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EC number: 245-152-0 | CAS number: 22673-19-4
- 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 16 June 2010 and 30 June 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:
- Dibutylbis(pentane-2,4-dionato-O,O')tin
- EC Number:
- 245-152-0
- EC Name:
- Dibutylbis(pentane-2,4-dionato-O,O')tin
- Cas Number:
- 22673-19-4
- Molecular formula:
- C18H32O4Sn
- IUPAC Name:
- Tin, dibutylbis(2,4-pentanedionato-kO2,kO4)-,
- Details on test material:
- Sponsor's identification: CAS No 22673-19-4
Description: amber coloured liquid
Lot number: TIB KAT 226 VP10-055
Date received: 01 March 2010
Expiry date: 01 March 2011
Storage conditions: room temperature in the dark over silica gel
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
- 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: animals weighed at least 200g
- Housing: The animals were housed in suspended solid floor polypropylene cages furnished with woodflakes. The animals were housed individually throughout the test period.
- 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.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- 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.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.66 ml/kg - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 1
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 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 fourteen days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: At the end of the study the animals were killed by cervical dislocation. 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 material 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 material was made.
Results and discussion
- Preliminary study:
- After consideration of the skin reactions produced in the first two animals, no additional animals were treated.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths. See Table 1.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy. See Table 4.
- Other findings:
- Dermal Reactions
Individual dermal reactions are given in Table 2.
Signs of dermal irritation noted were well-defined erythema, very slight oedema, loss of skin elasticity, small superficial scattered scabs, hardened dark brown/black coloured scab, scab cracking, scab lifting at edges to reveal dried blood, scab lifting to reveal glossy skin or further deep scabbing, scab undulating, dried blood, thickening of the skin and scar tissue. Adverse dermal reactions prevented accurate evaluation of erythema and oedema at both test sites during the test. The reactions were considered to be indicative of dermal corrosion.
The dermal reactions noted at both test sites were indicative of dermal corrosion.
Any other information on results incl. tables
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 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = No signs of systemic toxicity
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 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
2000 |
1-0 Male |
Erythema |
2 |
2 |
2 |
2 |
2 |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
Oedema |
1 |
1 |
1 |
1 |
1 |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
||
Other |
0 |
0 |
0 |
Ss |
SsLe |
SbStSw |
StSwSkBd |
StSwSkBd |
SkBdSgSw |
StSwSkSgBd |
StSwSgSk |
StSwSgSk |
StSgSk |
StSgSdThSc |
||
2-0 Female |
Erythema |
2 |
2 |
2 |
2 |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
?e |
|
Oedema |
1 |
1 |
1 |
1 |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
?od |
||
Other |
0 |
Le |
Le |
LeSs |
StSk |
StSkSg |
StSkSg |
SsSkSg |
SsSkSg |
StSgSs |
StSgSs |
StSgSs |
StSgSs |
SsSgSbThSc |
0 = No reactions
Le = Loss of skin elasticity
Ss = Small superficial scattered scabs
St = Hardened dark brown/black coloured scab
Sk = Scab cracking
Sb = Scab lifting at edges to reveal dried blood
Sd = Scab lifting to reveal further deep scabbing
Sg = Scab lifting to reveal glossy skin
Sw = Scab undulating
Bd = Dried blood
Th = Thickening of the skin
Sc = Scar tissue
?e = Adverse reactions prevent accurate evaluation of erythema
?od = Adverse 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 |
Bodyweight Change (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Male |
313 |
293 |
312 |
-20 |
19 |
2-0 Female |
201 |
198 |
211 |
-3 |
13 |
Table 4 Individual Necropsy Findings
Dose Level mg/kg |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Male |
Killed Day 14 |
No abnormalities detected |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute dermal toxicity of the test material 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 Method.
Two animals (one male and one female) were given a single, 24 Hour, semi occluded dermal application of the undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths and no signs of systemic toxicity.
Signs of dermal irritation noted were well-defined erythema, very slight oedema, loss of skin elasticity, hardened dark brown/black coloured scab, small superficial scattered scabs, scab cracking, scab lifting at edges to reveal dried blood, further deep scabbing or glossy skin, scab undulating, dried blood, thickening of the skin and scar tissue. Adverse skin reactions prevented accurate evaluation of erythema and oedema at both test sites during the study. The reactions were considered to be indicative of dermal corrosion.
Both animals showed bodyweight loss during the first week but expected gain in bodyweight during the second week.
No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
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