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EC number: 222-733-7 | CAS number: 3590-84-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Tetraoctyltin
- EC Number:
- 222-733-7
- EC Name:
- Tetraoctyltin
- Cas Number:
- 3590-84-9
- Molecular formula:
- C32H68Sn
- IUPAC Name:
- tetraoctylstannane
- Details on test material:
- - Name of test material (as cited in study report): Tetraoctyltin, TOT
- Substance type: organometallic
- Physical state: slightly yellowish liquid
- Analytical purity: 86.0%
- Lot/batch No.: UAKW060
- Expiration date of the lot/batch: 31 October 2011
- Storage condition of test material: ambient temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 8-12 weeks
- Housing: group housing in macrolon cages (maximally 5/cage), from the start of treatment animals were housed individually (macrolon cages)
- Diet: standard diet ad libitum (Rat and Mouse no.3 breeding diet RM3).
- Water: Domestic mains tap water, ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 45-65
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0%, 25%, 50% and 100%
- No. of animals per dose:
- 5 females/dose
- Details on study design:
- RANGE FINDING TESTS:
In a dose range finding test two mice were treated with a 50% or 10% concentration of the substance in vehicle for three consecutive days in a similar manner as described for the main test. These mice were observed for signs of toxicity and/or skin irritation as a result of this treatment. Based on the dose range finding test, concentrations of 100% (undiluted), 50% and 25% were selected for the main study.
Balb/c mice were used in the dose range finding test, because spare mice of the CBA/J strain were not available. It was assumed that skin irritation and dermal absorption and/or toxicity should be similar between strains of the same species, and the results obtained in Balb/c mice should be suitable for extrapolation to CBA/J mice. As a consequence of the decision to use mice of another strain for the dose range finding test, two different mice strains were present in the animal room during (a part of) the acclimatisation period until the start of the main study.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: The present Local Lymph Node Assay was conducted simultaneously with a LLNA reliability study. The results of the vehicle control group that is part of the reliability check was used for evaluation of the data of test groups. The 3H-thymidine incorporation was compared between the different treatment groups. Changes in 3H-thymidine incorporation in the test substance treatment groups were evaluated and expressed as stimulation index (SI) relative to the vehicle control group. The SI is obtained by dividing the individual values of the 3H-thymidine incorporation, expressed as DPM (corrected for background), with the mean proliferation of the vehicle control group. Since also the DPM-data of the vehicle-treated group are divided with its own mean DPM-data, this results in an average SI for vehicle-treated controls of 1. The decision process with regard to a positive response includes a stimulation index ≥3 together with consideration of dose response and statistical analyses based on the test guideline and the recommendations done by ICCVAM.
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance was applied topically once daily for three consecutive days on the dorsum of both ears (by means of a pipette 25 µl on each ear). Immediately after application, the test substance was spread over the dorsum of the ear with the tip of the pipette. Each animal received a total amount of 50 µL per dosing. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Statistical evaluation of the data (body weights and 3H-thymidine incorporation) was performed by one-way ANOVA, followed by Dunnett’s multiple comparison tests. Probability values of p<0.05 were considered significant.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 0%
- Parameter:
- SI
- Value:
- 1.96
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 4.32
- Test group / Remarks:
- 50%
- Parameter:
- SI
- Value:
- 7.9
- Test group / Remarks:
- 100%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 1400, 2740, 6048 and 11060 DPM for 0%, 25%, 50% and 100% groups, respectively
Any other information on results incl. tables
No signs of local irritation or other clinical signs were observed in any of the animals during the study period. No aberrant body weights or body weight gains were observed, and no statistical significant difference was found between the vehicle and the positive control group.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Since the SI was > 3 after 50% tetraocyltin treatment, the limiting value required for classification as a skin sensitiser, it was concluded that tetraocyltin should be regarded as a skin sensitiser when applied at concentrations of 50% (v/v) and higher.
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