Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']magnesate(2-)

Endpoint summary

Description of key information

Several repeated oral toxicity studies were available for EDTA-CaNa2; results of these studies were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3, another, Ca-containing chelate. Several ip and iv studies were also available showing various effects but mostly on kidneys. However, as workers and consumers are not exposed via these non-physiological routes these studies are not further taken into account. 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

The 2-year NOAEL in a rat study with EDTA-CaNa2 was >= 250 mg/kg bw. Other long term oral toxicity studies with other metal chelates or with EDTA showed comparable results.

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

Quality of whole database:

A repeated 12-day inhalation toxicity with another chelate (Ca-DTPA) at levels up to 1.18 mg/L induced only a mild, focal and reversible pulmonary histiocytosis in the rat.

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

A 2 -year oral toxicity study in rats with EDTA-CaNa2 revealed no toxicity up to and including 250 mg/kg bw. No toxicity was seen up to and including 338 mg/kg in a 1 -year oral study in dogs. Short-term studies with EDTA-CaNa2 in rats revelead a NOAEL of >= 3636 mg/kg (31 -day study) or a LOAEL of 2750 mg/kg bw (1 -month study). A 61 -day study with another metal chelate (EDTA-FeNa) revealed a NOAEL of >= 84 mg/kg bw in rats (higest dose tested), whereas a 14 -week study in rats with EDTA-MnNa2 resulted in a NOAEL of 500 mg/kg bw. Chronic studies with EDTA-Na3H revealed a NOAEL of >= 500 mg/kg bw in rats, and >= 938 mg/kg bw in mice. Finally, a 13 -week study with EDTA-Na2H2 resulted in a NOAEL of >= 500 mg/kg bw. These results together show that EDTA-CaNa2 like other EDTA's is of low toxicity following repeated oral exposure. The NOAEL observed in the 2 -year study in rats, which was at least 250 mg/kg bw, may therefore be higher. It is not expected that repeated inhalation exposure to EDTA-CaNa2 would result in harmful effects based on the results of a 12 -day exposure study with DTPA-CaNa3 in which a NOAEL of 420 mg/m3 was observed. Futher, because EDTA-CaNa2 is not irritating to the skin, local dermal effects are not expected and because the absorption via the skin is expected to be very low (EU RAR, 2004), no systemic toxicity is expected following dermal exposure.

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Several studies available for metal EDTA chelates (see read across document in section 13)

Justification for classification or non-classification

Based on the results indicated above and based on rread across document (see section 13) no classification is needed for EDTA-MgNa2 following repeated exposure.