NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	158237-07-1
Chemical Name	4-(2-Chlorophenyl)-N-cyclohexyl-N-ethyl-4,5-dihydro-5-oxo-1H-tetrazole-1-carboxamide [fentrazamide]
Substance ID	m-nite-158237-07-1_v1
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)
Sample SDS by MHLW (External link)
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	Classification not possible	- -	-	-	Because there is no information that a series of prescribed explosiveness tests was conducted, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	Due to no data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for solid substances with a melting point of 140 degrees C or lower.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Not containing metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It is an organic compound which does not contain fluorine but contains oxygen and chlorine and the oxygen and the chlorine are not chemically bonded to the elements other than carbon or hydrogen.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	It is an organic compound that does not contain bivalent -O-O- structure in the molecule.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No established test method suitable for solid substances.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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)	Not classified	- -	-	-	From a reported LD50 value of > 5,000 mg/kg for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008); Food sanitation research, Vol.54 No.6 (2004)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	From a reported LD50 value of > 5,000 mg/kg for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), it was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Not classified (Not applicable)	- -	-	-	"Solids" according to GHS definition.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	From a reported LC50 value (4 hours) of > 5.085 mg/L for rats (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)), it was classified as "Not classified." Besides, because a test substance is a solid, a reference value of dust was applied.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	In a skin irritation test using rabbits, after 4-hour semi-occlusive application of 500 mg this substance, it was judged as not irritating (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). From the above, the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	It is reported that in an eye irritation test using rabbits, after application of 0.1 mL this substance, it was not irritating (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). From the above, the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Not classified	- -	-	-	It is reported that in a maximization test using guinea pigs, this substance was not sensitizing because sensitization reaction by the substance was not observed after induction and challenge (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). Because the above test is a GLP compliance test corresponding to OECD TG406, the substance was judged as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a micronucleus test in mouse bone marrow cells after intraperitoneal administration was negative (Pesticide abstract (2008); Food sanitation research, Vol.54 No.6 (2004)), and as for in vitro, a bacterial reverse mutation test and a forward mutation test and a chromosomal aberration test in cultured mammalian cells were negative (Pesticide abstract (2008); Food sanitation research, Vol.54 No.6 (2004)). Therefore, the substance was classified as "Classification not possible" in accordance with Guidance.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	In a carcinogenicity test in 2-year diet administration of this substance in rats or mice, carcinogenic lesions suspicious of the relationship with the administration of this substance were not observed in mice. However, in rats, transitional cell cancer (1 female) and transitional cell papilloma (2 females) of the bladder, transitional cell cancer of the urethra (1 male), and thyroid follicular adenoma (2 males) were observed. Moreover, incidences of transitional cell tumors from the bladder to urethra are small. However, at the same time, increased incidences of hyperplasia in transitional epithelium of the bladder were observed, and images of enhanced cellular proliferation were confirmed in a hyperplastic region by immunohistochemical staining (Pesticide abstract (2008)). Although urothelial tumors and thyroid follicular epithelial tumors occurred in a lower incidence in rats, considering results of various mechanism tests and no genotoxicity observed for this substance, it is difficult to consider that a mechanism of each tumor occurrence is through genotoxicity. Therefore, Food Safety Commission of Japan concluded that a threshold could be set in evaluation (Pesticide evaluation report, Food Safety Commission of Japan (2008)). From the above, from the carcinogenicity test result, it is thought that there is no evidence of carcinogenicity in mice and "equivocal" evidence of tumor incidence by the administration of this substance in rats. However, because there is no carcinogenicity classification result by other organization, the substance was classified as "Classification not possible" due to lack of data in this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In a two-generation breeding toxicity test in diet administration of this substance in rats, at the dose (1,800 ppm) where F0 (P), or F1 parent animals showed general toxicity effects (findings in both P and F1 (inhibition of erythrocyte and brain cholinesterase activity, increased liver weight, liver cytoplasm becoming eosinophilic, hypertrophy of hepatocytes), findings only in F1 (weight gain reduction, hyperplasia of bladder epithelium, vacuolization of adrenal cortex (females))), decreased survival rate on day 4 after birth, weight gain reduction during a nursing period in F1 offspring, decreased litter size at birth and weight gain reduction during a nursing period in F2 offspring were observed, but effects on fertility were not found (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). On the other hand, in a teratogenicity test using pregnant rats or rabbits in gavage administration during an organogenetic period, in rats, effects related to administration of test substance were not found at doses up to 1,000 mg/kg/day in either maternal animals or fetuses (Pesticide abstract (2008)). Moreover, in rabbits, a dose-dependent increased abortion at 40 mg/kg/day or higher, weight gain reduction and decreased food consumption at the highest 640 mg/kg/day dose were observed in maternal animals, but toxicity effects were not found in fetuses. (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)). From the above, because developmental effects in offspring were observed over two generations at the dose where general toxicity effects occurred in parent animals in the two-generation breeding toxicity test in rats, the substance was classified in Category 2 in accordance with Guidance in this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Not classified	- -	-	-	There are no human data on this substance. As for experimental animals, there are data from tests in oral administration in rats and mice, dermal administration in rats, an inhalation exposure test in rats, and an oral administration neurotoxicity test in rats, an oral administration delayed neurotoxicity test in female chicken. (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012)) However, because an abnormality in signs and necropsy findings was not observed in any test even after administration up to the limit doses (or maximum possible concentration), the substance was classified as "Not classified."	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (liver, gallbladder), Category 2 (nervous system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	In a 1-year diet administration toxicity test using dogs, effects on liver (increased liver weight, hypertrophy of hepatocytes, increased serum ALT/ALP) and effects on gallbladder (epithelial hyperplasia of gallbladder) were observed at 200 ppm (males: 5.4 mg/kg/day, females: 5.5 mg/kg/day) within a range of Category 1. (Pesticide abstract (2008); Pesticide evaluation report, Food Safety Commission of Japan (2008)) Moreover, in a 24-month diet administration toxicity test using rats, effects on nervous system (erythrocyte cholinesterase activity inhibition (more than 20%), sciatic nerve myelin sheath degeneration) and effects on liver (centrilobular liver cytoplasm change) were observed at 1000 ppm (males: 52.7 mg/kg/day, females: 75.4 mg/kg/day) within a range of Category 2 (Pesticide evaluation report, Food Safety Commission of Japan (2008)). As above, effects on liver and gallbladder were observed within a range of Category 1, and effects on nervous system were found within a range of Category 2. Therefore, the substance was classified in Category 1 (liver, gallbladder), Category 2 (nervous system).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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)	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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