NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	12071-83-9
Chemical Name	Polymer of N,N'-propylenebis(dithiocarbamic acid) and zinc; Propineb
Substance ID	m-nite-12071-83-9_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. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2019	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. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Classification not possible	- -	-	-	No data available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.	FY2019	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	- -	-	-	It was classified as "Not classified" because it is estimated that it does not react vigorously with water from information: water solubility of 10 mg/L (20 deg C, GESTIS (Access on May 2019)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)."	FY2019	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. It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17	Desensitized explosives	Not classified	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: 8,500 mg/kg (ECH 78 (1988), GESTIS (Access on August 2019))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), the category could not be specified, therefore it was classified as "Classification not possible." [Evidence Data] (1) LD50 for rats: >1,000 mg/kg (EHC 78 (1988), GESTIS (Access on August 2019))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified (Not applicable)."	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	[Rationale for the Classification] Based on (1), the category could not be specified, therefore it was classified as "Classification not possible." [Evidence Data] (1) LC50 for rats (4 hours): >0.693 mg/L (GESTIS (Access on August 2019)) [Reference Data, etc.] (2) LC50 for rats (exposure time unknown): 983 mg/m3 (0.983 mg/L) (EFSA (2016))	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Since it was impossible to obtain the agricultural chemical registration application documents, the rationale for the previous classification as Category 1, therefore, it was classified as "Classification not possible" due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. In the previous classification, it was classified as "Not classified." However, it was impossible to obtain the agricultural chemical registration application documents, the rationale for the previous classification, and no new information was obtained. Therefore, the classification result was changed.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Category 1B	Danger	H350	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on classification results by other organizations in (1), it was classified in Category 1B in accordance with the GHS Classification Guidance for the Japanese Government. Since classification results by other organizations were added, the classification result was changed from the previous one. Besides, only increases in benign tumors in experimental animals were observed. Also, EFSA evaluated that this substance was not a carcinogen in humans. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified as "L (likely to be carcinogenic to humans)" by EPA (EPA Annual Cancer Report (2018): classified in 2013) [Reference Data, etc.] (2) In a carcinogenic test with mice by feeding (50-800 ppm), an increase in hepatocellular adenoma in males at 800 ppm was observed. However, no increase in the incidence of tumors was observed in females (JMPR (1993)). (3) In a long-term administration test with rats by feeding, an increase in benign tumors in the thyroid was observed at or above 1,000 ppm (JMPR (1993)). (4) In the absence of indications of a continuum in tumorigenic effects (from hyperplasia to carcinoma) and considering the high sensitivity in mice, this substance was thought to have no carcinogenic potential relevant to humans (EFSA (2016)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) and (2), decreased fertility and embryotoxicity/fetotoxicity were observed at doses of maternal toxicity (details unknown). Therefore, it was classified in Category 2. [Evidence Data] (1) In a three-generation reproductive toxicity test with rats by feeding, decreased fertility was observed at doses of maternal toxicity (details unknown) (JMPR (1993)). (2) In a developmental toxicity test with rats, embryotoxicity/fetotoxicity was observed at the dose of maternal toxicity (details unknown). However, no teratogenicity was observed (JMPR (1993)). [Reference Data, etc.] (3) In a developmental toxicity test with rabbits, maternal toxicity was observed, but teratogenicity and embryotoxicity/fetotoxicity were not observed (JMPR (1993)). (4) As a result of administering this substance to rats by gavage on Day 11 of gestation, this substance was fetotoxic and induced a variety of malformations in the surviving fetuses. However, they were effects at the highest dose (2,300 mg/kg) (EHC 78 (1988)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Category 1 (thyroid), Category 2 (nervous system)	Danger Warning	H372 H373	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1), in an oral administration test with rats by feeding, effects on the thyroid were observed at doses within the range for Category 1, and based on (2), effects on the nervous system were suggested at doses within the range for Category 2, therefore, it was classified in Category 1 (thyroid) and Category 2 (nervous system). [Evidence Data] (1) In a 62-day administration test with rats by feeding at 2-250 ppm, changes in thyroxine concentration and increased thyroid weight were observed at or above 50 ppm (converted guidance value: 1.7 mg/kg/day, within the range for Category 1) (JMPR (1993)). (2) In 90-day oral administration tests with rats and dogs, neuromuscular effects (flaccidity and paralysis of the hind legs, reduced motility and grip strength, muscle atrophy and nerve fiber swelling) and decreased thyroid hormones levels in rats, and neurological signs and changes in thyroid hormones in dogs were observed. The NOAELs were reported to be 7.6 mg/kg/day for rats, and 4.3 mg/kg/day for dogs respectively. Based on these results, it was classified in EU as STOT RE cat 2 (thyroid, peripheral nervous system) (EFSA (2016)). [Reference Data, etc.] (3) In a 24-month administration test in which rats were dosed (by feeding) with propylenethiourea (PTU) (CAS RN 2122-19-2), the main metabolite of this substance, at 1-1,000 ppm to investigate its effects on the thyroid, an increase in thyroid weight was observed at 100 ppm (converted guidance value: 5 mg/kg/day, in the range for Category 1). In another 24-month administration test with rats by feeding PTU at 1-1,000 ppm, increased mortality, reduced body weight gain and nonneoplastic lesions in the thyroid were observed at 100 ppm (converted guidance value: 5 mg/kg/day, within the range for Category 1) (JMPR (1993)). (4) In a comparative 21-day test with rats in which the effects of this substance, PTU, ethylenethiourea (ETU) (CAS RN 96-45-7), zineb (CAS RN 12122-67-7) and methylthiouracil (CAS RN 56-04-2) on thyroid weight were studied, PTU had an equivalent effect to that of methylthiouracil and was somewhat stronger than ETU. These results suggest that effects of this substance on the thyroid in rats may be caused primarily by the metabolite PTU (JMPR (1993)).	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2019	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)	Classification not possible	- -	-	-	The classification is not possible because appropriate data are not obtained.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	The classification is not possible because appropriate data are not obtained.	FY2019	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2019	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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