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EC number: 236-406-1 | CAS number: 13355-96-9
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Rabbits were treated with the test material under an occlusive dressing for 24 hours. Sites were scored according to Draize at 24 and 72 hours post treatment for oedema and erythema.
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP
Test material
- Reference substance name:
- Butylhydroxyoxostannane
- EC Number:
- 218-880-1
- EC Name:
- Butylhydroxyoxostannane
- Cas Number:
- 2273-43-0
- Molecular formula:
- C4H10O2Sn
- IUPAC Name:
- butyl(oxo)stannanol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: white powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: two test sites located lateral to the midline of the back, 10 cm apart, premoistened. The skin on one of the test sites was abraded and one was left intact.
- Type of wrap if used: Gauze patches secured with masking tape covered the site and the trunk of each animal was then wrapped with impervious plastic sheeting.
- Prior to the application of the test material, the hair was clipped from the back and flanks of each rabbit.
REMOVAL OF TEST SUBSTANCE
- At the end of 24 hours, the plastic wrappings, patches, and all residual test material were removed.
OBSERVATION TIME POINTS
- The intact and abraded test sites were examined and scored separately for erythema and oedema on a graded scale of 0 to 4. After 72 hours, the sites were again examined and scored.
- In evaluating the average irritation present, the mean scores for erythema and oedema of the intact test sites after 24 and 72 hours were added. Similarly, the mean scores for erythema and oedema of the abraded test sites after 24 and 72 hours were added. These two values were totalled and divided by four to obtain the mean primary irritation score.
SCORING SYSTEM:
- Mean Primary Irritation Score:
0 = Non-irritating
0.1 - 0.5 = Minimally Irritating
0.6 - 1.5 = Slightly Irritating
1.6 - 3.0 = Mildly Irritating
3.1 - 5.0 = Moderately Irritating
5.1 - 6.5 = Severely Irritating
6.6 - 8.0 = Extremely Irritating
- Erythema:
Barely perceptible (Edges of area not defined) = 1
Pale red in colour and area definable = 2
Definite red in colour and area well defined = 3
Beet or crimson red in colour = 4
- Oedema:
Barely perceptible (Edges of area not defined) = 1
Area definable but not raised more than 1 mm = 2
Area well defined and raised approximately 1 mm = 3
Area raised more than 1 mm = 4
- Injury in Depth:
Escharosis, Necrosis = 8
Maximum Primary Irritation Score = 8
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: abraded and intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: abraded and intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: abraded and intact skin
- Irritation parameter:
- other: Primary irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Reversibility:
- other: 48 hour score not recorded
- Remarks on result:
- other: 48 hour score not recorded
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Reversibility:
- other: 48 hour score not recorded
- Remarks on result:
- other: 48 hour score not recorded
Any other information on results incl. tables
Table 1: Summary of Results
Animal Number |
Irritation Scores for Abraded Skin Sites at: |
Irritation Scores for Intact Skin Sites at: |
||||||
24 hours |
72 hours |
24 hours |
72 hours |
|||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
|
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean |
1.0 |
0.0 |
0.0 |
0.0 |
0.3 |
0.0 |
0.0 |
0.0 |
Subtotal |
1.0 |
0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU Criteria.
- Conclusions:
- Under the conditions of this study the test material is not irritating to the skin.
- Executive summary:
The skin irritation potential of the test material was investigated using New Zealand white rabbits.
Rabbits were treated with the test material under an occlusive dressing for 24 hours on both abraded and intact sites. Sites were scored according to Draize at 24 and 72 hours post treatment for oedema and erythema.
Under the conditions of this study the test material is not irritating to the skin.
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