GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 2593-15-9
Chemical Name 5-ethoxy-3-trichloromethyl-1,2,4-thiadiazole
Substance ID R03-C-063-MHLW
Classification year (FY) FY2021
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 -
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-
- - -
2 Flammable gases -
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-
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3 Aerosols -
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-
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4 Oxidizing gases -
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-
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5 Gases under pressure -
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-
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6 Flammable liquids -
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7 Flammable solids -
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-
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8 Self-reactive substances and mixtures -
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9 Pyrophoric liquids -
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10 Pyrophoric solids -
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11 Self-heating substances and mixtures -
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12 Substances and mixtures which, in contact with water, emit flammable gases -
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13 Oxidizing liquids -
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14 Oxidizing solids -
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15 Organic peroxides -
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16 Corrosive to metals -
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17 Desensitized explosives -
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- - -

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) -
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1 Acute toxicity (Dermal) -
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1 Acute toxicity (Inhalation: Gases) -
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1 Acute toxicity (Inhalation: Vapours) -
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1 Acute toxicity (Inhalation: Dusts and mists) -
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2 Skin corrosion/irritation -
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3 Serious eye damage/eye irritation -
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4 Respiratory sensitization -
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4 Skin sensitization Category 1B


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 1B. Also, based on the new findings, the classification result was changed.

[Evidence Data]
(1) In a Maximization test (OECD TG 406, GLP, intradermal induction: 20% solution) with guinea pigs (n=20), animals were challenged with a 50% solution and an undiluted solution, and positive reactions were observed in all animals. It was reported that after animals were rechallenged at 1%, 5%, 10%, and 20%, positive reactions were observed in 1 animal, 5 animals, 16 animals, and 20 animals, respectively (ECHA RAC Opinion (2013), CLH Report (2012)).

[Reference Data, etc.]
(2) As a result of a medical examination in the manufacturing plant of this substance, 5 out of workers who were subjected to examination showed long lasting eczemas (weeks to months) and clinically due to a type IV sensitization (CLH Report (2012)).
(3) As a result of a medical survey in the manufacturing plant of this substance, 42% of the respondents indicated the experience of a dry skin or eczema, while the reference group had a score of 17%. A repeated survey three years later in the same plant did not result in respondents indicating the experience of dry skin or eczema (CLH Report (2012)).
(4) In the EU, it was classified in Skin Sens. 1 (EU-CLP Classification Results (Accessed Jan. 2022)).
5 Germ cell mutagenicity -
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- - -
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
In (1), increases in tumor incidences in the liver, thyroid, and testis were observed in rats, but an increase in malignant tumors in the liver was observed only in females, an increase in malignant tumors in the thyroid was observed only in males, and testis tumors were only benign tumors, and in (2), an increase in the incidence of the liver tumors in mice was caused at a dose above the maximum tolerable dose (MTD), and therefore, the information was judged to be not sufficient for classification in Category 1B, and it was classified in Category 2. Based on the new findings, the classification result was changed.

[Evidence Data]
(1) It was reported that, in combined chronic toxicity/carcinogenicity studies with rats dosed by feeding for two years (OECD TG 453, GLP), at 100 to 1,280 ppm (5 to 63 mg/kg/day (males), 6 to 84 mg/kg/day (females)), other than thyroid tumors in males observed at or above the mid dose (640 ppm), increases in tumor incidences were observed in the liver (hepatocellular adenoma and/or hepatocellular carcinoma, cholangiocarcinoma (females)), thyroid (follicular cell adenoma and/or carcinoma), and testis (interstitial tumor) in a high dose group (CLH Report (2012), ECHA RAC Opinion (2013)).
(2) In a carcinogenicity study with mice dosed by feeding for 18 months (OECD TG 451, GLP), at 50 to 2000 ppm (7.5 to 263.3 mg/kg/day (males), 9.1 to 312.1 mg/kg/day (females)), an increase in the incidence of the liver tumors (hepatocellular adenoma, hepatocellular carcinoma) was observed both in males and females at or above the mid dose (900/1300 ppm (184.7 mg/kg/day (males), 221.7 mg/kg/day (females)). However, it was reported that a marked increase in mortality was observed at or above the mid dose (CLH Report (2012), ECHA RAC Opinion (2013)).
(3) Based on (1), the EU indicated that increases in tumor incidences in rats were observed in the liver, thyroid, and testis. However, it analyzed that female rats were more prone to developing liver tumors than male rats and liver tumors in male rats were mainly benign, and in contrast, the thyroid tumors were markedly increased in males of the mid and high dose groups, whereas the tumor response in females was weaker and predominantly benign. As for mice in (2), the EU reported that neoplastic lesions were not relevant for classification because the mid and high doses appeared to exceed the maximum tolerable dose (MTD), based on high mortality rates (ECHA RAC Opinion (2013)).
(4) Based on (1) to (3), the EU concluded that because one tumor type was more prevalent in one sex in the rat and because the neoplastic lesions were observed at above the MTD in the mouse study, the carcinogenic potential of this substance was not sufficient for classification as Carc. 1B, and the EU classified this substance in Carc. 2 (ECHA RAC Opinion (2013)).
7 Reproductive toxicity -
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8 Specific target organ toxicity - Single exposure -
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9 Specific target organ toxicity - Repeated exposure -
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10 Aspiration hazard -
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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) -
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-
- - -
11 Hazardous to the aquatic environment Long term (Chronic) -
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12 Hazardous to the ozone layer -
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- - -


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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