GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 34014-18-1
Chemical Name 1-(5-tert-butyl-1,3,4-thiadiazol-2-yl)-1,3-dimethylurea; Tebuthiuron
Substance ID R02-A-031-METI
Classification year (FY) FY2020
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)
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 oxygen (but not fluorine or chlorine) which is 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) Category 4


Warning
H302 P301+P312
P264
P270
P330
P501
[Rationale for the Classification]
It was classified in Category 4 from (1) - (2).

[Evidence Data]
(1) LD50 for rats (males): about 477 mg/kg (EPA Pesticides RED (1994))
(2) LD50 for rats (females): about 387 mg/kg (EPA Pesticides RED (1994))
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 (1994))
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]
Because the category could not be identified from (1), the classification is not possible due to lack of data.

[Evidence Data]
(1) LC50 for rats: > 3.696 mg/L (EPA Pesticides RED (1994))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) No skin irritation was seen in a primary skin irritation test with rabbits (EPA Pesticides RED (1994)).
(2) It is reported that in an acute dermal toxicity test (14-day observation) with rabbits, when 200 mg/kg of this substance was applied to the abraded skin, there were no signs of skin irritation in all the animals except for one animal that died following the development of diarrhea and emaciation (HSDB (Accessed Sep. 2020)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) It is reported that in an eye irritation test with rabbits, slight irritation (slight conjunctival hyperemia 1 hour after application) was seen (EPA Pesticides RED (1994)).
(2) It is reported that in an eye irritation test with rabbits, no irritation of the cornea or iris was observed, but there was slight transient hyperemia in the conjunctiva, and all the animals recovered after 7 days (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 Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data. (1) was not adopted because the test methods used were not standard ones.

[Reference Data, etc.]
(1) It is reported that in a test with guinea pigs, after induction by 9-time dermal applications of a 2% solution over 3 weeks followed by challenges at 10 and 25 days after the last application, no skin sensitization was found (HSDB (Accessed Sep. 2020)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) In vivo sister chromatid exchange (SCE) tests (oral administration) at two different doses using the bone marrow cells of hamsters, negative results were obtained (HSDB (Accessed Spt. 2020)).
(2) As for in vitro, in a bacterial reverse mutation test and a UDS test using primary rat hepatocytes, negative results were obtained; in an in vitro mammalian cell gene mutation test, weakly positive (+S9) and negative (-S9) results were obtained; and in an in vitro mammalian cell chromosome aberration test, positive (+/-S9) results were obtained at the highest dose level where cytotoxicity was observed (EPA Pesticides RED (1994), HSDB (Accessed Spt. 2020)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), 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 D (Not Classifiable as to Human Carcinogenicity) (EPA Pesticides RED (1994), EPA Annual Cancer Report 2018 (Accessed Spt. 2020): Classification in 1993).
(2) In a two-year carcinogenicity study with rats and mice dosed by feeding, no carcinogenicity was observed (EPA Pesticides RED (1994), HSDB (Accessed Spt. 2020)).
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, no reproductive toxicity was observed (EPA Pesticides RED (1994), HSDB (Accessed Spt. 2020)).
(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 (1994)).
(3) It was reported that in a developmental toxicity study with rats dosed by gavage, no developmental toxicity was observed (EPA Pesticides RED (1994)).
(4) It was reported that in a developmental toxicity study with rabbits dosed by gavage, no developmental toxicity was observed (EPA Pesticides RED (1994), HSDB (Accessed Spt. 2020)).
8 Specific target organ toxicity - Single exposure Category 2 (central nervous system)


Warning
H371 P308+P311
P260
P264
P270
P405
P501
[Rationale for the Classification]
Based on (1), it was presumed that clinical signs related to the central nervous system were observed within the range for Category 2. Therefore, it was classified in Category 2 (central nervous system).

[Evidence Data]
(1) It was reported that in several acute oral toxicity tests with rats, mice and dogs, clinical signs related to the central nervous system, such as ataxia, anorexia, dyspnea, hypothermia, hyperirritability, loss of righting reflex, vomiting, and tremors were observed. In these tests, the reported LD50 values of rats, mice and dogs were 477/387 mg/kg (males/ females), 528/620 mg/kg (males/females) and > 500 mg/kg, respectively (EPA Pesticides RED (1994)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Concerning (1) to (6), the vacuolation of acinar cells and the increase in relative weight observed in the pancreas were not associated with other significant alterations such as inflammatory response. In addition, the clinical laboratory findings on the liver and kidney were obtained, but they presented minor signs and no histopathological alterations were observed. Therefore, the pancreas, liver, and kidney were not adopted as target organs. Accordingly, it was classified as "Not classified" in the oral and dermal routes. However, there was not sufficient information available for classification in the inhalation route. 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, increases in relative liver, kidney, and gonad weight and slight vacuolation of pancreatic acinar cells were observed at 125 mg/kg/day (in the range corresponding to “Not classified”) (EPA Pesticides RED (1994), HSDB (Accessed Sep. 2020)).
(2) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding, an increase in relative thyroid gland weight was observed at 1,000 ppm (50 mg/kg/day, within the range for Category 2) and anorexia, weight loss, an increase in BUN (females), an increase in ALP (males), and an increase in relative spleen weight (females) were observed at 2,000 ppm (100 mg/kg/day, within the range for Category 2) (EPA Pesticides RED (1994), HSDB (Accessed Sep. 2020)).
(3) It was reported that in a one-year oral toxicity test with dogs dosed by feeding, anorexia (females), diarrhea, emesis, hematological effects (an increase in platelet count) (males), an increase in ALT, an increase in ALP (males), increases in absolute and relative liver weight and increases in relative kidney and thyroid weight (males) were observed at 50 mg/kg/day (within the range for Category 2) (EPA Pesticides RED (1994), HSDB (Accessed Sep. 2020)).
(4) It was reported that in a three-month oral toxicity test with rats dosed by feeding, decreases in food consumption/efficiency of food utilization and slight to moderate diffuse vacuolation of the pancreatic acinar cells (not associated with necrosis or an inflammatory response) were observed at 250 mg/kg/day (in the range corresponding to “Not classified”) (HSDB (Accessed Sep. 2020)).
(5) It was reported that in a two-year oral toxicity test with rats dosed by feeding, an increase in relative kidney weight and vacuolization of the pancreatic acinar cells were observed at 1,600 ppm (80 mg/kg/day, within the range for Category 2) (EPA Pesticides RED (1994), HSDB (Accessed Sep. 2020)).
(6) It was reported that in a 21-day dermal toxicity test with rabbits, slight erythema and increased blood glucose values were observed at 1,000 mg/kg/day (converted guidance value: 233 mg/kg/day, in the range corresponding to “Not classified”) (EPA Pesticides RED (1994), 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) -
-
-
- - -
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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