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EC number: 276-696-7 | CAS number: 72490-01-8
- 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:
- 21 Mar 2016 to 29 Jun 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Version / remarks:
- 2004
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
- EC Number:
- 276-696-7
- EC Name:
- Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
- Cas Number:
- 72490-01-8
- Molecular formula:
- C17 H19 N O4
- IUPAC Name:
- ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- other: Human skin
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: physiological saline in a 1:1 (w/w) ratio (for the concentrate) and CIPAC D water (for the spray dilutions)
- Duration of exposure:
- The skin was exposed to the test preparations for 6 hours and receptor fluid samples were collected at 2, 4 and 6 hours post dose. To allow adequate characterisation of the absorption profile, receptor fluid samples were also collected at 8, 12 and 24 hours post dose.
- Doses:
- - 125 g test substance /kg Formulation Concentrate in saline
- 0.15 g test substance /L Spray Dilution 1
- 0.075 g test substance /L Spray Dilution 2
Results and discussion
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 24 h
- Dose:
- 125 g/kg
- Parameter:
- percentage
- Absorption:
- 0.44 %
- Remarks on result:
- other: Dermal absorption = (Sum of receptor fluid + receptor chamber wash + exposed skin + skin strips 3-20) + k(n=8) x SD
- Key result
- Time point:
- 24 h
- Dose:
- 0.075 g/L
- Parameter:
- percentage
- Absorption:
- 19 %
- Remarks on result:
- other: Dermal absorption = (Sum of receptor fluid + receptor chamber wash + exposed skin + skin strips (3-20) + k(n=8) x SD
- Key result
- Time point:
- 24 h
- Dose:
- 0.15 g/L
- Parameter:
- percentage
- Absorption:
- 21 %
- Remarks on result:
- other: Dermal absorption = (Sum of receptor fluid + receptor chamber wash + exposed skin + skin strips 3-20) + k(n=8) x SD
Any other information on results incl. tables
Table 1. Summary of the test substance through Human Split-Thickness Membranes
Test Preparation |
Formulation Concentrate in Saline (125 g/kg) |
Spray Dilution 1 (0.15 g/L) (Normalised) |
Spray Dilution 2 (0.075 g/L) |
Test substance |
Test substance |
||
Distribution |
% Applied Dose |
||
Dislodgeable Dose 6 h* |
99.62 |
73.49 |
80.47 |
Total Dislodgeable Dose** |
100.44 |
82.33 |
85.55 |
Donor Chamber Wash |
0.39 |
0.64 |
0.40 |
Tape Strips 1-2 |
0.05 |
1.15 |
0.29 |
Tape Strips 3-20 |
0.08 |
1.33 |
0.54 |
Unexposed Skin |
<0.01 |
0.08 |
0.04 |
Exposed Skin |
0.06 |
3.93 |
2.45 |
Receptor Fluid |
0.18 |
10.69 |
9.38 |
Receptor Chamber Wash |
0.01 |
0.49 |
0.43 |
Mass Balance |
100.84 |
100.00 |
98.68 |
Distribution |
µg equiv./cm2 |
ng equiv./cm2 |
ng equiv./cm2 |
Dislodgeable Dose 6 h* |
1170.88 |
1098.20 |
604.66 |
Total Dislodgeable Dose** |
1180.54 |
1230.19 |
642.85 |
Donor Chamber Wash |
4.57 |
9.60 |
3.04 |
Tape Strips 1-2 |
0.63 |
17.15 |
2.20 |
Tape Strips 3-20 |
0.88 |
19.94 |
4.04 |
Unexposed Skin |
0.03 |
1.23 |
0.28 |
Exposed Skin |
0.72 |
58.73 |
18.40 |
Receptor Fluid |
2.17 |
159.78 |
70.47 |
Receptor Chamber Wash |
0.17 |
7.25 |
3.22 |
Mass Balance |
1185.14 |
1494.27 |
741.47 |
* Dislodgeable Dose 6 h = Skin Wash 6 h + Tissue Swab 6 h + Pipette Tip 6 h
** Total Dislodgeable Dose = Dislodgeable Dose 6 h + Skin Wash 24 h + Tissue Swab 24 h + Pipette Tip 24 h + Donor Chamber Wash
Table 2. Summary of test substance Absorption through Human Split-Thickness Membranes
Application of Test substance and Actual Concentration of Dose Preparation |
Mean Absorption Rates |
|
Time Period (h) |
Absorption Rate |
|
Formulation Concentrate in Saline |
|
µg equiv./cm2/h ± SEM |
(115 g/kg test substance) |
0-2 |
0.28 ± 0.04 |
10.25 µg/cm2(1175 µg ai/cm2) |
2-6 |
0.12 ± 0.02 |
Unoccluded |
6-24 |
0.06 ± 0.01 |
Duration of experiment: 24 h, n = 8 |
0-24 |
0.09 ± 0.01 |
Spray Dilution 1 |
|
ng equiv./cm2/h ± SEM |
(0.149 g/L test substance) |
0-2 |
1.90 ± 0.43 |
10.00 µL/cm2(1.49 µg ai/cm2) |
2-6 |
10.19 ± 2.06 |
Unoccluded |
6-24 |
6.40 ± 0.78 |
Duration of experiment: 24 h, n = 8 |
0-24 |
6.66 ± 0.85 |
Spray Dilution 2 |
|
ng equiv./cm2/h ± SEM |
(0.075 g/L test substance) |
0-2 |
0.57 ± 0.18 |
10.00 µL/cm2(0.751 µg ai/cm2) |
2-6 |
4.78 ± 0.23 |
Unoccluded |
6-24 |
2.79 ± 0.37 |
Duration of experiment: 24 h, n = 7 |
0-24 |
2.94 ± 0.28 |
Dermal absorption was calculated according to the Efsa guidance on dermal absorption (2017): receptor fluid + receptor chamber wash + exposed skin + skin strips 3-20 + k (n=8) x SD. The following absorption values were calculated: 0.44 %, 19 % and 21 % for 125 g/kg, 0.075 g/L and 0.15 g/L, respectively at 24h. The k multiplication factor (n=8) was determined to be 0.84 and the following SD were calculated: 0.12, 5.76 and 5.38 for 125 g/kg, 0.075 g/L and 0.15 g/L, respectively.
Applicant's summary and conclusion
- Conclusions:
- The study demonstrated that the amount of the test substance absorbed through human split-thickness skin membranes over 24 h (following a 6 h exposure) from the Formulation Concentrate in Saline (125 g/kg) and the intended in-use concentrations (0.15 g/L and 0.075 g/L), was 0.19%, 11.18%, and 9.81% of the applied dose, respectively, as measured in the receptor fluid and receptor chamber wash. The recalculated values for sum of receptor fluid + receptor chamber wash + exposed skin + skin strips 3-20 + k(n=8) x SD were 0.44%, 19% and 21% for 125 g/kg, 0.075 g/L and 0.15 g/L of the test substance, respectively.
- Executive summary:
The purpose of this study was to determine the rate and extent of the in vitro percutaneous absorption of test substance through human split-thickness skin (following 6 h exposure) over an experimental period of 24 h to aid the quantitative assessment of the risk arising from skin contact with the test substance according to OECD TG 428 and GLP principles. The Formulation Concentrate was mixed with physiological saline (1:1, w/w) to generate a paste. A paste was generated because wettable granules cannot be applied accurately to the skin. This is equivalent to an operator becoming exposed to the wettable granule which in turn mixes with sweat.
The active ingredient (the test substance) was assessed with the following applications: 125 g test substance /kg Formulation Concentrate in saline, 0.15 g test substance /L Spray Dilution 1 and 0.075 g test substance /L Spray Dilution 2. The doses were applied at 10 mg/cm2 for the formulation concentrate in saline and 10 μL/cm2 for spray dilution 1 and 2. Following dosing cells were left unoccluded for an experimental period of 24 h, with an interim wash at 6 h post-application. The absorption process was followed by taking samples of the receptor fluid (phosphate buffered saline containing polyoxyethylene 20 oleyl ether (PEG, ca 6%, w/v), sodium azide (ca 0.01%, w/v), streptomycin (ca 0.1 mg/mL) and penicillin (ca 100 units/mL)) at recorded intervals throughout the experimental period. The distribution of the test substance within the test system and a 24 h absorption profile were determined using liquid scintillation counting. Before conducting the main study stability and solubility assessments were carried out.
Results showed that the amount of test substance absorbed through human split-thickness skin membranes over 24 h (following a 6 h exposure) from the concentrate formulation in saline (125 g/kg) and the intended in-use concentrations (0.15 g/L and 0.075 g/L) in the test substance was 0.20%, 11.18% and 9.81% of the applied dose, respectively, as measured in the receptor fluid and receptor chamber wash. The recalculated values for sum of receptor fluid + receptor chamber wash + exposed skin + skin strips 3-20 + k(n=8) x SD were 0.44%, 19% and 21% for 125 g/kg, 0.075 g/L and 0.15 g/L of the test substance, respectively.
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