Registration Dossier
Registration Dossier
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EC number: 824-774-1 | CAS number: 148124-40-7
Endpoint summary
Administrative data
Description of key information
Based on read across with EDTA-FeNa and EDTA-FeK:
LD50 (oral, rat) exceeds 2000 mg/kg bw
LD50 (dermal, rat) exceeds 2000 mg/kg bw (read across with ETD-FeNa)
LC50 (rat, 4h) exceeded 2.75 +/- 0.19 mg/L, the maximum attainable concentration (read across with EDTA-FeNa).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- One study available for EDTA-FeK, LD50 > 2000 mg/kg. Several studies available for EDTA-FeNa. LD50 > 2000 mg/kg and perhaps even > 5000 mg/kg bw.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Two studies available for EDTA-FeNa (see read across document in section 13); 4-h LC50 > 2.75 mg/L (maximum attainable concentration).
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Two studies available for EDTA-FeNa. LD50 > 2000 mg/kg and perhaps even > 5000 mg/kg bw.
Additional information
The key study with EDTA-FeK shows very low acute oral toxicity via the oral route of exposure. EDTA-FeNa also shows very low acute oral toxicity via the 'normal' routes of exposure, viz. oral, dermal and inhalation. No mortalities occured in the key studies. The LD50/LC50s found in the key studies are supported by values from literature.
Via a non-physiological route of human exposure, viz intraperitoneal injection, the LD50 for EDTA-FeNa in mice was lower, viz. 160 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
Key study
Justification for classification or non-classification
The key study with EDTA-FeK shows that LD50 (oral, rat) exceeds 2000 mg/kg bw. Read across with EDTA-FeNa (see also section 13) shows that LD50 (dermal, rat) exceeds 2000 mg/kg bw and LC50 (rat, 4h) exceeded 2.75 +/- 0.19 mg/L, the maximum attainable concentration. Therefore classification for acute toxicity is not warranted.
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