NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	283594-90-1
Chemical Name	3-Mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutanoate; Spiromesifen
Substance ID	R02-A-022-MHLW, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/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)	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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available.
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. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from information that it is stable to heat at up to 250 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
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). It was classified as "Not classified."
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen. It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	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)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (JMPR (2016)) (2) LD50 for rats: > 2,500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
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 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
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] LC50 was considered to exceed 5.0 mg/L practically from (1). Therefore, it was classified as "Not classified." [Evidence Data] (1) LC50 for rats (nose exposure, 4 hours): > 4.87 mg/L (no 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	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) No irritation was observed in a skin irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) No irritation was observed in an eye irritation test with rabbits (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1B	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1B from (1). [Evidence Data] (1) In a skin sensitization test with guinea pigs (maximization test, intradermal administration 5%), reactions were seen in 20/20 animals after 48 hours and 18/20 after 72 hours in a challenge, and the positive rate was 100% and 90%, respectively (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) As for in vivo, in a micronucleus test using the bone marrow cells after intraperitoneal injection to mice, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (2) As for in vitro, in a bacterial reverse mutation test, a chromosome aberration test and a gene mutation test using cultured mammalian cells, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for the classification results by domestic and international organizations, the EPA classified this substance in NL (Not Likely To Be Carcinogenic To Humans) (EPA Annual Cancer Report 2019 (Access on October 2020): Classification in 2008). (2) In a two-year carcinogenicity study with male and female rats dosed by feeding, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (3) In an 18-month carcinogenicity study with male and female mice dosed by feeding, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a two-generation reproduction study with rats dosed by feeding, at doses at which toxicity effects in parental animals (such as reduced body weight gain in males and females) were observed, reduced body weight gain, a delay in preputial separation, a delay in vaginal opening, etc. were observed in pups. This delay in sexual maturation was considered to be the result of the decreased body weight. No effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 19 of gestation, even at doses at which maternal toxicity effects (a reduction in food consumption, reduced body weight gain, saltatory spasm) were observed, no effect was observed in fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 28 of gestation, a decrease in the percentage of maternal animals having viable fetuses was observed due to a reduction in food consumption, a reduction in feces, reduced body weight gain, miscarriage (4/22 cases), and total resorption of embryos (2/22 cases) in maternal animals, but no effect in fetuses was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] There was no report on acute exposure effects of this substance in humans. In experimental animals, based on (1) to (3), there were no findings by which target organs could be identified in any of the tests in the oral, dermal, and/or inhalation routes. Therefore, it was classified as "Not classified." [Evidence Data] (1) In an acute oral toxicity test with rats, no deaths or symptoms were observed at 2,000 mg/kg (upper limit of Category 2) (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 an acute dermal application test with rats, no deaths or symptoms were observed at 2,000 mg/kg (upper limit of Category 2) (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 four-hour inhalation exposure test with rats (exposure of the nose), piloerection was observed at 4.873 mg/L (within the range for Category 2) in both males and females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013))
9	Specific target organ toxicity - Repeated exposure	Category 2 (thyroid, gastrointestinal tract, adrenal gland)	Warning	H373	P260 P314 P501	[Rationale for the Classification] There was no report on hazard by repeated exposure to this substance in humans. In experimental animals, based on (1) to (3), at doses for Category 2, the effects on the thyroid, liver, adrenal gland, and gastrointestinal tract were observed. Therefore, it was classified in Category 2 (thyroid, gastrointestinal tract, adrenal gland). Based on (4), since the effect on the liver was considered to reflect hepatic enzyme induction, the liver was not adopted as a target organ. [Evidence Data] (1) It was reported that in a 14-week oral toxicity study with mice dosed by feeding, at or above 140 ppm (males/females: 22/35 mg/kg/day, both within the range for Category 2), an increased incidence of cytoplasmic eosinophilia in zona fasciculata of the adrenal cortex with reduced or absent normal fine vesiculation was observed, and furthermore, in females, decreases in hemoglobin levels, discoloration of the adrenals, etc. were observed (JMPR (2016)). (2) It was reported that in a 14-week oral toxicity study with rats dosed by feeding, at or above 500 ppm (males/females: 31.7/36.6 mg/kg/day, both within the range for Category 2), an increase in thyroid stimulating hormones and cytoplasmic vacuolation of the jejunal mucosal epithelium were observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2016)). (3) It was reported that in a one-year oral toxicity study with rats dosed by feeding, at or above 300 ppm (males/females: 15.9/19.3 mg/kg/day, both within the range for Category 2), hypertrophy of thyroid follicular cells was observed in males; and at 800 ppm (males/females: 42.4/51.7 mg/kg/day, both within the range for Category 2), a decrease in total bilirubin levels, an increase in thyroid stimulating hormones, and thyroidal colloidal alterations were observed, and furthermore, an increase in triiodothyronine (T3) in males was observed, and brown discoloration of the both adrenals, hypertrophy of thyroid follicular cells, and an increased incidence of cytoplasmic eosinophilia in zona fasciculata in females was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), JMPR (2016)). (4) In several oral toxicity studies with dogs dosed by feeding, liver effects (an increase in liver weight, an increase in ALP activity, an increased T4 elimination, and hepatocellular cytoplasmic changes) were observed, but the JMPR (2016) concluded that these effects reflected hepatic enzyme induction (JMPR (2016)).
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 2	- -	H401	P273 P501	It was classified in Category 2 from 96-hour LC50 = 1.18 mg/L for fish (Cyprinus carpio) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 21-day NOEC = 0.00025 mg/L for crustacea (Daphnia magna) (ECOTOX, 2021, EPA OPP Pesticide Ecotoxicity Database, 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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