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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 22 September 2010 and 29 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
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
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 item is the responsibility of the Sponsor.
A Certificate of Analysis was supplied by the Sponsor.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Oxon, UK.
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: at the start of the study the animals weighed at least 200g
- Housing: The animals were individually housed in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet/water: Free access to mains drinking water and food (2014 Teklad Global Rodent diet supplied by Harlan Laboratories U.K. Ltd., Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 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
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- % coverage: approximately 10% of the total body surface area
- Type of wrap if used: a piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the 24-Hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with arachis oil BP to remove any residual test material.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.77 ml/kg (2000 mg/kg)
- Concentration (if solution): used as supplied
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 1 male and 1 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for seven days. Individual bodyweights were recorded prior to application of the test item on Day 0 and at death (Day 7).
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Statistics:
- Data evaluations included the relationship, if any, between the exposure of the animal to the test item and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects.
Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test item was made.
The results were evaluated according to EU labelling regulations Commission Directive 2001/59/EC for classification and labelling of dangerous substances.
Results and discussion
Effect levels
- Remarks on result:
- other: Inconclusive
- Mortality:
- Both animals were killed for humane reasons seven days after dosing, due to the approach of the moderate severity limit set by the UK Home Office.
- Clinical signs:
- other: Signs of systemic toxicity noted were hunched posture, pilo-erection, lethargy, dehydration and pallor of the extremities.
- Gross pathology:
- Raised limiting ridge of the stomach and scattered dermal haemorrhage at the sub cutaneous site of application were noted at necropsy.
- Other findings:
- Very slight or well-defined erythema and hardened dark brown black coloured scab were noted at both test sites. Additional signs of dermal irritation noted at the test site of the male were hardened light brown coloured scab and scab cracking. Additional signs of dermal irritation noted in the female were haemorrhage of dermal capillaries, hardened light brown coloured scab, small areas of pale green coloured dermal necrosis scattered around the edges of the test site, blanching of the skin and hardened dark brown coloured scab, approximately 10 mm x 20 mm in size, surrounded by loss of skin elasticity and light brown discolouration of the epidermis. Adverse dermal reactions prevented accurate evaluation of erythema and oedema at both test sites six and seven days after dosing. The reactions noted in the male were considered to be indicative of dermal corrosion.
Any other information on results incl. tables
Due to severe/corrosive dermal reactions no further animals were treated with the test item.
Table 1 Individual Clinical Observations and Mortality Data
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Initiation of Exposure (Hours) |
Effects Noted After Initiation of Exposure (Days) |
|||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||
2000 |
1-0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
H |
HPDh |
HPDhEX* |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
H |
HPLDh |
HPLDhEX* |
0 = No signs of systemic toxicity
H = Hunched posture
P = Pilo-erection
L = Lethargy
Dh = Dehydration
E = Pallor of the extremities
X* = Animal killed for humane reasons due to the approach of the moderate severity limit set by the UK Home Office
Table 2 Individual Dermal Reactions
Dose Level mg/kg |
Animal Number and Sex |
Observation |
Effects Noted After Initiation of Exposure (Days) |
||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|||||||||||||
2000 |
1-0 Male |
Erythema |
0 |
1 |
1 |
1 |
1 |
?e |
?e |
||||||||||
Oedema |
0 |
0 |
0 |
0 |
0 |
?od |
?od |
||||||||||||
Other |
0 |
0 |
0 |
0 |
0 |
St |
SpSk |
||||||||||||
2-0 Female |
Erythema |
1 |
1 |
0 |
0 |
0 |
?e |
?e |
|||||||||||
Oedema |
0 |
0 |
0 |
0 |
0 |
?od |
?od |
||||||||||||
Other |
0 |
0 |
0 |
Hd |
Hd |
St |
NBlSt*LeBr |
0 = No reactions
Hd = Haemorrhage of dermal capillaries
St = Hardened dark brown black coloured scab
Sp = Hardened light brown coloured scab
Sk = Scab cracking
N = Small areas of pale green coloured dermal necrosis scattered around the edges of the test site
Bl = Blanching of the skin
St* = Hardened dark brown coloured scab, approximately 10 mm x 20 mm in size
Le = Loss of skin elasticity
Br = Light brown discolouration of the epidermis
?e = Adverse dermal reactions prevent accurate evaluation of erythema
?od = Adverse dermal reactions prevent accurate evaluation of oedema
Table 3 Individual Bodyweights and Weekly Bodyweight Changes
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
At Death |
Bodyweight Change (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
|||
2000 |
1-0 Male |
223 |
- |
- |
166 |
- |
- |
2-0 Female |
211 |
- |
- |
160 |
- |
- |
- = Animal dead
Table 4 Individual Necropsy Findings
Dose Level mg/kg |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Male |
Humanely killed Day 7 |
Stomach: raised limiting ridge Sub-cutaneous at the site of application: scattered dermal haemorrhage |
2-0 Female |
Humanely killed Day 7 |
Stomach: raised limiting ridge Sub-cutaneous at the site of application: scattered dermal haemorrhage |
Applicant's summary and conclusion
- Interpretation of results:
- other: inconclusive
- Remarks:
- Criteria used for interpretation of results: not specified
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat could not be determined, as due to severe/corrosive dermal reactions, the animals were killed for humane reasons at 7 days.
- Executive summary:
The study was performed to assess the acute dermal toxicity of the test item in the Wistar strain rat. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987)
Method B3 Acute Toxicity (Dermal) of Commission Regulation (EC) No. 440/2008
Initially, two animals (one male and one female) were given a single, 24-hour, semi-occluded dermal application of the undiluted test item to intact skin at a dose level of 2000 mg/kg bodyweight. Based on the results of the initial test, no further animals were treated. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Both animals were killed for humane reasons seven days after dosing, due to the approach of the moderate severity limit set by the UK Home Office.
Signs of systemic toxicity noted were hunched posture, pilo-erection, lethargy, dehydration and pallor of the extremities.
Signs of dermal irritation noted were well-defined erythema, haemorrhage of dermal capillaries, hardened light brown, dark brown or dark brown black coloured scab, scab cracking, blanching of the skin, loss of skin elasticity, light brown discolouration of the epidermis and small areas of pale green coloured dermal necrosis. The reactions noted in the male were considered to be indicative of dermal corrosion. Bodyweight loss was noted over the study period.
Raised limiting ridge of the stomach and scattered dermal haemorrhage at the sub cutaneous site of application were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat could not be determined, as due to severe/corrosive dermal reactions, the animals were killed for humane reasons at 7 days.
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