NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	133-07-3
Chemical Name	folpet (ISO); N-(trichloromethylthio)phthalimide
Substance ID	m-nite-133-07-3_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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	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	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid	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	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	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	It contains chlorine and oxygen (but not fluorine), which are chemically bonded only to carbon.	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	- -	-	-	No data 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 values are documented to be >= 5000 mg/kg (JMPR (No. 897, 1995)) and >= 10000 mg/kg (Patty (5th, 2001)). Thus, the substance was classified into the "Not classified" category.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on its rabbit LD50 of 22600 mg/kg (Patty (5th, 2001)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid	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	Based on its rat LC50 of 0.39 mg/L/4h (JMPR (No. 897, 1995)), the substance was classified into Category 2. A total of three LC50 values for rats were obtained from two separate studies: 0.39 mg/L/4h for male, 0.43 mg/L/4h for female (JMPR (No. 897, 1995)), and > 5.0 mg/L/2h (Patty (5th, 2001)). Its saturated vapour pressure concentration (conversion value) is 0.02 ppm. Given that its LC50 value is higher than its saturated vapour pressure, classification was carried out using the criteria for dusts, not vapour.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	No data available.	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	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	In guinea pig maximization tests (JMPR (No. 897, 1995)), more than 30% of animals (18 of 20 treated subjects) showed extensive erythema, and the substance was evaluated to be a strong sensitizer. Thus, the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Since in vivo mutagenicity tests (micronucleus tests using rat bone marrow cells) yielded negative results (JMPR (No. 897, 1995), the substance was classified into the "Not classified" category. Regarding in vitro tests, Ames tests and chromosomal aberration tests using CHO cells gave positive results while hprt locus gene mutation tests using Chinese hamster lung fibroblasts yielded negative results (JMPR (No. 897, 1995)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	In studies using rats (strains: Charles River Crl:CD (SD) BR and Fischer) (JMPR (No. 897, 1995)), no carcinogenic effect was noted. In two separate tests using CD-1 mice (JMPR (No. 897, 1995)), duodenal adenomas, duodenal adenocarcinomas, and benign papillomas in the stomach were noted. Tumors seen in the duodenum are documented to be indirectly caused by congestion of folpet resulted from duodenal obstruction. However, tumorigenesis was detected mainly in the digestive system in a number of studies, and the substance is rated as B2 by the US EPA (IRIS (2002)). Thus, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In teratogenicity tests using rats (JMRP (No. 897, 1995)), reproductive toxic effects (implantation loss, reduced body weight gain in maternal animals, decreased uterine weights, and dose-related reduction in ossification) were noted at doses that showed general toxicity to parental animals, and in teratogenicity tests using rabbits, hydrocephaly and malformations of bones, digestive system, and lung were found at doses that showed toxic effects on parental animals (JMPR (No. 897, 1995)). Thus, the substance was classified into Category 2.	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 13-week oral administration tests using rats (doses: 24-72 mg/L) (JMPR (No. 897, 1995)), decreased total serum proteins and albumin, irritation of the proximal gastrointestinal tract, hyperkeratosis of the non-granular gastric mucosa, and acanthosis of the stomach occurred. Thus, the substance was classified into Category 2 (stomach, intestine, and blood). In a 12-week mixed diet test using rats (doses: 0.01, 0.32, and 1 % (90-day correction: 5, 160, and 500 mg/kg bw/day, respectively), no abnormalities were revealed in the liver, kidneys, adrenals, intestines, lungs, and gonads (JMPR (No. 897, 1995)). In a 13-week mixed diet test using rats (doses: 0, 0.03, 0.1, 0.3, and 1.0%), the NOAEL was found to be 300 mg/kg bw/day, and no abnormalities were shown in the blood, hepatic enzymes, renal functions, or organ weights (JMPR (No. 897, 1995)). Results from these two studies indicate that the substance falls under the "Not classified" category for oral route administration, but since no test results focusing on other administration routes are available, classification is not possible. In other studies using rats or dogs, doses used did not fall under the range of guidance values, thus, these studies were not used as grounds for classification.	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 1	Warning	H400	P273 P391 P501	Since its 96-hour LC50 = 0.015 mg/L for fish (rainbow trout) (ECOTOX, 2008), the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Since its classification for acute toxicity is Category 1, and it is not rapidly degradable (SRC: BiioWin V4.10), the substance was classified into Category 1.	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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