NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	2593-15-9
Chemical Name	5-ethoxy-3-trichloromethyl-1,2,4-thiadiazole
Substance ID	m-nite-2593-15-9_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	Containing no chemical groups with explosive properties	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
6	Flammable liquids	Not classified	- -	-	-	The flash point is 154.5degC (open cup flash test) (HSDB (2006)).	FY2006	GHS Classification Manual （10 Feb, 2006）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Containing no chemical groups with explosive or self-reactive properties	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Pyrophoric liquids	Not classified	- -	-	-	Considered non-pyrophoric when in contact with air at ordinary temperatures since the substance is stable to heat (up to 165degC) (Agricultural Chemical Registration Data).	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Self-heating substances and mixtures	Not classified	- -	-	-	Stable to heat (up to 165degC) (Agricultural Chemical Registration Data)	FY2006	GHS Classification Manual （10 Feb, 2006）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Containing no metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At)	FY2006	GHS Classification Manual （10 Feb, 2006）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Organic compounds containing chlorine (but not fluorine and oxygen), with the chlorine bound to carbon and hydrogen (but not to other elements)	FY2006	GHS Classification Manual （10 Feb, 2006）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Classified as "liquid" according to GHS definition	FY2006	GHS Classification Manual （10 Feb, 2006）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no "-O-O-" structure	FY2006	GHS Classification Manual （10 Feb, 2006）
16	Corrosive to metals	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2006	GHS Classification Manual （10 Feb, 2006）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	Based on the rat LD50 (oral route) value of 1,077mg/kg (Agricultural Chemical Registration Data (1987)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rat LD50 (dermal roue) value of >5,000mg/kg (Agricultural Chemical Registration Data (1985)).	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Due to the fact that the substance is a liquid according to the GHS criteria and inhalation of its gas is not expected.	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	Based on the rat LC50 (inhalation route) value of 0.8mg/L (Agricultural Chemical Registration Data (1991)).	FY2006	GHS Classification Manual （10 Feb, 2006）
2	Skin corrosion/irritation	Category 3	- Warning	-	-	Based on the evidence of irritation reactions (Draize score of 1.7), with some improvement occurring during 72 hours of observation, observed in rabbit skin irritation tests (Agricultural Chemical Registration Data (1987)).	FY2006	GHS Classification Manual （10 Feb, 2006）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）
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)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on negative data in in vivo studies (mouse micronucleus tests and rat chromosome aberration tests) (Agricultural Chemical Registration Data (1985, 1987)). The in vitro mutagenicity studies (chromosome aberration tests (Agricultural Chemical Registration Data (1985)) and reverse mutation tests in bacteria (Agricultural Chemical Registration Data (1987)) yielded weak positive results.	FY2006	GHS Classification Manual （10 Feb, 2006）
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)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
7	Reproductive toxicity	Not classified	- -	-	-	Based on no evidence of adverse effects on reproduction or offspring development observed in rat 3-generation reproduction studies and rat/mouse teratogenicity studies (Agricultural Chemical Registration Data (1987)).	FY2006	GHS Classification Manual （10 Feb, 2006）
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	Based on the evidence from animal studies including tremors, piloerection, sedation, debility and convulsions (Agricultural Chemical Registration Data (1985)). These effects were observed at dosing levels within the guidance value ranges for Category 2.	FY2006	GHS Classification Manual （10 Feb, 2006）
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	Based on the evidence from animal studies including increased liver weights and hepatic tissue lesions (Agricultural Chemical Registration Data (1987)). These effects were observed at dosing levels within the guidance value ranges for Category 2.	FY2006	GHS Classification Manual （10 Feb, 2006）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available	FY2006	GHS Classification Manual （10 Feb, 2006）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified into Category 1 from 72 hours EC50=0.39mg/L of the algae (Green Algae) (Agricultural Chemical Registration Data, 2004).	FY2006	GHS Classification Manual （10 Feb, 2006）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Although acute toxicity is Category 1 and bio-accumulation is low (log Kow=3.37(PHYSPROP Database, 2005)), since there was no rapidly degrading (BIOWIN), it was classified into Category 1.	FY2006	GHS Classification Manual （10 Feb, 2006）
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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