NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	2439-10-3
Chemical Name	dodine; dodecylguanidinium acetate
Substance ID	m-nite-2439-10-3_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	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. (136degC, 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)	- -	-	-	The substance contains oxygen (but not fluorine or chlorine) which is 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	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available. (melting point: 136degC (Howard (1997))	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 4	Warning	H302	P301+P312 P264 P270 P330 P501	The substance was classified into Category 4 based on its rat LD50 values (male: 750-1540, 851, and 1931 mg/kg bw; female: 660, 851, and 1117 mg/kg bw) (JMPR (2000)), and its rating of Xn; R22 in the EU classification.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on its rabbit LD50 value of > 2000 mg/kg (JMPR (2000)), 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)	Category 2	Danger	H330	P304+P340 P403+P233 P260 P271 P284 P310 P320 P405 P501	Based on its rat LC50 values of 0.47 mg/L/4h in males and 0.44 mg/L/4h in females (JMPR (2000)), the substance was classified into Category 2. (Since the test concentration of 0.44 or 0.47 mg/L was higher than the saturated vapour pressure concentration of the test substance: 2.32E-006 mg/L, the substance was estimated to be in a dust state.)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	A rabbit test concluded that the substance was severely irritating 7 days after application (JMPR (2000)), and another rabbit test found that the substance was slightly irritating (JMPR (2000)). Since the EU rated the substance as Xi; R36/38 in its classification, the substance was classified into Category 2.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	A rabbit test concluded that the substance caused severe corneal opacity at 21 days after application (JMPR (2000)), and another rabbit test found that the substance was severely irritating (JMPR (2000)). Since corneal clouding did not recover in 21 days, the substance was classified into Category 1.	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	Not classified	- -	-	-	Based on the description that the substance was not sensitizing in the guinea pig tests (JMPR (2000)), it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Not classified	- -	-	-	Based on two cases of negative results obtained in micronucleus tests using mice that underwent oral administration (in vivo mutagenicity tests using somatic cells) (JMPR (2000)), the substance was classified into "Not classified". As relevant notes, three in vitro mutagenicity tests (Ames test, gene mutation test using ovarian cells of hamsters, and chromosomal aberration tests using human lymphocytes) also yielded negative results (JMPR (2000)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Not classified	- -	-	-	In 106-week oral administration tests using rats, hepatocellular adenomas and carcinomas were observed in males in a dose-dependent fashion (JMPR (2000)). In addition, 78-week oral administration tests using mice, increased incidences of hepatocellular adenomas and combined hepatocellular adenomas/carcinomas were observed (JMPR (2000)). However, the substance was classified into the "Not classified" category based on the conclusion that it had no risk of carcinogenicity in humans.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Classification not possible	- -	-	-	In forced oral administration tests using pregnant rats and rabbits, there was no evidence of the administered substance affecting the reproduction and development of the offspring based on relevant parameters (JMPR (2000)). However, since no data are available on sexual functions and fertility of parental animals, the substance was classified into "Classification not possible".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	No data available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 2 (systemic)	Warning	H373	P260 P314 P501	Results of oral route exposure tests were gathered from the following nine tests: four mixed diet tests using rats (4 weeks, 28 days, 90 days, and 106 weeks); one stomach tube administration test (4 weeks); three mixed diet tests using mice (8 weeks, 13 weeks, and 78 weeks); and one mixed diet test using dogs (52 weeks) (JMPR (2000)). Among these tests, four mixed diet tests using rats (4 weeks, 28 days, 90 days, and 106 weeks) and one mixed diet test using dogs (52 weeks) did not provide any indications of serious toxic effects at the highest doses within the range of guidance values tested, as well as any data useful for the classification of the substance. In the three mixed diet tests using mice (8 weeks, 13 weeks, and 78 weeks), congestion of the lung, cellular depletion of the spleen and lymphoid atrophy, and/or necrosis of the thymus were observed at the doses higher than the upper limit of the guidance value range; no serious toxic effects were observed at the doses that fall under the guidance value range, however. On the other hand, the stomach tube administration test (4 weeks) resulted in occurrence of mortality cases at all doses tested (75, 100, and 200 mg/kg/day (90-day correction values: 23, 31, and 62 mg/kg/day)), and symptoms such as salivation, deteriorating health status, and respiratory distress occurred in a dose-dependent fashion. At the highest dose of 200 mg/kg/day, an increase in BUN, total bilirubin, and GPT; a decrease in glucose, protein, and albumin were observed; in addition, as histopathological symptoms, lesions were observed in the stomach, spleen, thymus, adrenal glands, and intestines. Furthermore, at the doses of 75 or 100 mg/kg/day, edema, mixed-cell infiltration, and hyperplasia of the squamous mucosa of the stomach were detected by gastrointestinal tests. The development of lesions in the stomach is likely to be caused by the irritating property of the test substance, but taking cases of death and other observed effects into account, it is difficult to specify a target organ on which the substance has an impact. Therefore, the substance was classified into Category 2 for systemic toxicity. In the case of dermal exposure, rats that received doses (maximum dose: 200 mg/kg/day (90-day correction: 62 mg/kg/day)) for 3 or 4 weeks did not show notable systemic toxicity as the effect of the test substance, excluding the development of lesions on the skin where the substance was applied (JMPR (2000)). Based on this dataset, classification is not possible.	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 48-hour EC50 = 0.0178 mg/L for crustaceans (Daphnia magna) (Aquire, 2008), 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 (estimated value: SRC: BioWin V4.10), 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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