NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	156963-66-5
Chemical Name	3-[2-Chloro-4-(methylsulfonyl)benzoyl]-4-(phenylsulfanyl)bicyclo[3.2.1]oct-3-en-2-one; Benzobicyclon
Substance ID	R02-A-072-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	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	Classification not possible	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine), and the oxygen is chemically bonded to the element other than carbon or hydrogen (S). 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	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, 2008))
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, 2008))
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] Classification is not possible due to lack of data because the category could not be determined from (1). [Evidence Data] (1) LC50 for rats (4 hours): > 2.72 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008))
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, 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, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
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 = 9) (GLP, 72-hour observation), slight conjunctival redness persisted for 48 hours in 1 out of 6 animals in the unwashed eye group but was reversed after 72 hours (in 6 in the unwashed eye group: mean corneal opacity score: 0, mean iritis score: 0, mean conjunctival redness score: 0.2, mean chemosis score: 0.06) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
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), (2). [Evidence Data] (1) It is reported that in a Buehler test with guinea pigs (n = 20) (GLP, topical administration: 50% sample), a positive rate was 0% at both 24, 48 hours after a challenge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (2) It is reported that in a maximization test with guinea pigs (n = 25) (GLP, intradermal administration: 1% sample), a positive rate was 0% at both 24, 48 hours after a challenge (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
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 from mice (GLP, single oral dose), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (2003)). (2) In a bacterial reverse mutation test (GLP), negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (2003)). (3) In an in vitro mammalian cell chromosome aberration test (GLP), positive results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (2003)). [Reference Data, etc.] (4) There was no concern for mutagenicity (US Federal Register vol. 82, No. 78 (2017)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), 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 (Access on May 2020): Classification in 2017). (2) In a 2-year combined chronic toxicity/carcinogenicity study with rats (dosed by feeding) and an 18-month carcinogenicity study with mice (dosed by feeding), carcinogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (2003)). [Reference Data, etc.] (3) This substance was classified as "Not Likely to be Carcinogenic to Humans" based on the absence of treatment-related tumors in the results of two adequate rodent carcinogenicity studies (US Federal Register vol. 82, No. 78 (2017)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), 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, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, days 6 to 15 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (GLP, days 6 to 18 of gestation), no teratogenicity was observed. At 1,000 mg/kg/day, miscarriage (3/18 cases) was observed in parent animals, but since it was also observed in 1 case in the control group, it was considered to be within the range of the historical control data and not treatment-related (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (4) Also in an assessment of the US EPA, only an increase in the frequency of hydropic degeneration of the pituitary (basophilic cells) was observed in males at the maximum dose (more significant in F1 than in F0) as effects in parent animals in a reproduction toxicity study, and it was reported that there was no developmental, reproductive, or offspring effect in a developmental toxicity and two-generation reproduction toxicity studies with rats, and there was no evidence of increases in qualitative/quantitative fetal or offspring susceptibility in the developmental toxicity study results (US Federal Register (2017)).
8	Specific target organ toxicity - Single exposure	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 acute oral toxicity tests with rats and mice (GLP), at 5,000 mg/kg (in the range corresponding to "Not classified"), neither death nor symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (2) It was reported that in an acute dermal toxicity test with rats (GLP), at 2,000 mg/kg (within the range for Category 2), neither death nor symptom was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (3) It was reported that in an acute inhalation (dust) toxicity test with rats (GLP, 4 hours), there was no death at 2.72 mg/L (within the range for Category 2), and eyelid closure was observed during the exposure period from 1 hour after the start of exposure (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), the blood system and the kidney were considered to be the target organs in male rats, but there was no finding that suggested the target organ toxicity even at a dose far exceeding Category 2 in female rats, and male and female mice and dogs in (1) to (5). Therefore, 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 test with rats dosed by feeding (GLP), at 400 ppm (22.7 mg/kg/day, within the range for Category 2), other than the finding that was considered to be alpha 2mu-globulin nephrosis, effects on the blood (a decrease in red blood cell count, and hemoglobin and hematocrit contents, an increase in MCH), and papilla calcification of the kidney were observed in males, but in females, only increases in absolute and relative weight of the kidney were observed at 10,000 ppm (630 mg/kg/day, in the range corresponding to "Not classified"), and there were no finding of clear target organ toxicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (2) It was reported that in a 90-day oral toxicity test with dogs dosed by gavage, at 2,000 mg/kg/day (in the range corresponding to "Not classified"), there was no finding of toxicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (3) It was reported that in a 1-year chronic toxicity study with dogs dosed by gavage (GLP), at 1,000 mg/kg/day (in the range corresponding to "Not classified"), there was no finding of toxicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (4) It was reported that in a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (GLP), only alpha 2mu-Glob nephrosis was observed in males at the maximum dose of 100 ppm (3.43 mg/kg/day, within the range for Category 1), and only increases in absolute and relative weight of the liver and changes in the serum biochemical value were observed in females at the maximum dose of 10,000 ppm (427 mg/kg/day, in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). (5) It was reported that in an 18-month carcinogenicity study with mice dosed by feeding (GLP), at a maximum dose of 30,000 ppm (3,820 mg/kg/day (male), 4,810 mg/kg/day (female), in the range corresponding to "Not classified"), only increases in absolute/relative weight of the liver and centrilobular hypertrophy of the hepatocytes were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)).
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	It was classified in Category 1 from 48-hour EC50 = 0.343 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it is not rapidly degradable (BIOWIN), and it was classified in Category 1 in acute toxicity.
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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