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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	314-40-9
Chemical Name	5-Bromo-3-sec-butyl-6-methyl uracil; Bromacil
Substance ID	R02-B-104-MHLW, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
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	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."
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	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2003)).
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. It was classified as "Not classified."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2003)).
11	Self-heating substances and mixtures	Not classified	- -	-	-	It was classified as "Not classified" from information that it is not combustible (ICSC (2003)).
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	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. It was classified as "Not classified."
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	- -	-	-	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. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] It was classified in Category 4 from (1) - (6). [Evidence Data] (1) LD50 for rats: females: 550 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)) (2) LD50 for rats: 641 mg/kg (GESTIS (Access on June 2020), HSDB (Access on June 2020)) (3) LD50 for rats: 641-5,200 mg/kg (Patty (6th, 2012)) (4) LD50 for rats: females: 691 mg/kg, males: 701 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 406 (Japan Crop Protection Association, 1992)) (5) LD50 for rats: females: 3,998 mg/kg, males: 5,126 mg/kg (EPA Pesticides RED (1996)) (6) LD50 for rats: males: 5,200 mg/kg (ACGIH (7th, 2001), HSDB (Access on June 2020))
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, 2016), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 406 (Japan Crop Protection Association, 1992)) (2) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)) (3) LD50 for rats: > 5,000 mg/kg (EPA Pesticides RED (1996), Patty (6th, 2012), GESTIS (Access on June 2020))
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)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). Besides, because exposure concentrations were higher than the saturated vapor pressure concentration (4.3E-006 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) LC50 for rats (4 hours): > 4.8 mg/L (ACGIH (7th, 2001), Patty (6th, 2012), HSDB (Access on June 2020)) (2) LC50 for rats (4 hours): > 14.4 mg/L (EPA Pesticides RED (1996)) (3) Vapor pressure of this substance: 3.07E-007 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 4.3E-006 mg/L)
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" (corresponding to Category 3 in UN GHS classification) from (1) - (3). [Evidence Data] (1) It was reported to be not irritating in a skin irritation test with rabbits according to OECD TG 404 (REACH registration dossier (Access on September 2020)). (2) In a skin irritation test with rabbits according to EPA OPP 81-5, the primary irritation score was 0.8, and it was classified in Category IV (no irritation or slight erythema seen at 72 hours after application) (EPA Pesticides RED (1996)). (3) In a skin irritation test with rabbits, no irritation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] It was classified in Category 2B from (1), (2). [Evidence Data] (1) In an eye irritation test with rabbits according to EPA OPP 81-4, it was a mild irritant and was classified in toxicity Category III (corneal effects or other symptoms clearing within 7 days after application) (EPA Pesticides RED (1996)). (2) In an eye irritation test with rabbits, slight irritation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). [Reference Data, etc.] (3) In an eye irritation test with rabbits according to OECD TG 405 on this substance (amount applied: 0.09 g), no corneal opacity was seen, and irritation responses were observed in the iris and conjunctiva but disappeared within 72 hours after application, and it was judged as not an irritant (REACH registration dossier (Access on September 2020)).
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) - (3). [Evidence Data] (1) In a skin sensitization test with guinea pigs according to OECD TG 406 on this substance (Buehler test, a mixture (0.5 g of the substance/0.5 mL of propylene glycol) was applied), no skin reactions were observed, and it was judged as negative for sensitization (REACH registration dossier (Access on September 2020)). (2) This substance did not cause skin sensitization (ACGIH (7th, 2001)). (3) In a skin sensitization test with guinea pigs (modified Buehler test) on this substance, no sensitization was found (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
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 reported to be negative in a micronucleus test with mouse bone marrow cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test and positive and negative in chromosomal aberration tests using cultured mammalian cells (same as the above).
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). [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified in A3 by ACGIH (ACGIH (7th, 2001)) and C (Possible Human Carcinogen) by EPA (EPA Annual Cancer Report 2019 (Access on September 2020): classified in 1993). (2) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female rats, no neoplastic lesions with treatment-related increases in incidence were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (3) In a carcinogenicity test by 18-month diet administration of this substance to male and female mice, a significant increase in the incidence of hepatocellular adenoma and carcinoma (combined) was found in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), an increase in resorption and a decrease in the number of live fetuses were observed at a dose at which maternal toxicity was observed, and since the degrees of maternal and fetal toxicity were unknown, it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, an increase in embryo resorption and a decrease in the number of live fetuses were observed at doses (at or above 300 mg/kg/day) at which maternal toxicity (decreases in body weight and food consumption) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). [Reference Data, etc.] (2) In a two-generation reproductive study with rats dosed by feeding, reduced body weight gain (without significant difference) was observed in offspring at a dose (2,500 ppm (P males: 145, P females: 173, F1 males: 191, F1 females: 217 mg/kg/day)) at which parental toxicity (excessive response, reduced body weight gain, a decrease in food consumption) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)). (3) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, only mild effects (skeletal variations, low body weight) were observed in fetuses at doses up to the maximum dose at which reduced body weight gain, a decrease in body weight, and increases in absolute and relative liver weight were observed in dams (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
8	Specific target organ toxicity - Single exposure	Category 1 (nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	[Rationale for the Classification] There was no report on acute exposure effects of this substance in humans. Based on (1), it was classified in Category 1 (nervous system). A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) In an oral toxicity test with rats (175, 550, 1,750 mg/kg), lethargy and ataxia at or above 175 mg/kg (within the range for Category 1), high carriage, bradypnea, lying on belly, paleness, and moribundity at 550 mg/kg (within the range for Category 2), and a decrease in muscle tone, lacrimation, mydriasis, gait abnormality, and tremor at or above 550 mg/kg (within the range for Category 2) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] There was no report on repeated exposure to this substance in humans. In a test with test animals by the oral route, based on (1) and (2), there were no toxicity findings by which target organs could be identified at doses within the range for Category 1 or Category 2, and therefore, it was considered to be "Not classified" in the oral route. However, since there was no information on toxicity in the other routes, it was determined that classification was not possible. [Evidence Data] (1) It was reported that, in a two-year test with rats dosed by feeding, at 2,500 ppm (males/females: equivalent to 103/144 mg/kg/day, exceeding Category 2 in both sexes), cystic follicles of the thyroid and round clear cell foci of the adrenal cortex in males, and epithelial hyperplasia of the thymus in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), EPA Pesticides RED (1996)). (2) It was reported that, in an 18-month test with mice dosed by feeding, at or above 1,250 ppm (males/females: equivalent to 163/256 mg/kg/day, exceeding Category 2 in both sexes), diffuse hepatocyte hypertrophy, testis interstitial cell hyperplasia/hypertrophy, testicular atrophy, and spermatocyte necrosis in males, and renal papillary necrosis in females were observed; and at 5,000 ppm (males/females: equivalent to 719/1,030 mg/kg/day, exceeding Category 2 in both sexes), degenerated hepatocytes and single cell necrosis, hyaline droplet degeneration of the liver cytoplasm, and testis interstitial cell ceroid deposition in males, and diffuse hepatocyte hypertrophy in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2016), EPA Pesticides RED (1996)).
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 = 0.027 mg/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, 2014).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 0.0010 mg/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, 2014).
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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