NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	731-27-1
Chemical Name	tolylfluanid (ISO); dichloro-N-[(dimethylamino)sulphonyl]fluoro-N-(p-tolyl)methanesulphenamide
Substance ID	m-nite-731-27-1_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	Classification not possible	- -	-	-	The molecule contains chemical groups associated with self-reactive properties (S=O: sulfonyl halide group). Due to lack of data, the substance was classified into "Classification not possible".	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	Classification not possible	- -	-	-	No data available.	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	- -	-	-	Since its rat LD50 value is > 5000 mg/kg bw (JMPR (2002)), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Since its rat LD50 value is > 5000 mg/kg bw (JMPR (2002)), 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 (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	Based on its rat LC50 values of 0.16, 0.20, and 0.38 mg/L/4h (JMPR (2002)), the substance was classified into Category 2. Since the test concentration was 0.16 mg/L, which was higher than the saturated vapour concentration of the test substance (0.028 mg/L), the test is thought to have been conducted with the substance in a dust state.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	Two tests have been conducted using rabbits; one test concluded that the substance was severely irritating (JMPR (2002)) and the other test found that it caused no irritation (using 1% water solution) (JMPR (2002)). Considering that the EU rated the substance as Xi; R36/37/38, it was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In tests using rabbits, the substance was found to be severely or moderately irritating (JMPR (2002)). Furthermore, the EU rated the substance as Xi; R36/37/38. Thus, it was classified into Category 2A.	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	A Buehler test using guinea pigs concluded that the substance was not sensitizing (JMPR (2002)). On the other hand, a maximization test using guinea pigs revealed that it was sensitizing (JMPR (2002)), and two tests using mice (local lymph node assays) concluded that it was possibly a sensitizing substance and that it was sensitizing (JMPR (2002)). In addition, the EU rated the substance as Xi; R43. Based on this information, the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	All of the following tests yielded negative results: dominant lethal tests using mice (in vivo heritable mutagenicity tests using germ cells), germ-cell cytogenetic assays using Chinese hamsters (in vivo mutagenicity tests using germ cells), spot tests using mice, micronucleus tests using bone marrow cells of mice or hamsters, and chromosomal aberration tests using bone marrow cells of hamsters (the latter two tests were in vivo mutagenicity tests using somatic cells) (JMPR (2002)). Based on these negative results, the substance was classified into "Not classified". Also, in vitro mutagenicity tests (Ames tests and gene mutation tests using V79 or CHO cells) yielded negative results, chromosomal aberration tests using V79 cells yielded weakly positive results, mouse lymphoma assays yielded positive results, and cytogenetic assays using human lymphocytes yielded positive results (JMPR (2002)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Not classified	- -	-	-	Two-year oral route exposure tests, in which rats or mice were fed with a diet containing the substance, were conducted twice for each animal species. In these tests, dose-dependent mortality rates were not detected although reduced body-weight gain was observed (JMPR (2002)). In one of the rat tests, only malignant uterine tumours appeared at higher incidence in all treated groups as compared with controls. Because these tumors develop under normal circumstances, it is reported that the difference observed was likely to be attributed to low incidences of tumor development in control groups (JMPR (2002)). In the other rat test, thyroid follicular-cell adenomas were observed in animals treated with the highest dose (7500 ppm). The probable cause of adenoma was related to the increased concentrations of the thyroid stimulating hormone and alterations in the thyroid feedback mechanism, so the concentration levels that do not affect the thyroid gland would not induce carcinogenicity in humans (JMPR (2002)). With regard to mice, hepatocellular adenomas and pulmonary adenomas were observed in both treated and control groups, and incidences of tumor development due to exposure to the substance did not increase in either mouse tests (JMPR (2002)). Thus, since the rat and mouse tests conducted twice did not show evidence of carcinogenicity, the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Not classified	- -	-	-	In three two-generation reproduction tests using rats, no effects on reproductive functions or fertility were detected (JMPR (2002)). In addition, in rats and rabbits that underwent oral route exposure during the organogenetic period, no effects on the development of offspring were observed (JMPR (2002)). Based on these negative results, the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 1 (respiratory system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	Its rat LC50 via single inhalation exposure (dust) is 0.16-0.20 mg/kg. The symptoms of exposure include not only morphological changes in the respiratory tracts observed in dead rats, but also extreme difficulties in breathing, respiratory sounds and sneezing, serous nasal discharge, and cyanosis after exposure (JMPR (2002)). Based on these results, the substance was classified into Category 1 (respiratory system). On the other hand, a test was conducted in which rats underwent single oral administration with doses up to 2000 mg/kg, with neurotoxicological studies being its main purpose. In this test, other than symptoms of reversible general toxicity being detected, no specific neurotoxicity appeared and the effect of exposure was not observed from the histopathological standpoint (JMPR (2002)). In addition, single oral administration tests, in which rats or rabbits were applied with 500 mg/kg, concluded that severe toxic effects were not detected in both animal species (JMPR (2002)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory system)	Danger	H372	P260 P264 P270 P314 P501	Rats that underwent inhalation exposure for four weeks exhibited labored breathing and abnormal respiratory sounds, as well as resulting in death cases at 0.05 mg/L/6hr (90-day conversion value: 0.015 mg/L/6hr). In addition, in terms of histopathology, the following were observed: squamous metaplasia and hyperkeratosis of the anterior nasal cavities, squamous metaplasia of the larynx, epithelial desquamation and round-cell infiltration of the trachea, and fibrosis around the bronchia and in lungs. In some cases, these symptoms were detected at the doses of 0.01-0.004 mg/L (90-day conversion values: 0.003-0.001 mg/L) (JMPR (2002)). All of these effects on the respiratory system developed with the doses equivalent to the Category 1 guidance values, so the substance was classified into Category 1 (respiratory system). On the other hand, serious toxic effects were not recognized with doses that fall under the range of guidance values in the following tests: four oral route exposure tests in which rats were administered with a diet containing the substance for 3 months, 13 weeks, 2 years, or 105 weeks; one test in which dogs were fed with a diet containing the substance for 92 days; two tests in which dogs were orally administered with a capsule containing the substance for 52 weeks; and a test in which mice were administered with a diet containing the substance for 105 weeks (JMPR (2002)). Furthermore, in 3-month, 13-week, and 2-year rat tests, serious toxic effects were not detected with administration doses that were higher than the upper limit of the guidance values (JMPR (2002)). As additional information, in tests in which mice were administered with doses that were higher than the range of guidance values for 105 weeks, the following were observed: the basophilic intranuclear inclusion bodies and lymphohistiocytosis in the liver, and vacuolization of the tubular epithelium in the kidney (JMPR (2002)). In addition, in rabbits that underwent dermal exposure for 3 weeks, no systemic toxicity was reported (except on the skin where application was made) even in the highest dose groups exposed to 300 mg/kg/day (90-day correction value: approximately 70 mg/kg/day) (JMPR (2002)); however, these results alone are insufficient for classification purposes.	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)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data available.	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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