NITE - Chemical Management Field

GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	131341-86-1
Chemical Name	Fludioxonil
Substance ID	R01-A-020
Classification year (FY)	FY2019
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 (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)
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	*	- -	-	-	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 associated with explosive or self-reactive properties present in the molecule. 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	*	- -	-	-	No data 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	*	- -	-	-	Classification is not possible because test methods applicable to solid substances are not available.
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 (ACGIH (7th, 2018), JMPR (2004)), male: >5,000 mg/kg, female: >5,000 mg/kg (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rats: >2,000 mg/kg (ACGIH (7th, 2018), JMPR (2004)), male: >2,000 mg/kg, female: >2,000 mg/kg (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017)).
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), since it was impossible to determine the category, it was classified as "Classification not possible." [Evidence Data] (1) LC50 (4 hours) for rats: >2.6 mg/L (ACGIH (7th, 2018), JMPR (2004)), >2.64 mg/L (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017)).
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Based on (1)-(3), it was classified as "Not classified." [Evidence Data] (1) In rabbits, this substance was a slight eye irritant with mild changes reversing within 24 hours and was nonirritating to the skin (ACGIH (7th, 2018)). (2) Among two skin irritation tests in which this substance was applied semi-occlusively to the skin of rabbits, in one test, slight erythema by 48 hours and slight edema after 1 hour were observed, and the mean score at 24/48 hours was 0.66. In the other test, no skin effects were observed. In both tests, this substance was judged to be not irritating to the skin (JMPR (2004)). (3) Slight eye irritation occurred in some experimental animals following exposure to this substance. No skin irritation or skin sensitization occurred, however (HSDB (Access on July 2019)). [Reference Data, etc.] (4) In a skin irritation test in which the preparation of this substance was applied to rabbits, slight erythema and edema were observed 1 hour after removal of the patches. Edema and erythema however disappeared after 24 hours and 72 hours, respectively. Based on these results, it was considered that this substance was a not a skin irritant (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017)).
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	[Rationale for the Classification] Based on (1)-(4), it was classified in Category 2B. [Evidence Data] (1) In an eye irritation test in which this substance was applied to rabbits, no damage to the cornea was observed, however, redness of the iris and conjunctiva and conjunctival edema were observed, and the mean scores at 24/48/72 hours were 6.8/3.7/0.7, and all symptoms disappeared after 96 hours (JMPR (2004)). (2) In rabbits, this substance was a slight eye irritant with mild changes reversing within 24 hours and was nonirritating to the skin (ACGIH (7th, 2018)). (3) In an eye irritation test in which this substance was applied to rabbits, slight conjunctival redness was observed but disappeared by 48 hours. Slight conjunctival edema was also observed but disappeared after 24 hours. Since no other findings were observed, this substance was judged to be a slight irritant (JMPR (2004)). (4) Slight eye irritation occurred in some experimental animals following exposure to this substance, however, no skin irritation or skin sensitization occurred (HSDB (Access on July 2019)). [Reference Data, etc.] (5) In an eye irritation test in which the preparation of this substance was applied to rabbits, slight redness and edema of the conjunctiva were observed 1 hour post-application but disappeared after 48 hours. Based on these results, it was considered a no irritant to the eyes (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017)).
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) No evidence of sensitization was seen in guinea pigs treated dermally with this substance (ACGIH (7th, 2018)). (2) In a skin sensitization test (maximization method) with guinea pigs, no sensitizing effects were observed (JMPR (2004)). (3) Slight eye irritation occurred in some experimental animals following exposure to this substance, however, no skin irritation or skin sensitization occurred (HSDB (Access on July 2019)). [Reference Data, etc.] (4) In a skin sensitization test (maximization method) with guinea pigs, no sensitizing effects were observed (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] Based on (1) and (2), because all standard combination tests, including in vivo and in vitro tests, were negative, it was classified as "Not classified." [Evidence Data] (1) As for in vivo, negative results are reported in a dominant lethal test, a micronucleus test and a chromosomal aberration test with rodents (JMPR (2004), ACGIH (7th, 2018)). (2) As for in vitro, negative results in a bacterial reverse mutation test and a mammalian cell unscheduled DNA synthesis test, on the other hand, a positive result in a mammalian cell chromosomal aberration test, were reported (JMPR (2004), ACGIH (7th, 2018)). (3) Food Safety Commission of Japan concluded that this substance was considered not to be genotoxic in vivo for the following reasons. An in vitro chromosomal aberration test was positive, however, both an in vivo chromosomal aberration test and an in vivo micronucleus test with the bone marrow or liver were negative, and all other in vivo tests were negative (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017)).
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on the latest classification results among those in (1), it was classified in Category 2 in accordance with the GHS Classification Guidance for the Japanese Government. [Evidence Data] (1) As for classification results by domestic and international organizations, it was classified as A3 by ACGIH (ACGIH (7th, 2018)), and in D by EPA (EPA Annual Cancer Report (2018); classified in 1996). [Reference Data, etc.] (2) The risk assessment report (Pesticides and Additives) (Food Safety Commission of Japan, 2017) states that this substance was not carcinogenic.
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 test with rats by feeding, reduced body weight gain and decreased food consumption in parental animals, and reduced body weight gain in pups were observed, however, no reproductive effects were observed (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017), JMPR (2004)). (2) In a developmental toxicity test with female rats dosed by gavage on gestational days 6-15, no effects on fetuses were observed even at the dose where reduced body weight gain and decreased food consumption were observed in parental animals (Evaluation Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017), JMPR (2004)). (3) In a developmental toxicity test with female rabbits dosed by gavage on gestational days 6-19, no effects on fetuses were observed even at the dose where reduced body weight gain and decreased food consumption were observed in parental animals (Evaluation Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017), JMPR (2004)).
8	Specific target organ toxicity - Single exposure	*	- -	-	-	[Rationale for the Classification] There was no information on single exposure to this substance in humans. Based on (1)-(3), since there were no findings that enable identification of target organs observed in toxicity tests with experimental animals in any administration route (oral, dermal and inhalation), it was classified as "Not classified." [Evidence Data] (1) In a single oral dose toxicity test with rats, the only observed effect was loose stool at 5,000 mg/kg (exceeding the range for Category 2), and no fatalities and no specific changes at necropsy were observed (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). (2) In a single dermal administration toxicity test with rats, piloerection, crouching posture, dyspnea and reduced body weight gain were observed at 2,000 mg/kg (upper limit of the range for Category 2), however, there were no fatal cases, and nor specific changes were observed at necropsy (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). (3) In a 4-hour single exposure inhalation test with rats, piloerection, crouching posture, dyspnea and reduced body weight gain were observed at 2.64 mg/L of the aerosol of this substance (corresponding to Category 2, described as the highest possible concentration of aerosol to be generated), however, no fatal cases were observed, and nor specific changes were observed at necropsy (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)). [Reference Data, etc.] (4) In an acute neurotoxicity test with rats by single oral administration, only reduced spontaneous motor activity was observed at up to 2,000 mg/kg, the maximum dose (upper limit of the range for Category 2), and no other obvious acute neurotoxicity was observed (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017)). (5) In a general pharmacological test with mice by single oral administration, tremors, reduced reactivity, abnormal gait, reduced extremity muscle tension and loss of righting reflex were observed at 3,000 mg/kg (exceeding the range for Category 2) (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1), in oral administration tests, it was classified as "Not classified." Besides, as for other administration routes, it was classified as "Classification not possible" due to lack of data. [Evidence Data] (1) Repeated dose toxicity tests for 90 days by feeding with rats, mice and dogs, a 1-year repeated dose toxicity test with dogs by feeding, a 2-year combined chronic toxicity/carcinogenicity test with rats by feeding, an 18-month repeated dose toxicity test with mice by feeding and a 28-day transdermal administration toxicity test with rats, etc. were conducted. The main effects were observed on the liver (hepatocyte hypertrophy, etc.), kidney (chronic nephropathy (rats), nephropathy, etc. (mice) and blood (anemia)). All these effects were observed at doses exceeding the range of Category 2 (Risk Assessment Report (Pesticides and Additives) (Food Safety Commission of Japan, 2017)). [Reference Data, etc.] (2) The test data in (1) were also cited in ACGIH (7th, 2018) and JMPR (2004). (3) According to ACGIH (7th, 2018), in a 1-year repeated dose toxicity test with dogs in (1) by feeding, reduced body weight gain in females at 35.5 mg/kg/day was confirmed. Based on NOAEL (3.3 mg/kg/day) determined from this evidence, a TLV-TWA (1 mg/m3) which was converted from the oral route to the inhalation route was proposed.
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 = 0.31 mg/L for fish (Lepomis macrochirus) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)).
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	It was classified in Category 1 due to being not rapidly degradable (BIOWIN), and 72-hour NOErC = 0.014 mg/L for algae (Pseudokirchneriella subcapitata) (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2017)).
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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