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EC number: 260-829-0 | CAS number: 57583-35-4
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-type study, conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Remarks:
- none that affected the results of the study
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
- EC Number:
- 260-829-0
- EC Name:
- 2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
- Cas Number:
- 57583-35-4
- Molecular formula:
- C22H44O4S2Sn
- IUPAC Name:
- 2-ethylhexyl 2-{[({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)dimethylstannyl]sulfanyl}acetate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Western Oregon Rabbit Company (Philomath, OR).
- Age at study initiation: 11 to 12 weeks
- Weight at study initiation: 2.25 to 2.78 kg for males and 2.32 to 2.81 kg for females.
- Fasting period before study: Recorded in raw data.
- Housing: The animals were housed individually in stainless steel cages suspended above noncontact bedding pans containing Sani-Chips hardwood bedding (P.J. Murphy Forest Products, Montville, NJ).
- Diet (e.g. ad libitum): Rabbits received a daily ration of Purina Certified High-Fiber Rabbit Chow Type 5325 (Richmond, IN)
- Water: ad libitum. All rabbits had free access to purified (filtered, deionized, and UV-treated) tap water via automatic watering:
- Acclimation period: 7 day quarantine period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19- 21
- Humidity (%): 36 – 67%
- Air changes (per hr): 10 air changes per hour with no recirculation
- Photoperiod (hrs dark / hrs light): 12 – hour on and 12 hour off
IN-LIFE DATES: From: March 25, 1993 To: April 8, 1993
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Two days before treatment, 10 male and 10 female rabbits were randomly selected from a healthy stock population and tentatively assigned to the study. The fur was clipped free from the dorsal area of the trunk of the selected rabbits by the use of electric clippers (Oster, Milwaukee, WI) with a size 40 blade. One day before treatment, the clipping was repeated. Care was taken to avoid abrading the skin, and only animals with healthy, intact skin were selected. Extra animals from the same shipment were available as substitutes for any animal assigned to the study that had unacceptable skin.
- % coverage: The test substance was applied uniformly within a 12 X 14 cm (168-cm-2) area of clipped intact skin.
- Type of wrap if used: Elastikon tape (Johnson & Johnson Products, Inc. New Brunswick, NJ).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The application sites were washed with a few milliliters (exact amount was not measured) of 1% (v/v) aqueous solution of Ivory® Liquid Hand Soap (Lot No. 2202 K 103; Proctor & Gamble, Inc., Cincinnati, OH). The soap was removed from the application sites by rinsing under a stream of running lukewarm tap water. The animals were then blotted dry with paper towels and returned to their respective cages.
- Time after start of exposure: 24-hour exposure period.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.89 ml/kg
- Concentration (if solution): Dose level of 1.05 g/kg
- Constant volume or concentration used: No, Use of the density measured by SRI, the volume dose was calculated.
- For solids, paste formed: NA, test material was liquid
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.89 ml/kg of saline (0.9% Sodium Chloride
- Concentration (if solution): 0.9%
- Lot/batch no.: Lot No. G869024, Baxter Health Care Corp., Deerfield, IL).
- Purity: 0.9% Sodium Chloride - Duration of exposure:
- 24 hours
- Doses:
- 1050 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations done at 0.00 hr to 1:11 hr; 1:45 to 2:56 hr; 2:25 to 3:36 hr; and 3:55 to 5:06 hr. Body weights were recorded on Day 0 (before dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No deaths, or test substance-related systemic effects were observed over the 14-day observation period. After removal of the screen and patches, the applications sites of 9 of the ten rabbits had a slight oily film; after washing and rinsing, one of 10 rabbits had no visible residue, and 9 of 10 had “no appreciable film” visible. Of those nine animals, three required a second rinse. The only observation of an effect other than skin irritation was a single observation of “hyperactivity’ in one treated female on Day 9. Because this effect was observed in only one animal, and the effect occurred relatively late in the study, the effect is judged to be incidental and not related to treatment with the test substance. All male and female rabbits had varying degrees of skin irritation. Males and females in both the treated and control groups showed transient irritation for the “non-irritating” tape at the perimeter of the application site. Males and females in the treated group showed additional irritation responses, such as thickened skin and chapped and flaky skin within the application site beginning as early as Day 2; all animals had recovered by Day 12. Because the contact period was 24 hr (compared to 4 hr for a dermal irritation assessment; e.g. 40 CFR 798.4470), these observations should not be used to evaluate the primary irritation potential of the test substance. - Statistics:
- Other than the calculation of the mean and standard deviations for the body weights, no statistical evaluations were conducted.
Results and discussion
- Preliminary study:
- Before animal studies were initiated, preliminary work was conducted to verify that the test substance coudl be washed from the surface with a 1% aqueous solution of Ivory (R) Lilquid Hand Soap. Samples of polypropylene screen were placed in aliquots of the test substance for 25 hr at room temperature, and were found to increase their weight by less than 3%. These preliminary data indicated that the screen would be compatible with the test substance and that the proposed method of washing the apploication sites after the 24-hr contact period would be effective.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 050 mg/kg bw
- Mortality:
- No deaths were observed over the 14-day observation period.
- Clinical signs:
- other: There were no treatment-related systemic clinical signs. The only observation of an effect other than skin irritation was a single observation of “hyperactivity” in one treated female on Day 9. Because this effect was observed in only one animal, and th
- Gross pathology:
- Necropsy revealed a slightly rough outer surface of the spleen of one treated male. The observation is judged to be incidental and to have no obvious relationship to treatment with the test substance.
- Other findings:
- Skin effects in the rabbits included the following observations: Irritation around the perimeter of the application site, redness, thickened skin, chapped, flaky skin, and edema.
Applicant's summary and conclusion
- Interpretation of results:
- other: coudl not be determined as the result is an inequality
- Conclusions:
- Based on the lack of observed mortality, the 14-day acute dermal LD50 of the test substance was reported as >1050 mg/kg for both sexes.
- Executive summary:
The acute dermal toxicity of the test substance was assessed by applying the liquid test substance within a 12 x 14 cm are of clipped intact skin of five male and five female New Zealand White rabbits at 1050 mg/kg body weight. The application site was covered with a 4 -ply 15 x 15 cm gauze patch held in place by nonirritating tape and polypropylene screen for 24 hours, after which the patch and the screen were removed. The application sites were washed with a dilute soap solution, rinsed with water, then blotted dry. A control group of five males and five females was treated with 0.89 mL/kg of saline and were handled in the same way as the animals that received the test substance. No deaths, or test substance related systemic effects were observed over the 14 -day observation period. The only systemic clinical sign was a single observation of hyperactivity in one treated female on Day 9. Because this effect was observed in only one animal, and the effect occurred relatively late in the study, the effect is judged to be incidental and not related to treatment with the test substance. All male and female rabbits had varying degrees of skin irritation. Males and females in both the treated group showed additional irritation responses such as thickened skin, edema, and chapped and flaky skin beginning as early as Day 2; all animals had recovered by Day 12. Because the contact period was 24 hr (compared to 4 hr for a dermal irritation assessment), these observations should not be used to evaluate the primary irritation potential of the test substance. There were no apparent body weight effects. Necropsy revealed no treatment related effects. Under the conditions of this study, the acute dermal LD50 in male and female rabbits was greater than 1050 mg/kg.
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