NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	27247-96-7
Chemical Name	2-Ethylhexyl nitrate
Substance ID	m-nite-27247-96-7_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	Classification not possible	- -	-	-	The classification is not possible due to no data although it contains a chemical group associated with an explosive property (nitrate ester). Besides, it is highly possible to be classified as "Not classified" if it is judged in a prescribed test in UN Recommendations on the Transport because the oxygen balance of -196 is very close to criteria of -200.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not an aerosol product.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Category 4	- Warning	H227	P370+P378 P210 P280 P403 P501	A flash point of 72 degrees C [closed cup] (IUCLID (2000)), which is > 60 degrees C and <= 93 degrees C, corresponds to Category 4.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Self-reactive substances and mixtures	Classification not possible	- -	-	-	It does not contain a chemical group associated with a self-reactive property but contains a chemical group associated with an explosive property (nitrate ester). But there are no data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Pyrophoric liquids	Not classified	- -	-	-	It is conceivable that it does not ignite at normal temperatures from an ignition point of 186 to 190 degrees C (IUCLID (2000).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	No established test method suitable for liquid substances.	FY2011	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)	- -	-	-	Not containing metals or semimetals (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Classification not possible	- -	-	-	An organic compound that does not contain fluorine or chlorine but contains oxygen which is bonded to nitrogen. But the classification is not possible due to no data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	An organic compound that does not contain -O-O- structure.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
16	Corrosive to metals	Classification not possible	- -	-	-	No data.	FY2011	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)	Not classified	- -	-	-	From an LD50 value of > 9600 mg/kg bw for rats (USEPA/HPV (2003), corresponding to List 1), it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Not classified	- -	-	-	From an LD50 value of > 4800 mg/kg bw for rats (USEPA/HPV (2003)), it was classified as "Not classified" in JIS classification (Category 5 or "Not classified" in UN GHS classification).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	"Liquids" according to GHS definition.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Not classified	- -	-	-	From an LC50 value of > 14 mg/L/4h for rats (IUCLID (2000), it was classified as "Not classified." Besides, it was considered to be a test by mists because the toxicity value (14 mg/L) is above the saturated vapour pressure concentration (2 mg/L). Furthermore, a state of the substance cannot be specified due to unknown test conditions at the concentration above the saturated vapour pressure concentration (2 mg/L), though an LC50 value of > 4.6 mg/L/1h (>2.3 mg/L/4h) for rats (OECD TG 403; GLP) was reported in a test by "vapour." (IUCLID (2000))	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	On the basis of the "not irritating" evaluation as a result of a test applied to rabbit skins for 4 hours (OECD TG 404, GLP), in which skin reactions were not observed until 24 hours after application and minimal to slight erythema observed at 1 or 2 animals in 48 to 124 hours disappeared after 148 hours (IUCLID (2000)), it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	From "slightly irritating" evaluation in a test using rabbits (OECD TG 405, GLP) (IUCLID (2000)), it was classified in Category 2B. Besides, another test dropped 0.1 mL of test substance into rabbit eyes reported "not irritating." (IUCLID (2000)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Not classified	- -	-	-	A positive rate of 15% (3/20) or 25% (5/20) including animals with ambiguous reactions which are less than 30% of decision criteria in a maximization test in guinea pigs (OECD TG 406; GLP) (IUCLID (2000)) and no sensitizing reactions (positive rate 0%) in all test animals reported in another maximization test in guinea pigs (IUCLID (2000)), it was classified as "Not classified."	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification is not possible due to no in vivo test data. Besides, as in vitro tests, both an Ames test and a chromosomal aberration test using human peripheral blood lymphocytes reported negatives. (IUCLID (2000)	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In an oral dose reproductive/developmental toxicity screening test (OECD TG 421; GLP) in rats, general toxicity such as salivation and decreased weight gain in parent animals were shown, but neither an effect on copulation ability nor numbers of corpora lutea, implantations, and litter size of pregnant animals differed from a control group were observed. (USEPA/HPV (2006)) Accordingly, it is judged to be no adverse effects on sexual function and fertility of parent animals. But it was classified as "Classification not possible" due to lack of data on effects on the development of the offspring because there is no data on a fetal examination at the end of gestation. Besides, the information of a high dose group (500 mg/kg/day) in which one maternal animal had all dead fetus or implantation scars and another animal delivered a litter of small pups all of which died within three days after delivery (USEPA/HPV (2006)) was not used as a basis for the classification, because they are not sufficient bases for fetal toxicity due to only the high dose findings and not clear dose-dependence despite undeniable relationship with administration.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	There is the information that three out of ten animals died in oral administration at 9600 mg/kg to rats, but no other signs and lesions in necropsy were observed (USEPA/HPV (2006)), though the classification is not possible due to lack of data. There is the information that neither deaths nor signs were observed as a result of 1-hour exposure of vapour of 4.6 mg/L to female rats (converted to a 4-hour equivalent value: 2.3 mg/L) in inhalation administration (IUCLID (2000)), but the classification is not possible due to only female results and unknown details. Besides, there is the information that neither deaths nor signs were observed by the dermal administration to rabbits (USEPA/HPV (2006)), but the classification is not possible due to unknown details. From the above, it was classified as "Classification not possible" in specific target organ toxicity (single exposure).	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	In a 28-day oral repeated dose test in rats, decreases in weight and food consumption, changes in hematology and blood biochemical tests, and urine parameters, increases in liver and kidney weights, and the appearance of hyaline droplets in the proximal tubular epithelium and degeneration of renal tubule of male kidneys as main microscopic changes were observed at 500 mg/kg/day or 100 mg/kg/day or higher. (USEPA/HPV (2006)) Besides, increased liver weights and eosinophilic cytoplasmic inclusions in cells of the renal proximal tubule of kidneys were observed at 14 ppm or higher by a 14-day inhalation exposure to rats. (USEPA/HPV (2006)) These above findings of kidneys in oral and inhalation routes were not used as bases for the classification because they are specific for male rats and are considered to be inapplicable to human. Therefore it corresponds to "Not classified" in an oral route because the highest dose of 500 mg/kg/day (converted to a 90-day equivalent: 155.5 mg/kg/day) is above the upper limit of Guidance values (100 mg/kg/day). But the classification is not possible in an inhalation route because the highest concentration of 420 ppm (converted to a 90-day equivalent: 0.468 mg/L) is within a range of Guidance values. Furthermore, it is reported that no systemic toxic effects were observed at the highest dose of 500 mg/kg/day (converted to a 90-day equivalent: 117 mg/kg/day) above the upper limit of Guidance values (100 mg/kg/day) in a 21-day dermal administration test in rabbits (USEPA/HPV (2006)). Therefore, it corresponds to "Not classified" in a dermal route. From the above, it was classified as "Classification not possible" in specific target organ toxicity (repeated exposure) because it corresponds to "Not classified" in the oral and dermal routes and "Classification not possible" in the inhalation route.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Aspiration hazard	Classification not possible	- -	-	-	No data.	FY2011	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)	Classification not possible	- -	-	-	Due to lack of data, the classification is not possible.	FY2011	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Hazardous to the aquatic environment Long term (Chronic)	Classification not possible	- -	-	-	No data.	FY2011	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.	FY2011	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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