NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	35554-44-0
Chemical Name	imazalil (ISO); 1-[2-(allyloxy)-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole
Substance ID	m-nite-35554-44-0_v2
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	Classification not possible	- -	-	-	The substance contains functional groups associated with self-reactive properties. Classification is not possible due to lack of data.	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	Classification not possible	- -	-	-	No data available.	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.	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 oxygen and chlorine, which are 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	- -	-	-	Its melting point is <= 55degC. Classification is not possible due to lack of data.	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)	Category 3	Danger	H301	P301+P310 P264 P270 P321 P330 P405 P501	[Rationale for the Classification] Based on (1) to (3), it was classified in Category 3. Besides, the classification result was changed by adopting the category with the higher hazard. [Evidence Data] (1) LD50 for rats (males): 343 mg/kg (OECD TG401) (DFG MAK (2013), EU FESA (2007), CLH Report (2012), JMPR (2018)) (2) LD50 for rats (females): 227 mg/kg (OECD TG401) (DFG MAK (2013), EU FESA (2007), CLH Report (2012), JMPR (2018)) (3) LD50 for rats: 664 mg/kg (DFG MAK (2013), EU FESA (2007), JMPR (2018)) [Reference Data, etc.] (4) This substance was classified in Category 3 in the EU CLH.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	[Rationale for the Classification] Based on (1) to (4), it was classified as "Not classified" (Category 5 in UN GHS classification). [Evidence Data] (1) LD50 for rabbits: > 2,000 mg/kg (DFG MAK (2013), CLH Report (2012), JMPR (2018)) (2) LD50 for rats: > 2,000 mg/kg (DFG MAK (2013), JMPR (2018)) (3) LD50 for rats: 4,880 mg/kg (JMPR (2018)) (4) LD50 for rats: 4,200 mg/kg (JMPR (2018), NIOSH in Pubchem (Accessed Dec. 2021))	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	[Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified."	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
1	Acute toxicity (Inhalation: Dusts and mists)	Category 4	Warning	H332	P304+P340 P261 P271 P312	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LC50 for rats: 2.43 mg/L (2.88 mg/L (males), 1.84 mg/L (females)) (CLH Report (2012), JMPR (2018), DFG MAK (2013))	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
2	Skin corrosion/irritation	Not classified	- -	-	-	In Draize tests using rabbits, mild skin irritation was detected (JMPR No. 12, 2005). However, in different tests using rabbits (OECD TG 404), erythema or oedema was not observed, and the substance was found to not be an irritant (JMPR No. 8 (2000)). In addition, in skin irritation tests involving several volunteers, no symptoms such as burning, itching or pain were detected (JMPR No. 8 (2000)). Based on these documents, the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	Since the substance was found to be moderately irritating in two Draize tests using rabbits (one test (OECD 405) gave an average score of 29 (JMPR No. 8 (2000)) and the other test resulted in an average score of 33.7 (JMPR No. 12 (2005)), the substance was classified into Category 2A. The EU Risk Phrase for this substance is R41 (EU-Annex, accessed in February 2009).	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 skin sensitization tests using guinea pigs (OECD 406), 5% of subjects showed positive reactions (JMPR No. 8 (2000)). In other skin sensitization tests using guinea pigs, the substance was found to be not sensitizing (0% positive rate) (JMPR No. 12 (2005)). Despite the low sensitizing rates obtained, the substance was classified into "Classification not possible" since the results cannot be clearly interpreted.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on negative results obtained in the following tests, the substance was classified into the "Not classified" category: dominant lethal mutation tests using mice (in vivo heritable mutagenicity tests using germ cells) (HSDB (2006)), micronucleus tests using mouse bone marrow cells (in vivo mutagenicity tests using somatic cells) (JMPR No. 8 (2000)), and several micronucleus tests using rats or mice (in vivo mutagenicity tests using somatic cells) (HSDB (2006)). Similarly, negative results were yielded in unscheduled DNA synthesis tests using mouse hepatocytes (in vivo genotoxicity tests using somatic cells) (JMPR No. 8 (2000): (JMPR No. 31 (1977)). Negative results were also acquired in in vitro mutagenicity tests such as Ames tests, chromosomal aberration tests, and mutation tests using cultured V79 cells from Chinese hamsters (JMPR No. 8 (2000), (HSDB (2006)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Not classified	- -	-	-	In 2-year oral administration tests using rats (JMPR No. 6 (2001)), hepatocellular adenoma and follicular-cell tumors of the thyroid were observed in the animal groups treated with the highest concentration tested; however, the purity of the test substance was 50%. In contrast, in other oral administration tests using rats that were conducted for 30 months (JMPR No. 8 (2000)), histopathological effects related to the administration on the liver were not observed, concluding that there is no evidence of carcinogenicity associated with this substance. Yet, in other 2-year oral administration tests using rats (JMPR No. 21 (1980)), the conclusion was drawn that this substance is not involved in tumorigenesis of the organs. Furthermore, in 23-month oral administration tests using mice (JMPR No. 8 (2000)), although increased incidences of adenoma were detected, the conclusion was drawn that there was no statistically significant trend for carcinomas. Similarly, no signs of carcinogenicity were detected in other tests including 18-month oral administration (through drinking water) tests using mice (JMPR No. 21 (1980)), and 2-year oral administration tests using mice (HSDB (2006)). Based on these results, the substance was classified into "Not classified".	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 several 2 or 3-generation tests using rats, no signs of teratogenicity were detected; on the other hand, decreased survival of fetuses and increased fetal death rates were identified (JMPR No. 31 (1977), IRIS (1990), JMPR No. 8 (2000)). In reproductive toxicity tests using rats that were in compliance with OECD guidelines, besides reduced body weight in maternal animals, no significant differences were noticed compared with control animals in terms of pregnancy rates, the number of corpora lutea and implantation rates. Furthermore, in above-mentioned tests, in which developmental toxicity tests were also conducted, no signs of teratogenicity were detected in fetuses, while the number of embryos and fetuses along with fetal body weight decreased (JMPR No. 12 (2005)). Overall, while no reports on general toxicity on parental animals are available, a decrease in survival rates of fetuses and increase in fetal death rates were detected; thus, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	In 4-hour inhalation exposure tests (dust) using rats (JMPR, No. 12 (2005)), no notable effects were observed at the doses of > 20.67 mg/L, which are higher than Category 2 guidance doses. Furthermore, in dermal administration tests using rats or rabbits (JMPR, No. 12 (2005)), no toxic effects were detected using doses that fall under the category guidance values. Though these results indicate that the substance is to be placed into the "Not classified" category (inhalation and dermal), in conclusion, it was classified into "Classification not possible" because information on its toxic effects via oral administration is not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 2 (liver)	Warning	H373	P260 P314 P501	In 3-month oral administration tests using rats, an increased frequency of hepatocytes with small vacuoles was seen at 2400 and 3200 ppm (conversion value: 180 and 250 mg/kg for male; and 240 and 330 mg/kg for female, respectively) (JMPR No. 6 (2001)). In 14-week (3-month) oral administration tests using rats, hepathocellular necrosis was documented at the concentration of 800 ppm (90-day conversion value: 40 mg/kg) (HSDB (2006)). Furthermore, in 3-month oral administration tests using mice, an increased incidence of dark livers was identified at the highest doses (male: 140 mg/kg/day, and female: 170 mg/kg) and the middle doses for males (53 mg/kg/day); histological examination showed an increase in the numbers of small and large vacuoles, especially in the periportal area in both sexes (JMPR No. 8 (2000)). In summary, in oral exposure tests using rats or mice, the effects of exposure on the liver, such as necrosis of hepatocytes, were found in the range of doses that are comparable to Category 2 guidance values. Thus, we decided to place the substance in Category 2 (liver).	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 2	- -	H401	P273 P501	Since its 96-hour LC50 = 1.48 mg/L for fish (rainbow trout) (ECOTOX, 2008), the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Category 2	-	H411	P273 P391 P501	Since its classification for acute toxicity is Category 2 and it is not rapidly degradable (SRC: BioWin V4.10), the substance was classified into Category 2.	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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