Diethyl phthalate

Basic toxicokinetics

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 for cross-reference:

reference to same study

Data source

Reference

Reference 1

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 2

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

Test material information

Constituent 1

Reference substance name:

Diethyl phthalate

EC Number:

201-550-6

EC Name:

Diethyl phthalate

Cas Number:

84-66-2

Molecular formula:

C12H14O4

IUPAC Name:

.

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 or test system 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 / concentration:

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.