GHS Classification Results by the Japanese Government

Japanese



GENERAL INFORMATION
Item Information
CAS RN 81510-83-0
Chemical Name Isopropylammonium (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl) nicotinate (synonym: Imazapyr or Imazapyr isopropylamine salt)
Substance ID R03-A-019-METI, MOE
Classification year (FY) FY2021
Ministry who conducted the classification Ministry of Economy, Trade and Industry (METI)/Ministry of the Environment (MOE)
New/Revised New
Classification result in other fiscal year  
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)  
Model SDS by MHLW (External link)  
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.
2 Flammable gases Not classified (Not applicable)
-
-
- - Solid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Solid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Solid (GHS definition)
6 Flammable liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
7 Flammable solids Classification not possible
-
-
- - No data available.
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.
9 Pyrophoric liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
10 Pyrophoric solids Classification not possible
-
-
- - No data available.
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 (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).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition)
14 Oxidizing solids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule.
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.

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]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats (males): > 10,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))
(2) LD50 for rats (females): > 10,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))

[Reference Data, etc.]
(3) For imazapyr (acid), LD50 for rats (males): > 2,500 mg/kg (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA (2014))
(4) For imazapyr (acid), LD50 for rats (females): > 2,500 mg/kg (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA (2014))
(5) For imazapyr (acid), LD50 for rats (males): > 5,000 mg/kg (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA (2014), JMPR (2013))
(6) For imazapyr (acid), LD50 for rats (females): > 5,000 mg/kg (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA (2014), JMPR (2013))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats (males): > 2,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))
(2) LD50 for rats (females): > 2,000 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))

[Reference Data, etc.]
(3) For imazapyr (acid), LD50 for rats (males and females): > 2,000 mg/kg (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013))
(4) For imazapyr (acid), LD50 for rabbits (males and females): > 2,000 mg/kg (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013))
(5) For imazapyr (acid), LD50 for rats: > 2,000 mg/kg (EFSA (2014))
(6) For imazapyr (acid), LD50 for rabbits: > 2,000 mg/kg (EFSA (2014))
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) Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was not classified in Categories 1 to 3, but no category could be identified. Therefore, classification was not possible.

[Reference Data, etc.]
(1) LC50 (4 hours) for rats (males and females): > 4.6 mg/L (GLP) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016))
(2) For imazapyr (acid), LC50 (4 hours) for rats (males and females): > 1.3 mg/L (GLP) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016), JMPR (2013))
(3) For imazapyr (acid), LC50 (4 hours) for rats (females): > 1.3 mg/L (GLP) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013))
(4) For imazapyr (acid), LC50 for rats: > 1.3 mg/L (GLP) (EFSA (2014))
(5) For imazapyr (acid), LC50 (4 hours) for rats: > 2.4 mg/L (OECD TG 403, GLP) (REACH registration dossier (Accessed June 2021))
2 Skin corrosion/irritation Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
3 Serious eye damage/eye irritation Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Not classified
-
-
- - [Rationale for the Classification]
Based on (1), the sensitization rate was less than 30%, and it was classified as "Not classified."

[Evidence Data]
(1) It was reported that, in a Maximization test (GLP, intracutaneous administration: 5% solution) with guinea pigs (n=20), the positive rates at 24 and 48 hours after challenge were 15% (3/20 animals) and 20% (4/20 animals) respectively (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on the findings of imazapyr (acid), which was an analogous substance, in (1) to (5), it was classified as "Not classified."

[Evidence Data]
(1) For imazapyr (acid), in a dominant lethal assay with rats (up to 1,000 mg/kg/day, dosed by gavage for 5 days), negative results were reported (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013), EFSA (2014)).
(2) For imazapyr (acid), in a micronucleus test using the bone marrow cells of mice (up to 2,000 mg/kg, single oral dose), negative results were reported (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013), EFSA (2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
(3) For imazapyr (acid), in a bacterial reverse mutation assay, negative results were obtained (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013), EFSA (2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
(4) For imazapyr (acid), in a gene mutation assay using the cultured mammalian cells (CHO), negative results were obtained (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013)).
(5) For imazapyr (acid), in a chromosomal aberration assay with Chinese hamster ovary (CHO) cells, negative results were obtained (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
Based on the findings of imazapyr (acid), which was an analogous substance, in (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) For imazapyr (acid), as for the carcinogenicity classification results by domestic and international organizations, the EPA classified this substance in Group E (Evidence of Non-Carcinogenicity for Humans) (EPA OPP Annual Cancer Report 2020: classification in 1995).
(2) For imazapyr (acid), in a 2-year combined chronic toxicity/carcinogenicity study with rats (dosed by feeding), a slightly increased incidence of brain astrocytomas was observed in males of a group treated at 10,000 ppm (503/639 mg/kg/day), however, since it was not statistically significant, it was not judged to be the effect of the administration of the test substance. In addition, it was concluded that both thyroid tumors (C-cell carcinomas) in males and adrenal medullary tumors in females, for which tumorigenesis was suspected, were not the effect of the administration of the test substance. In other words, no carcinogenicity was observed in this test (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013), EFSA (2014)).
(3) For imazapyr (acid), in an 18-month carcinogenicity study with mice (dosed by feeding), an increase in neoplastic lesions by the administration of the test substance was not observed at doses up to 10,000 ppm (1,560/2,000 mg/kg/day). In other words, no carcinogenicity was observed in this test (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013), EFSA (2014)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on the findings of imazapyr (acid), which was an analogous substance, in (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) For imazapyr (acid), it was reported that, in a two-generation reproductive toxicity study (GLP) with rats dosed by feeding, no effect on fertility was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013), EFSA (2014)).
(2) For imazapyr (acid), it was reported that, in a developmental toxicity study (GLP, days 6-15 of gestation) with rats dosed by gavage, salivation (days 8-15 of gestation) was observed in parent animals at 1,000 mg/kg/day, but no effects of the administration of the test substance were observed in offspring (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)). In the assessment by the EFSA, it was reported that an increase (not significant) in post-implantation embryo loss was observed at the highest dose but no effects in fetuses were observed, and the reproduction/developmental toxicity classification was not proposed (EFSA (2014)).
(3) For imazapyr (acid), it was reported that, in a developmental toxicity study (GLP, days 6-18 of gestation) with rabbits dosed by gavage, no teratogenicity was observed (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013), EFSA (2014), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified" in the oral route and dermal route. However, based on (3), in the inhalation route, although it did not correspond to Category 1, no category could be identified, and classification was not possible.

[Evidence Data]
(1) It was reported that, in an acute oral toxicity test with rats, no effects were observed except for a decrease in motor activity at 10,000 mg/kg (in the range corresponding to "Not classified") (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
(2) It was reported that, in an acute dermal toxicity test with rats, no effects were observed at 2,000 mg/kg (in the range corresponding to "Not classified") (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).

[Reference Data, etc.]
(3) It was reported that, in an acute inhalation (dust) toxicity test with rats (4 hours), no effects were observed at 4.6 mg/L (within the range for Category 2) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2016)).
(4) For imazapyr (acid), it was reported that, in an acute oral toxicity test with rats, no effects were observed at 2,500 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA (2014)).
(5) For imazapyr (acid), it was reported that, in an acute oral toxicity test with rats, salivation (males) was observed at 5,000 mg/kg (in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA (2014), JMPR (2013)).
(6) For imazapyr (acid), it was reported that, in an acute neurotoxicity test with rats, no effects were observed at 2,000 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020)).
(7) For imazapyr (acid), it was reported that, in an acute dermal toxicity test with rats, no effects were observed at 2,000 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA (2014), JMPR (2013)).
(8) For imazapyr (acid), it was reported that, in an acute dermal toxicity test with rabbits, a slight reddening was observed at 2,000 mg/kg (within the range for Category 2) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA (2014), JMPR (2013)).
(9) For imazapyr (acid), it was reported that, in an acute inhalation (dust) exposure test with rats (GLP, 4 hours), a slight nasal discharge was observed at 1.3 mg/L (within the range for Category 2) (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA (2014), JMPR (2013)).
(10) For imazapyr (acid), it was reported that, in an acute inhalation toxicity study (mist) (OECD TG 403, GLP, 4 hours), salivation during exposure, tachypnea during and immediately after exposure, and ruffled fur immediately after to one hour after exposure were observed at 2.4 mg/L (within the range for Category 2) (REACH registration dossier (Accessed June 2021)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified" in the oral route. However, classification was not possible due to lack of data since there was not sufficient information available for classification in other routes.

[Evidence Data]
(1) It was reported that, in a 90-day oral toxicity test (GLP) with dogs dosed by feeding, no effects were observed at 10,000 ppm (288 mg/kg/day (males), 326 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), EFSA(2014)).

[Reference Data, etc.]
(2) For imazapyr (acid), it was reported that, in a 90-day oral toxicity test (GLP) with rats dosed by feeding, no effects were observed at 10,000 ppm (816 mg/kg/day (males), 940 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013)).
(3) For imazapyr (acid), it was reported that, in a 90-day oral toxicity study (GLP) with rats dosed by feeding, increases in absolute and relative kidney weight (females) were observed at 20,000 ppm (1,700 mg/kg/day (males), 1,780 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013)).
(4) For imazapyr (acid), it was reported that, in a 1-year oral toxicity test (GLP) with dogs dosed by feeding, no effects were observed at 10,000 ppm (280 mg/kg/day (males), 292 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013)).
(5) For imazapyr (acid), it was reported that, in a 2-year combined chronic toxicity/carcinogenicity study (GLP) with rats dosed by feeding, no effects were observed at 10,000 ppm (503 mg/kg/day (males), 639 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013)).
(6) For imazapyr (acid), it was reported that, in an 18-month carcinogenicity study (GLP) with mice dosed by feeding, no effects were observed at 10,000 ppm (1,560 mg/kg/day (males), 2,000 mg/kg/day (females), in the range corresponding to "Not classified") (Risk Assessment Report (Pesticide) (Food Safety Commission of Japan, 2020), JMPR (2013)).
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
Since this substance becomes imazapyr ion in water, the classification was conducted by considering the information of imazapyr (CAS RN: 81334-34-1) in addition to the information of imazapyr (isopropylamine salt). It was classified in Category 1 from 14-day ErC50 = 0.064 mg/L for aquatic plants (Lemna gibba) (test substance: imazapyr (a converted value equivalent to this substance), REACH registration dossier, 2021).
11 Hazardous to the aquatic environment Long term (Chronic) Category 1


Warning
H410 P273
P391
P501
Since this substance becomes imazapyr ion in water, the classification was conducted by considering the information of imazapyr (CAS RN: 81334-34-1) in addition to the information of imazapyr (isopropylamine salt). If chronic toxicity data are used, then it is classified as "Not classified" because it is not rapidly degradable (BIOWIN), and due to NOAEC = 52.9 mg/L for fish (Oncorhynchus mykiss) (test substance: imazapyr (a converted value equivalent to this substance), REACH registration dossier, 2021).
There is no chronic toxicity data of species that were used as the evidence for classification in acute toxicity and it is not rapidly degradable. Therefore, based on the expert judgment, it was classified in Category 1 from 14-day ErC50 = 0.064 mg/L for aquatic plants (Lemna gibba).
By drawing a comparison between the above results, it was classified in Category 1.
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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