Registration Dossier
Registration Dossier
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EC number: 289-064-0 | CAS number: 85959-68-8
Endpoint summary
Administrative data
Description of key information
In an extended oral OECD 422 study with the structurally related chelate DTPA-FeHNa male animals were exposed for at least 13 weeks and females for almost 14 weeks. At the high dose level the following effects were observed: soft faeces (both sexes), decreased body weight gain (males), prolonged prothrombin time (males), increased haemoglobin concentration (males), decreased ALAT activity and chloride concentration (males) and increased relative weights of kidneys and liver (both sexes). No toxicologically relevant changes were observed at the lower levels of 500 and 150 mg/kg bw (see also read across document in section 13).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a repeated inhalation toxicity with DTPA-CaNa3 in rats only a mild, focal and reversible pulmonary histiocytosis was induced. At a level of 0.42 mg/L (420 mg/m3), the incidence and severity of the histiocytosis was comparable to that in the chamber- and aerosol control group; this level, therefore, was considered a NOAEC. Similar results are also expected for DTPA-Fe(NH4)2 (see also read across document in section 13).
Justification for classification or non-classification
Based on a NOAEL of 500 mg/kg bw in a study with the structurally related chelate DTPA-FeHNa in which male rats were treated for at least 13 weeks and females for almost 14 weeks, no classification is needed for STOT repeated exposure for DTPA-Fe(NH4)2.
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