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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	1582-09-8
Chemical Name	alpha, alpha, alpha-Trifluoro-2,6-dinitro-N,N-dipropyl-p-toluidine; Trifluralin
Substance ID	R02-B-081-MHLW
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)
New/Revised	Revised
Classification result in other fiscal year	FY2006 FY2019
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	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (a nitro group) present in the molecule, and the calculated oxygen balance is -143, higher than the criteria: -200, but the classification is not possible due to no data.
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. Besides, there is information that it is combustible (ICSC (2017)).
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (a nitro group) present in the molecule, but the classification is not possible due to no data.
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.
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	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine), which is chemically bonded to the element other than carbon or hydrogen (N). 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. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
17	Desensitized explosives	Classification not possible	- -	-	-	There is a chemical group associated with explosive properties (a nitro group) present in the molecule, but the classification is not possible due to no data.

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) - (4). [Evidence Data] (1) LD50 for rats: males: 2,520 mg/kg, females: 2,550 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)) (2) LD50 for rats: > 5,000 mg/kg (EU EFSA (2009)) (3) LD50 for rats: > 10,000 mg/kg (HSDB (Access on May 2020)) (4) LD50 for rats: > 36,500 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)) [Reference Data, etc.] (5) LD50 for rats (neonates): 570 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)) (6) LD50 for rats (weanling): 5,440 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) LD50 for rabbits: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), EU EFSA (2009)) (2) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), GESTIS (Access on May 2020), Japanese Journal of Pesticide Science Vol. 16, No. 3 (Pesticide Science Society of Japan, 1991))
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 not possible due to lack of data.
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). The classification result was changed due to new data (1) - (3) obtained. [Evidence Data] (1) It was not irritating in a skin irritation test with rabbits according to EPA OPP 81-5 (EPA Pesticides RED (1996)). (2) It was not irritating in a skin irritation test with rabbits (strain: unknown) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (3) In a skin irritation test with rabbits on this substance (Draize test), the score was all 0, and there was no irritation (HSDB (Access on May 2020)). [Reference Data, etc.] (4) Short-term exposure irritated the eye, skin, and respiratory tract and produced erythema and pain in the eye (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (3). The previous classification was considered to be based on data on a formulation (emulsions), and the classification result was changed because new data on the substance (1) - (3) were newly obtained. [Evidence Data] (1) In an eye irritation test with rabbits according to EPA OPP 81-4, it was judged as slight irritation (EPA Pesticides RED (1996)). (2) It was slightly irritating to the eye in an eye irritation test with rabbits (strain: unknown) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (3) This substance was not irritating in an eye irritation test with rabbits (HSDB (Access on May 2020)). [Reference Data, etc.] (4) Short-term exposure irritated the eye, skin, and respiratory tract and produced erythema and pain in the eye (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 from (1) - (4). [Evidence Data] (1) Long-term or repeated contact may sensitize the skin (Environmental Risk Assessment for Chemical Substances vol. 4, Tentative Hazard Assessment Sheet (Ministry of the Environment, 2005)). (2) It was sensitizing in a skin sensitization test with guinea pigs according to EPA OPP 81-6 (EPA Pesticides RED (1996)). (3) Skin sensitization tests with guinea pigs (a maximization test and a Buehler test) were conducted, and it was positive for skin sensitization (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (4) It was positive for skin sensitization in a skin sensitization test with guinea pigs (Buehler test) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (5) It was classified in Skin Sens. 1 (H317) in EU-CLP classification (EU CLP classification (Access on August 2020)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was negative in a sister chromatid exchange test with bone marrow cells after oral administration to Chinese hamsters, negative in a micronucleus test with bone marrow cells after oral administration to mice, and negative in a dominant lethal test with bone marrow cells after oral administration to rats (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). (2) As for in vitro, it was negative in a bacterial reverse mutation test, and as for test systems in cultured mammalian cells, it was negative in a chromosomal aberration test and negative in a gene mutation test (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] It was classified in Category 2 from (1) - (3). An investigation was conducted by using new information sources, and the classification result was changed. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in Group 3 by IARC (IARC 53 (1991)), C (possible human carcinogen) by EPA (IRIS (1989)), and Carc.2 in EU CLP classification (EU CLP classification (Access on May 2020)). (2) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female rats, significant increases in the incidences of transitional cell carcinoma in the kidney and follicular epithelial cell adenoma in the thyroid were observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (3) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female mice, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), no effect on fertility was observed. Developmental effects on fetuses were observed only at a dose at which severe effects were observed in the dams, but no teratogenicity was observed. Therefore, it was classified as “Not classified.” [Evidence Data] (1) In a two-generation reproductive study with rats dosed by feeding, at a dose at which reduced body weight gain, etc. were observed in parent animals, reduced body weight gain, etc. were observed in offspring, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (2) In another two-generation reproductive study with rats dosed by feeding, a decrease in body weight of weanling pups and a decrease in litter size were observed at a dose at which an increase in kidney lesions were observed in parent animals (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (3) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at a dose at which reduced body weight gain, etc. were observed in dams, low body weight in fetuses was observed, but no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (4) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 18 of gestation, a decrease in the number of live fetuses and an increase in the number of dwarf fetuses were observed at a dose at which maternal toxicity (anorexia, cachexia, abortion or death, reduced body weight gain, etc.) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	[Rationale for the Classification] There was no report on single exposure to this substance in humans. Based on (1) and (2), it was classified in Category 2 (nervous system). New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) It was reported that, in an acute oral toxicity test with mice, standing on tiptoes, out-toeing gait, and slight eyelid ptosis were observed at or above 500 mg/kg (within the range for Category 2); and death, tremor, muscle flaccid, a decrease in righting reflex, and clonic convulsions were observed at 1,500 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)). (2) It was reported that, in an acute oral toxicity test with rats, death was observed at or above 1,395 mg/kg (within the range for Category 2), and as symptoms, lacrimation, salivation, eyelid ptosis, convulsions, paralysis of the hindlimbs, etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)). [Reference Data, etc.] (3) It was reported that, in an oral toxicity test with newborn rats, death was observed at or above 365 mg/kg (within the range for Category 2), and liver fattening and hydrops, and thymus lymphocyte necrosis were observed in the dead animals. It was reported that similar symptoms as those in the dead animals were observed in weaning rats and mature rats within the range exceeding Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (blood system)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] There was no report on repeated exposure to this substance in humans. Based on (1), effects on the blood system at doses for Category 1 were observed in experimental animals. Therefore, it was classified in Category 1 (blood system). There was information that kidney toxicity was observed in rats, but as a result of reexamination of the information, it was found that the finding was suggestive of alpha 2mu-globulin nephropathy, which was specific to male rats, and therefore, the classification result was changed from the previous classification. [Evidence Data] (1) It was reported that, in a one-year test with dogs dosed by feeding, an increase in methemoglobin concentration was observed at or above 3.75 mg/kg/day (within the range for Category 1), and a decrease in erythrocyte count was observed at 18.75 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), Environmental Risk Assessment for Chemical Substances Vol. 2 (Ministry of the Environment, 2003), EPA Pesticides RED (1996)). [Reference Data, etc.] (2) In humans, inhalation can cause irritation of the respiratory tract with cough, phlegm, and/or tightness in the chest (HSDB (Access on May 2020)).
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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