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EC number: 212-449-1 | CAS number: 818-08-6
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 4-18, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dibutyltin oxide
- EC Number:
- 212-449-1
- EC Name:
- Dibutyltin oxide
- Cas Number:
- 818-08-6
- Molecular formula:
- C8H18OSn
- IUPAC Name:
- dibutylstannanone
- Details on test material:
- - Name of test material (as cited in study report): Dibutyltin Oxide
- Physical state: White Powder
- Analytical purity: 98.5%
- Lot/batch No.: EKRDX-052M
- Expiration date of the lot/batch: Feb 28, 1995
- Storage Conditions: Room Temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. , Denver, Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 3142 to 3482 grams
- Housing: Individual suspended wire-mesh cages at the WIL Research Laboratories
- Diet (e.g. ad libitum): Ad libitum, Purina Certified Rabbit Chow #5322
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days
- Method of Identification: Eartag
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 32-70%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Test system
- Type of coverage:
- other: The 3- and 60-minute exposures were occluded for the corrosion study, and the four-hour exposure was semi-occluded for the irritation study
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- For the 3- and 60-minute exposures, materials were not be moistened with water, but for the 4 hour exposure, the solid materials were moistened with deionized water
- Controls:
- not specified
- Amount / concentration applied:
- For the 3- and 60-minute exposures, 0.5 grams/site
For the 4-hour exposure, 0.5 grams/site - Duration of treatment / exposure:
- Three treatments:
3-minute exposure
60-minute exposure
4-hour exposure - Observation period:
- 3-minute exposure: 24 and 48 hours after dosing
60-minute exposure: 24 and 48 hours after dosing
4-hour exposure: 30 minutes, 60 minutes, 24, 48, and 72 hours after dosing, and daily thereafter through day 14 - Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: Dermal surface of shaved backs and flanks
- % coverage: 2.5 cm x 2.5 cm gauze patch
- Type of wrap if used: Patches were overwrapped with plastic wrap for the 3- and 6-minute occluded exposures and gauze bandaging for the four-hour semi-occluded exposure. Bandaging materials were secured with Dermiform Tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Sites were wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: Either 3-minutes, 60-minutes, of 4 hours after exposure.
SCORING SYSTEM: Draize method (Table 3)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.83
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.83
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 1.83
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: disquamination was seen in all rabbits
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- There was no evidence of corrosion following the three-minute, sixty-minute and four-hour exposures. Dermal irritation following the four-hour exposure included very slight to moderate erythema, very slight to slight edema and desquamation on all sites. All edema completely subsided within 72 hours of application. Very slight to slight erythema persisted through day 14 for all sites.
- Other effects:
- There was no evidence of corrosion following the 3- and 60-minute and 4-hour exposures to the test material. No irritation greater than very slight to slight erythema and no edema was observed on any three or 60-minute exposure site at both 24 and 48 hours post-exposure.
The test material induced very slight to moderate erythema and very slight to slight edema on all rabbits following the four-hour exposure. All sites had desquamation by day 11. There were no other dermal findings. Edema completely subsisted within 72 hours. Very slight to slight erythema was present on all sites at study termination (day 14).
Any other information on results incl. tables
There was no evidence of corrosion following the three- and 60- minute and 4-hour exposures to the test material. No irritation greater than very slight to slight erythema and no edema was observed on any three or 60 -minute exposure site at both 24 and 4 hours post-exposure.
The test material induced very slight to moderate erythema and very slight to slight edema on all rabbits following the four-hour exposure- All sites had desquamation by day 11. There were no other dermal. findings. Edema completely subsided within 72 hours. Very slight to slight erythema was present on all sites at study termination (day l4).
There were no deaths or significant body weight changes during the study period.
See attached tables for results.
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irritant (category 2) according to EU criteria
- Conclusions:
- There were no deaths or significant body weight changes during the study period. There was no evidence of corrosion following the 3-minute, 60-minute, and 4-hour exposures. Dermal irritation following the 4-hour exposure included very slight to moderate erythema, very slight to slight edema and desquamation on all sites. All edema completely subsided within 72 hours of application. Very slight to slight erythema persisted through day 14 for all sites.
- Executive summary:
Dibutyltin oxide was evaluated for dermal irritation on New Zealand White rabbits.
Single 0.5 g doses of the test material were applied to the shaved, intact skin of 6 albino rabbits under occlusive dressings for three and 60 -minute application sites and under semi-occlusive dressings for a four-hour expsoure period. The three and 60 minute application sites were observed immediately after bandage removal and at approximately 24 and 48 hours after dosing for the presence or absence of corrosion. The four hour exposure sites were washed immediately following bandage removal.
There were no deaths or significant body weight changes during the study period. There was no evidence of corrosion following the three-minute, sixty-minute and four-hour exposures. Dermal irritation following the four-hour exposure included very slight to moderate erythema, very slight to slight edema and desquamation on all sites. All edemas completely subsided within 72 hours of application. Very slight to slight erythema persisted through day 14 for all four-hour sites. Based on the data, dibutyltin oxide was found to be non-corrosive when applied under occlusion to the shaved, intact skin of albino rabbits for up to 4 hours.
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