concluded to be non-irritating (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
3	Serious eye damage/eye irritation	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) The mean scores for the cornea, iris, conjunctival redness and conjunctival edema at 24/48/72 hours were all 0 in an eye irritation test with rabbits according to OECD TG 405, and it was concluded to be non-irritating (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
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), it was classified as "Not classified." [Evidence Data] (1) In a skin sensitization test (maximization method) with guinea pigs, no skin reaction was observed, and it was judged to be negative for sensitization (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, there were reports of negative results in chromosomal aberration tests with hamsters or mice, a micronucleus test with mice and a sister chromatid exchange test with hamsters (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (2) As for in vitro, there were reports of negative results in bacterial reverse mutation tests, and a gene mutation test and unscheduled DNA synthesis test with cultured mammalian cells, negative and positive results in sister chromatid exchange tests, and a positive result in a chromosomal aberration test (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
6	Carcinogenicity	*	- -	-	-	[Rationale for the Classification] Based on classification results by other organizations in (1), it was classified as "Not classified" in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified as E (Evidence of Non-Carcinogenicity for Humans) by EPA (EPA Annual Cancer Report (2018): Classified in 1993). [Reference Data, etc.] (2) In a combined chronic toxicity/carcinogenicity study in which rats were given this substance by feeding for 2 years, no treatment-related neoplastic lesions with increased incidence were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (3) In a carcinogenicity study in which mice were given this substance by feeding for 2 years, no treatment-related neoplastic lesions with increased incidence were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Based on (1)-(4), it was classified as "Not classified." [Evidence Data] (1) In a 2-generation reproductive toxicity test with rats dosed by feeding, lower body weight was observed in pups at the dose where reduced body weight gain and decreased food consumption were observed in parental animals, but no reproductive effects were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (2) In a developmental toxicity test with female rats dosed by gavage on gestational Days 6-15, ossification failure was observed in the fetuses at the dose where maternal toxicity (reduced body weight gain, decreased food consumption) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (3) In a developmental toxicity test with female rabbits dosed by gavage on gestational Days 6-18, decreases in the number of implantation and fetuses, and lower body weight, and skeletal abnormalities (asymmetric sternebrae, fusion, etc.) due to maternal toxicity were observed in the fetuses at the dose where maternal toxicity (deaths (2/16 animals), abortion (1 animal), complete embryo absorptions (2 animals), decreased body weight, etc.) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (4) In a developmental neurotoxicity test with female rats dosed by feeding from Day 0 of gestation to Day 21 of lactation (post-delivery), reduced body weight gain, and reversible reductions in motor activity and locomotor activity were observed in pups at the dose where decreased food consumption was observed in maternal animals. However, no treatment-related effects were observed in FOB and neuro histopathological tests, etc., therefore, no developmental neurotoxicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] There are no reports on single exposure to this substance in humans. Based on the information on the mechanism of action in (1) and the results in experimental animals in (2) and (3), the nervous system was considered to be the target organ. Since effects were observed at doses within Category 1 based on the result in (2), it was classified in Category 1 (nervous system). [Evidence Data] (1) There is a description that the mechanism of action of this substance is an agonist action on the nicotinic acetylcholine receptors (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (2) In a single oral administration test with rats, indifference, transient labored breath and tachypnea, hypomobility, transient staggering gait, blepharophimosis, and transient tremors and convulsions were observed at or above 100 mg/kg (male) or 250 mg/kg (female). Dead animals were observed at or above 400 mg/kg in both males and females. The lowest effect level corresponds to Category 1 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (3) In a 4-hour single inhalation exposure test with rats, dyspnea, hypoactivity, piloerection and slight tremors were observed in both males and females at 2.577 mg/L and 5.32 mg/L of the dust of this substance, but no deaths were observed. The lowest effect level corresponds to Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (nervous system, liver)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1)-(3), it was classified as Category 2 (nervous system, liver). Besides, it was judged that the increased intracolloid mineral deposition observed in (2) does not affect thyroid function, and the thyroid was not adopted as the target organ. New information sources were used and reviewed, and the classification result was changed from the previous classification. [Evidence Data] (1) In a 90-day repeated dose toxicity test with dogs dosed by feeding, tremors, decreased body weight, and decreased food consumption were observed in males and females at 1,800/1,200 ppm (male/female: 45.3/45.9 mg/kg/day, within the range of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (2) In a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, increased accumulations of minerals in thyroid colloids in males at or above 300 ppm (male/female: 16.9/24.9 mg/kg/day, within the range of Category 2), and increased accumulations of minerals in thyroid colloids, etc. in females at or above 900 ppm (male/female: 51.3/73.0 mg/kg/day, within the range of Category 2), were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (3) In a 28-day inhalation toxicity test with rats (6 hours/day, 5 days/week), increased glutamate dehydrogenase and induction of hepatic drug-metabolizing enzyme in males and females, reduced body weight gain in males, and prolonged blood coagulation time, increased liver weight, ALT, ALP and total bilirubin, etc. in females were observed after exposure to 0.191 mg/L (converted guidance value: 0.059 mg/L, within the range of Category 2) of the dust of this substance was exposed via the nose (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). [Reference Data, etc.] (4) In addition, effects on the liver and nervous system were observed at doses exceeding the range of Category 2 in a 90-day repeated dose test with rats dosed by feeding, and effects on the nervous system and liver were observed at a dose exceeding the range of Category 2 in a 2-year carcinogenicity test with mice dosed by feeding. Besides, no toxic effects were observed at a dose exceeding the range of Category 2 in a 21-day dermal exposure test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
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.

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