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EC number: 261-645-3 | CAS number: 59185-95-4
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- June 12th to 23rd, 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Reliability of original study is 1
- Justification for type of information:
- Justification for Read Across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
- EC Number:
- 239-622-4
- EC Name:
- 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
- Cas Number:
- 15571-58-1
- Molecular formula:
- C36H72O4S2Sn
- IUPAC Name:
- 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecan-1-oate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2615-3446 g.
- Housing: individually.
- Diet: ad libitum.
- Water: ad libitum.
- Acclimation period: for a minimum of six days.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C.
- Humidity: 30-70 %.
- Photoperiod: 12-h light/dark period.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 ml. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 12 days
- Number of animals:
- Four males and two females
- Details on study design:
- TEST SITE
- On the day to dosing, the hair was removed from the backs and flanks of the rabbits using an Oster small animal clipper.
- Area of exposure: approximately 6.5 cm^2.
- Type of wrap if used: a secured two-ply gauze patch that was overwrapped with a gauze binder and secured with Dermiform tape was used. Plaxtic restraint collars were applied and remained on the animals for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE: at the end of four hours, the collars and bandages were removed and the sites wiped with disposable paper towels moistened with deionized water.
OBSERVATION TIME POINTS: the application sites were observed for erythema, edema and other dermal findings approximately 30-60 minutes and 24, 48 and 72 hours after patch removal and once daily through day 11 if irritation persisted.
SCORING SYSTEM: skin reactions were evaluated according to the OECD scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: # 20850
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- erythema score
- Basis:
- animal: #20899
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- erythema score
- Basis:
- animal: #20856, #20873, #20877, #20914
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 11 days
- Irritation parameter:
- edema score
- Basis:
- animal: #20850
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: #20856, #20877
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: # 20873, # 20899, #20914
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Six and four rabbits had slight to moderate erythema and very slight edema, respectively. Desquamation was noted for three animals. Edema completely subsided by day 6 or earlier. There were no other dermal findings. All irritation was reversible and completely subsided by day 11 or earlier.
Any other information on results incl. tables
Primary dermal irritation study in albino rabbits Individual dermal scores |
|||||||||||
0.5 ml/site |
|||||||||||
|
|
|
Erythema |
|
Edema |
||||||
Animal |
Sex |
Site |
0.5-1h |
24h |
48h |
72h |
Site |
0.5-1h |
24h |
48h |
72h |
20850 |
M |
A |
2 |
3 |
3 |
3 |
A |
0 |
1 |
1 |
1 |
20856 |
M |
A |
1 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
0 |
20873 |
M |
A |
0 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
1 |
20877 |
M |
A |
1 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
0 |
20899 |
F |
A |
1 |
1 |
2 |
2 |
A |
0 |
0 |
0 |
1 |
20914 |
F |
A |
2 |
2 |
2 |
2 |
A |
0 |
0 |
0 |
1 |
|
|
Total |
7 |
12 |
13 |
13 |
Total |
0 |
1 |
1 |
4 |
|
|
|
|
|
|
|
|
|
|
|
|
h = hours; M = Male; F = Female |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as a skin irritant according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- The substance is not considered to be a skin irritant.
- Executive summary:
The skin irritation potential of the test material to rabbits was evaluated according to the OECD Guideline 404. For this reason, four male and two female New Zealand white rabbits were treated with the test material (undiluted) on a semi-occlusive patch. After 4 hours of exposure the patch was removed, the treated sites were wiped with disposable paper towels moistened with deionized water and the skin reactions was observed at 30 -60 min, 24, 48, and 72 hours post-removal and once daily through day 11 if irritation persisted. The skin reactions were scored according to the OECD scoring system.
Desquamation was noted for three animals. Edema completely subsided by day 6 or earlier. All irritation was reversible and completely subsided by day 11 or earlier. The erythema score (mean: 24/48/72 hr) was 3 for one animal, 2 for 4 animals and 1.66 for one animal. The edema score (mean 24/48/72 hr) was 1 for one animal, 0 for two animals and 0.33 for three animals.
The substance is not considered to be a skin irritant.
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