NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	126833-17-8
Chemical Name	fenhexamid; N-(2,3-dichlor-4-hydroxyphenyl)-1-methylcyclohexancarboxamid
Substance ID	m-nite-126833-17-8_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)	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)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing chlorine and oxygen (but not fluorine), which are bonded only to carbon or hydrogen.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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	- -	-	-	Its rat LD50 of > 5000 mg/kg bw (JMPR (2005)) corresponds to the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Its rat LD50 of > 5000 mg/kg bw (JMPR (2005)) corresponds to the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Its rat LC50 of > 0.32 mg/L (aerosol) (JMPR (2005)) corresponds to Category 2. Although another rat LC50 value of > 5.05 mg/L (dust) has been documented (JMPR (2005)), we chose the former value that represents a higher hazard for the classification purpose. Based on its saturated vapour pressure concentration of 4.8E-008 mg/L, the experiment was presumably conducted in a dust (mist) state.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	In Draize tests using rabbits, signs of skin irritation were not observed, drawing a conclusion that the substance is not a skin irritant (JMPR (2005)). Thus, it was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Not classified	- -	-	-	In Draize tests using three rabbits, no signs of irritation were observed, except for eye mucus detected in one rabbit 1 hour after application, drawing a conclusion that the substance is not an eye irritant (JMPR (2005)). Thus, it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	Four skin sensitization tests using guinea pigs have been documented (JMPR (2005)), in which one Buehler test gave a negative result, three maximization tests gave two negative results and one positive result, and an LLNA method using mice gave a negative result (JMPR (2005). Since these reports alone do not provide sufficient information to justify classification of the substance into the "Not classified" category, it was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on negative results acquired in micronucleus tests using bone marrow cells of mice that underwent intraperitoneal administration (in vivo mutagenicity tests using somatic cells) (JMPR (2005)), the substance was classified into the "Not classified" category. As for in vitro mutagenicity tests, all of the following tests gave negative results: chromosomal aberration tests using cultured ovarian cells of Chinese hamsters, gene mutation tests using cultured pneumocytes of Chinese hamsters, and Ames tests (JMPR (2005)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Not classified	- -	-	-	In 2-year oral administration (mixed diet) toxicity tests using rats, no signs of carcinogenicity were found (JMPR (2005)). Similarly, in 2-year administration (mixed diet) toxicity tests using mice, no carcinogenic effects were observed in mice (JMPR (2005)). Based on these reports, the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Not classified	- -	-	-	In two-generation reproduction tests using rats that underwent oral administration (mixed diet), no signs of toxicity toward fertility were detected at 20000 ppm, the highest dose tested (JMPR (2005)), although body weight of offspring decreased at 5000 ppm at the doses that caused suppression of body weight gain in parental animals. In addition, in developmental toxicity tests using rats that underwent forced oral administration, no embryo or fetal toxicity, or no signs of teratogenicity were observed at the doses that had no toxic effects on maternal animals (JMPR (2005)). Similarly, in developmental toxicity tests using rabbits that underwent forced oral administration, no embryo or fetal toxicity, or no signs of teratogenicity were observed at the doses that caused suppression of body weight gain in maternal animals (JMPR (2005)). Based on these results, the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In 90-day oral administration (mixed diet) toxicity tests using rats, kidney damage was observed at 50000 ppm (5585 mg/kg bw /day for male and 8100 mg/kg bw /day for female), which is above Category 2 guidance doses (JMPR (2005)). In addition, in 90-day oral administration toxicity (mixed diet) tests using mice, a decreased kidney weight was noted at 10000 ppm (3283 mg/kg bw /day for male and 5151 mg/kg bw /day for female), which is above Category 2 guidance doses (JMPR (2005)). In different 90-day oral administration toxicity (mixed diet) tests, a decreased kidney weight and kidney degeneration identified by the naked eye or under the microscope were found at 20000 ppm (3416 mg/kg bw /day for male and 6145 mg/kg bw /day for female), which is above Category 2 guidance doses (JMPR (2005)). Based on these three reports, the effects of the substance on the kidney are suspected. All effects were observed at "Not classified" category guidance doses, and its effects at Category 2 guidance doses are unknown. As such, the substance was classified into "Classification not possible". Also, in 28-day repeated inhalation toxicity tests using rats, an increased lung weight, grey discolouration of the lungs, and bronchoalveolar proliferations were noted at 486.7 mg/m3 (= 0.487 mg/L) (90-day correction: 0.151 mg/L), which falls under Category 2 guidance doses; however, these changes were documented to be small from a toxicological standpoint (JMPR (2005)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

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 2	- -	H401	P273 P501	Since its 96-hour LC50 = 1.24 mg/L for fish (rainbow trout) (Aquire 2009), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Since its classification for acute toxicity is Category 2, and there are no data on its rapid degradability, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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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