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EC number: 268-500-3 | CAS number: 68109-88-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 July 1982 to 04 August 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- EC Number:
- 268-500-3
- EC Name:
- Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Cas Number:
- 68109-88-6
- Molecular formula:
- C28H48O8Sn
- IUPAC Name:
- ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate
- Test material form:
- other: liquid that tends to crystallise
- Details on test material:
- - Appearance: clear liquid, tends to crystallise
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAIF(SPF), F3-crosses of RII 1/Tif x RII2/Tif
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 180 - 196 g
- Housing: Groups of 5, in cages with standardised soft wood bedding
- Diet (e.g. ad libitum): Rat food, ad libitum
- Water (e.g. ad libitum): ad libitum
- Fasting period before study: Animals were fasted overnight before dosing.
ENVIRONMENTAL CONDITIONS
- Kept under conventional laboratory conditions.
- Air conditioned.
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): Approximately 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bodyweight
- Doses:
- 1000, 2500 and 5000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females per dose
- Control animals:
- no
- Details on study design:
- OBSERVATIONS
- Period: 14 days or until all symptoms have disappeared.
- Mortality: daily am and pm on working days.
- Clinical Signs: daily.
- Bodyweight: on days 1, 7, 14 and at death.
- Necropsies: spontaneously dying animals were subjected to gross necropsy as soon as possible and survivors at the termination of the study. - Statistics:
- - Bodyweights: Group means and standard deviations were calculated.
- The LD50 including the 95 % confidence limit was calculated by the logit method (Berkson, 1944).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 793 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 648 - 6 646
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 821 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 178 - 25 811
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 821 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 178 - 25 811
- Mortality:
- 4 males and 4 females died at the 5000 mg/kg dose level. All deaths occurred within 5 days post exposure. See Table 1 for details.
- Clinical signs:
- other: The following clinical signs were observed: sedation, dyspnoea, exophthalmus, ruffled fur and curved body position. Surviving animals recovered within 14 days. See Table 2 for details.
- Gross pathology:
- No treatment-related gross organ changes were observed.
Any other information on results incl. tables
Table 1 Mortality Data
Dose (mg/kg) |
Totals |
Time of Death |
|||||||||
In the Group |
Deaths |
Hours After Treatment |
Days After Treatment |
||||||||
Number |
% |
1 |
3 |
5 |
24 |
2 |
3 |
4 |
5 |
||
Males |
|
||||||||||
1000 |
5 |
0 |
|
|
|
|
|
|
|
|
|
2500 |
5 |
0 |
|
|
|
|
|
|
|
|
|
5000 |
5 |
4 |
80 |
|
|
|
|
|
1 |
1 |
2 |
Females |
|
||||||||||
1000 |
5 |
0 |
|
|
|
|
|
|
|
|
|
2500 |
5 |
0 |
|
|
|
|
|
|
|
|
|
5000 |
5 |
4 |
80 |
|
|
|
1 |
|
2 |
1 |
|
Table 2 Clinical Signs
Observations |
Hours After Treatment |
Days After Treatment |
||||||||||||||
1 |
3 |
5 |
24 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
|
1000 mg/kg |
|
|||||||||||||||
Sedation |
|
|
X |
X |
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea |
XX |
XX |
XX |
XX |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
Exophthalmus |
|
|
|
X |
X |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
Ruffled fur |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
X |
X |
X |
X |
X |
Curved body |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
|
2500 mg/kg |
|
|||||||||||||||
Sedation |
|
X |
X |
X |
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea |
XX |
XX |
XX |
XX |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
Exophthalmus |
|
|
|
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
|
|
Ruffled fur |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
X |
X |
X |
X |
X |
Curved body |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
|
|
|
|
5000 mg/kg |
|
|||||||||||||||
Sedation |
X |
XX |
XX |
XX |
XX |
XX |
XX |
X |
X |
|
|
|
|
|
|
|
Dyspnoea |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
X |
X |
X |
X |
X |
X |
X |
X |
|
Exophthalmus |
|
|
|
|
|
|
|
X |
X |
X |
X |
X |
X |
X |
|
|
Ruffled fur |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
XX |
X |
Curved body |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
X |
|
|
Table 3 Bodyweights (g)
Dose (mg/kg) |
Males |
Females |
||||
Day 1 |
Day 7 |
Day 14 |
Day 1 |
Day 7 |
Day 14 |
|
1000 |
183 (4.1) |
237 (6.3) |
272 (6.0) |
184 (3.0) |
211 (7.1) |
226 (12.6) |
2500 |
185 (5.0) |
199 (18.9) |
246 (7.9) |
188 (5.4) |
196 (24.3) |
222 (11.1) |
5000 |
185 (6.5) |
- |
- |
184 (4.1) |
- |
- |
( ) = Standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria.
- Conclusions:
- The LD50 of the test material was determined to be 3793 mg/kg in the male and female rat. The test material requires no classification in accordance with EU criteria.
- Executive summary:
The acute oral toxicity of the test material was evaluated in a study conducted in accordance with the standardised guideline OECD 401.
Albino rats were administered a single oral dose of the test material by gavage at dose levels of 1000, 2500 and 5000 mg/kg bodyweight. Five animals per sex were dosed at each concentration and the animals observed for 14 days.
Four male and 4 female animals died within 5 days at the 5000 mg/kg bodyweight dose level. No further mortality was seen. Clinical signs included sedation, dyspnoea, exophthalmus, ruffled fur and exhibiting a curved body position. All survivors had recovered by the end of the observation period and no gross abnormalities were observed at necropsy.
Under the conditions of this study, the LD50 was determined to be 3793 mg/kg bodyweight and the test material requires no classification in accordance with EU criteria.
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