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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 May 2010 to 26 May 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- Sponsor's identification: CAS No 818-08-6
Description: white solid
Batch number: not supplied
Date received: 26 March 2010
Expiry date: 26 March 2011
Storage conditions: approximately 4°C in the dark under nitrogen
The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Loughborough, UK.
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.38 kg
- Housing: The animal was housed in a suspended cage.
- Diet/water (e.g. ad libitum): Free access to mains drinking water and food (2030 Teklad Global Rabbit diet supplied by Harlan Laboratories U.K. Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 ml of the test material, which was found to weigh approximately 93 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. - Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test material, and then released.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were made on Days 7 and 14 to assess the reversibility of the ocular effects.
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: n/a
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- area of cornea involved
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Scattered or diffuse corneal opacity was noted in the treated eye at the 48, 72 Hour and 7 Day observations. Adverse ocular reactions prevented accurate evaluation of the cornea at the 14 Day observation.
Iridial inflammation was noted in the treated eye at the 24, 48, 72 Hour and 7 Day observations. Adverse ocular reactions prevented accurate evaluation of the iris at the 14 Day observation.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at the 24 and 48-Hour observations with severe conjunctival irritation noted at the 72 Hour, 7 and 14 Day observations. - Other effects:
- Blepharitis was noted in the treated eye at the 72 Hour observation. Off white appearance of the majority of the nictitating membrane and lower conjunctival membrane was noted at the 7 and 14 Day observation. Pannus formation, over the whole of the cornea, and blood stained discharge were noted in the treated eye at the 14 Day observation.
Any other information on results incl. tables
Due to the worsening reactions and evidence of irreversible effects the animal was killed for humane reasons immediately after the 14-Day observation, in accordance with Company policy and current UK Home Office guidelines.
Table 1 Individual and Total Scores for Ocular Irritation
Rabbit Number and Sex |
69203Male |
|||||
IPR= 2 |
||||||
Time After Treatment |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
14 Days K |
CORNEA |
|
|
|
|
|
|
Degree of Opacity |
0 |
0 |
1 |
1 |
1 |
?cPa |
Area of Cornea Involved |
0 |
0 |
4 |
4 |
4 |
?c |
IRIS |
0 |
1 |
1 |
1 |
1 |
?i |
CONJUNCTIVA |
|
|
|
|
|
|
Redness |
2 |
2 |
2 |
2 |
2P |
2PBs |
Chemosis |
2 |
2 |
2 |
3Bp |
3 |
3 |
Discharge |
2 |
3 |
3 |
3 |
3 |
3 |
IPR = Initial pain reaction
P = Off white appearance of the majority of the nictitating membrane and lower conjunctival membrane
Bp = Blepharitis
Bs =Blood stained discharge
Pa = Pannus formation over the whole of the cornea
?c = Adverse ocular reactions prevented accurate evaluation of the cornea
?i = Adverse ocular reactions prevented accurate evaluation of the iris
K = Animal killed for humane reasons in accordance with Company policy and current UK Home Office guidelines
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye damage (category 1) according to EU criteria
- Conclusions:
- The test material was considered to be corrosive to the rabbit eye due to the irreversible effects which persisted after 14 days.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
A single application of the test material to the non-irrigated eye of one rabbit produced scattered or diffuse corneal opacity, iridial inflammation and severe conjunctival irritation. Other ocular effects noted were blepharitis, off white appearance of the nictitating membrane and lower conjunctival membrane, blood stained discharge and pannus formation. Due to the worsening reactions and evidence of irreversible effects the animal was killed for humane reasons immediately after the 14 Day observation, in accordance with Company policy and current UK Home Office guidelines.
The test material was considered to be corrosive to the rabbit eye due to the irreversible effects noted.
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