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EC number: 205-759-3 | CAS number: 150-39-0
There are no repeated dose studies with the substance available. Studies on two structural analogues of the substance (Na3H-EDTA and Na2H2-EDTA) are available (for read-across justification refer to Section 13) which indicate no significant concerns for toxicity/carcinogenicity.
Table 1: Analyses of the Incidence of Primary Tumors at Specific Sites in Male Rats Fed EDTA Trisodium Salt in the Diet
Table 2 Analyses of the Incidence of Primary Tumors at Specific Sites in Female Rats Fed EDTA Trisodium Salt in the Diet
A one month feeding study in rats of EDTA-Na2H2, a structural analogue of the substance, revealed a NOAEL of 2.25% in the diet, corresponding to 1,125 mg/kg/day (Kawamata, 1980). In this study the substance was incorporated at levels of 1, 2.25 and 5% in the diet, corresponding to 500, 1125 and 2500 mg/kg/day). Fifteen rats/sex/dose level were exposed over a period of one month. At the high dose level body weight was decreased, some mortalities occurred and a reduction of total leucocytes and lymphocytes as well as an increase of bound urine nitrogen (BUN) and a decrease Ca serum levels were found. Pathological investigation at this dose level revealed reduced liver, spleen and thymus weights. Microscopic pathology revealed some parakeratosis in the oesophagus and forestomach. A 90 -day feeding study in rats with the same substance revealed a NOAEL of 500 mg/kg/day (Wynn, 1970). Groups of 10 male Holzman rats received 1, 5 and 10% (respectively 500, 2,500 and 5,000 mg/kg/day) EDTA-Na2H2 in the diet for 90 days. It should be noted that in this study detailed clinical chemistry investigations were not performed as required by OECD TG 408. Mid- and high-dose animals expressed a significant decrease of body weights and food consumption. Dose dependent mortality was evident by 20% in the 5% and 60% in the 10% group. In these groups animals exhibited diarrhoea and were emaciated. Water consumption was increased. In the upper dose there was an intermittent decrease of haematocrit and haemoglobin levels and livers appeared to be pale. Histological investigation failed to reveal any pathological alteration.
A two-year feeding study in rats with another structural analogue (Na3H-EDTA x 3H2O) resulted in a NOAEL of 500 mg/kg/day (corresponding to 7,500 ppm in the diet) (NTIS, 1977). In this feeding study two dose levels were investigated - 3,750 ppm and 7,500 ppm (corresponding to approximately 250 and 500 mg/kg/day). No substance related toxic effects could be observed. This substance was also investigated in a study of the same duration in mice at the same dose levels (3,750 ppm and 7,500 ppm; corresponding to approximately 469 and 938 mg/kg/day). Again there were no treatment related changes and a NOAEL of 938 mg/kg/day was assigned.
When comparing the acute inhalation toxicity studies of HEDTA-Na3 and EDTA-Na2H2, the first one showed no lethality at the technically highest available concentration of almost 4000 mg/m3 for 4 h whereas the latter showed 30% mortality at 1000 mg/m3 for 6 h, the diffference being considered to be due to the higher binding capacity of EDTA compared to HEDTA. For EDTA-Na2H2 a 14 -day and a 90 -day inhalation toxicity study are available showing local effects in the respiratory tract mainly in the larynx. Based on the acute tests, much less local toxicity is expected for HEDTA upon repeated exposure. Moreover, in accordance with REACH Regulation 1907/2006 (Annex IX, 8.6.2 Column 2) testing by the inhalation route is appropriate if exposure of humans via inhalation is likely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. As HEDTA-H3 is only produced as an aqueous solution there will be no exposure to dust particles, and also no exposure to the vapour because of the very low vapour pressure of HEDTA-H3.
According to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification and labelling is not indicated for repeat dose toxicity as clear functional disturbances or morphological changes were not apparent in chronic toxicity studies.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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