NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	91-15-6
Chemical Name	Phthalonitrile
Substance ID	m-nite-91-15-6_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)	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 molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	There is a description that its autoignition temperature is > 580 degC (ICSC (Oct. 2004)) and it is considered that the substance does not ignite at room temperature.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	Three LD50 values for rats of 85 mg/kg ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (Access on Jun. 2009)), 125 mg/kg and 30 mg/kg (both from SIDS (2001)) were reported. Based on the value of 85 mg/kg, which was obtained from the study complied with OECD Guideline (TG 401) and GLP with high reliability, the substance was classified as Category 3.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Although the test was carried out under the test condition of the saturated vapor atmosphere with low dust formation (SIDS (2001)), the LC50 value was not measured. Therefore, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	The substance was classified as "Not classified" based on the documented case of "not irritating" resulted from the rabbit test that application of 50% aqueous emulsion for 1 minute up to 20 hours (SIDS (2001)). As relevant information, 24-hour application of 1% or 10% solution to the inside of the forearm of humans did not induce skin irritation (IUCLID (2000)). On the other hand, there was the information that the substance caused irritation (SIDS (2001)). However, since it was finally concluded as "not irritating" (SIDS (2001)), and reference was old, the information was not adopted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Not classified	- -	-	-	The substance was classified as "Not classified" based on the documented case of "not irritating" resulted from the rabbit test in which 0.1 mL of undiluted substance was instilled to rabbit's eye (SIDS (2001)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The substance was classified as "Not classified" based on the negative results in the micronucleus test using bone marrow obtained from mice orally administered (in vivo mutagenicity test in somatic cells) (SIDS (2001)). As relevant information, as for in vitro studies, negative results in the Ames test ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (Access on Jun. 2009)), negative results in the gene mutation test using Chinese hamster V79 cells (SIDS (2001)) and positive results in the chromosome aberration test using Chinese hamster CHL cells (SIDS (2001)), were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	Insufficient data were available. As relevant information, in the oral, dermal or subcutaneously administration tests using rats and mice, the tumors were observed. However, no evidence of the incidences of tumors in the concurrent control group or the background data of the control groups was described, so that the data were reported to be unreliable (SIDS (2001)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral administration in rats (0, 1, 6 and 30 mg/kg/day), all dams of the high dose group (30 mg/kg) died at the late stage of pregnancy. However, no adverse effects on sexual functions and fertility of parental animals were observed at any dose groups, and no treatment-related changes were observed with respect to the general condition, viability index, and external findings in neonate ("Toxicity Testing Reports of Environmental Chemicals"(Chemicals Investigation Promoting Council) (Access on Jun. 2009)). However, since data concerning the influence on the development of fetus containing the teratogenicity were insufficient, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system)	Danger	H370	P308+P311 P260 P264 P270 P321 P405 P501	As the result of the acute oral study in rats, deaths occurred at dose levels more than 60 mg/kg corresponding to Category 1, the signs observed included convulsions, staining around the mouth, reduced locomotor activity, abnormal gait, prone position, vocalization, straub tail and cyanosis ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jun. 2009)). Moreover, it was also reported that the main effect of the substance was neurotoxicity (SIDS (2001)) and that the effects on central nervous system were remarkable (SIDS (2001)). Based on the information, the substance was classified as Category 1 (central nervous system).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nervous system), Category 2 (testis, eye)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	Based on the reports describing that ten of 20 workers exposed occupationally in the manufacturing plant of phthalodinitrile during the several months to 2 years caused sudden consciousness disturbances and clonic convulsions, bradycardia and transient retrograde amnesia on the occasion of stroke (Sangyo Cyudoku Binran, 2nd ed. (1994), original report: Ueda, H. Yokohama Igaku, 11 (1961)), and that three of 32 workers engaged in the work handling phthaladonitrile revealed consciousness disturbances with sudden convulsions at 3 to 8 months after the initiation of work (Sangyo Cyudoku Binran, 2nd ed. (1994), original report: Ministry of Labor, Department of Safety and Hygiene, Section of Rodo Eisei, Rodo Eisei, 6 (1965)), the substance was classified as Category 1 (nervous system). In the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral administration in rats (OECD TG 422, GLP-compliant), the effects on the nervous system was also suggested by the fact that convulsions occurred in all females in the high dose group (30 mg/kg/day) during the days from the gestation day (GD) 19 to GD23, then died. In the study, moreover, centrilobular hypertrophy of hepatocytes in the liver, hyaline droplet deposition and basophilic tubules in the proximal tubular epithelium of the kidneys, appearance of cell debris and loss of sperm in the ductus epididymis accompanied by atrophy of the seminiferous tubules of the testis were also observed in males of the same dose group ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jun. 2009)). In the 13-week feeding study in rats (OECD TG 408, US EPA guideline), furthermore, in addition to hyaline droplet formation in the renal tubules in males, clouding of the lens (cataract) were observed in both sexes at the dose levels equivalent to approx. 10 mg/kg/day on Week-13, which could not be detected on Week-4 (SIDS (2001)). As the results described above, the effects on the testis were observed at 30 mg/kg/day (converted value as that of 90-day study: 14.7 mg/kg/day) in the combined repeated oral dose and reproductive/developmental toxicity study (44-day treatment) and cataract was also observed at the dose levels over 10 mg/kg/day in the 13-week feeding study. Based on the information, the substance was classified as Category 2 (testis, eye). In addition, it was considered that hypertrophy of hepatocytes was possibly related to the change by induction of hepatic enzymes ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jun. 2009)), and that the renal changes were similar to nephropathy which was caused by male-rat specific alpha-2-micro globulin and were species-specific lesions ("Toxicity Testing Reports of Environmental Chemicals" (Chemicals Investigation Promoting Council) (Access on Jun. 2009)). Thus, neither of them was evidenced to classify.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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 3	- -	H402	P273 P501	Classified into Category 3 from its 96h-LC50 = 22.6 mg/L for fish (Oryzias latipes) (SIDS, 2003).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 3	- -	H412	P273 P501	Classified into Category 3 since its acute toxicity is Category 3 and it is not rapidly degradable (BOD degradation rate: 3.3% (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 1981)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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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