NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	36734-19-7
Chemical Name	iprodione (ISO); 3-(3,5-dichlorophenyl)-2,4-dioxo-N-isopropylimidazolidine-1-carboxamide
Substance ID	m-nite-36734-19-7_v1
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified (Not applicable)	- -	-	-	There are no chemical groups associated with explosive properties present in the molecules.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Its autoignition point is higher than 70degC (autoignition point: ca. 150-200degC (1013 hPa), IUCLID (2000)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to solid (melting point <= 140degC) substances are not available. (melting point: 134degC, Ullmanns (E) (6th, 2003))	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
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).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Organic compounds containing chlorine and oxygen (but not fluorine), which are chemically bonded only to carbon or hydrogen.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available. Non-corrosive to metals (HSDB (2003)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	Since its rat LD50 values documented are > 2000 (OECD TG 401) and 3700 mg/kg (JMPR (1992)), the substance was classified into "Not classified" using the JIS classification criteria (Category 5 or "Not classified" in the United Nations classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on its rat LD50 of > 2000 mg/kg (EPA TG 81-2) (JMPR (1992)), the substance was classified into "Not classified" using the JIS classification criteria (Category 5 or "Not classified" in the United Nations classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Its rat LC50 values documented are > 3.29 mg/L/4h (JMPR (1992)) and > 5.16 mg/L/4h (OECD TG 403) (IUCLID (2000)), which do not justify placing the substance into the "Not classified" category. It was instead classified into the "Classification not possible" category. Since test concentrations were > 3.29 and > 5.16 mg/L, which were higher than the saturated vapour pressure concentration of the test substance: 6.66E-008 mg/L, we concluded that the test was conducted in a dust state.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	Since the test using rabbits (US EPA Guidelines 81-5) found that the substance is not irritating (IUCLID (2000)), it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	Since the test using rabbits (US EPA Guidelines 81-4) found that the substance is slightly irritating (IUCLID (2000)), it was classified into Category 2B. It is documented that conjunctival irritation observed in this test diminished during the test period, and it healed completely 7 days after application.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Classification not possible	- -	-	-	In tests using guinea pigs, it was reported that the evidence for skin sensitization was not found (JMPR (1977)). Likewise, in a different test using guinea pigs (Buehler tests, US EPA Guidelines 81-6), the substance was found to be non-sensitizing (IUCLID (2000)). Despite these negative results reported, the substance was classified into "Classification not possible" because information provided in these tests is insufficient.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Dominant lethal tests using mice that underwent oral administration (mixed diet) for 49 days (in vivo heritable mutagenicity tests using germ cells) resulted in negative outcome (JMPR (1992), IUCLID (2000)). Thus, the substance was classified into "Not classified". In vitro mutagenicity tests (Ames tests, mutation tests using E. coli, mutation tests using CHO cells, and chromosomal aberration tests) also gave negative results (JMPR (1992)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Category 2	Warning	H351	P308+P313 P201 P202 P280 P405 P501	In 52- and 104-week oral administration (mixed diet) tests using rats, incidence of interstitial-cell tumors of the testis increased. In 24-months oral administration (mixed diet) tests using rats, development of pituitary adenoma, adenocarcinoma, or fibroadenoma of the mammary gland were observed (JMPR (1995)). In 99-week oral administration (mixed diet) tests using mice, an increased incidence of benign or malignant liver tumors in both sexes, and an increased incidence of luteomas in the ovaries were observed. In 18-month oral administration (mixed diet) tests using mice, tumors observed were lymphosarcomas involving the spleen, lymph nodes and thymus (JMPR (1995). Furthermore, the substance is rated as Category 3 in the EU's carcinogenicity evaluations. All these reports considered, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 2	Warning	H361	P308+P313 P201 P202 P280 P405 P501	In 2-generation tests using rats that underwent mixed diet administration, litter size decreased in animal groups treated with the highest dose (3000 ppm) that induced general toxicity (decrease in body weight or food consumption) in parental animals (JMPR (1992)). Moreover, in oral administration tests conducted using rats or rabbits during the oraganogenetic period, the number of implantation sites decreased in rat groups treated with the highest dose (400 mg/kg/day) that reduced body weight or food consumption of parental animals (JMPR (1992)); similarly, miscarriage and rates of postimplantation loss increased in rabbit groups treated with the highest dose (200 mg/kg/day) (JMPR (1992)). Based on these studies, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Category 2 (nervous system)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	In oral administration tests using rats, surviving animals treated at 2000 mg/kg or above comprised lethargy, decreased motor activity, prone posture, ataxia, unconsciousness, breathing irregularities, piloerection, ungroomed appearance, pigmented orbital secretion, hunched posture, thin body conformation, diarrhoea and reduced body temperature. At the doses of 900 or 1342 mg/kg, signs of lethargy, decreased motor activity, ataxia, and prone posture were observed (IUCLID (2000)). Based on these observations, the substance was classified into Category 2 (nervous system). In dermal administration tests using rabbits, no abnormalities were detected in 8 of the 10 animals treated with 2000 mg/kg based on visual inspection; one of the two remaining animals (it is noted that this animal got cut around the neck and in the mouth during the experiment) showed red staining on the skin around the mouth, and clear discharge on fur around the nares, distended abdomen, as well as distended small intestines, cecum and stomach with abnormal contents and vascularized stomach and cecum. However, it is noted that these observations are not clearly attributable to iprodione (IUCLID (2000)). Furthermore, in inhalation tests using rats, clinical signs were unspecific at the dose of 5.16 mg/L/4h and they were observed on the day of exposure and up to 2 days after the exposure; the signs observed include blepharospasm, periocular and perinasal wetness, periocular and perinasal encrustation, unkempt fur, and white powder on the fur (IUCLID (2000)). However, these signs developed at the doses higher than the guidance values.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 2 (hematopoietic system)	Warning	H373	P260 P314 P501	The substance was classified into Category 2 (hematopoietic system) based on 52-week oral administration (mixed diet) tests using rats, in which incidence of extramedullary haematopoiesis and haemosiderosis increased in the spleens of female rats at 1600 ppm (conversion value: 80 mg/kg bw /day) (JMPR (1995)). In 99-week oral administration (mixed diet) tests using mice, the kidney with irregular cortical scarring and altered shape were observed at a higher incidence in females at 4000 ppm; in the liver, an increased incidence of enlarged eosinophilic and fat-containing hepatocytes was observed in animals of each sex at the highest dose; and centrilobular hepatocyte enlargement was observed in female rats treated with 800 ppm (conversion value: 120 mg/kg bw /day) and both sexes treated with 4000 ppm. Pigmented macrophages and centrilobular hepatocyte vacuolation were found in males at 4000 ppm; and haemosiderosis in the spleen, amyloidosis, and cortical scarring in the kidneys were reported in female mice at the highest dose (JMPR (1995). In 28-day oral administration (mixed diet) tests, exposure to 6000 ppm or higher was associated with ataxia and lethargy; livers had a stippled appearance on gross examination, and the incidence of hepatocyte vacuolation and focal eosinophilic degeneration was increased at 6000 ppm or higher. At 15000 ppm, granulomatous inflammation (possibly in response to a foreign body) was observed in the heart, liver, and kidney (JMPR (1992). In 4-week oral administration (mixed diet) using mice, depression and ataxia were observed at 6000 ppm or higher. Gross necropsy revealed white foci in the liver of mice receiving 1900 ppm (male: 366 mg/kg bw /day; female: 439 mg/kg bw /day) and higher, a stippled appearance of the liver at 6000 ppm and higher, and liver enlargement at 9500 and 15000 ppm. White foci and granulomatous inflammation were observed in numerous tissues, primarily at the high dose. One granulomatous lesion was observed in the liver at 6000 ppm and five were observed in the bladder at 9500 ppm. The presence of spindle-shaped clear spaces in tissues and foreign body type giant cells suggested a reaction to crystal formation (JMPR (1992)). In 4-week oral administration (mixed diet) tests using mice, crystalline deposits and effects on the liver were observed at 6000 ppm or higher, and granulomatous lesions surrounding crystal deposits were found frequently in the urinary bladder and occasionally in liver parenchyma, myocardium, diaphragmatic muscle, and skeletal muscle. It was speculated that the crystals contained a major metabolite of iprodione (32490 R.P.), which was identified in the liver. Liver effects included increased weight, pale and mottled appearance on gross examination, and swelling of hepatocytes to form large homogeneous areas in the centrilobular region of the liver. Histopathological changes in the testes and spleen were observed at doses levels above 6000 ppm (JMPR (1992)). In 3-month oral administration (mixed diet) tests using rats, effects on the liver, spleen and thymus were observed at high doses in small examinations carried out (JMPR (1992)); however these observations were made on animals that received doses higher than guidance values.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	Since its 48h-EC50 = 0.25 mg/L for crustaceans (Daphnia magna) (IUCLID 2000), the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Since its classification for acute toxicity is Category 1, and it is not rapidly degradable (28-day degradability following OECD TG 301B = 0.16-0.2% (IUCLID 2000)), the substance was classified into Category 1.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Hazardous to the ozone layer	-	- -	-	-	-	-	-

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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