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EC number: 222-103-1 | CAS number: 3349-36-8
- 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:
- The study was performed between 22 September 2010 and 23 September 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted to GLP.
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
- Principles of method if other than guideline:
- An assessment of the initial pain reaction was not performed. This deviation from the General Study Plan was considered not to affect the purpose or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dibutoxydibutylstannane
- EC Number:
- 222-103-1
- EC Name:
- Dibutoxydibutylstannane
- Cas Number:
- 3349-36-8
- Molecular formula:
- C16H36O2Sn
- IUPAC Name:
- dibutoxydibutylstannane
- Details on test material:
- Sponsor's identification: CAS No 3349-36-8
Purity: >95%
Description: yellow liquid
Batch number: 2009175996
Date received: 24 June 2010
Expiry date: 07 May 2011
Storage conditions: room temperature in the dark
The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor.
A Certificate of Analysis was supplied by 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: 2.52 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 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 hours.
- 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: Assessment of ocular damage/irritation was made approximately 1 and 24 hours following treatment, according to the numerical evaluation given in Appendix 1, (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
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:
- other: 24 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- area of cornea involved
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- Severe conjunctival irritation was noted in the treated eye one hour after treatment. Scattered or diffuse corneal opacity, iridial inflammation and severe conjunctival irritation were noted in the treated eye at the 24-Hour observation.
- Other effects:
- Other ocular effects noted at the 24-Hour observation were haemorrhage of the upper and lower conjunctival membranes and blood stained discharge from the conjunctival and nictitating membranes.
Any other information on results incl. tables
Due to the severity of the reactions the animal was killed for humane reasons immediately after the 24 hour observation in accordance with current UK Home Office guidelines.
Table 1 Individual Scores for Ocular Irritation
Rabbit Number and Sex |
69630 Male |
|
Time After Treatment |
1 Hour |
24 Hours |
CORNEA |
|
|
Degree of Opacity |
0 |
1 |
Area of Cornea Involved |
0 |
4 |
IRIS |
0 |
1 |
CONJUNCTIVA |
|
|
Redness |
2 |
3HBs |
Chemosis |
3 |
3 |
Discharge |
3 |
3 |
H = Haemorrhage of the upper and lower conjunctival membranes
Bs = Blood stained discharge from the conjunctival and nictitating membranes
Table 2 Individual Bodyweights and Bodyweight Changes
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 1 |
||
69630Male |
2.52 |
2.46 |
-0.06 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The test item was considered to be corrosive to the rabbit eye.
- Executive summary:
The study was performed to assess the irritancy potential of the test item 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)
- Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008
A single application of the test item to the non-irrigated eye of one rabbit produced scattered or diffuse corneal opacity, iridial inflammation, severe conjunctival irritation, haemorrhage of the conjunctival and nictitating membranes and blood stained discharge. Due to the severity of the reactions the animal was killed for humane reasons immediately after the 24-hour observation in accordance with current UK Home Office guidelines.
Based on the results of the study the test item was considered to be corrosive to the rabbit eye, in addition, the test item was considered to be an irritant according to EU labelling regulations Commission Directive 2001/59/EC. It is reasonable to assume that the symbol “Xi”, the indication of danger “Irritant” and the highest risk phrase R 41 “RISK OF SERIOUS DAMAGE TO EYES” are therefore required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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