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EC number: 236-671-3 | CAS number: 13463-41-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
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:
- Pyrithione zinc
- EC Number:
- 236-671-3
- EC Name:
- Pyrithione zinc
- Cas Number:
- 13463-41-7
- Molecular formula:
- C10H8N2O2S2Zn
- IUPAC Name:
- Bis [1-hydroxy-2(1H)-pyridinethionato-O,S](T-4)-zinc
- Details on test material:
- Batch Number: 3620165
Purity: 99.5%
Radiolabelling: 14C on the 2 and 6 position
Specific activity: 3.09 mCi/mmol (radiodiluted test substance = 0.4214 uCi/mg)
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- human
- Strain:
- other: not applicable
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Human epidermal skin used
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- water
- Duration of exposure:
- 8 hours of exposure with 16 hours of post exposure monitoring
- Doses:
- Volume applied: 6.4 µL or 10 µL/cm2
Dose preparation:
The radiodiluted ZPT was formulated into the 48% aqueous dispersion to mimic the commercial product. Carboxymethyl cellulose and Darvan were blended with the radiodiluted ZPT (959.98 mg) with 1.00336 grams of water. The concentration of ZPT in the aqueous dispersion was 46.45% (w/w) (96.77% of the target concentration of 48% ZPT). The test preparation was verified for homogeneity with a coefficient of variation of 1.49%. - Details on study design:
- Preparation of test site:
Four samples of full-thickness human (3 abdomen and 1 abdomen/breast) were obtained from patients aged 22 to 40 years old. All of the samples were obtained from NHS Lothian, St. John’s Hospital, Livingston, UK. On arrival at Charles River, these samples were cleaned of subcutaneous fat and connective tissue using a scalpel blade. The skin samples were washed in cold running water and dried using tissue paper. The skin samples were then cut into smaller pieces (where appropriate), wrapped in aluminium foil, put into self sealing plastic bags and stored at ca -20°C until they were used in the study or used immediately. The age and sex of the donor and site from which the skin was taken were recorded centrally and in the study records.
Test site size: 1.5 x 1.5 cm of the skin membrane was cut out and positioned onto the receptor chamber of the diffusion cell. Exposed surface area of the skin was 0.64 cm2. The receptor chamber volume was 0.25 ml.
Sampling schedule: Hourly fractions of receptor fluid from 0-8 hours post dose and then 2 hourly fractions from 8-24 hours.
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- [14C]-ZPT in an aqueous dispersion (46.45% measured ZPT a.i.) applied to human split-thickness skin I n vitro, showed that a majority of the applied dose (98.8%) was removed by washing at the 8 hour post application. At 24 hours post application, the total dislodgeable dose was 98.85% of the applied dose. The stratum corneum retained 0.46% of the applied dose; 0.30% was removed with the first 5 tape strips. The total unabsorbed dose was 99.31% of the applied dose. The absorbed dose, dermal delivery and potentially absorbable dose were <0.01% (0.16 µg equiv./cm2), 0.24% (14.43 µg equiv./cm2) and 0.41% (23.91 µg equiv./cm2) of the applied dose, respectively.
- Total recovery:
- Mass balance was determined to be 99.56% (SD = 1.30%) for labelled compound
- Conversion factor human vs. animal skin:
- Sample is human, no conversion required
Any other information on results incl. tables
Table A6_2-1. Table for Percutaneous Absorptionin vitroof ZPT Table 1
Distribution of Radioactivity (% Applied Dose) at 24 h Post Dose Following Topical Application of [14C]‑Zinc Pyrithione in Aqueous DispersionTest Preparation (48%, w/w) to Human Split‑Thickness Skin
|
|
|||||||||||||
|
|
Cell Number and Donor Number |
|
|
||||||||||
|
|
Cell 1 |
Cell 2 |
Cell 4 |
Cell 5 |
Cell 6 |
Cell 8 |
Cell 9 |
Cell 10 |
Cell 12 |
Cell 14 |
|
|
|
|
|
0216 |
0216 |
0288 |
0288 |
0288 |
0294 |
0294 |
0294 |
0293 |
0293 |
Mean |
SD |
|
|
Skin Wash |
66.55 |
60.77 |
51.34 |
28.46 |
39.52 |
54.33 |
69.18 |
36.06 |
64.55 |
46.41 |
51.72 |
13.91 |
|
|
Tissue Swab 8 h |
32.03 |
36.83 |
49.90 |
70.33 |
59.72 |
44.99 |
28.57 |
59.29 |
35.49 |
53.30 |
47.05 |
13.78 |
|
|
Pipette Tips |
0.06 |
0.05 |
0.04 |
0.02 |
0.01 |
0.04 |
0.03 |
0.01 |
0.07 |
0.03 |
0.04 |
0.02 |
|
|
Dislodegeable Dose 8 h |
98.65 |
97.65 |
101.28 |
98.81 |
99.25 |
99.36 |
97.78 |
95.36 |
100.10 |
99.73 |
98.80 |
1.61 |
|
|
Cell Wash |
0.05 |
0.06 |
0.07 |
0.04 |
*0.03 |
0.10 |
0.08 |
*0.03 |
*0.03 |
0.04 |
°0.05 |
°0.02 |
|
|
Tissue Swab 24 h |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
0.01 |
*0.00 |
*0.00 |
0.00 |
°0.00 |
°0.00 |
|
|
Total Dislodgeable Dose |
98.70 |
97.71 |
101.35 |
98.85 |
99.28 |
99.46 |
97.87 |
95.39 |
100.13 |
99.78 |
98.85 |
1.62 |
|
|
Stratum Corneum 1-5 |
0.42 |
0.16 |
0.05 |
0.16 |
0.12 |
0.33 |
0.50 |
0.46 |
0.14 |
0.68 |
0.30 |
0.21 |
|
|
Stratum Corneum 6-10 |
0.06 |
0.05 |
0.01 |
0.02 |
0.03 |
0.22 |
0.13 |
0.17 |
0.03 |
0.08 |
0.08 |
0.07 |
|
|
Stratum Corneum 11-15 |
0.05 |
0.05 |
*0.00 |
*0.01 |
*0.01 |
0.15 |
0.08 |
0.07 |
0.01 |
0.03 |
°0.05 |
°0.04 |
|
|
Stratum Corneum 16-20 |
0.04 |
0.05 |
*0.01 |
*0.00 |
*0.00 |
0.08 |
0.06 |
0.04 |
0.02 |
0.04 |
°0.03 |
°0.02 |
|
|
Stratum Corneum |
0.56 |
0.31 |
0.07 |
0.20 |
0.17 |
0.78 |
0.77 |
0.73 |
0.20 |
0.83 |
0.46 |
0.30 |
|
|
Unexposed Skin |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
°0.00 |
°0.00 |
|
|
Total Unabsorbed |
99.26 |
98.02 |
101.42 |
99.05 |
99.44 |
100.24 |
98.64 |
96.12 |
100.33 |
100.61 |
99.31 |
1.51 |
|
|
Epidermis |
0.16 |
0.28 |
0.01 |
0.02 |
*0.01 |
0.31 |
0.47 |
0.83 |
0.12 |
0.04 |
°0.23 |
°0.26 |
|
|
Dermis |
0.08 |
0.02 |
*0.00 |
0.00 |
0.00 |
0.01 |
0.02 |
0.02 |
0.00 |
0.01 |
°0.02 |
°0.02 |
|
|
Receptor Fluid |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
°0.00 |
°0.00 |
|
|
Receptor Rinse |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
*0.00 |
°0.00 |
°0.00 |
|
|
Total Absorbed |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
|
|
Dermal Delivery |
0.24 |
0.30 |
0.02 |
0.02 |
0.01 |
0.32 |
0.49 |
0.85 |
0.13 |
0.05 |
0.24 |
0.27 |
|
|
Potentially Absorbable Dose |
0.39 |
0.46 |
0.04 |
0.06 |
0.05 |
0.77 |
0.76 |
1.13 |
0.19 |
0.21 |
0.41 |
0.37 |
|
|
Mass Balance |
99.50 |
98.32 |
101.44 |
99.07 |
99.46 |
100.56 |
99.13 |
96.98 |
100.46 |
100.66 |
99.56 |
1.30 |
|
*=Results calculated from data less than 30 d.p.m. above background
°=Mean includes results calculated from data less than 30 d.p.m above background
Applicant's summary and conclusion
- Conclusions:
- In conclusion, topical application of 14C-ZPT in an aqueous dispersion applied to human skin in vitro resulted in the absorbed dose of 14C-ZPT being very low, <0.01% and when considering the labelled material in transit (tape strips 6-20) the resulting potential dermal absorption of ZPT following a typical 8 hour work shift would be 0.41%. The results obtained in this study indicate that the absorption of ZPT through human epidermis in vitro is extremely slow. The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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