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EC number: 619-447-3 | CAS number: 99607-70-2
- 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:
- supporting study
- Study period:
- 07.06.1995 to 21.09.1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- Principles of method if other than guideline:
- The study design followed the available draft OECD guidelines for testing of chemicals ‘Percutaneous absorption: in vitro method’, draft document, March 1994. Methods for measuring dermal penetration of pesticides, MAFF, UK, Working Document 5/9, November 1992.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Daratech WP
- IUPAC Name:
- Daratech WP
- Reference substance name:
- CGA185072
- IUPAC Name:
- CGA185072
- Reference substance name:
- CGA184927
- IUPAC Name:
- CGA184927
Constituent 1
Constituent 2
Constituent 3
- Radiolabelling:
- yes
Test animals
- Species:
- other: Rat and human skin samples
- Strain:
- other: Tif: RAI f rats, human Caucasian donors
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- other: Diffusion cell apparatus
- Vehicle:
- other: For the radiolabeled compound toluene served as solvent. The formulated test substances in the aqueous suspension were stable as checked by TLC. Two sets of formulations designated A and B were prepared with the blank formulation containing [U-14C]phenyl
- Duration of exposure:
- 8 hours
- Doses:
- [14C]- clodinafop-propargyl - Rat : 0.04, 0.41, 4.05 mg/cm2; human: 0.04, 0.4, 3.87 mg/cm2
[14C]- cloquintocet-mexyl - Rat : 0.01, 0.09, 0.99 mg/cm2; human: 0.01, 0.1, 1.11 mg/cm2
- No. of animals per group:
- Between 5 and 7 skin replicates for rat and human membranes per test group
- Control animals:
- no
- Details on study design:
- See table presentd below
Results and discussion
Percutaneous absorption
- Remarks on result:
- other: Cloquintocet-mexyl: within 8 hours, 68%, 32%, and 2% of the dose penetrated the rat epidermis, but only 6%, 5% and 0.1% of the dose the human epidermis at the low, middle, and high concentration, respectively
- Conversion factor human vs. animal skin:
- At steady state conditions, reached after a lag time of less than 2 hours in both species (except in rat epidermis at the high concentration, i.e. 8 hours), the species difference is reflected in the flux constants determined to 4.9, 13.3 and 48.2 µg×cm-2×h-1 through rat epidermis and 0.8, 0.9, and 2.4 µg×cm-2×h-1 through human epidermis at the low, middle, and high concentration, respectively. This results in a rat/human ratio of the flux constants of 6:1, 16:1, and 20:1
Any other information on results incl. tables
Dermal penetration of clodinafop-propargyl and cloquintocet-mexyl formulated as TOPIK 15 WP (A-9526 A) through rat and human skin in vitro
Test compound |
|||||||
[14C]- CGA 184927 |
Species |
Rat |
Human |
||||
Dose (mg/cm2) |
0.04 |
0.41 |
4.05 |
0.04 |
0.4 |
3.87 |
|
Penetration within 8 h 24 h 48 h |
61.0 73.1 77.7 |
20.6 45.9 nd |
3.5 17.8 43.9 |
9.3 20.2 31.3 |
1.0 2.2 4.6 |
0.3 0.8 1.2 |
|
Flux constant [mg/(cm2 x h)] |
4.94 |
13.34 |
48.22 |
0.76 |
0.86 |
2.41 |
|
Lag time (h) |
0.3 |
1.0 |
8.2 |
1.1 |
1.4 |
0.7 |
|
[14C]- CGA 185072 |
Dose (mg/cm2) |
0.01 |
0.09 |
0.99 |
0.01 |
0.1 |
1.11 |
Penetration within 8 h 24 h 48 h |
68.0 72.8 75.0 |
32.4 50.9 63.8 |
1.7 4.7 10.1 |
6.4 13.5 20.8 |
4.5 7.1 8.8 |
0.1 0.2 0.2 |
|
Flux constant [mg/(cm2 x h)] |
1.79 |
4.69 |
4.66 |
0.12 |
0.81 |
0.25 |
|
Lag time (h) |
0.3 |
0.4 |
1.2 |
1.3 |
1.3 |
0.9 |
|
nd : not determined |
Applicant's summary and conclusion
- Conclusions:
- A skin penetration study through rat and human skin in vitro with TOPIK® 15 WP formulation showed that based on the absorption rate (flux) the human skin compared to the rat skin is 15-fold less permeable for the cloquintocet-mexyl, if the concentrated product is applied, and 19-fold less permeable if a representative spray dilution is applied.
- Executive summary:
The permeability of human and rat skin for cloquintocet-mexyl was studied in vitro under GLP to OECD TG 428, using a typical plant protection product formulation, which was applied to skin as concentrate and in form of a representative spray dilution.
Within 8 hours, 68%, 32%, and 2% of the dose of cloquintocet-mexyl penetrated the rat epidermis, but only 6%, 5% and 0.1% of the dose penetrated the human epidermis at the low, middle, and high concentration, respectively. The lag time was less than two hours for both species. At steady state conditions the flux constants through rat epidermis accounted for 1.8, 4.6, and 4.7 µg·cm-2·h-1 through rat epidermis and 0.8, 0.9, and 2.4 µg·cm-2·h-1 at the low, middle, and high concentration, respectively. The corresponding values for human epidermis accounted for 0.1, 0.8, and 0.3 µg·cm-2·h-1 resulting in a rat/human ratio of flux constant of 15:1 for the spray dilution and 19:1 for the concentrated formulation, respectively. Cloquintocet-mexyl remained unchanged while exposed to and penetrating through rat and human epidermis.
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