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EC number: 223-267-7 | CAS number: 3794-83-0
For sodium salts of HEDP, a study comparable to OECD 453 conducted with disodium etidronate showed no indication of carcinogenic potential.
The tumour types and incidence were normal for this strain. The following gives frequency (%) of neoplastic lesions of different types for control, 500ppm, 2000ppm, 10000ppm respectively (m = males, f = females):
In this well-performed study, in which sodium salt of Complexing Agent - Henkel 1-hydroxythane-1,1-diphosphonic acid (disodium etidronate) was administered to Sprague-Dawley-derived rats (40/sex/dose) in the diet for 104 weeks, at dietary concentrations of 500, 2000, 10000 ppm (equivalent to 19, 78 and 384 mg/kg/day for males, and 24, 96, 493 mg/kg/day for females). This 'main' group was primarily used to assess the carcinogenic potential of the test substance. A satellite group (10/sex/dose) received the same doses for 26 weeks, and was used to assess general toxicity (blood and urinary assessments made on this group only). The main groups were observed for mortality, clinical signs of toxicity, food and water consumption, ophthalmoscopy, and gross and microscopic examinations. There was no evidence of neoplastic potential, or other chronic toxicity effects for disodium etidronate apart from the perturbations of haematological parameters that were observed in the highest dose groups (discussed in Section 7.5.1). The NOAEL for carcinogenicity was 384 and 493 mg/kg bw/day for males and females, respectively.
In a well conducted and reported, pre-GLP, dietary Combined Chronic Toxicity / Carcinogenicity study (Huntingdon Research Centre, 1979), conducted using a protocol similar to OECD 453, there was no evidence of neoplastic activity for Complexing Agent - Henkel (sodium salt of 1-hydroxythane-1,1-diphosphonic acid (disodium etidronate)) tested up to 384 and 493 mg/kg bw/day for males and females, respectively.
Justification for grouping:
See CSR Annex I or IUCLID section 13.
Based on the available carcinogenicity study tetrasodium HEDP does not require classification for carcinogenicity.
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