Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Eye:
in vitro: In an in vitro eye irritation study the test material was assessed using the SkinEthic Reconstituted Human Corneal model. According to the protocol followed the test material was considered to be a Non-Irritant (NI) and so an in vivo test was carried out.
In the in vivo study (Sanders, 2010) the test material was considered to be corrosive to the rabbit eye due to the irreversible effects noted. (OECD 405).
Skin:
Dibutyltin oxide was evaluated for dermal irritation on New Zealand White rabbits using methods similar to OCED guidelines.
There were no deaths or significant body weight changes during the study period. There was no evidence of corrosion following the three-minute, sixty-minute and four-hour exposures. Dermal irritation following the four-hour exposure included very slight to moderate erythema, very slight to slight edema and desquamation on all sites. All edemas completely subsided within 72 hours of application. Very slight to slight erythema persisted through day 14 for all four-hour sites. Based on the data, dibutyltin oxide was found to be non-corrosive when applied under occlusion to the shaved, intact skin of albino rabbits for up to 4 hours.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 4-18, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc. , Denver, Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 3142 to 3482 grams
- Housing: Individual suspended wire-mesh cages at the WIL Research Laboratories
- Diet (e.g. ad libitum): Ad libitum, Purina Certified Rabbit Chow #5322
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Seven days
- Method of Identification: Eartag
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22 °C
- Humidity (%): 32-70%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Type of coverage:
- other: The 3- and 60-minute exposures were occluded for the corrosion study, and the four-hour exposure was semi-occluded for the irritation study
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- For the 3- and 60-minute exposures, materials were not be moistened with water, but for the 4 hour exposure, the solid materials were moistened with deionized water
- Controls:
- not specified
- Amount / concentration applied:
- For the 3- and 60-minute exposures, 0.5 grams/site
For the 4-hour exposure, 0.5 grams/site - Duration of treatment / exposure:
- Three treatments:
3-minute exposure
60-minute exposure
4-hour exposure - Observation period:
- 3-minute exposure: 24 and 48 hours after dosing
60-minute exposure: 24 and 48 hours after dosing
4-hour exposure: 30 minutes, 60 minutes, 24, 48, and 72 hours after dosing, and daily thereafter through day 14 - Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: Dermal surface of shaved backs and flanks
- % coverage: 2.5 cm x 2.5 cm gauze patch
- Type of wrap if used: Patches were overwrapped with plastic wrap for the 3- and 6-minute occluded exposures and gauze bandaging for the four-hour semi-occluded exposure. Bandaging materials were secured with Dermiform Tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Sites were wiped with disposable paper towels moistened with tepid tap water
- Time after start of exposure: Either 3-minutes, 60-minutes, of 4 hours after exposure.
SCORING SYSTEM: Draize method (Table 3) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.83
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.83
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 1.83
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: disquamination was seen in all rabbits
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.17
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- There was no evidence of corrosion following the three-minute, sixty-minute and four-hour exposures. Dermal irritation following the four-hour exposure included very slight to moderate erythema, very slight to slight edema and desquamation on all sites. All edema completely subsided within 72 hours of application. Very slight to slight erythema persisted through day 14 for all sites.
- Other effects:
- There was no evidence of corrosion following the 3- and 60-minute and 4-hour exposures to the test material. No irritation greater than very slight to slight erythema and no edema was observed on any three or 60-minute exposure site at both 24 and 48 hours post-exposure.
The test material induced very slight to moderate erythema and very slight to slight edema on all rabbits following the four-hour exposure. All sites had desquamation by day 11. There were no other dermal findings. Edema completely subsisted within 72 hours. Very slight to slight erythema was present on all sites at study termination (day 14). - Interpretation of results:
- other: Skin irritant (category 2) according to EU criteria
- Conclusions:
- There were no deaths or significant body weight changes during the study period. There was no evidence of corrosion following the 3-minute, 60-minute, and 4-hour exposures. Dermal irritation following the 4-hour exposure included very slight to moderate erythema, very slight to slight edema and desquamation on all sites. All edema completely subsided within 72 hours of application. Very slight to slight erythema persisted through day 14 for all sites.
- Executive summary:
Dibutyltin oxide was evaluated for dermal irritation on New Zealand White rabbits.
Single 0.5 g doses of the test material were applied to the shaved, intact skin of 6 albino rabbits under occlusive dressings for three and 60 -minute application sites and under semi-occlusive dressings for a four-hour expsoure period. The three and 60 minute application sites were observed immediately after bandage removal and at approximately 24 and 48 hours after dosing for the presence or absence of corrosion. The four hour exposure sites were washed immediately following bandage removal.
There were no deaths or significant body weight changes during the study period. There was no evidence of corrosion following the three-minute, sixty-minute and four-hour exposures. Dermal irritation following the four-hour exposure included very slight to moderate erythema, very slight to slight edema and desquamation on all sites. All edemas completely subsided within 72 hours of application. Very slight to slight erythema persisted through day 14 for all four-hour sites. Based on the data, dibutyltin oxide was found to be non-corrosive when applied under occlusion to the shaved, intact skin of albino rabbits for up to 4 hours.
Reference
There was no evidence of corrosion following the three- and 60- minute and 4-hour exposures to the test material. No irritation greater than very slight to slight erythema and no edema was observed on any three or 60 -minute exposure site at both 24 and 4 hours post-exposure.
The test material induced very slight to moderate erythema and very slight to slight edema on all rabbits following the four-hour exposure- All sites had desquamation by day 11. There were no other dermal. findings. Edema completely subsided within 72 hours. Very slight to slight erythema was present on all sites at study termination (day l4).
There were no deaths or significant body weight changes during the study period.
See attached tables for results.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- 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
- 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)
- 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. - 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. - 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.
- 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.
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Eye irritation
In an in vitro eye irritation study (Warren, 2010) the test material was assessed using the SkinEthic Reconstituted Human Corneal model. According to the protocol followed the test material was considered to be a Non-Irritant (NI) and so an in vivo test was carried out.
In the in vivo study (Sanders, 2010) the study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit.
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.
Skin irritation
In the in vivo study (Kiplinger, 1994) the study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.
A reliability rating of 2 was assigned to this study as the study was conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: corrosive
Justification for classification or non-classification
Eye:
According to EC/1272/2008 the test material will be classified as Eye Dam. Cat. 1; H318: Causes serious eye damage.
Skin:
According to EC/1272/2008, the test substance will be classified as Skin Irrit. Cat. 2; H315: Causes skin irritation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.