NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	116714-46-6
Chemical Name	(RS)-1-[3-Chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]-3-(2,6-difluorobenzoyl)urea [novaluron]
Substance ID	m-nite-116714-46-6_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	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive properties.	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	Not classified (Not applicable)	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.	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	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures due to being stable to heat up to 200 degrees C (Pesticide abstract (2013), Pesticide Handbook (2005)).	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating 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))
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 contains oxygen, fluorine, and chlorine, and the oxygen, fluorine, and 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 (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)), 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 > 2,000 mg/kg for rats (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)), 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 > 5,150 mg/m3 for rats (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)), it was classified as "Not classified." Besides, a reference value of dust was applied because the test substance is a solid.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Not classified	- -	-	-	It is reported that in a skin irritation test using rabbits, after 4-hour occlusive application of 500 mg this substance, no irritation change was observed (Pesticide abstract (2013)). 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	- -	-	-	In an eye irritation test using rabbits, as a result of applying 0.1 mL (72 mg) this substance, an irritation change was not observed in cornea and iris. It is reported that this substance was not irritating to eyes because redness was found in the conjunctiva but resolved after one day, (Pesticide abstract (2013)). From the above, the substance was classified as "Not classified." Besides, it is written in HSDB (Access on October 2015) that temporary but noted injury to eyes is shown (HSDB (Access on October 2015)) and that the substance is not irritating to eyes (HSDB (Access on October 2015)), but the rabbit information having detailed description was used for the classification.	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, the substance was not sensitizing due to no sensitization reaction observed after induction and challenge. (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)). Because the above test is a GLP compliance test corresponding to OECD TG 406, the substance was classified as "Not classified." Besides, it is written in HSDB (Access on October 2015) that repeated exposure could cause allergic reaction in part of humans (HSDB (Access on October 2015)) and that the substance is not a skin sensitizer (HSDB (Access on October 2015)), but they were not used for the classification due to unknown details.	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 was negative. As for in vitro, a bacterial reverse mutation test and a chromosomal aberration test in cultured human peripheral blood lymphocytes were negative. (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015); EPA Pesticide Fact Sheet (2001)) 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	- -	-	-	There is no carcinogenicity information in humans. As for experimental animals, in a carcinogenicity test in diet administration of this substance in rats for two years, or in mice for 1.5 years, non-tumor changes such as blood effects, tissue changes in spleen and liver were observed in dose groups of rats at 700 ppm or higher and mice at 450 ppm or above. However, increased incidences of tumor lesions were not observed in either males or females of rats and mice even at the doses where toxicity occurred (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)). As existing classification result in carcinogenicity, except NL classification (Not Likely to be Carcinogenic to Humans) in 2004 by EPA (U.S. EPA Office of Pesticide Program. Chemicals Evaluated for Carcinogenic Potential. (April, 2006); HSDB (Access on October 2015)), there is no classification done by the international organization. As above, from the carcinogenicity test results in an oral route and existing classification result, the substance was classified as "Not classified" according to Guidance in this hazard class.	FY2015	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Not classified	- -	-	-	There is no information on reproductive effects in humans. As for experimental animals, in a two-generation breeding toxicity test using rats in an oral route (diet administration), parent animals showed increased relative kidney weight (F1males) at a middle dose (4,000 ppm) or higher, hemosiderosis in the spleen (F0, F1 males and females), centrilobular hepatocellular hypertrophy (F1 males), perilobular hepatocellular fatty degeneration (F1 females), hemosiderosis in broad ligament of uterus (F0 females) in a high dose group (12,000 ppm), but toxic effects on fertility were not observed. In offspring, in a 12,000 ppm group, a decreased number of live pups at day 14 and 21 of nursing (F1) and increased weights of liver and spleen (F1, F2) in necropsy at weaning were found. Besides, increased weights of liver or spleen were sporadically observed mainly as relatively increased weights at 1,000 ppm or higher in males and females of both F1 and F2 generations (including dose groups that did not show statistical significance). (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)) As a teratogenicity test, doses up to 1,000 mg/kg/day were administered by gavage to pregnant rats on day 6 to 15 of gestation, or to pregnant rabbits on day 6 to 19 of gestation. In a test in rats, toxicity effects were not found in either maternal animals or fetuses even in administration up to the limit dose (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012); HSDB (Access on October 2015)). On the other hand, in a test in rabbits, weight gain reduction as maternal toxicity at 1,000 mg/kg/day and skeletal variations (increased incidence of incomplete ossification of the fifth sternebra) as effects on fetuses at 300 mg/kg/day or higher were observed respectively, but teratogenicity was not shown (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)). As above, from the results of the breeding toxicity test and the teratogenicity test using experimental animals, effects on sexual function and fertility, and teratogenicity were not shown. In an administration to pregnant rabbits during an organogenetic period, the only thing found as fetotoxicity from the dose without toxicity in maternal animals was an increased incidence of skeletal variations, but it is hard to say that it is an apparent developmental effect that can be used as evidence for the classification. Therefore, because the findings available as evidence for classification were not shown in the results from the breeding test and the teratogenicity test, 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, from piloerection and hunched posture in oral administration (LD50 > 5,000 mg/kg, above Category 2) in rats, no abnormal findings in dermal administration (LD50 > 2,000 mg/kg, above Category 2) in rats, and no abnormal findings in inhalation exposure (LC50 > 5.15 mg/L) in rats (Pesticide abstract (2013); Pesticide evaluation report, Food Safety Commission of Japan (2012)), an abnormality in signs and necropsy findings was not observed in any test even in administration up to the limit doses (or highest possible concentration). Therefore, 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)	Danger	H372	P260 P264 P270 P314 P501	There are no human data. As for experimental animals, in a 90-day diet administration toxicity test using rats, effects on blood system (decreased red blood cells and so on) were observed in females in dose groups of 50 ppm (females: 4.7 mg/kg/day) within in a range of Category 1 or higher (Pesticide evaluation report, Food Safety Commission of Japan (2012); Pesticide abstract (2013)). As above, effects on blood system were observed within in a range of Category 1. Besides this, effects on blood system were found within in a range of Category 2 in combined chronic toxicity/carcinogenicity test using rats, a 90-day diet administration toxicity test using mice, an 18-month diet administration toxicity test using mice, a 90-day diet administration toxicity test using dogs, and a 52-week diet administration toxicity test using dogs (Pesticide evaluation report, Food Safety Commission of Japan (2012); Pesticide abstract (2013)). Therefore, the substance was classified in Category 1 (blood 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)	Category 1	Warning	H400	P273 P391 P501	From 96-hour LC50 = 0.13 ppb for crustacea (Mysidopsis bahia) (AQUIRE, 2016), 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 1 due to being not rapidly degradable (BioWin), and 28-day NOEC = 0.026 ppb for crustacea (Mysidopsis bahia) (AQUIRE, 2016). 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 = 2.0 ppb for fish (Cyprinodon variegatus) (AQUIRE, 2016). It was classified in Category 1 from 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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