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GHS Classification Results by the Japanese Government

GENERAL INFORMATION

Item	Information
CAS RN	118-52-5
Chemical Name	1,3-Dichloro-5,5-dimethylimidazolidine-2,4-dione
Substance ID	R01-B-103
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)
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 is N-halogen, a chemical group associated with explosive properties, present in the molecule, but the classification is not possible due to no data.
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	*	- -	-	-	There is information that it is combustible (GESTIS (Access on October 2019)), but the classification is not possible due to no data.
8	Self-reactive substances and mixtures	*	- -	-	-	There is N-halogen, a chemical group associated with explosive properties, present in the molecule, but the classification is not possible due to no data.
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 chlorine and oxygen (but not fluorine), and the chlorine is chemically bonded to an element (N) other than carbon or hydrogen. However, the classification is not possible due to no data.
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	*	- -	-	-	It was classified as "Not classified" because it is not desensitized by wetting, dilution, etc.

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification
1	Acute toxicity (Oral)	Category 4	Warning	H302	P301+P312 P264 P270 P330 P501	[Rationale for the Classification] Based on (1), it was classified in Category 4. [Evidence Data] (1) LD50 for rats: 542 mg/kg (ACGIH (7th, 2001), HSDB (Access on October 2019), Committee of the Health Council of the Netherlands (2002))
1	Acute toxicity (Dermal)	*	- -	-	-	[Rationale for the Classification] Based on (1), it was classified as "Not classified." [Evidence Data] (1) LD50 for rabbits: >20,000 mg/kg (Committee of the Health Council of the Netherlands (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] Classification not possible due to lack of data. [Reference Data, etc.] (1) In a 1-hour inhalation exposure test (dust) with rats, 5 out of 10 animals died at 20,500 mg/m3 (20.5 mg/L) (converted 4-hour equivalent value: 5.125 mg/L) (Committee of the Health Council of the Netherlands (2002)).
2	Skin corrosion/irritation	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
3	Serious eye damage/eye irritation	*	- -	-	-	[Rationale for the Classification] Although there was a description in (1), classification was not possible due to lack of data. [Reference Data, etc.] (1) Potential symptoms of overexposure were irritation of the eyes, mucous membranes and respiratory system (HSDB (Access on October 2019)).
4	Respiratory sensitization	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data.
4	Skin sensitization	Category 1A	Warning	H317	P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501	[Rationale for the Classification] Based on (1), it was classified in Category 1A. [Evidence Data] (1) In a skin sensitization test (Buehler method, induction 1%, challenge 1%) with guinea pigs according to OECD TG 406, the result was positive (positive ratio 60%) (REACH registration dossier (Access on December 2019)). [Reference Data, etc.] (2) It was classified as "Skin Sens. 1 (H317)" in the EU CLP classification (EU CLP classification (Access on December 2019)).
5	Germ cell mutagenicity	*	- -	-	-	[Rationale for the Classification] There were no in vivo data. Therefore, classification was not possible due to lack of data. [Evidence Data] (1) As for in vitro, there were negative results in a bacterial reverse mutation test, and a sister chromatid exchange test and a chromosomal aberration test with cultured mammalian cells, and a positive result in a mouse lymphoma test (NTP DB (Access on October 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] As for classification results by domestic and international organizations in (1), it was classified as NL (Not Likely to be Carcinogenic to Humans.) by EPA (EPA Annual Cancer Report (2018): classified in 2000).
7	Reproductive toxicity	*	- -	-	-	[Rationale for the Classification] Classification not possible due to lack of data. [Reference Data, etc.] (1) In a developmental toxicity test (preliminary test) in which female mice were given one dose (500 mg/kg/day) by gavage on gestational days 6-13 and then allowed to deliver, no effects on the offspring were observed at the maternal toxicity dose (mortality in 18% of the animals) (HSDB (Access on October 2019), Committee of the Health Council of the Netherlands (2002)). Since this test was a preliminary test with one dose, the data were used as reference data.
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	[Rationale for the Classification] Based on one case in humans in (1) and on the result of the inhalation exposure test with experimental animals in (2), it was classified in Category 3 (respiratory tract irritation). Since the findings in the oral administration test in (3) were considered to be the symptoms around the lethal dose, they were not adopted as evidence. [Evidence Data] (1) There was a report that one worker, who was exposed to this substance at a concentration exceeding a time-weighted average of 0.2 mg/m3, experienced cough and chest discomfort (ACGIH (7th, 2001)). (2) In a 1-hour single inhalation exposure test with rats, 5 out of 10 animals died following exposure to 20.5 mg/L (converted 4-hour equivalent value: 5.125 mg/L, exceeding Category 2) of the dust of this substance. Signs observed in this test were lachrymation, salivation, mucoid nasal discharge, red nasal discharge, gasping, decreased activity, and partially closed eyes. Upon necropsy, discoloration of the lungs and liver and distention of the stomach with gas were seen (Committee of the Health Council of the Netherlands (2002)). [Reference Data, etc.] (3) In a single oral dose test with rats, at 400-900 mg/kg (equivalent to Category 2; These were considered to be lethal doses since the LD50 value was 542 mg/kg), generalized tremors, salivation, hyperpnea and cyclic running were observed. Upon necropsy, hemorrhages in the gastrointestinal tract were observed (Committee of the Health Council of the Netherlands (2002)).
9	Specific target organ toxicity - Repeated exposure	*	- -	-	-	[Rationale for the Classification] Based on (1), no effects were observed up to the range of Category 2 in the oral administration to rats. Therefore, it was classified as "Not classified" through the oral route. Since no data were available for other routes, classification was not possible. [Evidence Data] (1) When rats were dosed by feeding at 100-1,000 mg/kg/day for 2 years, at 1,000 mg/kg/day (exceeding Category 2), decreased survival time and reduced body weight gain in males, and decreased body weight in females were observed, but no effects were observed in relation to hematology, clinical chemistry, urinalysis, ophthalmology, organ weights or pathology (HSDB (Access on October 2019)). [Reference Data, etc.] (2) When dogs were dosed by feeding at 4,000-40,000 mg/kg/day for 1 year, increased relative adrenal weight and increased adrenal cortical diffuse/bilateral hypertrophy were observed in males at 40,000 ppm (converted guidance value: 1,000 mg/kg/day, exceeding Category 2) (HSDB (Access on October 2019)). (3) When rats were given this substance by drinking water at a concentration of 20 ppm "available chlorine" for 30 days, no effects were found on body weights, water consumption, clinical signs, hematological and urinalysis parameters, and gross and microscopic examination (ACGIH (7th, 2001), HSDB (Access on October 2019), Committee of the Health Council of the Netherlands (2002)).
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 48-hour EC50 = 0.47 mg/L for crustacea (Daphnia magna) (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. If acute toxicity data are used, 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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