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 |
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 |
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." |
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. |
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. |
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