Registration Dossier
Registration Dossier
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EC number: 212-611-1 | CAS number: 831-82-3
Dermal absorption
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:
- 2 003
- Bibliographic source:
- Food Chem Toxicol 41:259-264
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Diphenyl ether
- EC Number:
- 202-981-2
- EC Name:
- Diphenyl ether
- Cas Number:
- 101-84-8
- Molecular formula:
- C12H10O
- IUPAC Name:
- Diphenyl Ether
- Test material form:
- not specified
Constituent 1
- 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 or test system 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
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