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EC number: 247-666-0 | CAS number: 26401-97-8
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 April 1984 to 04 May 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act): Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals
- Version / remarks:
- Office of Pesticide Programs, U.S. Environmental Protection Agency, Office of Pesticides and Toxic Substances, October, 1982; Section 81-1, Acute Oral Toxicity Study
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA (Toxic Substances Control Act): Health Effects Test Guidelines; Office of Toxic Substances; Office of Pesticides and Toxic Substances; United States Environmental Protection Agency
- Version / remarks:
- August 1982, Acute Exposure, Oral Toxicity.
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Thermolite 831 Stabilizer Octyltin Compound KARFY-511K
- IUPAC Name:
- Thermolite 831 Stabilizer Octyltin Compound KARFY-511K
- Details on test material:
- Test Material: Thermolite 831
Label Information: Thermolite 831 Stabilizer Octyltin Compound KARFY-511K
Description: Oily liquid
Date of Receipt: March 16, 1984
Received from: M&T Chemicals, Inc.
Storage: Room temperature (dark)
Density: 1.087 g/ml
Constituent 1
- Specific details on test material used for the study:
- - Density: 1.087 g/mL
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- CDR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 12 weeks
- Weight at study initiation: males: 236 to 275 g, females: 219 to 244 g
- Fasting period before study: Animals were fasted overnight (for approximately 18 hours) prior to treatment.
- Housing: Group-housed (six/cage) during equilibration. Individually housed during study, in suspended, stainless steel cages with wire mesh bottoms
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature: 67 to 76 °F
- Humidity: 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 600, 800, 1200, 1700 and 2500 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21 days
- Frequency of observations and weighing: viability checks were performed twice daily. Observations of pharmacologic and toxicological signs were performed approximately 1, 2, and 4 hours after dosing and daily thereafter for twenty-one days. Body weights were measured pre-fast and on days 7, 14 and 21.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 040 - <= 2 560
- Mortality:
- At 600 mg/kg 1 animal died, at 800 mg/kg 3 animals died, at 1200 mg/kg 2 animals died, at 1700 mg/kg 6 animals dies and at 2500 mg/kg 5 animals died. Table 1 shows mortalities during the study.
- Clinical signs:
- other: Several abnormalities were seen on the day of dosing and for several days thereafter. Signs seen in most or all groups included ataxia, hypo activity, red or clear oral, nasal or ocular discharge, wet rales, urinary and/or faecal staining, soft stool, unt
- Gross pathology:
- Post-mortem examinations of animals found dead revealed a variety of changes, primarily in the lungs (discolouration), adrenals (reddened), gastrointestinal tract (stomach and intestinal walls - discoloured, containing red or black fluid) and testes (found in body cavity). These changes appeared to represent post-mortem autolysis, ante mortem stress and/or an irritant or corrosive effect of the test material on the gastrointestinal mucosa. One female in the 800 mg/kg group had red fluid in the urinary bladder. Changes seen in animals killed after 21 days were generally similar to those seen in control animals killed by carbon dioxide inhalation, or were considered to represent normal physiological variation.
Any other information on results incl. tables
Table 1: Mortalities during the study
Dose level (mg/kg) |
Mortality |
|||
Male |
Female |
Total |
Time of death |
|
600 |
1/5 |
0/5 |
1/10 |
Day 4 |
800 |
0/5 |
3/5 |
3/10 |
Days 2 to 5 |
1200 |
0/5 |
2/5 |
2/10 |
Days 2 to 3 |
1700 |
2/5 |
4/5 |
6/10 |
Days 2 to 4 |
2500 |
1/5 |
4/5 |
5/10 |
Days 2 to 7 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Acute oral (Category 4) in accordance with EU criteria
- Conclusions:
- Under the conditions of this study the acute oral LD50 of the test material is 1800 mg/kg with 95 % confidence interval of 1040 to 2560 mg/kg.
- Executive summary:
The acute oral toxicity of the test material was investigated in accordance with FIFRA and TSCA guidelines using male and female Sprague-Dawley derived rats.
Five animals per sex were dosed at the following concentrations: 600, 800, 1200, 1700 and 2500 mg/kg and then observed for 21 days. All animals were subjected to gross post-mortem examinations when they died during the study or when the study finished.
At 600 mg/kg 1 animal died, at 800 mg/kg 3 animals died, at 1200 mg/kg 2 animals died, at 1700 mg/kg 6 animals died and at 2500 mg/kg 5 animals died.
Signs seen in most or all groups included ataxia, hypo activity, red or clear oral, nasal or ocular discharge, wet rales, urinary and/or faecal staining, soft stool, unthrifty coat, hypopnea, hypothermia, food consumption decrease, emaciation and partially closed eyes. By Day 7 the incidence of abnormalities had subsided in animals dosed at the 600, 800, 1200 and 1700 mg/kg levels, although one animal in the 800 mg/kg dose group exhibited an unthrifty coat, emaciation, hypo activity and decreased food consumption for most of the post-dose period. Some survivors at the 2500 mg/kg level exhibited unthrifty coats, alopecia, abdominal griping, emaciation, hypo activity and food consumption decrease for much of the post-dose period. Most animals were free of significant abnormalities by study termination (Day 21), however. Animals that died exhibited substantial ante mortem weight losses, and several surviving animals exhibited weight losses at Day 7. However, all survivors gained weight between Days 7 and 21.
Post-mortem examinations of animals found dead revealed a variety of changes, primarily in the lungs (discolouration), adrenals (reddened), gastrointestinal tract (stomach and intestinal walls - discoloured, containing red or black fluid) and testes (found in body cavity).
Under the conditions of this study the acute oral LD50 of the test material is 1800 mg/kg with 95 % confidence interval of 1040 to 2560 mg/kg.
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