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EC number: 200-449-4 | CAS number: 60-00-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Carcinogenicity
Administrative data
Description of key information
Epidemiological studies are not available for evaluation of the carcinogenic potential of EDTA. There are also no carcinogenicity studies of EDTA free acid available. Therefore, the carcinogenicity studies with Na3EDTA have been used for evaluation. A bioassay of Na3EDTA for possible carcinogenicity was conducted by administration of test material in the diet to Fischer 344 rats and B6C3F1 mice. The studies did not report specific data on kidney toxicity in either species even though histology was performed. Although, a variety of tumors occurred among test and control animals of both species, no tumors were treatment related. Taking together the negative results of the carcinogenicity study and of the SHE cell transformation assays as well as the general non-mutagenicity after oral doses it can be concluded that there is no concern on a carcinogenic potential of EDTA.
Key value for chemical safety assessment
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test substance did not show carcinogenic potential in rats or mice. As a result, the substance is not considered to be classified for carcinogenicity under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179.
Additional information
A standard carcinogenicity study on mice and rats using Na3 EDTA did not demonstrate that the test substance is carcinogenic in experimental animals. 50 male and 50 female Fischer 344 rats were administered with 3,750 and 7,500 ppm (equivalent to about 248 and 495 mg/kg bw/day) daily in the diet for 103 weeks. Matched control groups were composed of 20 male and 20 female animals. The average body weights of treated males and females were comparable to those of the matched controls throughout the study. No treatment-related clinical signs were observed and no statistically significant differences in survival noted. Inflammatory and degenerative changes were observed in about the same frequency in all groups. The lesions appeared to be related to age and not to the administration of the test substance. A high incidence of tumors has been observed in the reproductive and endocrine systems and low incidences occurred in the hematopoietic, respiratory, integumentary, and digestive systems. No neoplasms were observed in the nervous, musculoskeletal, or urinary systems. No tumor appeared in a statistically significant positive trend in either dose groups or sexes. A variety of endocrine tumors were found, some types occurring only in treated animals. However, these tumors occurred in low numbers and have frequently been seen in untreated animals in other studies. Therefore, they are probably unrelated to treatment. In a similar study in mice, 50 male and 50 female B6C3Fl mice were administered with the same dose concentrations (3,750 and 7,500 ppm, equivalent to about 469 and 938 mg/kg bw/day) daily in the feed for 103 weeks. Matched control groups were composed of 20 male and 20 female animals. In male mice only the high-dose group showed a decrease in average body weight compared to the controls throughout most of the study period. In female mice average body weights of the treatment groups were depressed in a dose-related manner during the study period, although the effect was small. No treatment-related clinical signs were observed and no statistically significant differences in survival noted. Inflammatory and degenerative changes were observed in about the same frequency in all groups. The lesions appeared to be related to age and not to the administration of the test substance. A variety of neoplasms were found in both treated and control animals that were well known from historical controls of the same strain. There was a high incidence of tumors in the hematopoictic, endocrine, digestive, and respiratory systems. The incidence of neoplasms in other systems was variable. For all tumor types observed no statistical significance were seen between incidences in dose groups and control groups. With the exception of a splenic hemangioma in a control female and a 3,750 ppm-male, all of the tumors of the hematopoietic system were malignant lymphomas or leukemias. The distribution of endocrine tumors varied little between treated and control mice. For all groups, the incidences of hepatic neoplasms were considerably higher in males than in females. Liver tumors occurred in the 3,750 ppm-dose (10/44, 22 %) and 7,500 ppm-dose (10/47, 21 %) male groups. Percentage was approximately the same as in the male controls (3/19, 16 %). Primary neoplasms of the respiratory system were observed in both treated and control groups. The highest incidence of pulmonary neoplasms was found in the 7,500 ppm-dose male mice (control : 2/18, 11 % ; 3,750 ppm: 8/44, 18%; 7,500 ppm: 12/45, 26 %). This may suggest a treatment related effect. Lung tumors were frequently seen in mice of this strain and age, and therefore, the increase of incidence in this mouse study is probably not related to treatment. In conclusion, the non-significantly increased incidence of some tumor types observed in the study provides no clear evidence of carcinogenic effects in the mice.
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