GHS Classification Result

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GENERAL INFORMATION
Item Information
CAS RN 60-00-4
Chemical Name Ethylenediaminetetraacetic acid
Substance ID 23B5581
Classification year (FY) FY2011
Ministry who conducted the classification Ministry of Health, Labour and Welfare (MHLW)/Ministry of the Environment (MOE)
New/Revised Revised
Classification result in other fiscal year FY2006  
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) Physical Hazards & Health Hazards: GHS Classification Guidance by the Japanese Government (July, 2010) Environmental Hazards: UN GHS Document (4th revised edition)
UN GHS document (External link) UN GHS document
Definitions/Abbreviations (Excel file) Definitions/Abbreviations
Model Label by MHLW (External link) MHLW Website (in Japanese Only)
Model SDS by MHLW (External link) MHLW Website (in Japanese Only)
OECD/eChemPortal (External link) eChemPortal

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Explosives Not applicable
-
-
- - There are no chemical groups associated with explosive properties present in the molecule.
2 Flammable gases (including chemically unstable gases) Not applicable
-
-
- - Solid (GHS definition)
3 Aerosols Not applicable
-
-
- - Not aerosol products.
4 Oxidizing gases Not applicable
-
-
- - Solid (GHS definition)
5 Gases under pressure Not applicable
-
-
- - Solid (GHS definition)
6 Flammable liquids Not applicable
-
-
- - Solid (GHS definition)
7 Flammable solids Classification not possible
-
-
- - It is described that it is combustible (ICSC (2008)), but it was classified as "Classification not possible" due to no data in the prescribed test.
8 Self-reactive substances and mixtures Not applicable
-
-
- - There are no chemical groups present in the molecule associated with explosive or self-reactive properties.
9 Pyrophoric liquids Not applicable
-
-
- - Solid (GHS definition)
10 Pyrophoric solids Classification not possible
-
-
- - No data available.
11 Self-heating substances and mixtures Classification not possible
-
-
- - No data available.
12 Substances and mixtures which, in contact with water, emit flammable gases 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).
13 Oxidizing liquids Not applicable
-
-
- - Solid (GHS definition)
14 Oxidizing solids Not applicable
-
-
- - The substance is an organic compound containing oxygen (but not fluorine or chlorine) which is chemically bonded only to carbon or hydrogen.
15 Organic peroxides Not applicable
-
-
- - Organic compounds containing no bivalent -O-O- structure.
16 Corrosive to metals Classification not possible
-
-
- - Test methods applicable to solid substances are not available.

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
1 Acute toxicity (Oral) Not classified
-
-
- - It was classified as "Not classified" in the Classification JIS (Category 5 in UN GHS classification) based on LD50 values for rats of > 2000 mg/kg (EU-RAR 49 (2004)), 2,580, 4,500 mg/kg (the above, Initial Risk Assessment Report Ver.1.1, 14 (NITE, CERI, NEDO, 2007)).
1 Acute toxicity (Dermal) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Gases) Not applicable
-
-
- - Solid (GHS definition)
1 Acute toxicity (Inhalation: Vapours) Classification not possible
-
-
- - No data available.
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - Classification not possible due to lack of data. Besides, it is reported that there were no dead animals after 8-hour inhalation of a dust atmosphere at 20 or 80 deg C (Initial Risk Assessment Report Ver.1.1, 14 (NITE, CERI, NEDO, 2007)).
2 Skin corrosion/irritation Not classified
-
-
- - It was classified as "Not classified" because it is reported that it was not irritating in a Draize test with rabbits (Initial Risk Assessment Report Ver.1.1, 14 (NITE, CERI, NEDO, 2007)), and there was mild irritation at 24 hours in another test by 20-hour application to the ear of one rabbit (EU-RAR 49 (2004)).
3 Serious eye damage/eye irritation Category 2B
-
Warning
H320 P305+P351+P338
P337+P313
P264
It was classified in Category 2B because it is described that strong irritation, mild edema, and strong corneal opacity were seen in a test in which 50 mg was applied to the rabbit eye, but there were no findings at 8 days (EU-RAR 49 (2004)).
4 Respiratory sensitization Classification not possible
-
-
- - No data available.
4 Skin sensitization Classification not possible
-
-
- - No data available. Besides, for the disodium salt of this substance, it is reported that in a guinea pigs maximization test (OECD TG406), a positive rate was 30% (3/10) in the first challenge after 24 hours and 10% (1/10) in a second challenge after 7 days (EU-RAR 49 (2004)), and the substance was assessed as not sensitizing in another guinea pig maximization test (Initial Risk Assessment Report Ver.1.1, 14 (NITE, CERI, NEDO, 2007)).
5 Germ cell mutagenicity Not classified
-
-
- - As for in vivo tests on the disodium salt of this substance, negative results were obtained in all of a dominant lethal test by drinking water administration to mice (in vivo heritable germ cell mutagenicity test), a chromosomal aberration test with spermatogonial cells after intraperitoneal administration to mice (in vivo heritable germ cell mutagenicity test), and micronucleus tests with bone marrow after oral or intraperitoneal administration to mice (in vivo somatic cell mutagenicity tests) (all, EU-RAR 49 (2004)). Therefore, this substance was classified as "Not classified." Also, as for in vitro tests, this substance was negative in an Ames test and positive in a mouse lymphoma test, and there were negative results in an Ames test and a mouse lymphoma test on the trisodium salt of this substance (EU-RAR 49 (2004), Mutagenicity Test Data of Existing Chemical Substances based on the toxicity investigation system of the Industrial Safety and Health Law Supplement 2 (2000)). Besides, this substance was reported to be positive in a chromosomal aberration test with bone marrow and spleen cells of mice (in vivo somatic cell mutagenicity test) (Initial Risk Assessment Report Ver.1.1, 14 (NITE, CERI, NEDO, 2007)), but it was not used for classification based on expert judgment, claiming that test details such as administration route and doses are unknown, and the reproducibility of results is questionable for the test.
6 Carcinogenicity Classification not possible
-
-
- - No data available. Besides, in 103-week diet administration tests with rats and mice on the trisodium salt of this substance, there were no occurrences of treatment-related tumors in rats or mice, but it is mentioned that the substance was not tested at the maximum tolerated dose (EU-RAR 49 (2004)).
7 Reproductive toxicity Category 2


Warning
H361 P308+P313
P201
P202
P280
P405
P501
It is reported that after gavage administration to rats on gestational days 7-14, there were no effects in fetuses at the dose where effects such as death, diarrhea, and behavioral suppression were seen in parent animals (Initial Risk Assessment Report Ver.1.1, 14 (NITE, CERI, NEDO, 2007)), while it is reported that cleft palate, brain and eye defects, and skeletal anomalies occurred in fetuses in a test by diet administration to rats after day 6 of gestation (Teratogenic (12th, 2007)), although there is no description of general toxicity in parent animals, and incidences of malformations in fetuses were also reported after intraperitoneal or intramuscular administration to pregnant rats (Initial Risk Assessment Report Ver.1.1, 14 (NITE, CERI, NEDO, 2007), JECFA 796 (1993)). Therefore, it was classified in Category 2.
8 Specific target organ toxicity - Single exposure Classification not possible
-
-
- - No data available. Besides, as for effects of the related substance in humans, as acute symptoms when the disodium salt of EDTA (Na2EDTA) was intravenously administrated as an antidote for lead poisoning, numbness and tingling pain, arising around the hands and mouth, were reported (Initial Risk Assessment Report Ver.1.1, 14 (NITE, CERI, NEDO, 2007)).
9 Specific target organ toxicity - Repeated exposure Category 1 (kidney)


Danger
H372 P260
P264
P270
P314
P501
As effects in humans, it is described that renal tubular defects were seen when EDTA or its salts (sodium, calcium disodium) were ingested for a long time and in a large amount (Initial Risk Assessment Report Ver.1.1, 14 (NITE, CERI, NEDO, 2007)). Therefore, it was classified in Category 1 (kidney). Besides, the formulation of CaNa2EDTA, the related substance, is commercially sold as an antidote for lead poisoning, side effect information includes renal tubular defects after long-term administration of tablets, transient proteinuria for infusion, and renal tubular defects after long-term infusion, and it is described in other remarks that acute and large-amount administration may cause serious consequences such as death due to renal toxicity (Environmental Risk Assessment for Chemical Substances vol. 3 (Ministry of the Environment, 2004)).
10 Aspiration hazard Classification not possible
-
-
- - No data available.

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification
11 Hazardous to the aquatic environment (Acute) Category 3
-
-
H402 P273
P501
It was classified in Category 3 from 96-hour LC50 = 41 mg/L for fish (Lepomis macrochirus) (EU-RAR, 2005, etc.).
11 Hazardous to the aquatic environment (Long-term) Category 3
-
-
H412 P273
P501
If chronic toxicity data are used, then it is classified as "Not classified" due to 21-day NOEC = 5.5 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 2002), etc.), although it is not rapidly degradable (a 4-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1994)).
If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained, then it is classified in Category 3 due to being not rapidly degradable (a 4-week degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, 1994)), and 96-hour LC50 = 41 mg/L for fish (Lepomis macrochirus) (EU-RAR, 2005, etc.).
By drawing a comparison between the above results, it was classified in Category 3.
12 Hazardous to the ozone layer Classification not possible
-
-
- - This substance is not listed in the Annexes to the Montreal Protocol.


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.

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