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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vivo
Remarks:
in vivo and in vitro
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Evaluation of the dermal subchronic toxicity of diphenyl ether in the rat.
Author:
Api AM, Ford, RA
Year:
2003
Bibliographic source:
Food Chem Toxicol 41:259-264
Reference Type:
publication
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Specific details on test material used for the study:
Not specified
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
not specified
Details on test animals and environmental conditions:
Not specified

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: Diethyl phthalate (DEP)
Duration of exposure:
6 hours
Doses:
10 / 100 / 1 000 mg/kgbw
No. of animals per group:
Not specified
Details on study design:
Sprague-Dawley rats received a dermal application of [14C]DPE under a semi-occlusive dressing for 6 h. DPE was diluted in diethyl phthalate (DEP) to administer a total application volume of 2 ml/kg and concentrations of 0.5, 5 and 50% (approximately equal to 10, 100 and 1000 mg DPE/kg body weight).

Results and discussion

Signs and symptoms of toxicity:
not specified
Dermal irritation:
not specified
Absorption in different matrices:
Approximately 17.7% of the administered dose was eliminated in the urine, with small amounts also found in the feces (1.18-3.79%).
At 72 h post-dosing, approximately 0.2% of the applied dose was retained in the body with low levels also measured in the liver, kidney and gastrointestinal tract (approximately equal to 0.04, 0.02 and 0.3%, respectively).
Percutaneous absorption
Time point:
72 h
Dose:
10/ 100/ 1 000 mg/kgbw
Parameter:
percentage
Absorption:
ca. 20 %

Applicant's summary and conclusion

Conclusions:
After semi-occlusive application of 10–1 000 mg/kgbw to the clipped skin of rats, almost 20 % of the Diphenyl Ether dose was absorbed as measured by the amount excreted in urine
Executive summary:

After semi-occlusive application of 10–1 000 mg/kgbw to the clipped skin of rats, almost 20 % of the Diphenyl Ether dose was absorbed as measured by the amount excreted in urine