Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted schientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Nitrilotriacetate (NTA): Human Metabolism and its Importance in the Total Safety Evaluation Program
Author:
Budny, J.A., Arnold J.D.
Year:
1972
Bibliographic source:
Toxicology and Applied Pharmacology 25, 48-53 (1973)

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
basic toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
10 mg 14C-NTA (9.7 mCi/g, carboxyl-labelled) in gelatine capsules were administered orally to 8 volunteers
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium nitrilotriacetate
EC Number:
225-768-6
EC Name:
Trisodium nitrilotriacetate
Cas Number:
5064-31-3
Molecular formula:
C6H9NO6.3Na
IUPAC Name:
trisodium 2-[bis(carboxylatomethyl)amino]acetate
Details on test material:
- Name of test material (as cited in study report): Nitrilotriacetate (NTA), Trisodium nitrilotriacetate
- Locations of the label (if radiolabelling): 14C-NTA (9.7 µCi/g, carboxyl-labelled)
- Other: no details reported

Method

Type of population:
not specified
Subjects:
- Number of subjects exposed: 8
- Sex: male
- Age: no data
- Race: no data
- Demographic information: no data
- Known diseases: no data
- No other details reported
Route of exposure:
oral
Reason of exposure:
intentional
Exposure assessment:
measured

Results and discussion

Clinical signs:
No clinical signs were observed. 87 % of the urinary 14C was excreted in the first 24 h-period. Less than 0.1 % was recovered in the expired air. The total recovery was 89 % within 120 h. However, the amount of 14C remaining in the tissues was not included in the total recovery figure.

Applicant's summary and conclusion

Conclusions:
NTA is poorly absorbed and rapidly excreted by humans. A fraction of 12% was recovered in urine within 120 h (77% recovered in feces). Blood concentration peak occurred within 1-2 h. NTA is not metabolized to a significant extend. > 96% of the urinary radioactivity was found to be uncharged NTA. There was no evidence for enterohepatic circulation.