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EC number: 219-976-6 | CAS number: 2589-57-3
- 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:
- 17.10.1985 - 31.10.1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- unknown
- Molecular formula:
- unknown
- IUPAC Name:
- unknown
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- received 12 September 1985
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Equal numbers of male and female CD rats of the Sprague-Dawley derived strain were obtained from Charles River U.K. Limited, Margate, Kent, England. They were in a weight range of 110 to 150 g prior to dosing (Day 1) in the main study and approximately four to six weeks of age. All the rats were acclimated to the experimental environment for a minimum period of 7 days prior to the start of the main study.
The rats were randomly allocated to cages within the treatment groups. They were housed in groups by sex in metal cages with wire mesh floors. A standard laboratory rodent diet (Labsure LAD 1) and water were provided ad libitum. The batch of diet used for the study was analysed for certain chemical and microbiological contaminants. Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
Results of routine chemical examination of water at source (Grafham Final Water) as conducted quarterly by the Anglian Water Authority, are made available to Huntingdon Research Centre.
The mean daily minimum and maximum temperatures of the animal room were 21 °C and 22 °C respectively and the mean daily relative humidity value was 55%. The rate of air exchange was maintained at approximately 15 air changes/hour. Lighting was controlled by means of a time switch to 12 hours artificial light in each 24 hour period.
Each animal was identified by cage number and ear punching.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Decomposition Product of V-601 (colourless liquid) was administered as supplied by the Sponsor at a volume not exceeding 3.8 ml/kg.
The stability and absorption of the test substance were not determined.
The appropriate dose volume of the test substance was administered to each rat using a syringe and plastic catheter. - Doses:
- 1000, 1600, 2500 and 4000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Observations:
Animals were observed soon after dosing; then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice per day. Clinical signs were recorded at each observation.
The animals on the preliminary and main studies were observed for 5 and 14 days respectively, after dosing.
The following were recorded on the main study:
Approximate time of death of individual rats.
The nature, severity, approximate time of onset and duration of each toxic sign.
Individual bodyweights of rats on Days 1 (day of dosing), 8 and 15 and at death.
Post mortem examination:
Surviving animals on the main study were killed on Day 15 by carbon dioxide asphyxiation. All animals that died during the study and those killed on Day 15 were subjected to a macroscopic post mortem examination which consisted of opening the abdominal, thoracic and cranial cavities. The macroscopic appearance of abnormal organs when present was recorded. - Statistics:
- The acute median lethal oral dose (LD50) to male and female was calculated using the method of:
Finney (1971) Probit Analysis (3rd Edition) Cambridge University Press.
Seperate LD50 values for males and females were estimated by undertaking probit analysis on the mortality data by fitting two parallel lines on the data (males only and females only) using the technique described by Finney (1978, Statistical Method in Biological Assay, 3rd Edition, Charles Griffin, London). A chi-squared test was carried out to check that the data did not contain any evidence for non-parallelism.
Results and discussion
- Preliminary study:
- The results of the preliminary study indicated that the acute median lethal oral dose of Decomposition Product of V-601 was between 1000 and 2500 mg/kg bodyweight.
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 369 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 941 - <= 2 986
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 567 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 948 - <= 3 574
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 181 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 627 - <= 2 960
- Mortality:
- Mortalities occured amongst rats dosed at 1600 mg/kg and above within 22 and 47 hours of dosing.
- Clinical signs:
- other: Signs of reaction to treatment observed shortly after dosing in all rats were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, decreased respiratory rate, pallor of the extremities and increased salivatio. These
- Gross pathology:
- Autopsy revealed slight pallor of the liver and kidneys among animals that died.
Terminal autopsy findings were normal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute median lethal oral doses (LD50) and their 95% confidence limits to rats of V-601 Decomposition Product were estimated to be:
Males and females combined: 2369 (1941 to 2986) mg/kg bodyweight
Males only: 2567 (1948 to 3574) mg/kg bodyweight
Females only: 2181 (1627 to 2960) mg/kg bodyweight - Executive summary:
The acute median lethal oral dose of Decomposition Product V-601 and its 95% confidence limits were estimated to be:
Males and females combined: 2369 (1941 to 2986) mg/kg bodyweight
The slope of the probit line was 6.9 with a standard error of 1.9 using log transformation of dose. The heterogeneity factor was not significant.
When probit analysis was carried out by fitting the parallel lines the values were:
Males only: 2567 (1948 to 3574) mg/kg bodyweight
Females only: 2181 (1627 to 2960) mg/kg bodyweight
The slope of the probit line was 7.1 with a standard error of 1.9 using log transformation of dose. The heterogeniety factor was not significant.
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