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EC number: 215-960-8 | CAS number: 1461-25-2
- 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
Endpoint summary
Administrative data
Description of key information
Since the SI was > 3 after 1 % tetrabutyltin treatment, the limiting value required for classification as a skin sensitiser, it was concluded that tetrabutyltin should be regarded as a skin sensitiser when applied at concentrations of 1 % (v/v) and higher.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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:
- guideline study
- 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)
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-12 weeks
- Housing: group housing in cages (maximally 5/cage), from the start of treatment animals were housed individually
- Diet: standard diet ad libitum
- Water: Domestic mains tap water, provided 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 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 0.25, 0.5 and 1 %
- No. of animals per dose:
- 5 females/dose
- Details on study design:
- RANGE FINDING TESTS:
Based on the presence of systemic toxicity and skin irritation in previous studies, a dose range finding test was conducted to selected suitable dose concentrations for use in the main study. Five animals were treated in the dose range finding test, each with a test substance concentration from the series: undiluted, 50, 25, 10 and 5 %. Each test substance formulation was applied on both ears for three consecutive days. All animals were observed daily for signs of toxicity, including effects on body weights, and their treated ears for signs of irritation. All findings were recorded. The animals were sacrificed on day 3 approximately 24 hours after the last treatment.
Based on the results of the study, dose levels of 0.25, 0.5 and 1 % were selected for 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 were 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 was 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.
- Key result
- Parameter:
- SI
- Value:
- 1.85
- Test group / Remarks:
- 0.25 %
- Key result
- Parameter:
- SI
- Value:
- 1.96
- Test group / Remarks:
- 0.5 %
- Key result
- Parameter:
- SI
- Value:
- 10.82
- Test group / Remarks:
- 1 %
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 0 %
- Cellular proliferation data / Observations:
- Disintegrations per minute (DPM) were 1400, 2583, 2739 and 15149 for 0, 0.25, 0.5 and 1 % dose levels, respectively.
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Since the SI was > 3 after 1 % tetrabutyltin treatment, the limiting value required for classification as a skin sensitiser, it was concluded that tetrabutyltin should be regarded as a skin sensitiser when applied at concentrations of 1 % (v/v) and higher.
- Executive summary:
The sensitisation of Tetrabutyltin was examined in a Local Lymph Node Assay (LLNA) in accordance with OECD 429 and EU Method B.42 under GLP conditions. 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.
Since the SI was > 3 after 1 % tetrabutyltin treatment, the limiting value required for classification as a skin sensitiser, it was concluded that tetrabutyltin should be regarded as a skin sensitiser when applied at concentrations of 1 % (v/v) and higher.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The sensitisation of Tetrabutyltin was examined in a Local Lymph Node Assay (LLNA) in accordance with OECD 429 and EU Method B.42 under GLP conditions. 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.
Since the SI was > 3 after 1 % tetrabutyltin treatment, the limiting value required for classification as a skin sensitiser, it was concluded that tetrabutyltin should be regarded as a skin sensitiser when applied at concentrations of 1 % (v/v) and higher.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as set forth in Regulation (EC) No 1272/2008, the substance requires classification as Skin Sens. 1 (H317: May cause an allergic skin reaction).
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