GHS Classification Results by the Japanese Government

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GENERAL INFORMATION
Item Information
CAS RN 122008-85-9
Chemical Name Butyl (R)-2-[4-(4-cyano-2-fluorophenoxy)phenoxy]propionate; Cyhalofop-butyl
Substance ID R01-B-080
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

REFERENCE INFORMATION
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

PHYSICAL HAZARDS
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 *
-
-
- - 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 *
-
-
- - 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 (Not applicable)."
13 Oxidizing liquids *
-
-
- - Solid (GHS definition). It was classified as "Not classified (Not applicable)."
14 Oxidizing solids *
-
-
- - The substance is an organic compound containing fluorine and oxygen (but not chlorine) which are chemically bonded only to carbon or hydrogen. 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 *
-
-
- - It is a solid with a melting point of 55 deg C or lower, but the classification is not possible due to no data.
17 Desensitized explosives *
-
-
- - 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) *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats: >5,000 mg/kg (EPA Pesticide (2002), EFSA (2015), Food Sanitation Research, Vol.49, No.7 (Japan Crop Protection Association, 1999), HSDB (Access on September 2019))
1 Acute toxicity (Dermal) *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), it was classified as "Not classified."

[Evidence Data]
(1) LD50 for rats: >2,000 mg/kg (EPA Pesticide (2002), EFSA (2015), HSDB (Access on September 2019))
(2) LD50 for rats: >5,000 mg/kg (EPA Pesticide (2002))
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), it was classified as "Not classified."

[Evidence Data]
(1) LC50 for rats (a dust, 4 hours): >5.63 mg/L (EPA Pesticide (2002), EFSA (2015), HSDB (Access on September 2019))
2 Skin corrosion/irritation Category 2


Warning
H315 P302+P352
P332+P313
P362+P364
P264
P280
P321
[Rationale for the Classification]
Based on (1), it was classified in Category 2. The classification was changed because new data were obtained.

[Evidence Data]
(1) In a skin sensitization test with 3 rabbits, irritation scores at 1/24/48/72 hours were all 1-2, and the reactions remained even after 7 days. Besides, mild erythema was noted in one out of 3 rabbits after 21 days (EPA Pesticide (2002)).

[Reference Data, etc.]
(2) This substance was non-irritant (EFSA (2015)).
3 Serious eye damage/eye irritation *
-
-
- - [Rationale for the Classification]
Based on (1), it was classified as "Not classified."

[Evidence Data]
(1) This substance was non-irritant (EFSA (2015)).
4 Respiratory sensitization *
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
4 Skin sensitization *
-
-
- - [Rationale for the Classification]
Based on (1)-(3), it was classified as "Not classified."

[Evidence Data]
(1) This substance was a non-irritant and non-sensitizer (EFSA (2015)).
(2) In a skin sensitization test (maximization method) with guinea pigs, it was judged to be negative (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996)).
(3) In a skin sensitization test with guinea pigs, it was judged to be negative (EPA Pesticide (2002)).
5 Germ cell mutagenicity *
-
-
- - [Rationale for the Classification]
Based on (1) and (2), since all of the standard battery tests, including in vivo and in vitro tests, were negative, it was classified as "Not classified."

[Evidence Data]
(1) As for in vivo, there are reports of negative results in a mouse micronucleus test (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996), Food Sanitation Research, Vol.49, No.7 (Japan Crop Protection Association, 1999), HSDB (Access on September 2019)), and a negative result in a chromosomal aberration test with rodent cells (EFSA (2015)).
(2) As for in vitro, there are reports of negative results in a bacterial reverse mutation test and a mammalian cell chromosomal aberration test (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996), Food Sanitation Research, Vol.49, No.7 (Japan Crop Protection Association, 1999), HSDB (Access on September 2019), EFSA (2015)) and a negative result in a gene mutation test (HSDB (Access on September 2019)).
6 Carcinogenicity *
-
-
- - [Rationale for the Classification]
Based on classification results by other organizations in (1), it was classified as "Not classified" in accordance with the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) In classification results by domestic and international organizations, it was classified as NL (Not Likely to be Carcinogenic to Humans) by EPA (EPA Annual Cancer Report (2018): classified in 2007).

[Reference Data, etc.]
(2) In a combined chronic toxicity/carcinogenicity study with mice dosed this substance by feeding for 18 months, no carcinogenicity was observed (Food Sanitation Research, Vol.49, No.7 (Japan Crop Protection Association, 1999)).
(3) In a combined chronic toxicity/carcinogenicity study with rats dosed this substance by feeding for 24 months, no carcinogenicity was observed (Food Sanitation Research, Vol.49, No.7 (Japan Crop Protection Association, 1999)).
7 Reproductive toxicity *
-
-
- - [Rationale for the Classification]
Based on (1)-(3), it was classified as "Not classified."

[Evidence Data]
(1) In a two-generation reproductive toxicity study with rats dosed by feeding, no effects on pups and fertility were observed at doses where parental animals showed effects on the liver and kidney (increased liver weight and hepatocyte hypertrophy in both sexes, increased kidney weight and enlargement of renal tubular epithelium in males) (EFSA (2015), Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996)).
(2) In a developmental toxicity test with rats dosed by gavage, no effects on fetuses were observed at doses where maternal toxicity (reduced body weight gain, decreased food consumption) was observed (EFSA (2015), Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996)).
(3) In a developmental toxicity test with rabbits dosed by gavage, an increased incidence of skeletal variations (lumber limbs) was noted in fetuses at doses where maternal toxicity (death (no description of the number of animals), hematuria and opacity of the kidney) was observed, but this was within historical data (EFSA (2015), Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996)).
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 2 (liver, gallbladder, kidney)


Warning
H373 P260
P314
P501
[Rationale for the Classification]
Based on (1)-(4), since effects on the liver, gallbladder and kidney were noted in experimental animals at doses within the range of Category 2, it was classified in Category 2 (liver, gallbladder, kidney). The classification result was changed from the previous classification by the use of new information sources.

[Evidence Data]
(1) Lowered urinary pH, decreased ketones, increased liver weight in males, and increased kidney weight in females at or above 30 ppm (a converted guidance value: 4.5 mg/kg/day, within the range of Category 1), liver enlargement and darkening, hypertrophy of hepatocytes in both sexes, and increased liver weight and enlargement of the proximal renal tubules in females at or above 100 ppm (a converted guidance value: 15 mg/kg/day, within the range of Category 2), and hepatocyte necrosis in males at 300 ppm (a converted guidance value: 45 mg/kg/day, within the range of Category 2) were seen in a 3-month repeated dose toxicity study with mice by feeding (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996)).
(2) Hypertrophy of hepatocytes in males at or above 300 ppm (a converted guidance value: 15 mg/kg/day, within the range of Category 2), enlarged liver and darkening of the liver and kidney in both sexes and enlargement of hepatocytes in females at or above 1,000 ppm (a converted guidance value: 50 mg/kg/day, within the range of Category 2), and brown pigment deposition in the tubular epithelium and decreased eosinophilic bodies in the epithelium in the kidney in both sexes at 3,000 ppm (a converted guidance value: 150 mg/kg/day, above the range of Category 2) were observed in a three-month repeated dose toxicity study with rats by feeding (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996)).
(3) Gallbladder distention in females at or above 500 ppm (a converted guidance value: 12.5 mg/kg/day, within the range of Category 2), increased total bilirubin, an eosinophilic change of hepatocyte cytoplasm and hyaline droplet degeneration of the renal tubular epithelium in both sexes, increased relative liver weight and gallbladder distention in males and decreased absolute and relative thymus weights, etc. in females at a dose of 2,500 ppm (a converted guidance value: 62.5 mg/kg/day, within the range of Category 2) were observed in a repeated dose toxicity study with dogs by feeding (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996)).
(4) An eosinophilic change of hepatocyte cytoplasm and hyperplasia of the gallbladder epithelium accompanied with mucus secretion in both sexes, hypertrophy of the thyroid follicular epithelium and so on in females were abserved at 1,800 ppm (a converted guidance value: 45 mg/kg/day, within the range of Category 2) in a 12-month repeated dose toxicity study by feeding (Agricultural Chemicals Times supplement "Agricultural chemicals technology information," No.22 (Japan Crop Protection Association, 1996)).
10 Aspiration hazard *
-
-
- - [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 96-hour LC50 = 0.93 mg/L for fish (Lepomis macrochirus) (U.S.EPA: OPP Pesticide Ecotoxicity Database, 2020).
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
-
-
- - Classification not possible due to lack of data.


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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