NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	149877-41-8
Chemical Name	Isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate [bifenazate]
Substance ID	m-nite-149877-41-8_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	Classification not possible	- -	-	-	There is a chemical group present in the molecule associated with explosive properties (hydrazine), but the classification is not possible due to no data.	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	- -	-	-	There is a chemical group present in the molecule associated with explosive properties (hydrazine), but the classification is not possible due to no data.	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 or chlorine but contains oxygen, and the oxygen is 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 (Health Canada REG2006-01 (2006), EPA Pesticide Fact Sheet (1999)), 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 (Health Canada REG2006-01 (2006), EPA Pesticide Fact Sheet (1999)), 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)	Classification not possible	- -	-	-	The classification is not possible due to lack of data. Besides, there is a reported LC50 value (4 hours) of > 4.4 mg/L for rats (Health Canada REG2006-01 (2006), EPA Pesticide Fact Sheet (1999)), but the category cannot be determined only from this value. 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	- -	-	-	It was concluded that this substance is practically not irritating from a primary irritation index (PII) of 0.1 after 4-hour semi-occlusive application of the substance in a skin irritation test using rabbits (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012)). Besides this, it is reported to be slightly irritating (EPA Pesticide Fact Sheet (1999)) and it is written that this substance is not irritating to skin (Health Canada REG2006-01 (2006)). As above, from the detailed report from the skin irritation test using rabbits, 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	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	It is reported that in an eye irritation test using rabbits, after application of 0.1 mL this substance, slight redness, edema, or discharge were observed 1 hour after application and resolved after 48 hours (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012)). Besides, it is written that the substance is slightly irritating to eyes (EPA Pesticide Fact Sheet (1999), Health Canada REG2006-01 (2006)). From the above, the substance was classified in Category 2B.	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	Category 1	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 1. Also, based on the new findings and evaluation, the classification result was changed. [Evidence Data] (1) It was reported that, in a maximization test (OECD TG 406, intradermal induction: 6% solution) with guinea pigs (n=20), the positive rate was 85% (17/20 animals). The RAC considered that since there was no test result for an intradermal induction dose of 1% or lower in this test, a sub-categorization could not be specified and concluded that it was classified in Category 1 (ECHA RAC Opinion (2013), CLH Report (2013)). [Reference Data, etc.] (2) It was reported that, in a maximization test (intradermal injection: 2.5% solution) with guinea pigs (n=20), a change in the score by 1 (full score: 3) was observed in 2 animals and the positive rate was calculated to be 10% (2/20 animals) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2018), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). (3) It was reported that, in a Buehler test (OECD TG 406, local administration: 100% solution) with guinea pigs (n=20), the positive rate was 0% (0/20 animals) at 30 hours after challenge (ECHA RAC Opinion (2013), CLH Report (2013)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	As for in vivo, a micronucleus test in mouse bone marrow cells after intraperitoneal administration and an unscheduled DNA synthesis test in rat liver after oral administration were negative (Pesticide evaluation report, Food Safety Commission of Japan (2012); Pesticide abstract (2007)). As for in vitro, a bacterial reverse mutation test and a mouse lymphoma test and a chromosomal aberration test in cultured mammalian cells were negative (Pesticide evaluation report, Food Safety Commission of Japan (2012); Pesticide abstract (2007)). 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	Not classified	- -	-	-	As an existing classification result by other organization, there is only NL classification (Not Likely to be Carcinogenic to Humans) by US EPA (HSDB (Access on October 2015), EPA (Chemicals Evaluated for Carcinogenic Potential dated on April 26, 2006)). In a carcinogenicity test in diet administration of this substance for 2 years to rats, or 1.5 years to mice, in a high dose group (rats: 160 to 200 ppm (corresponding to 9.7 mg/kg/day), mice: 175 to 225 ppm (corresponding to 35.1 to 35.7 mg/kg/day)), weight gain reduction and low food consumption (only males for mice) were observed during a dosing period in males and females, but an increased tumor incidence was not shown in rats. In mice, males showed twice as much incidence of hepatocellular adenoma as a control group (20% (10/50) for a 225 ppm group, 10% (5/50) for a control group). However, it is not a statistically significant increase, and it was concluded that carcinogenicity was not observed in either rats or mice (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)). From the above, from the EPA carcinogenicity classification result, the substance was classified as "Not classified" in accordance with Guidance in this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Not classified	- -	-	-	In a two-generation breeding toxicity test in diet administration in rats, parent animals showed weight gain reduction in a high dose group (200 ppm) of F0 generation and groups of mid-dose (80 ppm) or higher of F1 generation. However, toxic effects on fertility of parent animals and growth/development after a birth of F1, F2 offspring were not found (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)). Moreover, in a teratogenicity test in gavage administration of this substance in pregnant rats or rabbits during an organogenetic period (rats: day 6 to 15 of gestation, rabbits: day 7 to 19 of gestation), in rats, maternal animals showed weight gain reduction and low food consumption at 100 mg/kg/day or higher, discoloring of extremities, decreased defecation, and brown discharge from the vagina at 500 mg/kg/day, but effects of test substance administration were not observed in fetuses. Moreover, in a teratogenicity test using rabbits, toxic effects were not found up to 200 mg/kg/day of high dose in either maternal animals or fetuses. (Pesticide evaluation report, Food Safety Commission of Japan (2012); EPA Pesticide Fact Sheet (1999); HSDB (Access on October 2015)). From the above, there are no findings suggesting reproductive toxicity in results of the breeding test and the teratogenicity test using experimental animals, taking into account the evaluation result by Food Safety Commission of Japan, the substance was classified as "Not classified" 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 test data in oral administration in rats and mice, dermal administration in rats, and inhalation exposure in rats (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 (blood system), Category 2 (liver, adrenal gland)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	The following was observed in an oral route (Pesticide abstract (2007); Health Canada REG2006-01 (2006); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)): effects on blood system (decreased red blood cell count, decreased hemoglobin and so on), effects on liver (centrilobular hypertrophy of hepatocytes, single cell necrosis, lymphohistiocytic cellular infiltration), adrenal (vacuolization of zona fasciculata of the adrenal cortex) at 200 to 400 ppm (13.8 to 32.63 mg/kg/day) within a range of Category 2 in a 13-week diet administration toxicity test using rats; effects on liver (increased weight, centrilobular or diffuse hypertrophy of hepatocytes) at 400 to 1000 ppm (10.4 to 28.2 mg/kg/day) within a range of Category 2 in a 13-week diet administration toxicity test using dogs; effects on blood system (decreased red blood cell count, hemoglobin, and hematocrit, increased reticulocyte count, nucleated red blood cell count, and platelet count, increased leukocyte count, bone marrow hyperplasia and so on) at 400 ppm (males: 8.9, females: 10.4 mg/kg/day) almost within a range of Category 1 in a 52-week diet administration toxicity test using dogs; effects on blood system (decreased red blood cell count, hemoglobin, and hematocrit and so on) at 80-200/160 ppm (3.9 to 9.7 mg/kg/day) within a range of Category 1 in a 104-week diet administration toxicity test using rats. In a dermal route, in a 21-day dermal administration toxicity test using rats, effects on blood system (abnormal stainability and morphology of red blood cell, increased extramedullary hematopoiesis of spleen) were observed at 400 mg/kg/day (converted to a 90-day equivalent: 93 mg/kg/day) within a range of Category 2 (Pesticide abstract (2007); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)). As above, effects on blood system were observed from Category 1, and effects on liver and adrenal were found within a range of Category 2. Therefore, the substance was classified in Category 1 (blood system), Category 2 (liver, adrenal).	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)	Category 1	Warning	H400	P273 P391 P501	From 48-hour EC50 = 500 micro g/L for crustacea (Daphnia magna) (US EPA: Registration Review, 2012), it was classified in Category 1.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (BIOWIN), and NOAEC (reproduction, growth) = 150 micro g/L for crustacea (Daphnia magna) (US EPA: Registration Review, 2012). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 due to being not rapidly degradable (BIOWIN), and 96-hour LC50 = 580 micro g/L for fish (Lepomis macrochirus) (US EPA: Registration Review, 2012). It was classified in Category 1 by drawing a comparison between the above results.	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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