NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	161050-58-4
Chemical Name	1-tert-Butyl-1-(3,5-dimethylbenzoyl)-2-(3-methoxy-2-methylbenzoyl)hydrazine; Methoxyfenozide
Substance ID	R02-A-090-METI
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Economy, Trade and Industry (METI)
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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
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	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
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	- -	-	-	No data 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	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.
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	- -	-	-	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.

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: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010))
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 are unknown at a dose near the upper limit for Category 4 in (1). [Reference Data, etc.] (1) LC50 for rats (4 hours): > 4.3 mg/L (dust) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010))
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) (GLP, semi-occlusive, 4-hour application, 72-hour observation), no irritation changes were seen in any animal (erythema/eschar score: 0/0/0/0/0/0, edema score: 0/0/0/0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), JMPR (2003), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)).
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 = 6) (GLP, 72-hour observation), erythema, edema, and discharge in the conjunctiva were observed after 1 hour but disappeared after 24 hours (corneal opacity score: 0/0/0/0/0/0, iritis score: 0/0/0/0/0/0, conjunctival redness score: 0/0/0/0/0/0, chemosis score: 0/0/0/0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), JMPR (2003), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)).
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) (GLP, intradermal administration: 5% solution), the 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, 2018), JMPR (2003), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)).
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 (single oral dose), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010), HSDB (Accessed Dec. 2020)). (2) In a bacterial reverse mutation test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010), HSDB (Accessed Dec. 2020)). (3) In a gene mutation test using the cultured mammalian cells (CHO), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010), HSDB (Accessed Dec. 2020)). (4) In a chromosomal aberration test using the cultured mammalian cells (CHO), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010), HSDB (Accessed Dec. 2020)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), 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): Classification in 1999). (2) In a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, a significant increase in the incidence of hepatocellular adenomas was observed in females (5.7% of all animals) at the highest dose (20,000 ppm). However, the increase in hepatocellular adenomas was not accompanied by an increase in altered hepatocellular foci, and the incidence was within the range of background data (1.4% to 21.7%). Therefore, it was considered to be accidental alterations. In addition, although a significant increase in mammary adenocarcinomas was observed in females in the low and middle dose groups, no dose-relationship was observed and the incidence was within the range of background data. Therefore, it was considered to be accidental alterations. It was concluded that no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)). (3) In an 18-month carcinogenicity study with mice dosed by feeding, there was no increased incidence of neoplastic lesions up to 7,000 ppm above the limit dose (1,000 mg/kg/day) and no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)). (4) In a combined chronic toxicity/carcinogenicity study with rats, an increase in the incidences of thyroid C-cell adenomas and hepatocellular adenomas was observed at or above the middle dose. It was considered to be the effect of the administration of this substance and it was proposed that this substance should be classified as "Carc. 2" for carcinogenicity. But it was concluded that the increased incidence was not related to the administration of the test substance. No carcinogenicity was observed in mice (EFSA (2017)).
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), no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, days 6-15 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (GLP, days 7-19 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)).
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 with rats, there was no death case, and diarrhea (one case, two hours after the administration) and white matters in feces were observed in males at 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) It was reported that in an acute oral toxicity test with mice, no deaths or symptoms were observed at 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) It was reported that in an acute dermal toxicity test with rats, no deaths or symptoms were observed at 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (4) It was reported that in an acute inhalation (dust, 4 hours) with rats, no deaths or symptoms were observed at 4.3 mg/L (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (5) It was reported that in an acute oral toxicity test (acute neurotoxicity test) with rats, no acute neurotoxicity was observed at 2,000 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (8), it was classified as "Not classified" in the oral and dermal routes. However, classification was not possible due to lack of data since there was not sufficient information available for classification in the inhalation route. [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with rats dosed by feeding, no toxicological findings were observed within the range for Category 1 or Category 2, and liver effects were observed at or above 5,000 ppm (353 mg/kg/day (males), 379 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (2) It was reported that in a 90-day oral toxicity test with mice dosed by feeding, no toxicological findings were observed at doses of up to 7,000 ppm (1,150 mg/kg/day (males), 1,740 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (3) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding, no toxicological findings were observed within the range for Category 1 or Category 2, and blood effects were observed in males at or above 5,000 ppm (198 mg/kg/day (males), 209 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (4) It was reported that in a 90-day subacute neurotoxicity test with rats dosed by feeding, no subacute neurotoxicity was observed at doses of up to 20,000 ppm (1,320 mg/kg/day (males), 1,580 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (5) It was reported that in a 28-day subacute dermal toxicity test with rats (6 hours/day, 5 days/week, 20 days in total), no toxicological findings were observed at up to the highest dose of 1,000 mg/kg/day (converted guidance value: 222 mg/kg/day, in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (6) It was reported that in a one-year chronic toxicity study with dogs dosed by feeding, at or above 3,000 ppm (106 mg/kg/day (male), 111 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the blood were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (7) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, at or above 8,000 ppm (411 mg/kg/day (male), 491 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the blood, liver, and thyroid and other effects were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). (8) It was reported that in an 18-month carcinogenicity study with mice dosed by feeding, no toxicological findings were observed up to the highest dose of 7,000 ppm (350 mg/kg/day (males), 350 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)). [Reference Data, etc.] (9) The results of various toxicity tests showed that the effects of the administration of methoxyfenozide were observed mainly in the blood (anemia), the liver (hypertrophy of periportal hepatocytes, etc.: rats), and the kidney (hyperplasia of renal pelvic epithelial cells, etc.: rats) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2018)).
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)	-	- -	-	-	-
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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