Registration Dossier

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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Information retrieved from secondary source (OECD SIDS report)

Data source

Reference
Reference Type:
review article or handbook
Title:
Dimethyl terephthalate, CAS N°: 120-61-6 -SIDS Initial Assessment Report For SIAM 11 - United States, January 23-26, 2001
Author:
United States/IT National SIDS Contact Point in Sponsor Country: Oscar Hernandez Director, Risk Assessment Division Office of Pollution Prevention and Toxics US EPA Washington, DC 20460
Year:
2001
Bibliographic source:
OECD - UNEP Chemicals 11-13 chemin des Anémones, CH-1219 Châtelaine Geneva, Switzerland

Materials and methods

Objective of study:
absorption
excretion
metabolism
Principles of method if other than guideline:
combined toxicokinetic information from several in vivo toxicokinetic studies
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dimetthyl terephthalate

Administration / exposure

Route of administration:
oral: unspecified

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Several studies conducted in rats, rabbits, and mice are summarised in the OECD SIDS document. These studies show that dimethyl terephthalate is readily absorbed from the gastrointestinal tract.
Details on excretion:
In the studies summarised in the OECD SIDS document the test substance was rapidly eliminated in the urine within 48-hours

Metabolite characterisation studies

Details on metabolites:
Absorbed dimethyl terephthalate was metabolized to terephthalic acid (TPA) via hydrolysis (partly precipitated as TPA-Ca++). In mice, monomethyl terephthalate was the major metabolite.

Applicant's summary and conclusion

Executive summary:

Information from a peer-reviewed secondary source (OECD SIDS) shows that the major component of the submission substance, dimethyl terephthalate is well absorbed from the gastrointestinal tract, metabolised by hydrolysis to terephthalic acid (in mice: monomethyl terephthalate), and mainly excreted in the urine.