Item | Information |
---|---|
CAS RN | 60-00-4 |
Chemical Name | Ethylenediaminetetraacetic acid |
Substance ID | m-nite-60-00-4_v1 |
Download of Excel format | Excel file |
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) |
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. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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. | FY2011 | 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. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | No data available. | 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) |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (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 | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
14 | Oxidizing solids | 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. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure. | FY2011 | 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. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
17 | Desensitized explosives | - |
- |
- | - | - | - | - |
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 |
- |
- | - | 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)). | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Dermal) | Classification not possible |
- |
- | - | No data available. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Inhalation: Gases) | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition) | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | No data available. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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)). | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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)). | 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 |
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)). | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | No data available. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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)). | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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)). | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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)). | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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)). | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
10 | Aspiration hazard | Classification not possible |
- |
- | - | No data available. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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 |
It was classified in Category 3 from 96-hour LC50 = 41 mg/L for fish (Lepomis macrochirus) (EU-RAR, 2005, etc.). | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
11 | Hazardous to the aquatic environment Long term (Chronic) | 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. |
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 the Annexes to the Montreal Protocol. | FY2011 | GHS Classification Guidance by the Japanese Government (July, 2010) |
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