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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	12122-67-7
Chemical Name	Zinc N,N'-ethylenebis(dithiocarbamate); Zineb
Substance ID	R02-B-040-MHLW, MOE
Classification year (FY)	FY2020
Ministry who conducted the classification	Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised	Revised
Classification result in other fiscal year	FY2006
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
UN GHS document (External link)	UN GHS document
Definitions/Abbreviations (Excel file)	Definitions/Abbreviations
Model Label by MHLW (External link)	MHLW Website (in Japanese Only)
Model SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	eChemPortal

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
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."
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products. It was classified as "Not classified."
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
7	Flammable solids	Classification not possible	- -	-	-	No data available. Besides, there is information that it is combustible (ICSC (2017)).
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."
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
10	Pyrophoric solids	Not classified	- -	-	-	It was classified as "Not classified" because it is estimated that it does not ignite at normal temperatures from an autoignition temperature of 149 deg C (ICSC (2017)).
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No data available.
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	It contains a metal (Zn), but it was classified as "Not classified" because it is estimated that it does not react vigorously with water from water solubility data of about 10 mg/L (25 deg C) (HSDB (Access on May 2020)).
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition). It was classified as "Not classified."
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified."
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified."
16	Corrosive to metals	Classification not possible	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
17	Desensitized explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified."

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (4). Besides, the category was changed from the previous classification due to the use of new information sources. [Evidence Data] (1) LD50 for rats: > 5,000 mg/kg (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 14 (Japan Crop Protection Association, 1993)) (2) LD50 for rats: > 5,200 mg/kg (GESTIS (Access on May 2020), HSDB (Access on May 2020)) (3) LD50 for rats: > 5,600 mg/kg (GESTIS (Access on May 2020)) (4) LD50 for rats: > 10,000 mg/kg (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 14 (Japan Crop Protection Association, 1993))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1) - (4). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (GESTIS (Access on May 2020), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 14 (Japan Crop Protection Association, 1993)) (2) LD50 for rats: > 2,500 mg/kg (GESTIS (Access on May 2020)) (3) LD50 for rats: > 7,000 mg/kg (GESTIS (Access on May 2020)) (4) LD50 for rats: > 10,000 mg/kg (HSDB (Access on May 2020))
1	Acute toxicity (Inhalation: Gases)	Not classified	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
1	Acute toxicity (Inhalation: Dusts and mists)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	[Rationale for the Classification] It was classified in Category 3 from (1). Besides, the classification result was changed from the previous classification due to the use of new information sources. Because an exposure concentration was higher than the saturated vapor pressure concentration (1.5E-006 mg/L), a reference value in the unit of mg/L was applied as dust. [Evidence Data] (1) LC50 for rats (4 hours): 0.8 mg/L (GESTIS (Access on May 2020)) (2) Vapor pressure of this substance: 1.0E-007 mmHg (25 deg C) (HSDB (Access on May 2020)) (converted value for the saturated vapor pressure concentration: 1.5E-006 mg/L)
2	Skin corrosion/irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1), (2). The classification result was changed because new data were obtained. [Evidence Data] (1) This substance was not irritating in a skin irritation test with rabbits (GESTIS (Access on May 2020)). (2) In a patch test on 50 persons, this substance produced no effects for 49 persons but irritation for only one person (GESTIS (Access on May 2020)). [Reference Data, etc.] (3) Dithiocarbamates, including this substance, cause skin and eye irritation (EHC 78 (1988)).
3	Serious eye damage/eye irritation	Not classified	- -	-	-	[Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) This substance did not cause clear irritation in the rabbit eye (HSDB (Access on May 2020)). [Reference Data, etc.] (2) Dithiocarbamates, including this substance, cause skin and eye irritation (EHC 78 (1988)).
4	Respiratory sensitization	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] It was classified in Category 1 from (1), (2). [Evidence Data] (1) It was reported to be positive in a skin sensitization test in guinea pigs (maximization test) (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 14 (Japan Crop Protection Association, 1993)). (2) Skin disorders were described as a disease due to work involving exposure to this substance in Article 35 of the Ordinance for Enforcement of the Labor Standards Act (Notification No. 33 (1996)).
5	Germ cell mutagenicity	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. Negative knowledge in a host-mediated test in mice, which was the rationale in the previous classification, could not be used for direct assessment, and the classification result was changed based on the newly obtained information. [Evidence Data] (1) As for in vitro, it is reported that it was negative in a bacterial reverse mutation test and positive in a chromosomal aberration test with cultured mammalian cells (CEBS (Access on May 2020), Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 14 (Japan Crop Protection Association, 1993)). [Reference Data, etc.] (2) It was reported to be negative in an in vivo genotoxicity test in mice (host-mediated test) (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 14 (Japan Crop Protection Association, 1993)).
6	Carcinogenicity	Classification not possible	- -	-	-	[Rationale for the Classification] There were no available reports in humans. IARC classified it in Group 3 in (1), but because information on carcinogenicity was limited, it was classified as "Classification not possible." [Evidence Data] (1) As for classification results by domestic and international organizations, IARC classified it in Group 3 (IARC Sup7 (1987)). (2) In a carcinogenicity test by 2-year diet administration of this substance to male and female rats, there were no treatment-related incidences of tumors (EHC 78 (1988), JMPR (1993)).
7	Reproductive toxicity	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) and (2), it was classified as "Not classified." [Evidence Data] (1) In a three-generation reproduction toxicity study with rats dosed by feeding, no effects on fertility and fetal development were observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 14 (Japan Crop Protection Association, 1993)). (2) In a developmental toxicity study with rabbits dosed by gavage, at doses at which maternal toxicity (a reduction in food consumption) was observed, no effects were observed in fetuses (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 14 (Japan Crop Protection Association, 1993)). [Reference Data, etc.] (3) In developmental toxicity studies in pregnant rats and mice orally dosed with this substance (purity: 85.5%, containing 0.35% ethylene thiourea (ETU)), at a high dose (2,000 mg/kg/day) at which maternal toxicity (a decrease in body weight) was observed in rats, malformations (such as hydrocephalus, skeletal anomalies, and short or bent tails) were observed but it was possible that they were caused by ETU, which was an impurity. On the other hand, no malformations were observed in mice (EHC 78 (1988)).
8	Specific target organ toxicity - Single exposure	Category 3 (narcotic effects, respiratory tract irritation)	Warning	H336 H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on (1) and (2), it was classified in Category 3 (narcotic effects, respiratory tract irritation). It was stated in (1) that convulsions and unconsciousness were observed, but in other data, there was no statement indicating that the central nervous system could be adopted as the target organ. Therefore, it was determined that it was insufficient to adopt the central nervous system as the target organ. New information sources were used and the classification results were changed from the previous classification. [Evidence Data] (1) In spray or dust forms, this substance is moderately irritating to the skin and respiratory mucous membranes. Early symptoms from exposure of humans to inhalation of this substance include tiredness, dizziness, and weakness. More severe symptoms include headache, nausea, fatigue, slurred speech, convulsions, and unconsciousness (HSDB (Access on May 2020)). (2) In an acute oral toxicity test with mice, half of the animals in the group dosed at 2,000 mg/kg showed a decrease in locomotor activity, crouching and drowsiness or closed eyes 15 to 30 minutes after the treatment. However, 6 hours later, all the animals recovered. In the group dosed at 5,000 mg/kg, a decrease in locomotor activity was observed (Agricultural Chemicals Times supplement "Agricultural chemicals technology information" No. 14 (Japan Crop Protection Association, 1993)).
9	Specific target organ toxicity - Repeated exposure	Category 1 (respiratory organs)	Danger	H372	P260 P264 P270 P314 P501	[Rationale for the Classification] Based on (1) and (2), among the effects observed in the epidemiological study on humans, chronic bronchitis was regarded as the effect of this substance. Therefore, it was classified in Category 1 (respiratory organs). [Evidence Data] (1) In an epidemiological study on 137 workers engaged in manufacturing of this substance (51 men and 86 women), hepato-cholecystitis (28.4% of workers, 13.5% in control groups), vegetovascular dystonia connected with disorders in the central nervous system (34.9%, 22.3% in control groups), chronic bronchitis (4.4%, 0.5% in control groups), contact dermatitis (11.9%, 0.1% in control groups), and disorders in the menstrual cycle (16.91%, 4.3% in control groups) were reported (EHC 78 (1988)). (2) In a four-month inhalation toxicity study with rats (6 days/week, daily exposure time unknown), local irritation of the mucosa of the upper respiratory tract was observed at or above 2 mg/m3 (0.002 mg/L) (EHC 78 (1988)). [Reference Data, etc.] (3) In multiple chronic toxicity studies with rats and dogs in the oral route, hyperplasia of the thyroid was observed at 10,000 mg/kg/day, the dose substantially exceeding the range for Category 2 (EHC 78 (1988)).
10	Aspiration hazard	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour LC50 = 0.97 mg/L for crustacea (Daphnia magna) (EHC 78, 1988).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. It was classified in Category 1 because it was not rapidly degradable (a 4-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 2002)), and it was classified in Category 1 in acute toxicity.
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.

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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