L-Aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt (1:3)

PBT assessment

PBT assessment: overall result

Reference

Name:

l-aspartic acid, N,N'-1,2-ethanediylbis-, trisodium salt

Type of composition:

legal entity composition of the substance

State / form:

solid: bulk

Reference substance:

l-aspartic acid, N,N'-1,2-ethanediylbis-, trisodium salt

PBT status:

the substance is not PBT / vPvB

Justification:

Not P / vP

A ready biodegradability test using activated sludge and carried out according to OECD Guideline 301 B (and in compliance with GLP) in an aerobic aqueous medium showed that trisodium EDDS was readily biodegradable. Initial test concentrations were 10 and 20 mg/L and biodegradation reached about 83-85% by day 28 and 88-90% by day 35.

A read across substance, [S,S]-EDDS, in an unacclimated river water die-away test, reached about 75% degradation, corresponding to a half-life of about 6.3 days, suggesting that biodegradation also occurs under realistic environmental conditions.

Not B / vB

In a preliminary GLP study conducted according to OECD Guideline 107 (shake-flask method), the log Pow (n-octanol/water partition coefficient) for trisodium EDDS was estimated to be <-4.7 at 20°C (de Vries, 1993a).

Not T

In a GLP study conducted according to OECD Guideline 210, the effect on hatching, survival and the occurrence of egg and larval malformations following exposure to trisodium EDDS in the freshwater Zebra fish, Brachydanio rerio, was investigated. At nominal concentrations of 348 mg/L and above, growth (measured as dry weight) was significantly retarded for the surviving fish, but no effects on growth were seen at 196 mg/L (considered the 30-d NOEC for such effects) and below. The 30-d NOEC for mortality and condition was 61 mg/L.

In 2 GLP studies conducted according to or similar to OECD Guideline 471, trisodium EDDS (in water) showed no mutagenic potential in a bacterial mutagenicity assay (Ames test) when tested at up to 5 mg/plate in five strains of S. typhimurium and two strains of E. coli, both in the presence and absence of S9.

In a GLP study, trisodium EDDS showed no evidence of mutagenic potential at the tk locus in mouse lymphoma L5178Y tk+/- cells in an in vitro mammalian cell mutation assay when tested at up to about 5 mg/mL, with and without S9.

In a GLP study equivalent to OECD Guideline 475, trisodium EDDS showed no evidence of induction of numerical or structural chromosome aberrations when administered as a single oral dose at up to 2000 mg/kg bw in a bone marrow cytogenetic assay in male and female rats.

In good-quality NCI studies, conducted according to a protocol similar to OECD Guideline 451, trisodium ethylenediaminetetraacetate (EDTA) showed no evidence of carcinogenic potential when fed to rats and mice in the diet for 2 years at up to 7500 ppm (about 375 and 1125 mg/kg bw/day, respectively) (NCI, 1977). Based on their structural similarity, it is expected that trisodium EDDS is also unlikely to induce tumorigenicity following long-term oral exposure at comparable doses.

In a GLP study, conducted according to EPA Guidelines (OPPTS 870.3700), a NOAEL of 551 mg/kg bw/day was derived for both maternal and developmental toxicity in rats given trisodium EDDS in the diet from day 6 to 15 of pregnancy.

In a GLP study conducted according to OECD Guideline 408 (available at the time), a 90-d NOAEL of 300 mg/kg bw/day was established for trisodium EDDS based on a reduction in body weight gain and single cell death and fatty infiltration in the pancreas seen of rats at 700 mg/kg bw/day and above following repeated dietary administration.

In a GLP study designed to assess toxicity and mineral balance, no adverse effects were observed when trisodium EDDS was given to male rats in the diet for 28 days at up to 400 mg/kg bw/day, considered the study NOAEL. A dose-related and statistically significant increase in the urinary excretion of zinc was observed at all tested doses (50 mg/kg bw/day and above; considered the study LOEL), which was compensated for by a decrease in faecal zinc excretion (measured only in the two highest dose groups) so that the overall total excretion of zinc was unaltered.

In a GLP study, trisodium EDDS showed no evidence of toxicity when fed in the diet to male rats for 14 days at up to 1250 mg/kg bw/day, considered the study NOEL.

In a 14-day dietary study, trisodium EDDS exhibited toxicity at 2500 mg/kg bw/day and above in male and female rats, seen as loss of body weight, reduced food and water consumption, diarrhoea and hunched posture. The study NOAEL is therefore 500 mg/kg bw/day.