NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	83164-33-4
Chemical Name	N-(2,4-Difluorophenyl)-2-[3-(trifluoromethyl)phenoxy]nicotinamide; Diflufenican
Substance ID	m-nite-83164-33-4_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)
Sample SDS by MHLW (External link)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing fluorine and oxygen (but not chlorine) which are chemically bonded only to carbon or hydrogen.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from 3 test results in (1) - (3). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)) (2) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)) (3) LD50 for rats: > 5,000 mg/kg (EFSA (2007))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)) (2) LD50 for rats: > 2,000 mg/kg (EFSA (2007)) (3) LD50 for rabbits: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LC50 for rats (4 hours, dust): > 5,210 mg/m3 (5.12 mg/L) (GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)) (2) LC50 for rats (4 hours): > 5.12 mg/L (EFSA (2007))	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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), skin 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, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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, 7-day observation), slight conjunctival irritation was observed after 1 hour in all of 6 in the unwashed eye group but disappeared after 48 hours (corneal opacity score: 0/0/0/0/0/0, iritis score: 0/0/0/0/0/0, conjunctival redness score: 0.3/0.3/0/0/0/0, chemosis score: 0/0/0/0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 maximization test with guinea pigs (n = 20) (GLP, intradermal administration: 2% solution), the positive rate was 0% (0/19, 1 animal died before intradermal administration) at both 24, 48 hours after the removal of challenge covering (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (2) It is reported that in a Buehler test with guinea pigs (n = 10) (GLP, topical administration: 25% suspension), the positive rate was 0% (0/10) at both 24, 48 hours after a challenge (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (6), it was classified as "Not classified." [Evidence Data] (1) In a chromosomal aberration test using the bone marrow cells of rats (GLP, single intraperitoneal injection), 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, 2014)). (2) In a bacterial reverse mutation test (GLP), 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, 2014)). (3) In a gene mutation test using the cultured mammalian cells (mouse lymphoma cells) (GLP), negative (+S9) and positive (-S9) 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, 2014)). (4) In a gene mutation test using the cultured mammalian cells (Chinese hamster lung cells (V79)) (GLP), 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, 2014)). (5) In a chromosomal aberration test using the human lymphocytes (GLP), 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, 2014)). (6) In the gene mutation test using the mouse lymphoma cells in (3), it was positive at a dose at which cytotoxicity was strongly observed in the absence of a metabolic activation system, but since it was negative in a gene mutation test at a higher dose and in an in vivo chromosomal aberration test, this substance was considered to have no genotoxicity that might become a problem for a living body (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] There were no classification results by domestic and international organizations. However, based on the test results of (1) to (3), it was classified as "Not classified." [Evidence Data] (1) In a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, no carcinogenicity was observed at doses up to 12,500 ppm (males and females: 614/749 mg/kg/day) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (2) In a two-year combined chronic toxicity/carcinogenicity study with mice dosed by feeding, no carcinogenicity was observed at doses up to 12,500 ppm (males and females: 1,620/1,990 mg/kg/day) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (3) In tests with rats and mice, no evidence of carcinogenicity was observed (EFSA (2007)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
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 (OECD TG 416, GLP), at 12,500 ppm, reduced body weight gain, a reduction in food consumption, and dystocia were observed in P, F1 and F2 parent animals; and reduced body weight gain and the increased incidence of death were observed in F1 and F2 offspring. Dystocia and the increased incidence of death at birth that were observed at the same dose were inferred to be caused by the maternal physical status worsened by the administration exceeding the limit dose, and were determined to be the changes caused by systemic general toxicity to parent animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), RAC Opinion (2019), CLH Report (2018)). (2) It was reported that in a developmental toxicity study with rats dosed by gavage (OECD TG 414, GLP, days 6-15 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), RAC Opinion (2019), CLH Report (2018)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (OECD TG 414, GLP, days 6-18 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), RAC Opinion (2019), CLH Report (2018)). (4) It was reported that in a developmental toxicity study with rats dosed by gavage (OECD TG 414, GLP, days 6-15 of gestation), no effect was observed in parent animals and offspring up to the limit dose (1,000 mg/kg/day) (RAC Opinion (2019), CLH Report (2018)). [Reference Data, etc.] (5) The EU proposed that it was reasonable to classify this substance as "Not classified" in the CLP classification for reproduction toxicity, and RAC agreed to it (RAC Opinion (2019), CLH Report (2018)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (6), it was classified as "Not classified." [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats (GLP), at 5,000 mg/kg (in the range corresponding to "Not classified"), uterine horn distension was observed in 1 female (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (2) It was reported that in another acute oral toxicity test with rats (GLP), no symptoms or deaths were observed at 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (3) It was reported that in an acute oral toxicity test with mice (GLP), no symptoms or deaths were observed at 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (4) It was reported that in an acute dermal toxicity test with rats (GLP), at 2,000 mg/kg (within the range for Category 2), scale and chap on the skin surface (4 females), and sporadic small crusts (3 females) were observed in the treated areas, and there was no death (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (5) It was reported that in an acute dermal toxicity test with rabbits (GLP), at 2,000 mg/kg (within the range for Category 2), 1 female died on day 8 after the administration, but no other symptoms were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (6) It was reported that in an acute inhalation (dust) toxicity test with rats (4 hours, GLP), no deaths or symptoms were observed at 5,120 mg/m3 (5.12 mg/L) (in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (5), 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 toxicity information available for classification in the other routes. [Evidence Data] (1) It was reported that in a repeated dose 90-day oral toxicity study with rats dosed by feeding, at or above 5,000 ppm (339 mg/kg/day (males), 418 mg/kg/day (females), in the range corresponding to "Not classified"), reduced body weight gain, a reduction in food consumption, and a decrease in Glu were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (2) It was reported that in another repeated dose 90-day oral toxicity study with rats dosed by feeding (GLP), at or above 2,500 ppm (185 mg/kg/day (males), 208 mg/kg/day (females), in the range corresponding to "Not classified"), reduced body weight gain, a reduction in food consumption, and hepatocyte hypertrophy (males) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). (3) It was reported that in a repeated dose 90-day oral toxicity study with mice dosed by feeding (GLP), at or above 5,000 ppm (836 mg/kg/day (males), 1,020 mg/kg/day (females), in the range corresponding to "Not classified"), reduced body weight gain, an increase in ALP, increases in absolute and relative liver weight, centrilobular hepatocyte hypertrophy (males), and a decrease in Glu (females) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), CLH Report (2018)). (4) It was reported that in a one-year chronic toxicity study with dogs dosed by gavage (GLP), at or above 300 mg/kg/day (in the range corresponding to "Not classified"), an increase in ALP, increases in absolute and relative liver weight (females) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), CLH Report (2018)). (5) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with mice dosed by feeding (OECD TG 453, GLP), at or above 2,500 ppm (322 mg/kg/day (males), 384 mg/kg/day (females), in the range corresponding to "Not classified"), reduced body weight gain, a decrease in Chol, a reduction in food consumption, centrilobular hepatocyte hypertrophy (52 weeks) (males), increases in AST and ALT, a decrease in Glu, and increases in absolute and relative liver weight (females) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014), CLH Report (2018)).	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2020	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
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 = 0.0006 mg/L for algae (Raphidocelis subcapitata) (EU CLP CLH, 2018).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 due to being not rapidly degradable (BIOWIN) and 72-hour NOErC = 0.000095 mg/L for algae (Raphidocelis subcapitata) (EU CLP CLH, 2018).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

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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