NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	111-46-6
Chemical Name	2,2' -oxybisethanol; diethylene glycol
Substance ID	m-nite-111-46-6_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)	- -	-	-	Liquid (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)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified	- -	-	-	Its flash point is 124degC (ICSC (2007)), which is above 93degC.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	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	- -	-	-	Its autoignition point is 229degC (ICSC (2007)), which is above 70degC.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid 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)	- -	-	-	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）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Containing no bivalent -O-O- structure	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	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	- -	-	-	All of the rat LD50 values documented (15.6, 16.6, and 20.8g/kg bw) (PATTY 5th (2001)) fall within "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the rabbit LD50 of 13300mg/kg bw (DFGOT vol. 10 1998), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (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	- -	-	-	There was no mortality in rats exposed to 4500mg/m3 (mist) for 4 hours (DFGOT (vol. 10, 1998)). However, since no other data were available, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	Skin irritation tests using rabbits (Draize tests) concluded that the substance was slightly irritating (IUCLID (2000)). Similarly, 48-hour application to humans and repeated application to guinea pigs suggested that the substance produced no skin irritation (DFGOT vol. 10 (1998). Thus, the substance was classified into "Not classified" using JIS classification criteria (Category 3 in the United Nations GHS classification).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Not classified	- -	-	-	Since no irritation was detected in rabbit tests (DFGOT vol. 10 (1998), PATTY (5th, 2001)), the substance was classified into "Not classified".	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	- -	-	-	Since skin sensitization tests using guinea pigs (maximization tests) (DFGOT vol. 10 (1998)) and patch tests in humans (IUCLID (2000)) provided no evidence of sensitization. The substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	Among in vivo chromosomal aberration tests using hamsters, intraperitoneal administration resulted in a slight increase in chromosomal aberrations in the form of gaps; and oral administration tests yielded ambiguous results (DFGOT vol. 10 (1998)). In micronucleus tests and dominant lethal tests, basic information such as animal species used, administration methods, and administration durations are lacking, and the results are inadequate and contain some uncertainty to assess the genotoxicity of the substance (DFGOT vol. 10 (1998), IUCLID (2000)). As such, the substance was classified into "Classification not possible". Most in vitro mutagenicity tests resulted negative (DFGOT vol. 10 (1998), NTP DB (accessed June 2008), IUCLID (2000)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	Decreased survival rates, as well as bladder tumors or kidney tumors have been documented in 2-year oral route exposure tests using rats (DFGOT vol. 10 (1998)). However, the data on bladder tumors were obtained from studies involving male rats only, and the data are old. Regarding kidney tumors, initiation / promotion tests conducted by the same author later revealed that diethylene glycol was not carcinogenic and does not have promotion effects (DFGOT vol. 10 (1998)). Other documented tests do not provide sufficient data either. As such, the substance was classified into "Classification not possible".	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 a 2-generation reproduction test using mice that were exposed to the substance prior to mating, reduced litter size, craniofacial malformations such as exencephaly and cleft palate were observed (DFGOT vol. 10 (1998)). Cleft palates have been also documented in hamsters that received intraperitoneal administration on day 8 of gestation (DFGOT vol. 10 (1998)). These toxic doses were also associated with decreased body weight of maternal animals and mortality in hamsters (DFGOT vol. 10 (1998)). That is to say, clear cases of reproductive toxicity are documented at doses that induce general toxicity in parental animals. As such, 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	- -	-	-	Although specific acute toxicity symptoms that are common among different animal species, are documented (DFGOT vol. 10 (1998), PATTY (5th, 2001), their relationships to exposure doses are not documented. As such, classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 1 (kidney, liver)	Danger	H372	P260 P264 P270 P314 P501	In repeated oral route exposure using rats, increased excretion of oxalic acid, formation of calcium oxalate crystals, and kidney damage (nephrosis) were observed as common symptoms (DFGOT vol. 10 (1998)). Long-term exposure, bladder stones, kidney damage, and infrequent liver damage were also observed in some studies (PATTY (5th, 2001)). However, these symptoms were associated with much higher doses than the cutoff value of the guidance range (100mg/kg/day). In humans, several epidemiological studies have been conducted, which revealed many cases of death, progressive kidney damage followed by kidney failure, and a few cases of liver damage (DFGOT vol. 10 (1998)). Based on the results of the human epidemiological studies, with the results of the repeated exposure in rats taken into account, the substance was classified into Category 1 (kidney, 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)	Not classified	- -	-	-	Since its 96-hour LC50 = 75200mg/L for fish (fathead minnow) (AQUIRE, 2008), the substance was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Since it is water soluble (water solubility: 1,000,000mg/L (SRC, 2005)) and its classification for acute toxicity is "Not classified", the substance was classified into "Not classified".	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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