GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 31895-21-3
Chemical Name N,N-Dimethyl-1,2,3-trithian-5-amine; Thiocyclam
Substance ID R02-B-115-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  
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.
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 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 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 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
* For health hazards, because there were no data on this substance, the classification was conducted by using data on the hydrogen oxalate of this substance (CAS RN 31895-22-4).

[Rationale for the Classification]
It was classified in Category 3 from (1), (2).

[Evidence Data]
(1) LD50 for rats: females: 195 mg/kg, males: 310 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
(2) LD50 for rats: females: 370 mg/kg, males: 399 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
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) Category 4


Warning
H332 P304+P340
P261
P271
P312
[Rationale for the Classification]
It was classified in Category 4 from (1).

[Evidence Data]
(1) LC50 for rats (4 hours): males: 1.02 mg/L, females: 1.20 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))
2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) In a skin irritation test with rabbits, slight erythema and edema were observed but disappeared 72 hours after administration (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) In an eye irritation test with rabbits, transient redness in the conjunctiva was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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 (maximization test), no skin sensitization was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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 dominant lethal test, a micronucleus test with mouse bone marrow cells, and chromosomal aberration tests with bone marrow cells from mice or rats (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) As for in vitro, a negative result was obtained in a bacterial reverse mutation test (same as the above).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
From classification results by other organizations in (1) and animal test results in (2) and (3), it was classified as "Not classified."

[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 November 2020): classified in 1994).
(2) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration 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, 2019)).
(3) In a carcinogenicity test by 78-week diet administration to male and female mice, no neoplastic lesions with treatment-related increases in incidence were found (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) In a three-generation reproduction study with rats dosed by feeding, no maternal toxicity, no offspring toxicity, or no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, no effect was observed in fetuses even at a dose at which maternal toxicity (death (3/25 cases), salivation, tendency of reduced body weight gain, etc.) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 18 of gestation, no effect was observed in fetuses even at a dose at which maternal toxicity (death (5/17 cases), restlessness, piloerection, hunched posture and irregular movements/posture, etc.) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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]
Based on (1) to (4), it was classified in Category 1 (nervous system).

[Evidence Data]
(1) In an acute oral toxicity test with rats (There was no description of the minimum dose at which effects were observed. It was assumed that effects were observed near the doses at which death began to occur (males: 250 mg/kg, females: 125 mg/kg, both within the range for Category 1)), tremor, emotional disturbances, ataxia, convulsions, and tonic seizure were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) In an acute oral toxicity test with rats, at or above 228 mg/kg (within the range for Category 1), a decrease in locomotor activity and sedation in males and females, and prone position in females were observed; at or above 296 mg/kg (within the range for Category 1), tremor, piloerection, lack of luster of fur, and emaciation were observed; and at or above 500 mg/kg (within the range for Category 2), tonic-clonic convulsions were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) In a 4-hour inhalation toxicity test with rats (There was no description of the minimum dose at which effects were observed. It was assumed that effects were observed near the doses at which death began to occur (males: 0.626 mg/L, females: 0.965 mg/kg, both within the range for Category 1)), reduced body weight gain, a decrease in food consumption, abnormal breathing, and stained body fur were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(4) In a general pharmacological test (oral administration) in mice, tremor, hypomyotonia (decreased grip strength, decreased muscle tone of the limbs, and hypotonia of the trunk), hyporeactivity, decreased alertness, and reduced righting reflex were observed at 100 mg/kg (within the range for Category 1) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
9 Specific target organ toxicity - Repeated exposure Category 2 (nervous system)


Warning
H373 P260
P314
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 2 (nervous system).

[Evidence Data]
(1) It was reported that, in a 90-day feeding test with rats, at 400 ppm (males/females: 33.9/37.0 mg/kg/day, both within the range for Category 2), death (4/10 cases in both males and females), piloerection, and lack of luster of fur were observed, and furthermore, a decrease in hemoglobin in males and a decrease in hematocrit in females were observed. In the animals that died, hypodynamia-like symptoms and decreased response to sound and light were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) It was reported that, in a two-year feeding test with dogs, at 375 ppm (males/females: 11.1/10.7 mg/kg/day, both within the range for Category 2), death (1/4 cases in males, 2/4 cases in females), salivation, hindlimb cramps, and ataxia were observed, and furthermore, increases in AST and LDH and hyperkeratosis of the skin in males, and a decrease in albumin and pigmentation in hepatocytes in females were observed. In the animals that died, tremor, convulsions, salivation, ataxia, twisting of the small intestine (only in males), pulmonary congestion and edema, and liver congestion (only in females) were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).

[Reference Data, etc.]
(3) It was reported that, in a two-week dermal exposure test with rabbits, no effect was observed at doses up to 2.0 mg/kg/day (converted guidance value with 6 hours/day: 13.5 mg/kg/day, within the range for Category 1) (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) -
-
-
- - -
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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