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EC number: 259-627-5 | CAS number: 55406-53-6
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-03-27 to 1995-09-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: data requirement UK HSE Control of Pesticides Regulations
- Version / remarks:
- 1986
- Deviations:
- yes
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- yes
- Principles of method if other than guideline:
- Deviations: The sampling time of the receptor fluid was 8 hours instead of 24 hours, as recommended. There is no information about the solubility of the test substance in the receptor fluid.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-iodo-2-propynyl butylcarbamate
- EC Number:
- 259-627-5
- EC Name:
- 3-iodo-2-propynyl butylcarbamate
- Cas Number:
- 55406-53-6
- Molecular formula:
- C8H12INO2
- IUPAC Name:
- 3-iodoprop-2-yn-1-yl butylcarbamate
Constituent 1
- Specific details on test material used for the study:
- Three different comercially available formulations were investigated.
Formulation I containing 2.32 % w/w
Formulation II containing 0.604 and 0.583 % w/w
Formulation III containing 17.1 % w/w test item
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 31-83-a
RADIOLABELLING INFORMATION
- Radiochemical purity: 247 µCi (ca. 9 MBq)
- Specific activity: 962 MBq/mmol - Radiolabelling:
- yes
Test animals
- Species:
- other: human epidermis in vitro
Administration / exposure
- Vehicle:
- other: the test item was applied in each of three different commercially available formulations
- Duration of exposure:
- 8 h
- Doses:
- - Applied volume: 50 µL
- Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: abdominal autopsy skin
- Type of skin: epidermal membranes
- Preparative technique: the full thickness skin sample was immersed in water heated to ca 60 °C for ca 1 minute. On removal, the epidermis was peeled away using forceps, floated on water and picked up onto aluminium foil. The membranes were then either used immediately, or stored wrapped in foil at ca 4°C overnight.
- Membrane integrity check: yes
- Storage conditions: at -20 °C or 4 °C overnight
PRINCIPLES OF ASSAY
- Diffusion cell: automated flow-through diffusion apparatus
- Receptor fluid: 0.9 % saline solution containing ca. 1 mg/mL tetracycline hydrochloride
- Solubility od test substance in receptor fluid:
- Flow-through system: yes
- Test temperature: 30-32 °C
- Reference substance: not applicable
Results and discussion
- Total recovery:
- - Total recovery:
In samples treated with formulation I unabsorbed material accounted for 69-93% (mean 84%), with a further 1-17% associated with the solubilised skin sample itself. The radioactivity associated with the skin may be unabsorbed material not fully removed by die skin wash, or absorbed material within the membrane. Given the low cumulative absorption observed, the former explanation seems most likely. Radioactivity associated with die residual receptor contents was low (mean 0.13%).
As the proportion of the dose absorbed was greater for the formulation II the amount associated with unabsorbed material washed from the skin surface at 8 h was correspondingly lower than that observed for the Microtech formulation (48-69%, mean 60%). A small proportion of the applied dose was also recovered in the solubilised skin (2-4%). Again, diis may be either unabsorbed material not removed in the skin wash, or absorbed chemical within the membrane. The residual receptor fluid contents accounted for 1-2 % of the applied dose for this group of samples.
Unabsorbed material accounted for 93-100% (mean 97%) of the applied dose for die samples treated with formulation III reflecting the very low absorption observed in these samples. Correspondingly, the amount of material associated with die solubilised skin was lowest for this formulation (ca 1%), while the residual receptor contents amounted to a mean of only 0.04% of the applied dose.
- Limit of detection, LOD of LSC 30 dpm:
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 8 h
- Dose:
- Formulation I
- Parameter:
- percentage
- Absorption:
- 3.7 %
- Key result
- Time point:
- 8 h
- Dose:
- Formulation II
- Parameter:
- percentage
- Absorption:
- 26.3 %
- Key result
- Time point:
- 8 h
- Dose:
- Formulation III
- Parameter:
- percentage
- Absorption:
- 0.8 %
Any other information on results incl. tables
Table 1 In Vitro dermal Absorption
|
Formulation I |
Formulation II |
Formulation III |
Number of replicates |
9 |
9 |
7 |
Applied radioactivity |
3.75 to 3.94 mg/cm2 |
736 to 714 µg/cm2 |
32.81 to 33.12 mg/cm2 |
Test item concentration [%] |
2.3 |
0.6 |
17.1 |
|
[% applied dose] |
||
|
|
|
|
Receptor fluid after 8 hours |
3.66 |
26.25 |
0.80 |
Receptor rinse |
0.13 |
1.29 |
0.04 |
Washings |
83.85 |
59.71 |
96.79 |
Skin retention |
6.49 |
3.20 |
0.77 |
Total recovery |
94.12 |
90.45 |
98.40 |
Applicant's summary and conclusion
- Conclusions:
- Following application of 14C-labelled test item to human epidermis in each of three different commercially available formulations the extent of absorption on a % dose basis was found to be formulation dependent. Cumulative absorption reached 3.66%, 26.25% and 0.80% for formulation I, II and III respectively. However, when the concentration in the different formulations was taken into account, the actual quantities of 14C-labelled test item absorbed were found to be similar for the three formulations. The corresponding absolute amounts of 14C-labelled test item absorbed were 140.49, 190.27 and 262.55 µg/cm^2 respectively. The data obtained suggest that absorption of 14C-labelled test item from these commercially available formulations is dependent on the capacity of the membrane for transport of the chemical rather than the amount of test item on the skin surface.
- Executive summary:
14C-labelled test item was applied to human epidermis in vitro in each of three different commercially available formulations, and absorption measured over an 8 h period, equivalent to the likely duration of worker exposure to the chemical. Three different formulations were used in this study. Following application of 14C-labelled test item in formulation I, the cumulative absorption at 8 h reached 3.66 % of the applied dose, equivalent to 140.49 µg/cm^2. Proportional absorption was greater for formulation II, reaching 26.25 % at 8 h. However, due to the lower concentration of 14C-labelled test item in this formulation, this was equivalent to absorption of a similar total amount of test item (190.27 µg/cm^2). For the formulation III, the proportional absorption was lowest, reaching only 0.80 % of the applied dose in 8 h. This was equivalent to absorption of 262.55 µg/cm^2 over the 8 h period, as the concentration of test item in this formulation was greater than in the other formulations. The results indicate that absorption of 14C-labelled test item from the commercially available formulations is limited by the skin transport capacity for the chemical, rather than the quantity of chemical available for absorption.
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