NITE - Chemical Management Field

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

GENERAL INFORMATION

Item	Information
CAS RN	64-02-8
Chemical Name	Tetrasodium ethylenediaminetetraacetate
Substance ID	m-nite-64-02-8_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)	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.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid (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)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Flammable solids	Classification not possible	- -	-	-	Since no test results are available, classification is not possible. As relevant notes, it is reported that this substance is combustible (ICSC (2006)) and it doesn't easily ignite (nicht leichtentzuendlich) (IUCLID (2000)).	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 (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
10	Pyrophoric solids	Not classified	- -	-	-	Since its auto ignition point is 260 degC (Selbstentzuendung rnit Luft bei 260 Grad C.) (IUCLID (2000), Original literature: BASF AG Ludwigshafen), it is considered that the substance does not ignite at room temperature.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	Since no test results are available, classification is not possible. As relevant note, it is reported that this substance is combustible (ICSC (2006)) and it doesn't easily ignite (nicht leichtentzuendlich) (IUCLID (2000)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified	- -	-	-	Although it contains a metal (Na), its water solubility is 103 g/100 mL (Merck (14th, 2006)) and it is considered that the substance doesn't react strongly with water.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
14	Oxidizing solids	Classification not possible	- -	-	-	Although this substance is an organic compound containing oxygen which is chemically bonded to Na, other than carbon or hydrogen, due to lack of additional data, classification is not possible.	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	- -	-	-	Test methods applicable to solid substances are not 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	The five LD50 values of 2700, 3200, 1700, 1780 - 1913 and 1210 - 2150 mg/kg for rats were documented in the data from the "List 1" information source designated in the GHS classification guidance for the Japanese government (EU-RAR (2004)). The two data are equivalent to the guidance value of Category 4, the other two are "Not classified" category (corresponding to Category 5 in the UN-GHS classification), and the other one is Category 4 or Category 5. The applicable amount of the data for each Category 4 and "Not classified" category was the same. Selecting the category of greater hazard, the substance was classified as Category 4.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Solid (GHS definition)	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	The classification was not possible due to lack of data. Although it was reported that no mortalities occurred in the 8-hour inhalation test for rats with dust (EU-RAR (2004)), the test concentration was uncertain.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
2	Skin corrosion/irritation	Not classified	- -	-	-	In the rabbit test (OECD TG 404) by contact with 80% aqueous solution for 4 hours, the average score of erythema at 24, 48 and 72 hours after application were 1, 0, and 0.3, respectively, and the symptoms disappeared after 8 days. Edema was not observed (EU-RAR (2004)). Based on the result, the substance was classified as "Not classified". In other rabbit studies by contact with 80% aqueous solution for 20 hours, severe erythema and exfoliation were observed after 24 hours and 8 days respectively. But edema was not observed (EU-RAR (2004)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
3	Serious eye damage/eye irritation	Category 2A	Warning	H319	P305+P351+P338 P337+P313 P264 P280	In the rabbit test, instillation of 50 mg of an 88% aqueous preparation of the substance to the eye of one rabbit resulted in strong irritation at 1 - 24 hours application, and extreme edema, mild corneal opacity, pus formation were observed. After 8 days, a mild corneal opacity was seen (EU-RAR (2004)). In the other rabbit test which exposed 0.1ml of 40% aqueous preparation of the substance to the eye of three rabbits, irritation scores after 72 hours were 1 for corneal opacity, 1 for iritis, 3 for conjunctivae redness and 2 - 3 for chemosis (EU-RAR (2004)). Based on the information, the substance was classified as Category 2A.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Respiratory sensitization	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
4	Skin sensitization	Classification not possible	- -	-	-	Insufficient data were available. As relevant information, a 78-year-old woman with recurrent leg ulcers revealed a positive response by twice contact to the aqueous solution of this substance (EU-RAR (2004)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	The classification was not possible due to lack of in vivo test data. As relevant information, as for in vitro studies, negative results were reported in the Ames test (HSDB (2004)), the chromosome aberration test using CHO cells, and the transformation test using Syrian hamster embryo cells (IUCLID (2000)).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
6	Carcinogenicity	Classification not possible	- -	-	-	No data available.	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
7	Reproductive toxicity	Classification not possible	- -	-	-	In the developmental toxicity test in rats by oral administration of the test substance from 7th to 14th day of gestational period, general toxic signs containing diarrhea and depression of activity and reduced weight gain were observed in the dams, while the mortality index of offspring by postimplantation loss, litter size and mean fetal body weight were comparable to that of the control group. The evidence indicated the teratogenicity was not found in the external, visceral and skeletal examinations (EU-RAR (2004)). However, since sufficient information was not provided regarding sexual functions and fertility of parental animals, 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 2 (systemic)	Warning	H371	P308+P311 P260 P264 P270 P405 P501	It was reported that there were multiple data on acute oral toxicity studies with rats (LD50 value: 1210 - 3200 mg/kg), and the most prominent clinical signs were dyspnea, ataxic gait, abnormal gait, tremor or piloerection, and that autopsy findings of redness and hemorrhagic ulcer of the glandular part of the stomach, redness of the mucous membranes of the intestine and systemic hyperemia or flaccid intestines (EU-RAR (2004)). It was difficult to identify the target organ(s) from the findings described above, and the effects were seen in the doses equivalent to Category 2 of the guidance values or more. Therefore, the substance was classified as Category 2 (systemic toxicity).	FY2010	GHS Classification Guidance by the Japanese Government （July, 2010）
9	Specific target organ toxicity - Repeated exposure	Classification not possible	- -	-	-	No data available.	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)	Not classified	- -	-	-	It was classified as "Not classified" from 96-hour LC50 = 157 mg/L [converted value 121 H4EDTA mg/L] for fish (Lepomis macrochirus) (EU RAR: 2004).	FY2018	GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11	Hazardous to the aquatic environment Long term (Chronic)	Not classified	- -	-	-	If chronic toxicity data are used, then it is classified as "Not classified" from 21-day NOEC (reproduction, lethal) = 28 mg/L [22 H4EDTA mg/L (converted value)] for crustacea (Daphnia magna) and 35-day NOEC (effects unknown) > 35 mg/L [26.8 H4EDTA mg/L (converted value)] for fish (Danio rerio) (both EU RAR: 2004) despite unknown environmental dynamics of the inorganic compound. Because there are no acute toxicity data for a trophic level for which chronic toxicity data are not obtained (for algae), the classification is not possible. From the above results, it was classified as "Not classified."	FY2018	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.	FY2018	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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