GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 12071-83-9
Chemical Name Polymer of N,N'-propylenebis(dithiocarbamic acid) and zinc; Propineb
Substance ID R01-B-066
Classification year (FY) FY2019
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 (FY2013 revised edition (Ver. 1.1))
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 *
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified (Not applicable)."
2 Flammable gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
3 Aerosols *
-
-
- - Not aerosol products. It was classified as "Not classified (Not applicable)."
4 Oxidizing gases *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
5 Gases under pressure *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
6 Flammable liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
7 Flammable solids *
-
-
- - No data available.
8 Self-reactive substances and mixtures *
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified (Not applicable)."
9 Pyrophoric liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
10 Pyrophoric solids *
-
-
- - No data available.
11 Self-heating substances and mixtures *
-
-
- - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases *
-
-
- - 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)).
13 Oxidizing liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14 Oxidizing solids *
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)."
15 Organic peroxides *
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)."
16 Corrosive to metals *
-
-
- - Classification is not possible because test methods applicable to solid substances are not available.
17 Desensitized explosives *
-
-
- - 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) *
-
-
- - [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))
1 Acute toxicity (Dermal) *
-
-
- - [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))
1 Acute toxicity (Inhalation: Gases) *
-
-
- - [Rationale for the Classification]
Solid (GHS definition). It was classified as "Not classified (Not applicable)."
1 Acute toxicity (Inhalation: Vapours) *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
1 Acute toxicity (Inhalation: Dusts and mists) *
-
-
- - [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))
2 Skin corrosion/irritation *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
3 Serious eye damage/eye irritation *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Respiratory sensitization *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization *
-
-
- - [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.
5 Germ cell mutagenicity *
-
-
- - [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.
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)).
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)).
8 Specific target organ toxicity - Single exposure *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
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)).
10 Aspiration hazard *
-
-
- - [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) Classification not possible
-
-
- - The classification is not possible because appropriate data are not obtained.
11 Hazardous to the aquatic environment Long term (Chronic) Classification not possible
-
-
- - The classification is not possible because appropriate data are not obtained.
12 Hazardous to the ozone layer Classification not possible
-
-
- - Classification not possible due to lack of data.


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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