NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	5902-51-2
Chemical Name	3-tert-Butyl-5-chloro-6-methyluracil; 3-tert-Butyl-5-chloro-6-methylpyrimidine-2,4(1H,3H)-dione; Terbacil
Substance ID	R02-A-037-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. Besides, there is information that it is combustible (Accessed Sep. (2020)).
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	There is a chemical group associated with self-reactive properties (ethylene 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)
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] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (EPA Pesticides RED (1998))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rabbits: > 5,000 mg/kg (EPA Pesticides RED (1998))
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] The category could not be determined from (1), and the classification is not possible. [Evidence Data] (1) LC50 for rats: > 4.4 mg/L (EPA Pesticides RED (1998))
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) There was no report of a primary skin irritation test with rabbits, but as a result of a 21-day subacute dermal toxicity test with rabbits, this substance (purity 80.0%) was judged as not a skin irritant (EPA Pesticides RED (1998)).
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) in accordance with the GHS classification guidance for the Japanese government. [Evidence Data] (1) It is reported that in an eye irritation test with rabbits, mild conjunctival irritation was observed but disappeared within 72 hours (EPA Pesticides RED (1998), HSDB (Accessed Sep. 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). [Evidence Data] (1) In a skin sensitization test with guinea pigs, this substance was concluded as not a skin sensitizer (EPA Pesticides RED (1998)).
5	Germ cell mutagenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified." [Evidence Data] (1) In a chromosomal aberration test with the bone marrow cells of rats (dosed once by gavage, up to 500 mg/kg), negative results were reported (EPA Pesticides RED (1998), Japan Crop Protection Association (1991)). (2) In a bacterial reverse mutation test, negative results were reported (Japan Crop Protection Association (1991), Patty (6th, 2012)). (3) In a gene mutation test using CHO cells, negative results were reported (EPA Pesticides RED (1998)). (4) In a UDS test using rat hepatocytes, negative results were reported (EPA Pesticides RED (1998)).
6	Carcinogenicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (3), it was classified as "Not classified." [Evidence Data] (1) As for the classification results by domestic and international organizations, EPA classified this substance in Group E (Evidence of Non-Carcinogenicity for Humans) (EPA Annual Cancer Report 2018 (Accessed Sep. 2020): Classification in 1994). (2) In a two-year chronic toxicity study with rats dosed by feeding, no carcinogenicity was observed at doses up to 7,500 ppm (EPA Pesticides RED (1989), Patty (6th, 2012)). (3) In a two-year combined chronic toxicity/carcinogenicity study with mice dosed by feeding, an increased incidence of lung neoplasms (adenomas and adenocarcinomas) was observed at or above the lowest dose of 50 ppm. However, the increased incidence was not dose-related and it was within the background data (EPA Pesticides RED (1989), Japan Crop Protection Association (1991), Patty (6th, 2012)).
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1), it was classified in Category 2. [Evidence Data] (1) It was reported that in a developmental toxicity study with rats dosed by feeding, at 1,250 ppm, reduced body weight gain was observed in parental animals and a decreased number of live fetuses/liter (due to pre- and post-implantation losses of embryos/fetuses) was observed in pups (EPA Pesticides RED (1989), Japan Crop Protection Association (1991)). [Reference Data, etc.] (2) It was reported that in a three-generation reproduction toxicity study with rats dosed by feeding, no reproductive toxicity was observed (EPA Pesticides RED (1989)). (3) It was reported that in a developmental toxicity study with rabbits dosed by gavage, at 600 mg/kg/day, which was the lethal dosage of parental animals (in 18 rabbits, five died and two were sacrificed in extremis), lower body weight and delayed ossification of live fetuses were observed in pups (EPA Pesticides RED (1989), Japan Crop Protection Association (1991)).
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was considered to be classified as "Not classified" in the oral and dermal routes, while based on (3), no category could be identified in the inhalation route. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in an acute oral toxicity test with rats, no toxic symptoms were observed and LD50 was > 5,000 mg/kg (EPA Pesticides RED (1989), HSDB (Accessed Sep. 2020)). (2) It was reported that in an acute dermal toxicity test with rabbits, no toxic symptoms were observed and LD50 was > 5,000 mg/kg (EPA Pesticides RED (1989), Patty (2012), HSDB (Accessed Sep. 2020)). (3) It was reported that in an acute (dust) inhalation toxicity test with rats, no toxic symptoms were observed and LD50 was > 4.4 mg/L (EPA Pesticides RED (1989)).
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was considered to be classified as "Not classified" in the oral route, but there was no information on toxicity in the dermal and inhalation routes. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) It was reported that in a 90-day oral toxicity test with rats dosed by feeding, liver effects (increases in absolute and relative weight, vacuolation and hypertrophy of hepatocytes) were observed at 5000 ppm (25 mg/kg/day, in the range corresponding to "Not classified") (EPA Pesticides RED (1989), Patty (2012), HSDB (Accessed Sep. 2020)). (2) It was reported that in a two-year chronic toxicity study with dogs dosed by feeding, an increase in relative thyroid weight, a slight increase in liver weight, and an increase in ALP were observed at 250 ppm (6.25 mg/kg/day, within the range for Category 1) (EPA Pesticides RED (1989), Patty (2012), HSDB (Accessed Sep. 2020), IRIS (1987)). (3) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, an increase in relative liver weight and slight centrilobular hepatocyte hypertrophy were observed at 1,500 ppm (58 mg/kg/day (males), 83 mg/kg/day (females), within the range for Category 2); and centrilobular hepatocyte hypertrophy with fatty changes and an increase in biliary hyperplasia were observed at 7,500 ppm (308 mg/kg/day (males), 484 mg/kg/day (females), in the range corresponding to "Not classified") (EPA Pesticides RED (1989)). (4) It was reported that in a two-year combined chronic toxicity/carcinogenicity study with mice dosed by feeding, an increase in liver weight and hepatocellular hypertrophy were observed at 1,250 ppm (187.5 mg/kg/day, in the range corresponding to "Not classified") (Patty (2012), HSDB (Accessed Sep. 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)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 14-day EC50 = 0.14 mg/L for aquatic plants (Lemna gibba) (EPA RED, 1998).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 14-day NOEC = 0.065 mg/L for aquatic plants (Lemna gibba) (EPA RED, 1998). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 because it is not rapidly degradable (BIOWIN) and due to 96-hour LC50 = 56.4 mg/L for crustacea (Palaemonetes vulgaris) (EPA RED, 1998). By drawing a comparison between the above results, it was classified in Category 1.
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.

To GHS Information