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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Review paper from peer reviewed journal
Cross-reference
Reason / purpose:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Toxicological profile of diethyl phthalate: a vehicle for fragrance and cosmetic ingredients
Author:
Api AM
Year:
2000
Bibliographic source:
Food and chemical toxicology 39: 97-108 2001
Reference Type:
publication
Title:
Unnamed
Year:
1976

Materials and methods

Principles of method if other than guideline:
Oral administration of 14C DEP to rats and mice and subsequent analysis of radio activity levels in kidney liver blood spleen and fat.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): diethyl phthalate

Radiolabelling:
yes
Remarks:
C14

Test animals

Species:
other: rats & mice
Strain:
not specified
Details on test animals and environmental conditions:
None

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on exposure:
None
Duration and frequency of treatment / exposure:
Not specified
Doses / concentrations
Remarks:
Doses / Concentrations:
Not specified
No. of animals per sex per dose:
Not specified
Control animals:
not specified
Details on study design:
Not specified
Details on dosing and sampling:
Not specified
Statistics:
Not specified

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Not reported
Details on distribution in tissues:
maximum concentrations of radio activity in kidney liver blood spleen & fat were observed within 20 minutes of administration followed by a decrease to trace levels 24h after dosing. Excretion occured primarily via the urine. Cumulative urinary & faecal excretion respectively were 47 & 0.7% within 12h, 82 & 2.5% within 24h & 90 & 2.7% within 48h after dosing.
Transfer into organs
Transfer type:
secretion via gastric mucosa
Observation:
distinct transfer
Details on excretion:
Excretion occured primarily via the urine. Cumulative urinary & faecal excretion respectively was 47 & 0.7% within 12h, 82 & 2.5% within 24h & 90 & 2.7% within 48h after dosing.

Metabolite characterisation studies

Metabolites identified:
not measured

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
A study of the absorption, distribution, metabolism and elimination of diethyl phthalate reports that approximately 90% of radioactivity from an administered dose was excreted in the urine within 48 hours following oral administration of14C-DEP to rats and mice, with the majority (82%) being eliminated during the first 24 hours. Approximately 3% of the radioactivity was found in the faeces over the same period of time. Radioactivity was widely distributed with the highest concentrations observed in kidney and liver, followed by blood, spleen and adipose tissue. Highest levels were noted within 20 minutes, followed by a rapid decrease to only trace amounts after 24 hours. The mono-ester (MEP) was the major urinary metabolite identified and phthalic acid was identified as a minor secondary metabolite.
Executive summary:

A study of the absorption, distribution, metabolism and elimination of diethyl phthalate reports that approximately 90% of radioactivity from an administered dose was excreted in the urine within 48 hours following oral administration of14C-DEP to rats and mice, with the majority (82%) being eliminated during the first 24 hours. Approximately 3% of the radioactivity was found in the faeces over the same period of time. Radioactivity was widely distributed with the highest concentrations observed in kidney and liver, followed by blood, spleen and adipose tissue. Highest levels were noted within 20 minutes, followed by a rapid decrease to only trace amounts after 24 hours. The mono-ester (MEP) was the major urinary metabolite identified and phthalic acid was identified as a minor secondary metabolite.