NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	51218-49-6
Chemical Name	2-chloro-2',6'-diethyl-N-(2-propoxyethyl)acetanilide [Pretilachlor]
Substance ID	m-nite-51218-49-6_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)	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 molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2016	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)	- -	-	-	The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2016	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	- -	-	-	Based on the LD50 values for rats of 3,600 mg/kg (male) and 2,200 mg/kg (female) (Evaluation of effect for the food safety (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (Access on October 2016)), this substance was classified as "Not classified" (Category 5 in UN GHS classification).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the LD50 value for rats of > 4,000 mg/kg (female and male) (Evaluation of effect for the food safety (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Japan Crop Protection Association (Access on October 2016)), this substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, an LC50 (4 hours) value for rats of > 2.8 mg/L (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)) is reported, and it corresponds to Category 4 to "Not classified," but it is not possible to specify the category from only this value. 　Besides, since the LC50 value is higher than the saturated vapor pressure concentration (0.082 microg/L), the reference value of mist was applied.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	In a skin irritation test using rabbits, primary skin irritation index was 2.3 for the intact skin immediately after application and 24 hours later, and an average score of erythema was 1.5-2 (4 out of 6 animals) and a score of edema was less than 1 (4 out of 6 animals) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Based on these results, this substance was evaluated as moderately irritating (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), Japan crop protection association (Access on October 2016)). 　Therefore, it was classified in Category 2.	FY2016	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	In an eye irritation test using rabbits, the eye irritation score (corresponding to AOI) of the non-washed eye was 4.7 (maximum value 110), and the reaction completely disappeared after 3 days (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). Since the eye irritation of this substance is considered to be very slight (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), Japan crop protection association (Access on October 2016)), this substance was classified in Category 2B.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	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	It is reported that in a skin sensitization test (Buehler test) using guinea pigs, it was positive (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). In addition, also in skin sensitization tests (Optimization test (test method that is not approved by OECD)) using guinea pigs, positive result is reported (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). Therefore, this substance was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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, micronucleus tests using bone marrow cells of rats and mice were negative (Evaluation of effect for the food safety (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), Japan Crop Protection Association (Access on October 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). As for in vitro, bacterial reverse mutation tests and mammalian cell chromosomal aberration test were negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), Japan Crop Protection Association (Access on October 2016), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Not classified	- -	-	-	In 2-year carcinogenicity studies using rats or mice dosed by feeding, no increase in the incidence of neoplastic lesions associated with the administration of this substance was observed in rats. In mice, increased incidence of hepatocellular adenomas was observed in males of 1,000 ppm (33/80 animals, 41.3%) and in females of 3,000 ppm (18/80 animals, 22.5%). However, since in both males and females, there was no dose-dependency in the incidence, and they were within the range of historical data (male: 22.0-49.0%, female: 6.0-24.0%), etc., it was judged that the development of hepatocellular adenomas was not the effects by administration of the test substance, and it was concluded that this substance does not have carcinogenicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). Therefore, this substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Not classified	- -	-	-	In a 2-generation reproductive toxicity study using rats by oral route (administration by feeding), even when it was administered at up to doses (300-3,000 ppm) where general toxicity effects (weight gain suppression, reduced food consumption, increased relative weight of the liver and kidney) occurred in F0-F2 parent animals, there were no effects on reproductive ability, and only general toxicity effects (weight gain suppression, increased relative liver weight, decreased relative spleen weights) were observed in F1-F2 pups. In addition, in developmental toxicity studies using pregnant rats and pregnant rabbits dosed by gavage during the organogenesis period (rats: Day 7 to 17 of gestation, rabbits: Day 6 to 19 of gestation), in both rats and rabbits, even at the doses (150-300 mg/kg/day) where maternal toxicity was manifested, no abnormality was observed in the fetuses (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). From the above, this substance was classified as "Not classified" for this hazard class since this substance shows only general toxicity effects, but no reproductive and developmental toxicity.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Category 2 (central nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	It is described that in single dose studies using rats and mice orally given this substance, vomiting-like behavior, piloerection, systemic convulsion, decreased locomotor activity, diarrhea, incontinence, sedation, and weakness were observed at 1,000 mg/kg, corresponding to Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). In addition, it is reported that in a single dermal dose study using rats, vomiting-like behavior and slight systemic convulsion were observed at 4,000 mg/kg, which is above Category 2, but that there was no death case (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2007)). From the above, this substance was classified in Category 2 (central nervous system).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 2 (kidney)	Warning	H373	P260 P314 P501	There is no information on humans. 　As for experimental animals, in a 2-year repeated dose toxicity study using rats dosed by feeding, increase in relative weights of the liver and spleen, increase in absolute and relative weights of the kidney and adrenal gland, fine granular surface of the kidney, and chronic nephropathy (glomerular sclerosis, fibrosis, nephrosis) in males, and increase in blood glucose in females were observed at 300 ppm (male: 18.3 mg/kg/day, female: 18.5 mg/kg/day), which is equivalent to category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2008)). 　Therefore, this substance was classified in Category 2 (kidney).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	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 72-hour ErC50 = 0.0032 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)), it was classified in Category 1.	FY2016	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 72-hour NOEC (r) = 0.00038 mg/L for algae (Pseudokirchneriella subcapitata) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)). 　If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 2 due to being not rapidly degradable (BIOWIN), and 96-hour LC50 = 2.4 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Environment Agency in Japan (Environment Agency, 1997)). 　It was classified in Category 1 by drawing a comparison between the above results.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	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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