NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	88402-43-1
Chemical Name	N-(4-Chlorophenyl)-1-cyclohexene-1,2-dicarboximide (synonym: Chlorphthalim)
Substance ID	R03-A-020-METI, MOE
Classification year (FY)	FY2021
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	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are 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	- -	-	-	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] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 24,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)) (2) LD50 for rats: > 5,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)) (2) LD50 for rabbits: > 2,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 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] Based on (1) and (2), it was not classified in Categories 1 to 3, but no category could be identified. Therefore, classification was not possible. [Evidence Data] (1) LC50 (4 hours) for rats: > 0.243 mg/L (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)) (2) LC50 (4 hours) for rats: > 3 mg/L (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in a skin irritation test (closed patch, healthy skin and damaged skin, 24-hour application, 2-day observation) with rabbits (n=6), a very slight erythema was observed on the healthy skin and the damaged skin 30 minutes after removal of the patch, but it disappeared after 48 hours (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in an eye irritation test with rabbits (n=9), in 3 animals of a group with eye washing, slight effects on the conjunctiva were observed 24 hours after application, but they disappeared after 48 hours. It was reported that, in 6 animals of a group without eye washing, slight eye irritation reactions were observed 24 hours after application, but they disappeared after 48 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) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 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] Based on (1), it was classified as "Not classified." [Evidence Data] (1) It was reported that, in a Buehler test (topical administration: 100% specimen) with guinea pigs (n=10), the positive rates were both 0% (0/10 cases) at 24 and 48 hours after challenge (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
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 of mice (up to 2,000 mg/kg, 2-day intraperitoneal injection), negative results were reported (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (2) In a bacterial reverse mutation test, negative results were reported (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (3) In a chromosomal aberration test using the cultured mammalian cells (CHO), negative results were reported (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
7	Reproductive toxicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Besides, no developmental toxicity effects were observed in (1) and (2), and there were no data about effects on fertility. [Evidence Data] (1) It was reported that, in a developmental toxicity study with rats dosed by gavage (days 6-19 of gestation), at a dose at which no general toxic effects were observed in parent animals, a slight effect (lower body weight) but no teratogenicity was observed in pups (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (2) It was reported that, in a developmental toxicity study with rabbits dosed by gavage (days 6-18 of gestation), no teratogenicity was observed (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (5) and (6), lung congestion and dyspnea were observed, and therefore, it was classified in Category 3 (respiratory tract irritation). [Evidence Data] (1) It was reported that, in an acute oral toxicity test with rats, no effects were observed at 24,000 mg/kg (in the range corresponding to “Not classified”) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (2) It was reported that, in an acute oral toxicity test with rats, a decrease in body weight (1/10 males) was observed at 5,000 mg/kg (in the range corresponding to “Not classified”) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (3) It was reported that, in an acute dermal toxicity test with rats, no effects were observed at 5,000 mg/kg (in the range corresponding to “Not classified”) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (4) It was reported that, in an acute dermal toxicity test with rabbits, a slight erythema was observed at 2,000 mg/kg (within the range for Category 2) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (5) It was reported that, in an acute inhalation (dust) exposure test (4 hours) with rats, lung congestion was observed at 0.243 mg/L (within the range for Category 1) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (6) It was reported that, in an acute inhalation (dust) exposure test (4 hours) with rats, dyspnea, salivation, lacrimation, red nasal discharge, and dry matter around the face were observed at 3 mg/L (within the range for Category 2). It was reported that they decreased gradually after exposure (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
9	Specific target organ toxicity - Repeated exposure	Category 2 (blood system)	Warning	H373	P260 P314 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 2 (blood system). [Evidence Data] (1) It was reported that, in a 3-month oral toxicity test with rats dosed by feeding, cyanosis and increases in liver and spleen weight were observed in females and males, decreased red blood cell count, decreases in hematocrit and hemoglobin, prolonged blood clotting time, and increases in total cholesterol and total protein in the serum were observed in males, and an increase in uric acid in the serum was observed in females at 800 ppm (46 mg/kg/day (males), 53 mg/kg/day (females), within the range for Category 2); death, dark-reddish eyes, and increased MCV were observed in males, and decreased red blood cell count, prolonged blood clotting time, and decreased MCHC were observed in females at 2,000 ppm (110 mg/kg/day (males), 120 mg/kg/day (females), in the range corresponding to "Not classified"); spleen congestion and hemosiderin deposits were observed in females and males, decreased MCHC was observed in males, and dark-reddish eyes, increased MCV, and increased urinary bilirubin were observed in females at 5,000 ppm (350 mg/kg/day (males), 360 mg/kg/day (females), in the range corresponding to "Not classified"); and increased urinary bilirubin was observed in males at 7,000 ppm (380 mg/kg/day (males), 390 mg/kg/day (females), in the range corresponding to "Not classified") (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (2) It was reported that, in a 3-month oral toxicity test with rats dosed by feeding, increased hemoglobin was observed in females and males at 150 ppm (11.3 mg/kg/day (males), 13 mg/kg/day (females), within the range for Category 2); and decreases in red blood cell count, hematocrit, and hemoglobin, increased total bilirubin, increases in liver, kidney, and spleen weight, and increased reticulocyte count were observed in females and males, an increase in testis weight was observed in males, and increased cholesterol was observed in females at 750 ppm (56.8 mg/kg/day (males), 64.1 mg/kg/day (females), within the range for Category 2) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). (3) It was reported that, in a 3-month oral toxicity test with mice dosed by feeding, dark-reddish eyes were observed in females and males, and increased white blood cell count was observed in males at 800 ppm (120 mg/kg/day (males), 170 mg/kg/day (females), in the range corresponding to "Not classified"); an increase in liver weight was observed in females and males, and decreases in red blood cell count, hematocrit, and hemoglobin, increased white blood cell count, and a decrease in plasma urea nitrogen were observed in females at 2,000 ppm (310 mg/kg/day (males), 370 mg/kg/day (females), in the range corresponding to "Not classified"); cyanosis was observed in females and males, decreases in red blood cell count, hemoglobin, and MCHC, increased MCV, increased urinary bilirubin and ketone bodies, and effects on the spleen (increased weight in females and males, and blackening in females) were observed in males at 5,000 ppm (1,000 mg/kg/day (males), 1,200 mg/kg/day (females), in the range corresponding to "Not classified"); and effects on the liver (change of the color to blackish green, and bile pigmentation) and decreased hematocrit were observed in males, and increased urinary bilirubin and urobilinogen were observed in females at 7,000 ppm (1,000 mg/kg/day (males), 1,400 mg/kg/day (females), in the range corresponding to "Not classified") (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)). [Reference Data, etc.] (4) It was reported that, in a 90-day oral toxicity study with dogs dosed by gavage, no effects were observed at 1,000 mg/kg/day (in the range corresponding to "Not classified") (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
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 72-hour ErC50 = 0.0158 mg a.i./L for algae (Raphidocelis subcapitata) (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, 2016) (a.i.: active ingredient).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it was not rapidly degradable (BIOWIN) and due to 72-hour NOECr = 0.00235 mg/L for algae (Raphidocelis subcapitata) (Food and Agricultural Materials Inspection Center, 2012)). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (crustacea, fish), then it is classified as "Not classified" because it was not rapidly degradable, and due to 48-hour EC50 > 5.71 mg a.i./L for crustacea (Daphnia magna) (limit test, 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, 2016)). From the above results, it was classified in Category 1. (a.i.: active ingredient)
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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