GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 533-74-4
Chemical Name 2-Thioxo-3,5-dimethyltetrahydro-2H-1,3,5-thiadiazine; Dazomet
Substance ID R02-B-102-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 Classification not possible
-
-
- - No data available. Besides, there is information that it is combustible (GESTIS (Access on June 2020)).
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" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 270 deg C (GESTIS (Access on June 2020)).
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 Not classified (Not applicable)
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine. 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), (2).

[Evidence Data]
(1) LD50 for rats: males: 550 mg/kg, females: 710 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), Japanese Journal of Pesticide Science Vol. 17, No. 4 (Pesticide Science Society of Japan, 1992))
(2) LD50 for rats: 320 mg/kg (GESTIS (Access on June 2020), 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, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012))
(2) LD50 for rats: males: 2,260 mg/kg, females: 2,600 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), Japanese Journal of Pesticide Science Vol. 17, No. 4 (Pesticide Science Society of Japan, 1992))
(3) LD50 for rabbits: 7,000 mg/kg (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 (2.4E-005 mg/L), a reference value in the unit of mg/L was applied as dust.

[Evidence Data]
(1) LC50 for rats (4 hours): females: 7.29 mg/L, males: > 8.40 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), Japanese Journal of Pesticide Science Vol. 17, No. 4 (Pesticide Science Society of Japan, 1992))
(2) LC50 for rats (4 hours): 8.4 mg/L (GESTIS (Access on June 2020), HSDB (Access on June 2020))
(3) Vapor pressure of this substance: 2.8E-006 mmHg (20 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 2.4E-005 mg/L)
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) This substance was not a skin or eye irritant and was not a dermal sensitizer, but the degradation product, methyl isothiocyanate (CAS RN 556-61-6), was a skin irritant and a dermal sensitizer (Canada Pesticides (2018)).
(2) In a skin irritation test with rabbits, no irritation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), Japanese Journal of Pesticide Science Vol. 17, No. 4 (Pesticide Science Society of Japan, 1992)).

[Reference Data, etc.]
(3) In a test using a 15% solution of this substance, necrosis was seen, and several tests in rabbits, including standardized tests, were carried out with differing results ranging from irritating through to corrosive (GESTIS (Access on June 2020)).
(4) In human, a dilute solution causes skin irritation and dust may cause irritation of skin and eyes (HSDB (Access on June 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) This substance was not a skin or eye irritant and was not a dermal sensitizer, but the degradation product, methyl isothiocyanate (CAS RN 556-61-6), was a skin irritant and a dermal sensitizer (Canada Pesticides (2018)).
(2) In an eye irritation test with rabbits on this substance (39 mg), contraction of the pupils was observed 1-hour after application, and slight reddening of the conjunctiva was found but disappeared after 72 hours, and slight swelling of the conjunctiva was seen only at 1 hour after application (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), GESTIS (Access on June 2020), Japanese Journal of Pesticide Science Vol. 17, No. 4 (Pesticide Science Society of Japan, 1992)).

[Reference Data, etc.]
(3) Dust may cause irritation of the skin and eyes (HSDB (Access on June 2020)).
(4) This substance was a severe eye irritant (HSDB (Access on June 2020)).
(5) It was classified in Eye Irrit. 2 (H319) in EU-CLP classification (EU CLP classification (Access on June 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), (2).

[Evidence Data]
(1) This substance was not a skin or eye irritant and was not a dermal sensitizer, but the degradation product, methyl isothiocyanate (CAS RN 556-61-6), was a skin irritant and a dermal sensitizer (Canada Pesticides (2018)).
(2) This substance was reported to be negative in a skin sensitization test with guinea pigs (maximization test) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012), GESTIS (Access on June 2020), Japanese Journal of Pesticide Science Vol. 17, No. 4 (Pesticide Science Society of Japan, 1992)).

[Reference Data, etc.]
(3) This substance was a mild sensitizer (HSDB (Access on June 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 reported to be negative in an unscheduled DNA synthesis test with rat liver and a micronucleus test with mouse bone marrow cells (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
(2) As for in vitro, it was reported to be weakly positive and negative in bacterial reverse mutation tests. And a chromosomal aberration test using cultured mammalian cells gave a negative result, and a gene mutation test using cultured mammalian cells gave a positive result (same as the above).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) As for classification results by domestic and international organizations, EPA classified it in D (Not Classifiable as to Human Carcinogenicity) (EPA Annual Cancer Report 2019 (Access on September 2020): classified in 1993).
(2) In carcinogenicity tests by diet administration of this substance to male and female rats for 2 years and male and female mice for 18 months, no neoplastic lesions with treatment-related increases in incidences were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 1B because effects on embryos/fetuses were observed at a dose at which no maternal toxicity was observed. 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 6 to 18 of gestation, starting from a dose (25 mg/kg/day) at which no maternal toxicity was observed, an increase in the percentage of post implantation embryo loss and a decrease in the number of viable fetuses were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).

[Reference Data, etc.]
(2) In a two-generation reproductive toxicity study with rats dosed by feeding, even at a dose at which parental toxicity (reduced body weight gain and an increase in relative liver weight) was observed, no reproductive effects were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, no effect in fetuses was observed even at doses at which maternal toxicity (reduced body weight gain) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(4) In a developmental toxicity study with female rabbits dosed by gavage on days 7 to 19 of gestation, at a dose (the maximum dose of 45 mg/kg/day) at which maternal toxicity (death (1/15 cases), reduced body weight gain, a decrease in uterine weight) was observed, an increase in the percentage of post implantation embryo loss, an increase in the number of resorbed embryos, a decrease in the number of viable fetuses, an increase in extra ribs, and an increase in fused sternebrae were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 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]
Based on (1) and (2), since the acute toxicity tests using experimental animals showed death cases at doses within the range for Category 2 in the oral and dermal routes although the doses at which the symptoms appeared were unknown, it was judged that the symptoms appeared at the doses of death cases, and that the symptoms due to the effects on the nervous system were observed, and therefore, it was classified in Category 2 (nervous system).

[Evidence Data]
(1) In acute oral toxicity tests with rats and mice, rough respiration, lacrimation, salivation, a decrease in locomotor activity, crouching posture, red mucoid secretion on the nose, piloerection, and weakness were observed, in addition, convulsion was observed in mice. At the necropsy, slight dilatation of the whole intestinal tract, etc. were found. Deaths occurred from 350 mg/kg (within the range for Category 2) both in rats and mice, and the LD50 values in rats were 550 mg/kg in males and 710 mg/kg in females, and in mice, 455 mg/kg in males and 430 mg/kg in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) In acute dermal toxicity tests with rats and mice, rough respiration, a decrease in locomotor activity, lacrimation, crouching posture, etc. were observed. Deaths occurred starting from 1,820 mg/kg (within the range for Category 2) both in rats and mice, and the LD50 values in rats were 2,260 mg/kg in males and 2,600 mg/kg in females, and in mice, 2,400 mg/kg in males and 2,530 mg/kg in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).

[Reference Data, etc.]
(3) In an acute neurotoxicity test with rats dosed by the oral route, a decrease in locomotor activity was observed at or above 50 mg/kg/day in males and at or above 13 mg/kg in females; and salivation, lacrimation, and a decrease in the number of rearing behaviors were observed within several hours after treatment at or above 50 mg/kg in males and females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(4) In an acute inhalation toxicity test with rats (LC50: males: > 8.40 mg/L, females: 7.29 mg/L), at or above 8.40 mg/L in males and at or above 5.11 mg/L in females (both exceeding Category 2), death cases were observed, and symptoms of poisoning observed in males and females were convulsive gait, reddish secretion from the nose, yellow stained fur on the abdomen, reddish crust on the nose (positive for blood), piloerection, crouching, red urine (positive for blood), and anemia, and only at 8.40 mg/L, dragging of hindlimbs was observed. At the necropsy, generalized congestion was observed in male and female animals that died, and in animals dosed at 8.40 mg/L, slight pulmonary emphysema in one male and intense hyperemia of the lungs in two females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2012)).
9 Specific target organ toxicity - Repeated exposure Category 1 (blood system, liver)


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) to (4), the effects on the blood system and liver at doses of Category 1 were observed in experimental animals. Therefore, it was classified in Category 1 (blood system, liver). With the addition of new information, the classification results were changed from the previous classification.

[Evidence Data]
(1) It was reported that, in a 90-day feeding test with rats, centrilobular fatty degeneration of hepatocytes was observed in males at or above 50 ppm (equivalent to 4 mg/kg/day, within the range for Category 1) and in females at or above 200 ppm (equivalent to 16 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) It was reported that, in a 90-day feeding test with rats, decreases in hemoglobin, red blood count, and hematocrit were observed in a group given the dose which was reduced from 400 ppm to 200 ppm on day 23 (males/females: equivalent to 7.0/6.4 mg/kg/day, both within the range for Category 1), and furthermore, in females, an increase in platelet count, a decrease in ALT, hemosiderosis in the spleen, etc. were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) It was reported that, in a one-year feeding test with dogs, at or above 50 ppm (equivalent to 1.4 mg/kg/day, within the range for Category 1), hemosiderosis in the liver was observed in females; and at 150 ppm (males and females: equivalent to 3.6/4.0 mg/kg/day, both within the range for Category 1), increases in AST, ALT, and ALP and a decrease in albumin were observed in males and females, decreases in red blood cell count, hemoglobin, and hematocrit, longer partial thromboplastin time and prothrombin time, increases in total bilirubin and globulin, hemosiderosis in the liver, and hepatic cirrhosis were observed in males, and chronic hepatitis was observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(4) It was reported that, in a two-year feeding test with rats, at or above 80 ppm (males/females: equivalent to 3.4/4.6 mg/kg/day, both within the range for Category 1), an increase in platelet count, decreases in total protein, albumin, globulin, triglycerides, and cholinesterase were observed in females; and at 320 ppm (males/females: equivalent to 14.0/19.1 mg/kg/day, both within the range for Category 2), decreases in red blood cell count, hemoglobin, and hematocrit, an increase in total bilirubin, altered hepatocellular foci, hepatocyte vacuolation, and centrilobular fatty degeneration of hepatocytes in females were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(5) It was reported that, in a two-year feeding test with rats, at or above 80 ppm (males/females: equivalent to 3.4/4.8 mg/kg/day, both within the range for Category 1), hepatocyte vacuolation and fatty degeneration of hepatocytes were observed in males, and altered hepatocellular foci were observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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 = 0.5 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
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 was not rapidly degradable (a 28-day degradation rate by BOD: 4% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2001)) and due to 72-hour NOErC = 0.056 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)).
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 was not rapidly degradable (a 28-day degradation rate by BOD: 4% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2001)) and due to 48-hour EC50 = 11.9 mg/L for crustacea (Daphnia magna) (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, 2015).
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.

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