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 |
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 |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
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1 | Explosives | - |
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- | - | - |
2 | Flammable gases | - |
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- | - | - |
3 | Aerosols | - |
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- | - | - |
4 | Oxidizing gases | - |
- |
- | - | - |
5 | Gases under pressure | - |
- |
- | - | - |
6 | Flammable liquids | - |
- |
- | - | - |
7 | Flammable solids | - |
- |
- | - | - |
8 | Self-reactive substances and mixtures | - |
- |
- | - | - |
9 | Pyrophoric liquids | - |
- |
- | - | - |
10 | Pyrophoric solids | - |
- |
- | - | - |
11 | Self-heating substances and mixtures | - |
- |
- | - | - |
12 | Substances and mixtures which, in contact with water, emit flammable gases | - |
- |
- | - | - |
13 | Oxidizing liquids | - |
- |
- | - | - |
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 | - |
- |
- | - | - |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | - |
- |
- | - | - |
1 | Acute toxicity (Dermal) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Gases) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Vapours) | - |
- |
- | - | - |
1 | Acute toxicity (Inhalation: Dusts and mists) | - |
- |
- | - | - |
2 | Skin corrosion/irritation | - |
- |
- | - | - |
3 | Serious eye damage/eye irritation | - |
- |
- | - | - |
4 | Respiratory sensitization | - |
- |
- | - | - |
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 | - |
- |
- | - | - |
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 | - |
- |
- | - | - |
9 | Specific target organ toxicity - Repeated exposure | - |
- |
- | - | - |
10 | Aspiration hazard | - |
- |
- | - | - |
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 | - |
- |
- | - | - |
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