GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 105024-66-6
Chemical Name Dimethyl(4-ethoxyphenyl)[3(4-fluoro-3-phenoxyphenyl)propyl]silane; Silafluofen
Substance ID R02-A-024-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)
-
-
- - Liquid (GHS definition)
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products.
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
6 Flammable liquids Classification not possible
-
-
- - No data available.
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
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 Classification not possible
-
-
- - No data available.
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
11 Self-heating substances and mixtures Classification not possible
-
-
- - Test methods applicable to liquid substances are not available.
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified
-
-
- - It contains a metalloid (Si), but it is estimated that it does not react vigorously with water from measured data: water solubility of 1 microg/L (20 deg C) (Document by the Ministry of the Environment (2020)).
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - The substance is an organic compound containing fluorine and oxygen (but not chlorine), which are chemically bonded only to carbon.
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition)
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
-
-
- - No data 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: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
1 Acute toxicity (Dermal) Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) LD50 for rats: > 5,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
(2) LD50 for rabbits: > 4,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
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). Besides, because the exposure concentration exceeded the saturated vapor pressure concentration (4.12*10-7 mg/L), it was judged as a test on mist.

[Evidence Data]
(1) LC50 for rats (4 hours): > 6.61 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012))
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 primary skin irritation test with rabbits (n = 6) (GLP, 4-hour application, 72-hour observation), all the animals showed very slight to clear erythema 30-60 minutes after the end of application but fully recovered after 72 hours (erythema score: 0.3/0/0.7/0/0.3/0, edema score: 0/0.3/0/0/0/0) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), 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).

[Reference Data, etc.]
(1) It is reported that in a primary eye mucosa irritation test with rabbits (n = 9) (GLP, 72-hour observation), the mean score after 24/48/72 hours was 0 for corneal opacity, 0 for iritis, 0.33 for conjunctival redness, and 0 for chemosis in the group whose eyes were washed after 1 minute (n = 3), and the mean score after 24/48/72 hours was 0 for corneal opacity, 0 for iritis, 0.67 for conjunctival redness, and 0 for chemosis in the group whose eyes were washed after 24 hours (n = 6). These changes were fully reversible within 72 hours (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), 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 Not classified
-
-
- - [Rationale for the Classification]
It was classified as "Not classified" from (1), (2).

[Evidence Data]
(1) It is reported that in a Buehler test with guinea pigs (n = 20) (GLP, topical administration: undiluted), no skin sensitization was seen (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(2) It is reported that in a maximization test with guinea pigs (n = 20) (GLP, intradermal administration: 5% solution), no skin sensitization was found (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), 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 (4), it was classified as "Not classified."

[Evidence Data]
(1) In a micronucleus test with mouse bone marrow cells (OECD TG475), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(2) In a chromosomal aberration test with hamster bone marrow cells (OECD TG474), negative results were obtained (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(3) In a bacterial reverse mutation test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013).
(4) In an in vitro mammalian chromosomal aberration test, negative results were reported (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).

[Reference Data, etc.]
(5) It was considered that this substance has no genotoxicity (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
6 Carcinogenicity Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (2), it was classified as "Not classified."

[Evidence Data]
(1) In a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding (OECD TG453), no treatment-related increase in the incidence of neoplastic lesions was observed at doses of up to 20,000 ppm. Therefore, no carcinogenicity was observed in male and female rats (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(2) In a two-year carcinogenicity study with mice dosed by feeding (OECD TG453), higher incidences of alveolar adenoma in females at 3,500 ppm and bronchiolar adenoma and bronchiolar/alveolar cancer in males at 7,000 ppm were observed. However, the tumors found were considered not treatment-related because there was no dose-relationship, or the incidences were within the range of the background tumor incidence data. Therefore, carcinogenicity was not observed in male and female mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).

[Reference Data, etc.]
(3) There are no classification results for carcinogenicity by domestic and international organizations.
7 Reproductive toxicity Category 1B


Danger
H360 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 1B.

[Evidence Data]
(1) It was reported that in a two-generation reproduction toxicity study with rats dosed by feeding, general toxicity effects (testicular toxicity (such as seminiferous tubule atrophy associated with decreased sperms and exfoliation of seminiferous tubule epithelial cells to the epididymis) (males), reduced food consumption (females)), reduced fertility (males) and decreases in fertility index, fertility rate, and the average number of neonates per litter (females) were observed in parental animals at 5,000 ppm (highest dose), while an increase in the number of stillborn pups per litter and reduced food consumption (females) were observed in F1 parental animals at 2,000 ppm (highest dose) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(2) It was reported that in a developmental toxicity study with rabbits dosed by gavage, a slight decrease of food consumption and increased resorption were observed in parental animals and increased incidences of the 13th rib were observed in pups both at 1,000 mg/kg/day (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).

[Reference Data, etc.]
(3) It was reported that in a developmental toxicity study with rats dosed by gavage, no teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012)).
(4) In EU, it was classified in Repr. 1B (CLP classification (Accessed May 2020)).
8 Specific target organ toxicity - Single exposure Not classified
-
-
- - [Rationale for the Classification]
Based on (1) to (5), it was classified as "Not classified."

[Evidence Data]
(1) It was reported that in an acute oral toxicity test with rats dosed by gavage (GLP), reduced spontaneous activity, crouching posture and contraction of the lateral abdomen were observed at 5,000 mg/kg (in the range corresponding to “Not classified”) but all the symptoms regressed within 24 hours (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(2) It was reported that in an acute oral toxicity test with mice dosed by gavage (GLP), reduced spontaneous activity was observed at 5,000 mg/kg (in the range corresponding to “Not classified”) but the symptom regressed within two hours after the administration (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(3) It was reported that in an acute dermal toxicity test with rats (GLP), no effects were observed at 5,000 mg/kg (in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(4) It was reported that in an acute dermal toxicity test with rabbits (GLP), no effects other than erythema at the treated areas were observed at 4,000 mg/kg (in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(5) It was reported that in an acute oral toxicity test with rats exposed by inhalation (mist) (GLP, for 4 hours), irregular breathing was observed at 6.61 mg/L (in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
9 Specific target organ toxicity - Repeated exposure Category 2 (liver, reproductive organs (male))


Warning
H373 P260
P314
P501
[Rationale for the Classification]
Based on (1) to (3) in the oral route, it was classified in Category 2 (liver, reproductive organs (male)).

[Evidence Data]
(1) It was reported that in a 90-day oral toxicity test with dogs dosed by feeding (GLP), diarrhea, increased absolute/relative liver weight and an increase in ALP (males) were observed at 320 ppm (24.1 mg/kg/day (males), 21.5 mg/kg/day (females), within the range for Category 2); diarrhea, reduced body weight gain, increased absolute/relative liver weight, an increase in ALP (females) and a decrease in Cre/Glu/TP were observed at 1,600 ppm (120.5 mg/kg/day (males), 107.5 mg/kg/day (females), in the range corresponding to “Not classified”); and diarrhea, a tendency of reduced body weight gain, transient reduced food consumption (one male and one female), increased absolute/relative liver weight, an increase in ALT/AST and a decrease in Cre/Glu/TP were observed at 8,000 ppm (602.5 mg/kg/day (males), 537.5 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(2) It was reported that in a one-year oral toxicity test with dogs dosed by feeding (GLP), a decrease in RBC/Hb/Ht (males), diarrhea, reduced body weight gain and increased relative liver weight were observed at 320 ppm (23.7 mg/kg/day (males), 21.4 mg/kg/day (females), within the range for Category 2); a decrease in RBC/Hb/Ht and an increase in AST/ALP were observed at 1,600 ppm (129.4 mg/kg/day (males), 114.7 mg/kg/day (females), in the range corresponding to “Not classified”); and death due to production of liver connective tissue and hepatic failure (one male), liver fibrosis (females), cachexia (females), production of liver connective tissue, and bile duct hyperplasia were observed at 8,000 ppm (592.0 mg/kg/day (males), 575.2 mg/kg/day (females). in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(3) It was reported that in a two-year oral toxicity test with rats dosed by feeding (GLP), centrilobular hepatocyte hypertrophy, degeneration of seminiferous tubules in the testis/inhibition of spermatogenesis/a decrease in epididymal sperms (males) and an increase in relative liver weight (females) were observed at and above 2,000 ppm (101 mg/kg/day (males), 130 mg/kg/day (females), in the vicinity of the upper limit of Category 2); and reduced body weight gain, decreased food consumption, an increase in absolute specific liver weight (females), increased liver specific weight (males), symptoms (hunched posture, emaciation, colored liquid discharge from nostrils, loose stool), decreased absolute and specific testis weights, atrophy of epididymal epithelial cells, seminiferous tubule atrophy (males), and foamy alveolar macrophage (females) were observed at 10,000 ppm (500 mg/kg/day (males), 661 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).

[Reference Data, etc.]
(4) It was reported that in a 90-day oral toxicity test with rats dosed by feeding (GLP), increases in absolute/relative liver weight, decreases in RBC/Ht (males) were observed at 10,000 ppm (827.4 mg/kg/day (males), 819.3 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center), etc. (2013)).
(5) It was reported that in a 90-day oral toxicity test with mice dosed by feeding (GLP), increases in absolute/relative liver weight, decreases in RBC/Hb/Ht (males) and increases in reticulocyte/platelet counts (males) were observed at 10,000 ppm (1,668 mg/kg/day (males), 2,003 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(6) It was reported that in a two-year oral toxicity test with mice dosed by feeding (GLP), increases in absolute/relative liver weight, hepatocellular hypertrophy, and reduced body weight gain (males) were observed at 3,500 ppm (615 mg/kg/day (males), 728 mg/kg/day (females), in the range corresponding to “Not classified”); and a slight increase in mortality, symptoms (abnormal posture, reduced activity: males), and hepatocellular hypertrophy (females) were observed at 1,271 mg/kg/day (in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2013)).
(7) It was reported that in a one-year toxicity test with dogs dosed by feeding (GLP), there was one case of sacrifice in extremis (female) at 60 ppm (4.7 mg/kg/day (males), 4.5 mg/kg/day (females), within the range for Category 1); and two cases of sacrifice in extremis (pallor of muscles) (females), decreases in RBC/Hb/Ht (females), a tendency of decreases in RBC/Hb/Ht (males) and increases in platelet count/ALP were observed at 1,600 ppm (124.6 mg/kg/day (males), 119.0 mg/kg/day (females), in the range corresponding to “Not classified”) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2012), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 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
It was classified in Category 1 from 48-hour EC50 = 0.00067 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 = 0.0177 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 = 0.00067 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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