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EC number: 932-833-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
No data on repeat dose toxicity were available for the reaction mass of iron ammonium (III) citrate and ammonium sufate. Data were therefore read across from iron trichloride (CAS 7705-08-0).
In an oral dose range-finding study (Sato et al., 1992) in which iron trichloride hexahydrate was administered to rats in their drinking water for 13 weeks, the NOAEL was 0.5% (equivalent to 277 and 314 mg/kg bw/day in males and females, respectively and to 57 and 65 mg Fe/kg bw/day in males and females, respectively). In the 1.0 and 2.0% groups there was a reduced body weight gain of at least 10% compared with the controls at the termination of treatment. There was a significant reduction in the intake of drinking water observed in groups given concentrations of 0.5% or more. Males of the treated groups had significantly increased red blood cell counts.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 277 mg/kg bw/day
Additional information
No data on repeat dose toxicity were available for the reaction mass of iron ammonium (III) citrate and ammonium sufate. Data were therefore read across from the analogous substance iron trichloride (CAS 7705-08-0). Additional information on basis of read across approach is given in an expert report (Peter Fisk Associates, 2012) attached in Section 13 of the IUCLID dossier.
In an oral dose range-finding study (Sato et al., 1992) in which iron trichloride hexahydrate was administered to rats in their drinking water for 13 weeks, the NOAEL was 0.5% (equivalent to 277 and 314 mg/kg bw/day in males and females, respectively and to 57 and 65 mg Fe/kg bw/day in males and females, respectively. Based on the known composition of the registered substance being 12.2% iron, the NOAEL expressed as the reaction mass of ammonium iron (III) citrate and ammonium sulfate is therefore 772 mg/kg bw/day)). In the 1.0 and 2.0% groups there was a reduced body weight gain of at least 10% compared with the controls at the termination of treatment. There was a significant reduction in the intake of drinking water observed in groups given concentrations of 0.5% or more. Males of the treated groups had significantly increased red blood cell counts.
Justification for classification or non-classification
Based on the available information, no classification is proposed for the reaction mass of iron ammonium (III) citrate and ammonium sulfate in accordance with current regulation (EC 1272/2008).
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