GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 560121-52-0
Chemical Name (E)-2-[4-(tert-Butyl)phenyl]-2-cyano-1-(1,3,4-trimethyl-1H-pyrazol-5-yl)vinyl 2,2-dimethylpropanoate; Cyenopyrafen
Substance ID R02-A-046-METI, MOE
Classification year (FY) FY2020
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
-
-
- - 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).
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]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) LD50 for rats (females): > 5,000 mg/kg (OECD TG 423, GLP) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))

1 Acute toxicity (Dermal) 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, 2019))

1 Acute toxicity (Inhalation: Gases) Not classified
-
-
- - [Rationale for the Classification]
Liquid (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): > 5.01 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019))

2 Skin corrosion/irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in a skin irritation test with rabbits (n = 3) (GLP, semi-occlusive, 4-hour application, 72-hour observation), no irritation changes were observed in any animal (erythema/eschar score: 0/0/0, edema score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2013), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
3 Serious eye damage/eye irritation Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1).

[Evidence Data]
(1) It is reported that in an eye irritation test with rabbits (n = 3) (GLP, 8-day observation), all the animals showed conjunctival redness at 1 hour after application, and it temporarily disappeared after 24 hours but appeared again after 48, 72 hours in 1 animal. Conjunctival redness persisted for 24 hours in the other 2. No irritation changes were seen in any animal after 8 days (corneal opacity score: 0/0/0, iritis score: 0/0/0, conjunctival redness score: 0.3/0.7/0.3, chemosis score: 0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
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 is reported that in a maximization test with guinea pigs (n = 20) (GLP, intradermal administration: 4% solution), the positive rates of the 0.5% challenge group and the 5% challenge group were 95% and 100% (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013), Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) It is reported that in a local lymph node assay with mice (n = 5/group) (LLNA) (GLP), stimulation index (SI values) was 7.4 (10%), 4.3 (25%), 3.3 (50%) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
5 Germ cell mutagenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (6), it was classified as "Not classified."

[Evidence Data]
(1) In a micronucleus test using the bone marrow from mice (GLP, oral administrations), the substance was negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(2) In a comet assay (oral dose) with the uterine cells and hepatocytes as the target organs, the substance was negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) In a UDS test with the hepatocytes of rats (GLP), which was carried out as an in vivo/in vitro assay, the substance was negative (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(4) In a bacterial reverse mutation test (GLP), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(5) In a mammalian cell gene mutation test (GLP), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(6) In a chromosomal aberration test with human lymphocytes (GLP), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 1B. In female rats in (1), an increase in the incidence of endometrial adenocarcinoma associated with the dose was observed, the incidence of endometrial adenocarcinoma was as high as 16/50, and it was considered to be the effect of the administration of this substance. The evidence of carcinogenicity was not observed in male rats and male and female mice.

[Evidence Data]
(1) In a 2-year chronic toxicity/carcinogenicity study with rats (GLP, dosed by feeding), in the group at or above 10,000 ppm, an increase in the total frequency of adenoma and adenocarcinoma of the endometrium (7/50) was observed; and at 20,000 ppm, an increase in the incidence frequency of endometrial carcinoma (16/50) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(2) In an 18-month carcinogenicity study with mice (GLP), at a dose of up to 8,000 ppm, there was no increase in neoplastic lesions associated with the treatment, and carcinogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).

[Reference Data, etc.]
(3) In a uterine hypertrophy test, no estrogen effect was observed, and in a 28-day toxicity test with rats, no effect on sex hormone was observed. Meanwhile, in a liver drug metabolizing enzyme induction test, induction of various CYP was observed, and a significant increase in the estradiol hydroxylase activities, which was considered to be derived from the above, was observed. Since an increase in the estradiol 4-hydroxylase activities, which generated 4-hydroxide estradiol that showed stronger carcinogenicity of the uterus than estradiol, was observed, an increased estrogen metabolic activity in the liver, especially the involvement of 4-hydroxide estradiol was suggested as a factor of the mechanism of tumor formation (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) to (3), it was classified in Category 2.

[Evidence Data]
(1) In a two-generation reproduction toxicity study with rats dosed by feeding (GLP), at 1,500 ppm, increases in absolute and relative weight of the adrenal gland (P female) in parent animals, and a delay in preputial separation (male) in F1 offspring were observed; and at 7,500 ppm, increases in absolute and relative weight of the adrenal gland (P female), inhibition of body weight gain, a decrease in food consumption (P male/female), a decrease in feed efficiency (P male), loss of fur, decreases in absolute and relative weight of the ovary (P female), an extension of the estrus cycle and an extension of the period of living together before mating, a shortening of the gestation period, and a decrease in the number of implantations in parent animals; and a decrease in the number of litters, low body weight at birth, and inhibition of body weight gain in F1 offspring were observed. F1 offspring were slaughtered because growth impairment, serious clinical signs, and a significant decrease in weight gain were observed after weaning. It was reported that because of the above, assessment could not be carried out for the F1 generation and subsequent generations at 7,500 ppm (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(2) It was reported that in a developmental toxicity study with rats dosed by gavage (GLP, days 6 to 19 of gestation), at 1,000 mg/kg/day, low body weight (male) in offspring was observed, but teratogenicity was not observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(3) It was reported that in a developmental toxicity study with rabbits dosed by gavage (GLP, days 6 to 27 of gestation), no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
8 Specific target organ toxicity - Single exposure Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (3), in any of the oral, dermal, and inhalation routes, the target organ toxicity was considered not to occur within the dose range for Category 1 and Category 2, and it was classified as "Not classified."

[Evidence Data]
(1) It was reported that in an acute oral toxicity test with rats (OECD TG 423, GLP), at 5,000 mg/kg (in the range corresponding to "Not classified"), there was no death, and piloerection was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) It was reported that in an acute dermal toxicity test with rats, no symptom nor death was observed at 5,000 mg/kg (in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) It was reported that in an acute inhalation (dust, mist) exposure test with rats (4 hours), at 5.01 mg/L (in the range corresponding to "Not classified"), there was no death, and slight symptoms (discharges (chromodacryorrhea, and reddish nasal discharge)), and moist fur and soiled fur were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
9 Specific target organ toxicity - Repeated exposure Classification not possible
-
-
- - [Rationale for the Classification]
Based on (1) to (6), in the oral and dermal routes, the target organ toxicity was not observed within the dose range for Category 1 and Category 2, therefore, it was classified as "Not classified." However, classification was not possible due to lack of data since there was not sufficient toxicity information available for classification in the inhalation route.

[Evidence Data]
(1) It was reported that in a 90-day oral toxicity test with rats dosed by feeding (GLP), at or above 5,000 ppm (409 mg/kg/day (male), 465 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the thyroid, liver, and kidney were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(2) It was reported that in a 90-day oral toxicity test with dogs dosed by gavage (GLP), at a maximum dose of 300 mg/kg/day (in the range corresponding to "Not classified"), no finding of the toxicity associated with the administration was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(3) It was reported that in a 21-day dermal toxicity test with rats (GLP), at or above 1,000 mg/kg/day (converted guidance value: 233 mg/kg/day, in the range corresponding to "Not classified"), inhibition of body weight gain and a decrease in feed efficiency were observed in males, but specific target organ toxicity was not observed in both males and females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(4) It was reported that in a 1-year chronic toxicity study with dogs dosed by gavage (GLP), at or above 400 mg/kg/day (in the range corresponding to "Not classified"), effects on the hematology (finding of anemia) were observed in females (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(5) It was reported that in a 2-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (GLP), at or above 2,000 ppm (104 mg/kg/day (male), 140 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the thyroid, liver, and kidney were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
(6) It was reported that in an 18-month carcinogenicity study with mice dosed by feeding (GLP), at or above 4,000 ppm (465 mg/kg/day (male), 581 mg/kg/day (female), in the range corresponding to "Not classified"), effects on the liver were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2019)).
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 = 0.00294 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
11 Hazardous to the aquatic environment Long term (Chronic) Category 1


Warning
H410 P273
P391
P501
If chronic toxicity data are used, then it is classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 72-hour NOErC = 0.03 mg/L for algae (Raphidocelis subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 1 because it is not rapidly degradable (BIOWIN) and due to 48-hour EC50 = 0.00294 mg/L for crustacea (Daphnia magna) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
From 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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