NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	100-37-8
Chemical Name	Ethanol, 2-(diethylamino)-
Substance ID	m-nite-100-37-8_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)	To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link)	To Workplace Safety Site (MHLW)
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 molecule.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 3	Warning	H226	P303+P361+P353 P370+P378 P403+P235 P210 P233 P240 P241 P242 P243 P280 P501	Since its flash point 52 degC (closed-cup) (ICSC (J) (2002)) is >= 23 degC and <= 60 degC, it is classified into Category 3.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	Since its autoignition temperature is 250 degC (ICSC (J) (2002)), it is considered that the substance does not ignite at room temperature.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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, C, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
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	Based on the rat LD50 values of 1320 mg/kg and 1300 mg/kg (SIDS (Access on Jun. 2009)), the substance was classified into Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Category 4	Warning	H312	P302+P352 P362+P364 P280 P312 P321 P501	Among three LD50 values of 1100 mg/kg (SIDS (Access on Jun. 2009)), 890 mg/kg (ACGIH (2001)) and 1260 mg/kg (DFGMAK-Doc.14 (2000)) for rabbits, one of them corresponded to Category 3, and the two corresponded to Category 4. The substance was classified as Category 4, since the majority of obtained data corresponded to it.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Category 3	Danger	H331	P304+P340 P403+P233 P261 P271 P311 P321 P405 P501	Based on the rat LC50 (4-hour exposure) value of 945 ppm (ACGIH (2001)), the substance was classified as Category 3. The LC50 value (945 ppm) was lower than 90% of the saturated vapor pressure concentration (1842 ppm), it was judged as "vapor hardly coexisting mists" and the criterion values for gas were adopted.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Category 1	Danger	H314	P301+P330+P331 P303+P361+P353 P305+P351+P338 P304+P340 P260 P264 P280 P310 P321 P363 P405 P501	In the rabbit test (OECD TG 404), occlusive application of the substance for 3 minutes up to 4 hours caused necrosis and resulted that the substance was corrosive (SIDS (Access on Jun. 2009)). Similarly, in other reports of rabbit tests, necrosis was observed and resulted that the substance was corrosive (SIDS (Access on Jun. 2009)). Based on these test results, the substance was classified as Category 1. As relevant information, the substance was classified as "R34" in the EU classification (EU Annex I (2006)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 1	Danger	H318	P305+P351+P338 P280 P310	In the rabbit test, instillation of 50 microL of undiluted test substance caused corrosion of the conjunctiva and eyelids, these effects were not reversible after 8 days, and irreversible damage to corneal tissue was observed (SIDS (Access on Jun. 2009)). In the other rabbit test, severe corneal injury, iritis and severe conjunctival irritation with necrosis were observed (SIDS (Access on Jun. 2009)). Based on these results, the substance was classified as Category 1.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data were available. As relevant information, in the accidental case of the leak of the substance into the airflow of the heating system of the building, irritatiing symptoms of the upper respiratory tract were experienced by most of the 2,500 employees, and 14 workers developed asthma. And seven of the 14 cases were defined as occupational asthma (SIDS (Access on Jun. 2009)). But it was reported that these symptoms corresponded to "reactive airways dysfunction syndrome" rather than respiratory allergic reaction, so it was not the evidence indicating sensitization effects (DFGMAK-Doc.14 (2000)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Not classified	- -	-	-	The substance was classified as "Not classified" based on the documented cases of "non-sensitizing" from 2 reports of guinea pig maximization tests in which positive rate was 0% (0/20 and 0/40, respectively) (SIDS (Access on Jun. 2009)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Not classified	- -	-	-	The substance was classified as "Not classified" based on the negative results in the micronucleus test using bone marrow cells obtained from mice orally administered (in vivo mutagenicity test in somatic cells) (SIDS (Access on Jun. 2009)). As relevant information, as for in vitro studies, negative results were reported in the Ames test and HGPRT test using Chinese hamster V79 cells (SIDS (Access on Jun. 2009)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	Insufficient data were available. As relevant information, in the 2-year dietary administration test in rats, no evidence of carcinogenicity was found showing no increase in tumor incidence in the treatment groups compared with the control group (SIDS (Access on Jun. 2009)). However, the test was old in the 1960s, and not compliant with the current guidelines, therefore, these data was not proper to evaluable carcinogenicity.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In the developmental toxicity study in which rats were exposed via inhalation during the organogenetic period, the general toxicity such as decreased body weight gain, decreased food consumption, and dry rale was observed in the high dose group in the dams, but no effects were observed in gestational parameters such as pre- and post-implantation loss, and no developmental effects containing teratogenicity were observed (SIDS (Access on Jun. 2009)). However, no data were available on the effects of the sexual functions and fertility of parental animals that were exposed prior to mating. Therefore, the substance was classified as "Classification not possible".	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Category 1 (central nervous system), Category 3 (respiratory tract irritation)	Danger Warning	H370 H335	P308+P311 P260 P264 P270 P321 P405 P501 P304+P340 P403+P233 P261 P271 P312	As for the effects in humans, a laboratory worker who was briefly exposed to approx. 100 ppm (480 mg/m3) of the substance resulted in nausea and vomiting within 5 minutes. The corrosion inhibitor containing the substance was used for boiler, and 65 workers who were exposed to the vapor of the substance via humid air complained the symptoms such as dizziness, nausea, and vomiting (SIDS (Access on Jun. 2009)). Moreover, there were descriptions mentioning that accidental human exposure to the substance at the concentration of below 200 ppm for few minutes resulted in nausea and vomiting (ACGIH (2001)) and that the symbol of "CNSconvul" was designated in the ACGIH-TLV (ACGIH (2009)). Thus, the substance was classified as Category 1 (central nervous system). While in the inhalation study in rats, clinical signs indicating severe irritation were noted, namely, attempts to escape from exposure, irritation in mucous membrane and dyspnea were observed (SIDS (Access on Jun. 2009). And it was reported that irritation of the mucous membrane of respiratory tract was caused in humans (DFGMAK-Doc.14 (2000)), and that throat irritation was caused in humans exposed occupationally (SIDS (Access on Jun. 2009)). Thus, the substance was classified as Category 3 (respiratory tract irritation).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Category 2 (central nervous system)	Warning	H373	P260 P314 P501	In the oral study in dogs, weakness, tremors, convulsions and ataxia were observed accompanied with occurrence of deaths at the dose level of 200 mg/kg/day or more, and tremors and shaking of the head from side to side were observed at 40 mg/kg/day (SIDS (Access on Jun. 2009). In either 2-week inhalation study in rats at 1.438 mg/L/6hrs (DFGMAK-Doc. 14 (2000)) or in 5-month inhalation study in rats at 0.622 mg/L/4hrs (0.507 mg/L/6hrs) exposed by vapors (ACGIH (2001)), effects on the central nervous system such as decreased activity, incoordination and clonic-tonic convulsions were observed. Since the findings were observed at the dose levels equivalent to Category 2 of the guidance values, the substance was classified as Category 2 (central nervous system). Besides, no serious toxic effects were seen in any of the following repeated oral dose toxicity studies in rats: 4-week administration study via drinking water up to 500 mg/kg/day (converted value as that of 90-day study: 154 mg/kg/day), 6-month administration study via drinking water up to 300 mg/kg/day, or 2-year feeding study up to 50 - 400 mg/kg/day (SIDS (Access on Jun. 2009)). Likewise, in the 6-month oral dose study in rats, depression of body weight and slight elevation of relative kidney weight were merely noted at 100 mg/kg/day (ACGIH (2001)), but no effects on the liver or on any other organs were reported.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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 3	- -	H402	P273 P501	Classified into Category 3 from its 72h-ErC50 = 44 mg/L for algae (Scenedesmus subspicatus) (SIDS, 2004).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	Classified as "Not classified" since it is rapidly degradable (22-day degradation rate tested by OECD TG301A: 95% (SIDS, 2002)) and the bioaccumulation potential is low (BCF < 6.1 (Biodegradation and Bioconcentration of Existing Chemical Substances under the Chemical Substances Control Law, 2002)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in Annexes to the Montreal Protocol.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）

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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