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GHS Classification Result

GENERAL INFORMATION

Item	Information
CAS RN	80844-07-1
Chemical Name	2-(4-Ethoxyphenyl)-2-methylpropyl 3-phenoxybenzyl ether (Ethofenprox)
Substance ID	H26-B-024, R-008
Classification year (FY)	FY2014
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2013 revised edition)
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

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Explosives	Not applicable	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule.
2	Flammable gases (including chemically unstable gases)	Not applicable	- -	-	-	Solid (GHS definition)
3	Aerosols	Not applicable	- -	-	-	Not aerosol products.
4	Oxidizing gases	Not applicable	- -	-	-	Solid (GHS definition)
5	Gases under pressure	Not applicable	- -	-	-	Solid (GHS definition)
6	Flammable liquids	Not applicable	- -	-	-	Solid (GHS definition)
7	Flammable solids	Classification not possible	- -	-	-	No data available.
8	Self-reactive substances and mixtures	Not applicable	- -	-	-	There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9	Pyrophoric liquids	Not applicable	- -	-	-	Solid (GHS definition)
10	Pyrophoric solids	Not classified	- -	-	-	Because it is described that it is stable at 150 deg C (DSC) (Agricultural Chemical Registration Data), it does not spontaneously ignite in contact with air at normal temperatures.
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140 deg C) substances are not available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not applicable	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).
13	Oxidizing liquids	Not applicable	- -	-	-	Solid (GHS definition)
14	Oxidizing solids	Not applicable	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15	Organic peroxides	Not applicable	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.
16	Corrosive to metals	Classification not possible	- -	-	-	It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	Based on LD50 values for rats of > 2,000 mg/kg and > 42,880 mg/kg (JMPR (2011)), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010), it was classified as "Not classified."
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on LD50 values for rats of > 2,000 mg/kg (JMPR (2011)), > 2,140 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)), it was classified as "Not classified."
1	Acute toxicity (Inhalation: Gases)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Vapours)	Not applicable	- -	-	-	Solid (GHS definition)
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	Based on LC50 values (4 hours) for rats of > 5.88 mg/L (JMPR (2011)) and >5,900 mg/m3 (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)), it was classified as "Not classified." Besides, since these LC50 values were higher than the saturated vapor concentration (1.23*10-9 mg/L), the reference value as the dust or mist was applied.
2	Skin corrosion/irritation	Not classified	- -	-	-	There is a report that in a primary irritation test using 6 rabbits (GLP-compliant), as a result of applying 0.5 mL of this undiluted substance, 5 animals showed no irritation, and 1 had mild erythema which resolved after 7 days (JMPR (2011)), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010), OEL Documentations (Japan Society For Occupational Health (JSOH), 1995). From the above, it was classified as "Not classified."
3	Serious eye damage/eye irritation	Not classified	- -	-	-	There is a description that in an eye irritation study with 6 rabbits, slight (grade 1) erythema (6/6) and slight edema (1/6) were observed, but because they resolved within 72 hours, it was judged as no eye irritation (JMPR (2011)), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010), OEL Documentations (Japan Society For Occupational Health (JSOH), 1995). From the above, it was classified as "Not classified."
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. Besides, there is a report that in a maximization test using guinea pigs (GLP-compliant), as a result of applying 20% of this substance, no sensitization was shown (JMPR (2011)), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010), OEL Documentations (Japan Society For Occupational Health (JSOH), 1995). The previous classification was based on applying 20% of this substance, and the data was judged to be insufficient for classification.
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese government. As for in vivo, it was negative in a mouse bone marrow micronucleus test (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010), JMPR (2011)). As for in vitro, it was negative in a bacterial reverse mutation test, a gene mutation test and a chromosomal aberration test with cultured mammalian cells (OEL Documentations (Japan Society For Occupational Health (JSOH),1995), Etofenprox_eval_WHO_july_2007, JMPR (2011), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2010)).
6	Carcinogenicity	Classification not possible	- -	-	-	Carcinogenicity studies by 2-year oral administration using rats and mice showed no tumors related to this substance (Japanese Journal of Pesticide Science (Pesticide Science Society of Japan) vol.14, 505-509 (1989), Food Sanitation Research (vol.46 No.11 (1996)), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 1986)). However, because there is no carcinogenicity classification by domestic and international organizations, it was classified as "Classification not possible."
7	Reproductive toxicity	Not classified	- -	-	-	No effects on the sexual function or fertility were observed in a two-generation reproduction study with rats through the oral route (feeding) at doses which cause toxicity of parental animals (4900 ppm for F0, 700 ppm for F1 and F2) (JMPR (2011)). In addition, also in a test with rats dosed during the organogenesis period, the fertility of F0 and F1 maternal animals were not affected even at the dose where maternal toxicity (5,000 mg/kg bw/day) was observed (symptoms such as salivation and red-brown staining around the mouth and a slight decrease in body weight gain). Also, no abnormality was seen in either F1 or F2 pups (JMPR (2011)). Thus, it is judged that there is no teratogenicity, including a test with rabbits dosed during the organogenesis period (JMPR (2011)). From the above, since no clear evidence suggesting reproductive toxicity was found, it was classified as "Not classified."
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (narcotic effects)	Danger Warning	H370 H336	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	Although diarrhea, soft feces, piloerection, hunched posture, reduced activity and reduced frequency of respiration, and scattered diffuse hemorrhages in the lungs at necropsy in oral administration of 21,440 or 42,880 mg/kg to rats, suppression of locomotor activity in oral administration of 50000 mg/kg to mice, closed eyelids, abnormal respiratory movements, transient hyperactivity and lethargy in inhalation exposure of 5.88 mg/L to rats, reduced activity, hunched posture in dermal application of 2,140 mg/kg to rats were observed, there was no death through any route, and there was no histopathological abnormality at the end of the observation periods (JMPR (2011), OEL Documentations (Japan Society For Occupational Health (JSOH), 1995), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 1986)). These findings were outside the range of guidance values corresponding to the categories for oral, dermal or inhalation routes. This substance is an insecticide, and its mode of action is described as inhibiting the nervous system function like other pyrethroids (OEL Documentations (Japan Society For Occupational Health (JSOH), 1995)). From the above, it was classified in Category 1 (central nervous system), and Category 3 (narcotic effects).
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver, kidney)	Warning	H373	P260 P314 P501	In a 13-week feeding study with rats, effects on the liver (hepatocyte enlargement, increased serum AST, ALT and LDH activities) and thyroid (an increase in the number of microfollicles, lowered plasma concentrations of T4) were observed at doses slightly exceeding the range of Category 2 (1800 ppm: equivalent to 120 mg/kg/day). In 2-year feeding studies with rats and mice, effects on the liver (rats: foci of eosinophilic hepatocytes, vacuolation of hepatocytes) or kidney (mouse: dilatation or basophilic changes of renal cortical tubules) were observed at or above doses corresponding to the range of Category 2, 700 ppm (equivalent to 25.5 mg/kg/day) in rats and 100 ppm (equivalent to 10.4 mg/kg/day) in mice (JMPR (2011), WHO Specification and Evaluation (2007)). In rat studies, a histopathological change in the thyroid (increased cystic follicles) was also noted, but the dose was much higher than the range of Category 2 (4,900 ppm: equivalent to 249.1 mg/kg/day) (JMPR (2011), WHO Specification and Evaluation (2007)). From the above, it was classified in Category 2 (liver, kidney). Besides, after the fiscal year of the previous classification, a detailed evaluation has been conducted by JMPR and WHO, and these were used as information sources, so the classification result was revised.
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 96-hour LC50 = 0.0188 microg/L for crustacea (Mysidopsis bahia) (AQUIRE, 2015).
11	Hazardous to the aquatic environment (Long-term)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 due to being not rapidly degradable (BIOWIN), and 21-day NOEC = 0.103 microg/L for crustacea (Daphnia magna) (AQUIRE, 2015).
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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.

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