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EC number: 700-567-0 | CAS number: 1231728-34-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-04-05 to 2011-04-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- tin(2+) bis(3,5,5-trimethylhexanoate)
- EC Number:
- 700-567-0
- Cas Number:
- 1231728-34-9
- Molecular formula:
- C18H34O4Sn
- IUPAC Name:
- tin(2+) bis(3,5,5-trimethylhexanoate)
- Test material form:
- liquid: viscous
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kissleg, Germany
- Age at study initiation: no data
- Weight at study initiation: 1968.0 g, 1832.4 g and 2054.8 g
- Housing: housed single in steel cages with a plastic bottom mould
- Diet (e.g. ad libitum): ad libitum Altromin 2023 Maintenance diet for rabbits
- Water (e.g. ad libitum): tap water from municipal source ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 % - 70 %
- Air changes (per hr): 8 times/hour
- Photoperiod (hrs dark / hrs light): dimmed day light
IN-LIFE DATES: From: To: 2011-03-29 to 2011-04-26
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye remained untreated and served as a control.
- Amount / concentration applied:
- 0.1 mL of the test substance was applied by means of a syringe to the eye of the animals.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes have not been rinsed.
- Time after start of exposure: -
SCORING SYSTEM: According to OECD guideline 405, (Draize system)
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
After recording the observations at 24 hours, the eyes of all rabbits were further examined with the aid of fluorescein (Fluorescein sodium C.1. 45350, Merck KGaA, Darmstadt, Germany, Batch No. K 38004887 746, durable till 2013-02-28) to look for damage of the cornea. One drop of a 0.5 % (w/v) fluorescein solution in saline was poured into both eyes and washed off with saline solution 30 seconds later. Afterwards scoring was carried out by use of an UV-Iight lamp. This procedure was repeated at all observation time points until day 14.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24,48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24,48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- other: mean 24,48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #3
- Time point:
- other: mean 24,48 and 72 hours
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24,48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Irritant / corrosive response data:
- Moderate to strong ocular reactions including iris irritation and cornea damage were observed within 24 hour following application of 0.1 ml of the
test substance to the eyes. In all animals cornea damage, iris irritation and irritating effects to the conjunctivae were irreversible within 21 days. - Other effects:
- Symptoms of systemic toxicity caused by the test substance were not observed during the whole study.
Body weight gain was positive and within normal range.
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae Redness |
Conjunctivae Chemosis |
Conjunctivae Discharge |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
Max.score: 3 |
|
1 h |
0/0/0 |
1/0/1 |
1/2/2 |
1/1/1 |
2/2/2 |
24 hours |
4/4/4 |
1/1/1 |
2/2/2 |
3/2/3 |
2/2/2 |
48 hours |
4/4/4 |
1/1/1 |
2/2/2 |
2/2/2 |
2/2/2 |
72 hours |
4/4/4 |
1/1/1 |
2/2/2 |
2/1/2 |
2/2/2 |
Day 7 |
4/4/4 |
1/1/1 |
2/2/2 |
1/1/2 |
1/1/1 |
Day 14 |
4/4/4 |
1/1/1 |
1/1/2 |
1/1/1 |
1/1/1 |
Day 21 |
2/2/2 |
1/1/1 |
1/1/1 |
1/1/1 |
0/0/0 |
Average 24h, 48h, 72h |
4/4/4 |
1/1/1 |
2/2/2 |
2.33/1.67/2.33 |
2/2/2 |
Area effected (Average 24h, 48h, 72h) |
4/4/4 |
|
|
|
|
Reversibility |
not |
not |
not |
not |
not |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- Interpretation is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material, in consideration of reversibility. Moderate to strong effects were observed in all three animals. Cornea damage, iris irritation and slight irritation of the conjunctivae persisted until study termination (day 21 p.a.) in all animals.
- Executive summary:
In a primary eye irritation study according to OECD Guideline 405 (2002) 0.1 mL of hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1) was instilled into the conjunctival sac of three White New Zealand rabbits. The eyes were not rinsed after substance application. Animals then were observed for 21 days. Irritation was scored by the method of Draize. At 24, 48, 72 hours as well as 7 and 14 days post application the eyes were further examined with fluorescein to look for cornea damage.
All 3 animals showed moderate ocular reactions 1 h after application of the test substance.
24 h, 48 hand 72 h after application moderate to strong ocular reactions were observed in all three animals. In addition all rabbits showed irritation of the iris (score 1). Opaque cornea (score 4) over the whole area was observed in all animals 24 h, 48 hand 72 h after application.
Cornea damage, iris irritation and slight irritation of the conjunctivae persisted until study termination (day 21 p.a.) in all animals.
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