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EC number: 205-232-8 | CAS number: 136-23-2
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ziram
- EC Number:
- 205-288-3
- EC Name:
- Ziram
- Cas Number:
- 137-30-4
- Molecular formula:
- C6H12N2S4Zn
- IUPAC Name:
- zinc bis(dimethyldithiocarbamate)
- Reference substance name:
- zinc bis dimethyldithiocarbamate
- IUPAC Name:
- zinc bis dimethyldithiocarbamate
Constituent 1
Constituent 2
- Radiolabelling:
- yes
- Remarks:
- [methyl-14C]-Ziram
Test animals
- Species:
- human
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 6h
- Doses:
- 1.55, 643 mg/mL
- No. of animals per group:
- 4-6 diffusion cells per dose
- Control animals:
- no
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Full-thickness human skin samples (3 abdomen) were obtained post-mortem from two females and one male aged 24 to 64 years old.
- Thickness of skin (in mm): 200-400 µm
- Membrane integrity check: Yes
PRINCIPLES OF ASSAY
- Receptor fluid: 0.01 M phosphate-buffered saline, supplemented with 5% w/v bovine serum albumin, adjusted to pH 7.4 was used as the receptor fluid for the barrier integrity assessment and Ziram permeability assessment.
- Specific activity of test substance: 11.3 MBq/mg (= 305.4 µCi/mg)
- Volume applied: 6.4 µl of each preparation (per 0.64 cm²)
- Sampling time: Receptor fluid: in hourly fractions for the duration of the experiment (24 h).
Tape strips, remaining receptor fluid and washings: at study termination (24 h).
Results and discussion
- Absorption in different matrices:
- see Table 6_2-1
- Total recovery:
- see Table 6_2-1
Any other information on results incl. tables
Table A6_2-1 Table for in vitro percutaneous absorption study in human skin |
|
||
Distribution of Radioactivity (% Applied Dose) |
|||
Samples |
1.55 mg/mL |
643 mg/mL |
|
1. Receptor fluid (0-24 h) |
0.38 |
0.02 |
|
2. Receptor fluid at termination |
0.01 |
nd |
|
3. Skin |
nd |
nd |
|
4. Receptor chamber |
nd |
nd |
|
5. Tape (stratum corneum) |
1.84 |
0.04 |
|
6. Total absorbed (1+2+3+4+5) |
2.23 |
0.06 |
|
7. Skin swab (after 6 h) |
87.82 |
93.95 |
|
8. Tape (surface) |
1.49 |
0.11 |
|
9. Donor chamber |
0.21 |
nd |
|
10. Total non-absorbed (7+8+9) |
89.52 |
94.06 |
|
11. Total recovery (6+10) |
91.75 |
94.12 |
|
Applicant's summary and conclusion
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