Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Toxicokinetics assessment
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Based on the known physico-chemical properties and the available toxicologic studies, a justified assessment of the toxicokinetic and biotransformational properties of ITC 288/S could be made, therefore an in vivo toxicokinetic study is at present not an urgent requirement.

Data source

Reference
Reference Type:
other: Toxicocinetics assessment
Title:
Unnamed
Year:
1993

Materials and methods

Objective of study:
other: Assessment of toxicokinetic behaviour
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment of Toxicokinetics

Test material

Constituent 1
Constituent 2
Chemical structure
Reference substance name:
A mixture of: tetrasodium-phosphonoethane-1,2-dicarboxylate; hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate
EC Number:
410-800-5
EC Name:
A mixture of: tetrasodium-phosphonoethane-1,2-dicarboxylate; hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate
Cas Number:
143239-08-1
Molecular formula:
Constituent 1 (tetrasodium phosphonoethane-1,2-dicarboxylate): Hill formula: C4H3Na4O7P CAS formula: C4 H7 O7 P .4Na Constituent 2 (hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate): Hill formula: C8H5Na6O11P CAS formula: C8 H11 O7 P .6Na
IUPAC Name:
Reaction mass of tetrasodium phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4-tetracarboxylate
Specific details on test material used for the study:
Purity of the test material is based on the phosphonate composition, with no direct measure of % sodium. ITC 288 is not the "Reaction mass of tetrasodium-phosphonoethane-1,2-dicarboxylate and hexasodium-phosphonobutane-1,2,3,4--tetracarboxylate" (EC 410-800-5) rather the substance "Reaction mass of trisodium-phosphonoethane-1,2-dicarboxylate and pentasodium-phosphonobutane-1,2,3,4--tetracarboxylate" (EC 701-079-0) as demonstrated by the manufacturing specs reported in Section 1.2, legal entity composition.

Results and discussion

Applicant's summary and conclusion

Categories Display