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Diss Factsheets
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EC number: 205-286-2 | CAS number: 137-26-8
- 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:
- 2 Aug - 17 Sep 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Thiram
- EC Number:
- 205-286-2
- EC Name:
- Thiram
- Cas Number:
- 137-26-8
- Molecular formula:
- C6H12N2S4
- IUPAC Name:
- thiram
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- thionyl-14C
Test animals
- Species:
- human
Administration / exposure
- Duration of exposure:
- 6 h
- Details on study design:
- DOSE PREPARATION
- Method for preparation of dose suspensions: labelled stock solution was evaporated to dryness, dry unlabelled thiram was added and taken up with 200 mL acetone. Radioactivity was measured and the solvent was evaporated to a small volume. Aliquots were transferred to vials and formulated to give a Thiram 80WG formulation that was mixed with water to give a workable slurry.
VEHICLE
- Justification for use and choice of vehicle (if other than water): water
- Amount(s) applied (volume or weight with unit): 6.4 µL
- Concentration (if solution): high dose: 617 g/L (nominal 500 g/L); low dose: 1.46 g/L (nominal 1.6 g/L)
TEST SITE
- Area of exposure: 0.64 cm²
REMOVAL OF TEST SUBSTANCE
- Washing procedures and type of cleansing agent: swabbing with 1% Tween 80 in distilled water on cotton wool buds until no further radioactivity was removed
- Time after start of exposure: 6 h
SAMPLE COLLECTION
- Receptor fluid: collected at hourly intervals for the duration of the experiment (24 hours)
- Terminal procedure: skin samples were tape stripped to remove residual surface dose and stratum corneum
ANALYSIS
- Method type(s) for identification: LSC - Details on in vitro test system (if applicable):
- SKIN PREPARATION
- Source of skin: Skin samples were obtained from human donors post mortem and were supplied by the International Institute for the Advancement of Medicine.
- Ethical approval if human skin:
- Type of skin: full thickness (see Table 1)
- Preparative technique: dermatome
- Thickness of skin (in mm): 0.2-0.4
- Membrane integrity check: with tritiated water
- Storage conditions: Skin samples were stored at ca. -20°C
- Justification of species, anatomical site and preparative technique: specified in OECD TG 428
PRINCIPLES OF ASSAY
- Diffusion cell: Scott-Dick flow-through diffusion cell, flow rate 1.5 mL/h
- Receptor fluid: 0.01 M phosphate-buffered saline, supplemented with 5% bovine serum albumin
- Solubility of test substance in receptor fluid: solubility was verified for the high-dose level
- Test temperature: 32°C
- Humidity: 41.2%-54.1% (high dose); 49.8%-56.4% (low dose)
- Occlusion: open
Results and discussion
- Absorption in different matrices:
- see Table 2
- Total recovery:
- see Table 2
Percutaneous absorptionopen allclose all
- Time point:
- 24 h
- Dose:
- 500 mg/mL
- Parameter:
- percentage
- Absorption:
- 2.82 %
- Remarks on result:
- other: 24 h
- Remarks:
- Flux: 0.201 µg/cm²/h
- Time point:
- 24 h
- Dose:
- 1.6 mg/mL
- Parameter:
- percentage
- Absorption:
- 11.9 %
- Remarks on result:
- other: 24 h
- Remarks:
- Flux: 0.048 µg/cm²/h
- Conversion factor human vs. animal skin:
- not applicable
Any other information on results incl. tables
Table 2: Summary of results
|
Recovery of [14C]-Thiram [% of dose, mean ± SD] |
|
|
Slurry of commercial formulation (500 g/L) n=6 |
In-use dilution (1.6 g/L) n=4 |
Skin wash |
90.24 ± 3.54 |
70.88 ± 8.22 |
Donor compartment wash |
2.22 ± 2.56 |
0.13 ± 0.25 |
Receptor fluid (0-24 h) |
0.06 ± 0.02 |
3.77 ± 2.27 |
Receptor compartment wash |
0.06 ± 0.00 |
0.04 ± 0.02 |
Skin1) |
nd |
1.02 ± 0.97 |
Stratum corneum |
|
|
Tape strips (1 + 2) |
2.28 ± 0.73 |
14.49 ± 6.80 |
Tape strips (3 – last) |
1.53 ± 1.01 |
2.16 ± 1.68 |
Absorbed dose2) |
0.12 ± 0.16 |
4.82 ± 3.24 |
Potentially absorbed dose3) |
1.65 ± 1.17 |
6.98 ± 4.92 |
Dermal absorption value |
1.65 + 1.17 = 2.82 =3 |
6.98 + 4.92 = 11.9 =12 |
Total recovery |
96.39 ± 1.58 |
92.47 ± 4.49 |
1) Skin without stratum corneum 2) The absorbed dose is the amount in receptor fluid plus receptor compartment wash plus skin (excluding tape strips, i.e. stratum corneum) 3) The potentially absorbed dose is the amount in receptor fluid plus receptor compartment wash plus skin and tape strips (excluding the first 2 tape strips) nd: not detected |
Applicant's summary and conclusion
- Conclusions:
- The dermal absorption values for the test substance when formulated as Thiram 80 WG were estimated to be 3% and 12%, respectively, for the commercial formulation and the 1.6 g/L in-use dilution. For DNEL calculation, the result on the commercial formulation was considered.
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