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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to the OECD testing guideline for acute dermal toxicity. The study was performed in compliance with 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:
- other: OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Principles of method if other than guideline:
- The study was performed to the OECD guideline 402 to determine the acute dermal toxicity of the substance.
- 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
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
- 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: animals weighed at least 200g
- Housing: The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet/water (e.g. ad libitum): 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 test. 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: acclimatisation period of 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.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.77 ml/kg (dose 2000 mg/kg bw) - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- TEST SITE
- % coverage: The calculated volume of test material, as received, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body surface area) using a graduated syringe.
- 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.
OBSERVATIONS
- Time after start of exposure: 24 hours
- 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 material on Day 0 and 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.
Results and discussion
In vivo
- Irritant / corrosive response data:
- Dermal Reactions
Individual dermal reactions are given in Table 2.
Signs of dermal irritation noted were 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. - Other effects:
- Mortality Data: 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 Observations: Signs of systemic toxicity noted were hunched posture, pilo-erection, lethargy, dehydration and pallor of the extremities.
Bodyweight: Bodyweight loss was noted over the study period.
Necropsy: Raised limiting ridge of the stomach and scattered dermal haemorrhage at the sub cutaneous site of application were noted at necropsy.
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:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Signs of dermal irritation noted were 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.
- 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.
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.
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