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EC number: 809-920-4 | CAS number: 1047637-37-5
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Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 April - 24 August 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)
- EC Number:
- 253-760-2
- EC Name:
- 2,2-bis(chloromethyl)trimethylene bis(bis(2-chloroethyl)phosphate)
- Cas Number:
- 38051-10-4
- Molecular formula:
- C13H24Cl6O8P2
- IUPAC Name:
- 2,2-bis(chloromethyl)propane-1,3-diyl tetrakis(2-chloroethyl) bis(phosphate)
- Details on test material:
- - Product name: Antiblaze TL-10-ST
- Test material name: [14C]-TL-10-ST
- Radiochemical purity: consistent with Antiblaze TL-10-ST standard
- Specific activity: 23 mCi/mmol
- Storage of radiolabelled test material: -20 degree C
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- human
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: neat substance and ethanol (2 experiments)
- Duration of exposure:
- Exposed skin surface was washed and dried 8 hours after dosing. At 24 hours after dosing the diffusion cells were disconnected and the skin washed and analysed by liquid scintillation couting.
- Doses:
- - [14C]-TL-10-ST: neat, application rate: 14.03 mg equiv./cm2
- [14C]-TL-10-ST in ethanol: 20.96 g/L, application rate: 0.210 mg equiv./cm2 - Details on study design:
- 8 samples were dosed topically with undiluted radiolabelled test material and 8 samples with the radiolabelled test material in ethanol at a concentration of 20.96 g/L..
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: 6 samples of full-thickness human skin
- Ethical approval: skin from patients undergoing surgery at the Plastic Surgery Unit of St Johns Hospital in Livingston, UK
- Type of skin: 1 abdomen, 5 breast
- Preparative technique: split-thickness membranes
- Thickness of skin (in mm): 0.2 - 0.4
- Membrane integrity check: yes
PRINCIPLES OF ASSAY
- Diffusion cell: Automated flow -through cell apparatus (Scott/Dick, University of Newcastle-upon-Tyne, UK)
- Receptor fluid: physiological saline (0.9% w/v) for barrier integrity assessment, ethanol:water (1:1 v/v) for test item permeability test
- Occlusion: no
Results and discussion
- Absorption in different matrices:
- Neat test item
- Skin wash: dislodgeable dose after 8 h: 99.3 % +- 5.92% (range 89.21 - 106.76%), after 24 h: 102.63% +- 3.05% (range: 99.89 - 106.89%)
- Skin test site: dermal delivery (sum of absorbed dose and dose on recovered on the skin): 0.51 % +- 0.5% (range: 0.05 - 1.48%), 72.04 +- 69.74 micro g-equivalent/cm2
- Receptor fluid, receptor chamber: 0.19 % +- 0.18% (range: 0.01 to 0.55%)
- Stratum corneum (in vitro test system): (i.e tape strips): 1,83 % +- 1.67% (range: 0.19 - 4.63%), 1.36 % +- 1.25% (range 0.1 - 3.5%) removed with the first 5 tape strips
- Steady state flux was achieved from 14 to 24 h post dose: 1.10 microg-equiv/cm2
- the absorbed dose was 26.95 +- 25.27 microg equiv/cm2
Test item in Ethanol (20.96 g/L):
- Skin wash: dilodgeable dose after 8 h: 68.82 % +- 20..05% (range: 42.26 to 88.91%) , at 24 h further: 9.28% +- 8.84%, total dislogeable dose: 78.1 %+- 16.2% (range: 57.49 -95.25%)
- Skin test site: dermal delivery (sum of absorbed dose and dose on recovered on the skin): 6.1 % +- 4.20% (range: 0.82 - 12.14%)
- Receptor fluid, receptor chamber: 2.19 % +- 1.77% (range: 0.73 - 6.26%)
- Stratum corneum (in vitro test system): (i.e tape strips): 9.71 % +- 6.13% (range: 1.16 - 16.78%), 5.79 % +- 3.74% (range 0.56 - 9.56%) removed with the first 5 tape strips
- Steady state flux was achieved from 2 to 5 h post dose: 0.24 microg-equiv/cm2
- the absorbed dose was 4.6 +- 3.72 microg equiv/cm2 - Total recovery:
- All samples had a mass balance within 100+-10% (one cell rejected because of incomplete receptor fluid collections)
Total recovery 105.03 % for neat substance, 98.57 % for the test substance in Ethanol.
Percutaneous absorptionopen allclose all
- Parameter:
- percentage
- Absorption:
- 0.2 %
- Remarks on result:
- other: 24h post dose
- Remarks:
- radiolabelled neat test substance
- Parameter:
- percentage
- Absorption:
- 2.2 %
- Remarks on result:
- other: 24h post dose
- Remarks:
- radiolabelled test sustance in ethanol
Any other information on results incl. tables
- Dermal delivery (sum of the absorbed dose and amount in skin) of the test substance was 0.51% +- 0.5 (72.04 microg equiv./cm2) and 6.10% (12.78 microg equiv./cm2) for the test substance in ethanol
- Steady state flux was achieved for the neat test substance from 14 -24h, and from 2 -5h for the test substance in ethanol
- The mass balance was complete for the test substance (105.03%) and the test substance in ethanol (98.57%).
- The majority of the dose was not aborbed and could be removed by washing.
Applicant's summary and conclusion
- Conclusions:
- Following topical application to human skin in vitro for 8 h, the absorbed dose of the neat test substance after 24 h was 0.19% (26.95 microg equiv/cm2), and 2.19% for the test substance (20.96 g/L) in ethanol (4.60 microg equiv/cm2). Dermal delivery was 0.51% (72.04 microg-equiv/cm2) and 6.1% (12.78 microg/equiv/cm2) respectively. The majority of the dose (102 and 78 % respectively) did not penetrate the skin and coudl be removed by washing. Further 1.4 and 5.8% of the dose respectivly could be removed in the first 5 tape strips i.e. on the stratum, corneum surface and not associated with the skin.
- Executive summary:
In an in vitro skin absorption study 8 human skin samples were treated with radiolabelled 2,2 -bis(chloromethyl)trimethylene bis(bis(2 -chloroethyl)phosphate) either undiluted or at a concentration of 20.96 g/L in ethanol at application rates of 14.03 mg equiv./cm2 and 0.210 mg equiv./cm2 respectively for 8h under open condittions. Sampling continued after washing at 8h until 24 hours after dosing.
Dermal delivery of the test substance was 0.51% (72.04 microg equiv./cm2) and 6.10% (12.78 microg equiv./cm2) for the test substance in ethanol.
The absorbed dose of the test substance was 0.19% (26.95 microg equiv/cm2), and 2.19% for the test substance in ethanol (4.60 microg equiv/cm2).
This study is classified as valid without restrictions and is conducted in accordance with GLP regulations and OECD Guideline No.428 and OECD Guidance document No.28.
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