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EC number: 947-865-9 | CAS number: -
- 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:
- 30 May 1996 to 09 October 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- other: read-across target
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on read-across material
- Justification for type of information:
- Read-across from Dioctyltin bis (2-ethylhexylmercaptoacetate) (DOTE) (CAS No. 15571-58-1), see attached justification.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- area
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean individual scores : 0.67-0.67-0.33-1.33-0-0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean individual scores : 0-0.33-0-1-0-0
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: All mean individual scores were 0
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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:
- 8-Oxa-3,5-dithia-4-stannatetradecanoic acid, 10-ethyl-4,4-dioctyl-7-oxo-, 2-ethylhexyl ester
- Reference substance name:
- 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (purity >98%)
- IUPAC Name:
- 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (purity >98%)
- Test material form:
- liquid
- Details on test material:
- Physical description: clear colorless liquid
Storage conditions: original container stored at room temperature.
A sufficient amount of the material was transferred from the original container to a labeled storage vessel and stirred prior to dispensation and throughout the dosing procedure.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: males and females
- Body weights: 2828 and 4148 g at initiation of dosing
- Housing: individual suspended mesh-bottom cages
- Diet: ad libitum
- Water: ad libitum
- Acclimitisation: minimum of six days
ENVIRONMENTAL CONDITIONS
Room temperature: 66.5 - 68.2 °F
Relative humidity: 49.0 - 69.9 %.
Photoperiod: 12 hours light/12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted amount applied: 0.1 mL
- Duration of treatment / exposure:
- 96 hour(s)
- Observation period (in vivo):
- 4 days.
Animals observed twice daily for mortality.
Both eyes of the rabbits were examined for occular abnormalities prior to initiation of dosing, including the use of sodium fluorescein and UV light for detection of corneal abnormalities. Both eyes were examined macroscopically for ocular irritation using a hand-held penlight in accordance with the method of Draize. - Number of animals or in vitro replicates:
- 3/sex
- Details on study design:
- Eyes were not rinsed; the test material was placed directly into the cupped lower conjunctival sac of the right eye.
Body weight recorded on day 0 and at termination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- area
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean individual scores : 0.67-0.67-0.33-1.33-0-0
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Mean individual scores : 0-0.33-0-1-0-0
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: All mean individual scores were 0
- Irritant / corrosive response data:
- None of the rabbits vocalised upon installation of the test material.
The left (control) eyes were free of evidence of ocular irritation and other findings for the duration of the study.
There were no test material related deaths, clinical findings, or body weight changes during the study period. The maximum average score for the test material was 8.0 at one hour post instillation. Positive conjunctival irritation was noted for 4/6 rabbits. All animals had minor conjunctival irritation. There were no iridal or corneal findings. All irritation was reversible and completely subsided by day 4. - Other effects:
- One female (no. 21091) lost 390g (14%) of initial (day 0) bodyweight. This weight loss was not considered to be related to test material administration. There were no other remarkable changes or differences observed in body weights during the study period.
Any other information on results incl. tables
Table 1. Individual ocular irritation scores for conjuctiva.
Animal/sex | 1h (R-C-D) | 24h (R-C-D) | 48h (R-C-D) | 72h (R-C-D) | 4d (R-C-D) |
1 m | 2 -1 -1 | 1 -0 -0 | 1 -0 -0 | 0 -0 -0 | |
2 m | 2 -1 -1 | 1 -1 -0 | 1 -0 -0 | 0 -0 -0 | |
3 m | 1 -1 -1 | 1 -0 -0 | 0 -0 -0 | 0 -0 -0 | |
4 f | 2 -1 -2 | 2 -1 -0 | 1 -1 -0 | 1 -1 -0 | 0 -0 -0 |
5 f | 1 -1 -2 | 0 -0 -0 | 0 -0 -0 | 0 -0 -0 | |
6 f | 2 -1 -1 | 0 -0 -0 | 0 -0 -0 | 0 -0 -0 | |
R-redness
C-chemosis
D-discharge
m-male
f-female
Table 2. Individual body weights (g).
Animal number | Sex | Initation (day 0) | Termination (interval) |
21044 | m | 2841 | 2898 (day 3) |
21049 | m | 3159 | 3286 (day 3) |
21055 | m | 2876 | 3027 (day 3) |
20638 | f | 4148 | 4120 (day 4) |
21072 | f | 3088 | 3125 (day 3) |
21091 | f | 2828 | 2438 (day 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 was not irritating to the eye.
- Executive summary:
The preliminary ocular irritation potential of the test material was evaluated in accordance with the stamdardosed guidelines OECD 405 and EPA OTS 798.4500, under GLP conditions.
During the study, single 0.1 mL doses of the test material were instilled into the lower conjuctival sac of the right eye of 6 New Zealand White rabbits. The eyelids were held closed for approximately 1 second and released. Left eyes were manipulated in a similar manner as the right eyes and served as contralateral controls. The eyes of all animals remained unwashed.
The eyes were examined for ocular reactions in accordance with the method of Draize at approximately 1, 24, 48, and 72 hours after dosing and on day 4 if irritation persisted. Sodium fluorescein was used to aid in revealing possible corneal damage at 24, 48, and 72 hours and on day 4. Postive conjunctival reactions were noted in the treated eye of 4 animals while minor conjuctival irritation was noted for all rabbits. There were no corneal or iridal findings. All irritation was reversible and completely subsided by day 4 or earlier.
Under the conditions of this study, the test material was not irritating to the eye.
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