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EC number: 249-528-5 | CAS number: 29232-93-7
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 Sep 1996 to 06 Sep 1996
- 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:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pirimiphos-methyl
- EC Number:
- 249-528-5
- EC Name:
- Pirimiphos-methyl
- Cas Number:
- 29232-93-7
- Molecular formula:
- C11H20N3O3PS
- IUPAC Name:
- O-2-(diethylamino)-6-methylpyrimidin-4-yl O,O-dimethyl phosphorothioate
Constituent 1
- Radiolabelling:
- no
Administration / exposure
- Doses:
- - Nominal doses: 503.7 g/L; 4.5 g/L
- Dose volume: 25.4 µL (10 µL/cm2, 2.54 cm2 application area)
- Rationale for dose selection: The two doses were prepared to mimic the commercial formulation - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Human
- Preparative technique: Epidermal membranes were prepared from human whole skin by immersion in water at 60°C for 40-45 seconds and the epidermis teased off the dermis.
- Membrane integrity check: The integrity of the membranes was checked by measurement of the electrical resistance across the skin. Only those membranes with an acceptable resistance, thereby showing that they were intact, were used on the study.
PRINCIPLES OF ASSAY
- Diffusion cell: Measured using glass diffusion cells in which the epidermis formed a horizontal membrane and provided an application area of 2.54 cm2.
- Receptor fluid: The receptor chambers of the cells were filled with a recorded volume of receptor fluid (50% v/v ethanol in water) and placed in a water bath maintained at 30 ± 1°C. A pre-treatment sample (0 5mL) was taken from each receptor chamber for analysis by gas-liquid chromatography (GLC). An equal volume of fresh receptor fluid was added to each receptor chamber to replace the volume removed.
- Test temperature: Throughout the experiment the receptor fluid was stirred and the epidermal membranes were maintained at a normal skin temperature of 30 ± 1°C in a water bath.
- Occlusion: Unoccluded
Results and discussion
Percutaneous absorptionopen allclose all
- Key result
- Time point:
- 24 h
- Dose:
- 4.5 g/L
- Parameter:
- percentage
- Absorption:
- 8.46 %
- Time point:
- 6 h
- Dose:
- 4.5 g/L
- Parameter:
- percentage
- Absorption:
- 1.9 %
- Time point:
- 10 h
- Dose:
- 4.5 g/L
- Parameter:
- percentage
- Absorption:
- 3.4 %
- Time point:
- 6 h
- Dose:
- 503.7 g/L
- Parameter:
- percentage
- Absorption:
- 0.11 %
- Time point:
- 10 h
- Dose:
- 503.7 g/L
- Parameter:
- percentage
- Absorption:
- 0.22 %
- Time point:
- 24 h
- Dose:
- 503.7 g/L
- Parameter:
- percentage
- Absorption:
- 0.56 %
Any other information on results incl. tables
Table 1. Summary of the test substance 500 g/L absorption through human epidermis
Application of Test Materials |
Mean Absorption Rates |
Mean Amount and Percentage of Dose Absorbed |
|||
|
Time period (h) |
Absorption rate (µg/cm2/h±SEM) |
Time (h) |
Amount (µg/cm2) |
Percentage absorbed |
Concentrate Formulation |
0.5 - 54 |
1.17+0.097 |
|
|
|
(503.7 g a.i/L) |
|
|
6 |
5.72 |
0.11 |
10 µL/cm2(5037 µg ai/cm2) |
|
|
8 |
8.32 |
0.17 |
Unoccluded |
|
|
10 |
10.9 |
0.22 |
Duration of exposure: 54h |
|
|
24 |
28.4 |
0.56 |
n = 5 |
|
|
|
|
|
0.9:100 v/v aqueous spray diln |
0.5 – 54 |
0.155 +0.028 |
|
|
|
(4.536 µg a.i/L) |
6 |
0.883 |
1.9 |
||
10 µL/cm2(45.36 µg ai/cm2) |
|
|
8 |
1.20 |
2.6 |
Unoccluded |
|
|
10 |
1.53 |
3.4 |
Duration of exposure: 54h |
|
|
24 |
3.84 |
8.5 |
n = 6 |
|
|
|
|
|
Applicant's summary and conclusion
- Conclusions:
- The results obtained in this study demonstrate that the absorption of the test substance through human epidermis is slow when compared with the absorption rates of other penetrants measured using this in vitro technique (Dugard et al, 1984; Dugard and Scott, 1984). These data predict that the dermal absorption of the test substance from normal exposure to this 500g/L formulation would be low and the percentage of absorption would be 8.46 % in the worst case scenario.
- Executive summary:
The absorption of the test substance from a nominal 500g/L formulation (actual content 504 g test substance/L) has been measured in vitro through human epidermis. The formulation was applied as the concentrate formulation and as a 0.9:100 v/v (4.54 g test substance/L) spray strength dilution of the formulation in water. The concentrate formulation and the spray strength dilution were applied to the epidermal membranes at a rate of 10 µL/cm2; all applications were left unoccluded throughout the entire exposure period. These applications were designed to simulate potential human dermal exposure to the formulation during normal use.
Absorption of the test substance from both the concentrate and spray strength dilution maintained essentially constant rates over the entire exposure period (54 h). The absorption rate measured from the spray dilution (mean 0.155 µg/cm2/h) was approximately 8 times less than the rate obtained from the concentrate (1.172 µg/cm2/h). Mean amounts of the test substance absorbed during typical working day periods from the concentrate varied from 5.72 µg /cm2 (0.11% of dose) at 6 h to 10.9 µg/cm2 (0.22% of dose) at 10 h. This increased to 28.44 µg /cm2 (0.56% of dose) after 24 h exposure. The amounts absorbed from the spray dilution varied from 0.883 µg /cm2 (1.9% of dose) at 6 h to 1.53 µg/cm2 (3.4% of dose) at 10 h. This increased to 3.84 µg /cm2 (8.46% of dose) after 24 h exposure.
The results obtained in this study demonstrate that the absorption of the test substance through human epidermis is slow when compared with the absorption rates of other penetrants measured using this in vitro technique (Dugard et al, 1984; Dugard and Scott, 1984). These data predict that the dermal absorption of the test substance from normal exposure to this 500g/L formulation would be low and the percentage of absorption would be 8.46 % in the worst case scenario.
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