Registration Dossier

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1947
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP, short documentation, purity not specified, reliability of detection method unclear

Data source

Reference
Reference Type:
publication
Title:
Die Bernsteinsaeureausscheidung bei Stoffwechselbelastung mit hoeheren n-Dicarbonsaeuren.
Author:
Weitzel G (1947).
Year:
1947
Bibliographic source:
Hoppe-Seylers Z. physiol. Chemie 282, 185-191.

Materials and methods

Objective of study:
excretion
Principles of method if other than guideline:
Adipic acid was orally administered to 4 different humans to investigate the excretion of this compound. Urine was collected and the adipic acid concentration analyzed.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Adipic acid
EC Number:
204-673-3
EC Name:
Adipic acid
Cas Number:
124-04-9
Molecular formula:
C6H10O4
IUPAC Name:
Hexanedioic Acid
Details on test material:
IUCLID4 Test substance: purity not specified

Test animals

Species:
human

Results and discussion

Main ADME results
Type:
excretion
Results:
Adipic acid is readily excreted in urine, unchanged.

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parameters
Test no.:
#1
Toxicokinetic parameters:
other: One Person (70 kg) received 7 g adipic acid per day (100 mg/kg bw/day) over 10 days (70 g in total) given in several portions over the day.   Urine was collected for these 10 days and two additional days after end of administration. 61% of the administere

Metabolite characterisation studies

Metabolites identified:
no

Any other information on results incl. tables

One Person (70 kg) received 7 g adipic acid per day (100 mg/kg bw/day) over 10 days (70 g in total) given in several portions over the day.  Urine was collected for these 10 days and two additional days after end of administration. 61% of the administered dose was found in the urine. Three further persons received 23.4, 19.0, and 23.4 g adipic acid over 6, 5, and 9 days, respectively. 53% of the administered dose was found in the urine. No symptoms were reported during and after exposure.

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Adipic acid is readily excreted in urine, unchanged.