GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 110956-75-7
Chemical Name 3-[4-Chloro-5-(cyclopentyloxy)-2-fluorophenyl]-5-(1-methylethylidene)-2,4-oxazolidinedione; Pentoxazone
Substance ID R02-A-018-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 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) 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.
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 information that it degenerates at around 230 deg C (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not 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). It was classified as "Not classified."
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Solid (GHS definition). It was classified as "Not classified."
14 Oxidizing solids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing fluorine, chlorine, and oxygen, which are chemically bonded only to carbon or hydrogen. 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).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009))
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) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LC50 for rats (4 hours): > 5.1 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009))
2 Skin corrosion/irritation Classification not possible
-
-
- - [Rationale for the Classification]
There is a description in (1) with only data on preparations. Therefore, the classification is not possible due to lack of data.

[Reference Data, etc.]
(1) No irritation was observed in skin irritation tests with rabbits on 8.6% wettable powder and 1.5% powder of this substance (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
3 Serious eye damage/eye irritation Classification not possible
-
-
- - [Rationale for the Classification]
There is a description in (1) with only data on preparations. Therefore, the classification is not possible due to lack of data.

[Reference Data, etc.]
(1) No irritation was seen in an eye irritation test with rabbits on 8.6% wettable powder of this substance. However, in a test on 1.5% powder, findings such as conjunctival redness, edema, and corneal opacity were observed but disappeared by 4 days after application (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization Category 1B


Warning
H317 P302+P352
P333+P313
P362+P364
P261
P272
P280
P321
P501
[Rationale for the Classification]
It was classified in Category 1B from (1).

[Evidence Data]
(1) In a skin sensitization test with guinea pigs (maximization test, intradermal administration 2.5%) on this substance, reactions were seen in about half of the animals, and it was judged as positive for sensitization (positive rate 65%) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).

[Reference Data, etc.]
(2) No sensitization was observed in skin sensitization tests with guinea pigs (Buehler tests) on 8.6% wettable powder and 1.5% powder of this substance (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, in a micronucleus test using the bone marrow cells after intraperitoneal injection or oral administration to mice, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)). In a comet assay using the urinary bladder and a micronucleus test using the bone marrow cells of rats dosed by feeding for 4 weeks, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
(2) As for in vitro, in a bacterial reverse mutation test, negative results were reported, and in an in vitro mammalian cell chromosome aberration test, positive results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
6 Carcinogenicity Category 2


Warning
H351 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
There are no classification results by domestic and international organizations. There was no report available on humans. Based on (1) to (3), it was classified in Category 2.

[Evidence Data]
(1) In a two-year combined chronic toxicity/carcinogenicity study with male and female rats dosed by feeding, a significant increase in the incidence of transitional epithelium papilloma of the urinary bladder was observed in female rats (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
(2) In an 18-month carcinogenicity study with male and female mice dosed by feeding, no carcinogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
(3) A test for clarifying the nature and the mechanism of development of hyperplastic changes of the urinary bladder mucosa epithelium was carried out. As a result, it was considered that the changes in the urinary bladder mucosa due to this substance were not caused by the changes in the urine nature or mutagenicity of the metabolites in urine (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
7 Reproductive toxicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), it was classified as "Not classified."

[Evidence Data]
(1) In a two-generation reproduction study with rats dosed by feeding, at doses at which toxicity in parent animals (increases in absolute and relative kidney weight, etc. in males, reduced body weight gain, etc. in females) was observed, low body weights were observed in offspring on postnatal day 21, but no effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
(2) In a developmental toxicity study with female rats dosed by gavage on days 6-15 of gestation, no effect was observed in maternal animals and fetuses even at the highest dose of 1,000 mg/kg/day (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
(3) In a developmental toxicity study with female rabbits dosed by gavage on days 6-18 of gestation, no effect was observed in fetuses even at doses at which maternal toxicity (death (2/18 cases), abortion and premature delivery) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
8 Specific target organ toxicity - Single exposure Not classified
-
-
- - [Rationale for the Classification]
There was no report on acute exposure effects of this substance in humans. In experimental animals, based on (1) to (3), there were no findings by which target organs could be identified in any of the tests in the oral, dermal, and/or inhalation routes. Therefore, it was classified as "Not classified."

[Evidence Data]
(1) In an acute oral toxicity test with rats, no deaths or symptoms were observed at 5,000 mg/kg (exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
(2) In an acute dermal application test with rats, no deaths or symptoms were observed at 2,000 mg/kg (upper limit of Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
(3) In a 4-hour inhalation exposure test (systemic exposure) with rats, at 5.1 mg/L (exceeding Category 2), no deaths or symptoms were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
There was no report on repeated exposure to this substance in humans. In a test in the oral route with test animals, based on (1) to (3), there were no toxicity findings by which target organs could be identified at doses within the range for Category 1 and Category 2, and therefore, it was considered to be "Not classified" in the oral route. However, since there was no information on toxicity in the other routes, it was determined that classification was not possible.

[Evidence Data]
(1) It was reported that in a 90-day test with rats dosed by feeding, an increase in relative liver weight and bile duct proliferation were observed in females at or above 2,000 ppm (males/females: 117/129 mg/kg/day, exceeding Category 2 in both cases) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
(2) It was reported that in a 90-day test with mice dosed by feeding, deposit of eosinophilic bodies of the urinary bladder mucosa epithelium was observed in females at or above 2,000 ppm (males/females: 251/271 mg/kg/day, exceeding Category 2 in both cases) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
(3) It was not reported that in 90-day to two-year tests with rats, mice, and dogs dosed by feeding, findings of toxicity were observed within the range for Category 1 or Category 2 (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2009)).
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 EC50 = 0.51 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2009)).
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 is not rapidly degradable (BIOWIN), 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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