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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well-documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
The Excretion and Metabolism of Triethylene Glycol
Author:
McKennis, H. et al.
Year:
1961
Bibliographic source:
International Journal of Toxicology 25 (2), 121 - 138

Materials and methods

Objective of study:
excretion
Principles of method if other than guideline:
Administration of C14-triethyleneglycol to the rat.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): triethylene glycol
- Analytical purity: 99.9%
- Locations of the label (if radiolabelling): randomly labeled 14C-triethylene glycol
- Specific activity (if radiolabelling): 5.13 µc/mg
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
other: albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Albimno Farms, Red Bank, New Jersey, USA
- Metabolism cages: yes
- Diet: ad libitum; during study no food was allowed
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses / concentrations
Remarks:
Doses / Concentrations:
125, 140, 250 and 600 mg/kg bw
No. of animals per sex per dose:
2
Control animals:
yes

Results and discussion

Main ADME resultsopen allclose all
Type:
other: excretion (24 h)
Results:
66% of dose recovered in urine chloroform extracts (125 mg/kg bw group)
Type:
other: excretion (24 h)
Results:
65% of dose recovered in urine chloroform extracts (140 mg/kg bw group)
Type:
other: excretion (24 h)
Results:
38% of dose recovered in urine chloroform extracts (250 mg/kg bw group)
Type:
other: excretion (24 h)
Results:
56% of dose recovered in urine chloroform extracts as hydroxyacid (250 mg/kg bw group)
Type:
other: excretion (24 h)
Results:
27% of dose recovered in urine chloroform extracts (600 mg/kg bw group)
Type:
other: excretion (24 h)
Results:
40% of dose recovered in urine chloroform extracts as hydroxyacid (600 mg/kg bw group)
Type:
other: excretion (5 days)
Results:
91-98% of dose recovered (14C elimination)

Toxicokinetic / pharmacokinetic studies

Details on excretion:
Following administration of 14C-triethyleneglycol to the rat, 86-94% of the radioactivity was recovered in the urine in the subsequent 5-day period. The total excretion by way of the urine and faeces amounted to 94-97%. The expired air over a 60-h period contained approximately 1% of the administered dose.

Metabolite characterisation studies

Details on metabolites:
The chromatograms of chloroform extracts of urine showed no evidence of ethylene glycol or diethyleneglycol.
One oxidation product is suggested to be a monocarboxylic acid which arises by metabolic oxidation of a single terminal hydroxyl group of the parent glycol.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
High degree of elimination of triethyleneglycol and its metabolites via the urine