NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	78-42-2
Chemical Name	Tris(2-ethylhexyl) phosphate
Substance ID	m-nite-78-42-2_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 molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Flammable liquids	Not classified	- -	-	-	Based on a flash point of 207 deg C (closed-cup) written in HSDB (Access on October 2016), it was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Flammable solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Pyrophoric liquids	Not classified	- -	-	-	It is estimated that it does not ignite at normal temperatures from an autoignition temperature of 370 deg C (ICSC (1997)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Pyrophoric solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Test methods applicable to liquid substances are not available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	There is a metalloid (P) present in the molecule, but due to the water solubility data of 0.6 mg/L (HSDB (Access on October 2016)), it is estimated that it does not react vigorously with water.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13	Oxidizing liquids	Classification not possible	- -	-	-	The substance is an organic compound containing oxygen which is chemically bonded to the element other than carbon or hydrogen, but the classification is not possible due to no data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14	Oxidizing solids	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15	Organic peroxides	Not classified (Not applicable)	- -	-	-	Organic compounds containing no bivalent -O-O- structure in the molecule.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16	Corrosive to metals	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
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	- -	-	-	Based on a reported LD50 value (OECD TG 401) of > 2,000 mg/kg (JECDB (Access on October 2016)) for rats, this substance was classified as "Not classified." 　Besides, in the previous classification, LD50 values of 37,000 mg/kg, >10,000 mg/kg and >36,800 mg/kg (EHC 218 (2000)) for rats were used as the rationale for classification. However, since an LD50 value was obtained in an OECD TG 401 study, which has a higher priority according to the workflow of the GHS Classification Guidance, this value was used for the classification.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Dermal)	Not classified	- -	-	-	Based on the LD50 value of 18,400 mg/kg (Hazard Assessment Report (CERI, NITE, 2005), BUA 172 (1995)) for rabbits, this substance was classified as "Not classified."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Liquid (GHS definition)	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　There is a report that the LC50 (3.5 hours) value of rats is > 447 mg/m3 (converted 4-hour equivalent value: > 0.39 mg/L) (EHC 218 (2000), Hazard Assessment Report (CERI, NITE, 2005), BUA 172 (1995)), but this substance was classified as "Not classified" because it is difficult to specify the category from only these values. Besides, since the LC50 value is higher than the saturated vapor pressure concentration (0.00194 microg/L), the reference value as mist was applied.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2	Skin corrosion/irritation	Category 2	Warning	H315	P302+P352 P332+P313 P362+P364 P264 P280 P321	It is described that in a skin irritation test (OECD TG 404) using rabbits, well-defined erythema, slight to moderate oedema, crust formation and desquamation were observed; PII (primary irritation index) was 4.2/8.0; and therefore, this substance is a moderate irritant to rabbit skin (Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000)). 　From the above, this substance was classified in Category 2.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3	Serious eye damage/eye irritation	Not classified	- -	-	-	It is described that in an eye irritation test (OECD TG 405) using rabbits, this substance did not indicate irritation (Hazard Assessment Report (CERI, NITE) (2005)). In addition, it is reported that in the eye irritation test using rabbits, moderate conjunctivitis was observed when this substance was applied but was cleared after 24 hours (Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000)). 　Based on the result of a test conducted according to an OECD test guideline, this substance was judged as "Not classified." By adding data, the category was changed.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4	Skin sensitization	Classification not possible	- -	-	-	Classification not possible due to lack of data. 　Besides, there is a report stating negative in a test using guinea pigs (Hazard Assessment Report (CERI, NITE, 2005)), and there is a report stating weakly positive in a Landsteiner test using guinea pigs (Hazard Assessment Report (CERI, NITE, 2005)). However, it was judged that both data are insufficient to be used for the classification as the details are unknown.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The substance was classified as "Classification not possible" because it was not possible to classify a substance as "Not classified" according to the revised GHS classification guidance for the Japanese Government. 　As for in vivo tests, micronucleus tests using mouse bone marrow cells and peripheral blood erythrocytes were negative, a micronucleus test using rats was negative, a chromosomal aberration test using mouse bone marrow cells was negative, a sister chromatid exchange test using mouse bone marrow cells was positive and an unscheduled DNA synthesis test using mouse liver was negative (NTP DB (Access on October 2016), EHC 218 (2000), Hazard Assessment Report (CERI, NITE, 2005)). As for in vitro, a bacterial reverse mutation test, a mouse lymphoma assay, a chromosomal aberration test and a sister chromatid exchange test using cultured mammalian cells were negative (NTP DB (Access on October 2016), ECETOC JACC (1992), JECDB (Access on October 2016), Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000)).	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6	Carcinogenicity	Classification not possible	- -	-	-	In a carcinogenicity study in which rats or mice were administered by gavage for 2 years, in the male rats, an increase in the incidence of pheochromocytoma of the adrenal glands was observed. However, it was pointed out that the incidence in the controls was low compared with the background data, thus it was judged as equivocal evidence of carcinogenicity (NTP TR274 (1984), Hazard Assessment Report (CERI, NITE, 2005)). 　On the other hand, in female mice, a significant increase in the incidence of hepatocellular carcinoma was observed; it was concluded that there was some evidence of carcinogenicity. In addition, there was no evidence of carcinogenicity in female rats and male mice (NTP TR274 (1984), Hazard Assessment Report (CERI, NITE, 2005)). 　As described above, there is no clear evidence of carcinogenicity in the experimental animals, and there are also no classifications by other organizations. Therefore, classification is not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7	Reproductive toxicity	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8	Specific target organ toxicity - Single exposure	Classification not possible	- -	-	-	Classification not possible due to lack of data. There is no single exposure data of this substance in humans. As for experimental animals, it is reported that in a single oral dose study using rats, there were no death cases at 2,000 mg/kg; and no changes suggesting toxic effects observed either, in terms of general conditions, changes in body weight and necropsy findings (JECDB (Access on November 2016)). In addition, it is reported that in a 3.5-hour single inhalation exposure study using rats at 460 mg/m3 of this substance, there were no death cases (EHC 218 (2000), ECETOC JACC (1982), Hazard Assessment Report (CERI, NITE, 2005)). 　Because there is no other information providing the rationale for the classification, this substance was classified as "Classification not possible" according to the GHS Classification Guidance for the Japanese Government.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	There is no information in humans. 　As for experimental animals, multiple repeated dose toxicity studies using rats or mice dosed by gavage were conducted. 　Of these studies, it has been reported that in a 13-week study using mice, inflammatory lesions in the gastric mucosa, etc. are observed at the doses equal to or above 500 mg/kg/day (converted guidance value: 361 mg/kg/day), which is above Category 2 (NTP TR274 (1984), Hazard Assessment Report (CERI, NITE, 2005)), and that in a 103-week study using mice, increased thyroid follicular cell hyperplasia is reported at the doses equal to or above 500 mg/kg/day), which is above Category 2 (NTP TR274 (1984), Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000), ECETOC JACC (1992)). Moreover, 3-month inhalation toxicity studies using guinea pigs, dogs and rhesus macaques were conducted (Hazard Assessment Report (CERI, NITE, 2005), EHC 218 (2000), ECETOC JACC (1992)). Of these studies, it is reported that in the study using dogs, moderate chronic inflammatory changes in the lung parenchyma and a significant dose-dependent deterioration in conditioned avoidance performance were observed. However, since this study used hybrid dogs and the number of animals used was as small as one of each sex, it is not possible to be used for classification. 　Therefore, this substance was classified as "Classification not possible."	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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	From 48-hour EC50 = 0.13 mg/L for crustacea (Daphnia magna) (Environmental Risk Assessment for Chemical Substances vol. 9 (Ministry of the Environment, 2011), Hazard Assessment Report (CERI, NITE, 2005)), it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	Reliable chronic toxicity data were not obtained. Because it is not rapidly degradable (a degradation rate by BOD: 0 % (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1985)), and it is classified in Category 1 for acute toxicity, it was classified in Category 1.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	No data available.	FY2016	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

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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