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EC number: 239-290-0 | CAS number: 15245-44-0
- 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:
- Nov 1992-April 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented and corresponded to the requirements of the recommended Annex V test guidelines
- Justification for data waiving:
- other:
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The experiments are being conducted in order to comply with Department of Transportation regulations on the transport of hazardous substances (49 CFR, section 173.132).
- Deviations:
- no
- Principles of method if other than guideline:
- All work was done in compliance with an approved, study-specific protocol.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- [phthalato(2-)]dioxotrilead
- EC Number:
- 273-688-5
- EC Name:
- [phthalato(2-)]dioxotrilead
- Cas Number:
- 69011-06-9
- IUPAC Name:
- 69011-06-9
- Details on test material:
- - Name of test material (as cited in study report): Dibasic lead Phthalate
- Molecular formula (if other than submission substance): Pb (CH6H4) (CO2)2.2PbO
- Molecular weight (if other than submission substance): 817.6
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: White powder, odorless
- Analytical purity: 100%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components: 78.5% Lead oxide
- Isomers composition:
- Purity test date:
- Lot/batch No.: Lot no. 999; Sample No. 4255
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: Stable, but avoid temperatures in excess of 400 degrees F.
- Storage condition of test material: To be stored at room temperature
- Other: High temperatures or fire may produce lead oxide fume, vapor or dust
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: At initiation of dosing 6-8 weeks old
- Weight at study initiation: 150-250 gm weight range
- Fasting period before study:
- Housing: The animals were housed individually in stainless steel suspension cages
- Diet (e.g. ad libitum): Agway Prolab 3000 ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: Upon arrival at the laboratories the animals were housed separately from animals in the facility. The quarantine and laboratory acclimation period was one week in duration.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 69-74 degrees farenheit
- Humidity (%): 50-70%
- Air changes (per hr): Room air was filtered
- Photoperiod (hrs dark / hrs light): Lights were automatically cycled with 12 hours of light per day.
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sodium carboxymethylcellulose (NaCMC)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 0.25%
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED: 10ml/kg of body weight
DOSAGE PREPARATION (if unusual): Accurately weighed samples of dibasic lead phthalate were suspended in 0.25% sodium carboxymethylcellulose (Na CMC) solution at concentrations up to 200 mg/ml. The compound was added to one half the volume of Na CMC in a glass beaker and mixed with a glass rod to form a paste. The remaining Na CMC was added stirring and the resulting mixture was then sonicated for 5 minutes.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Range Finding Test- Animals (one male and one female) received oral doses of 250 mg/kg of dibasic lead phthalate. The animals were observed for 24 hours then a second pair of animals was dosed with 500 mg/kg. Animals were similarly observed for 24 hours prior to repeating the dosing/observation regimen with 1,000 mg/kg then 2,000 mg/kg. Individual body weights were recorded prior to the administration of the first dose then prior to the terminal sacrifice. - Doses:
- 2000 mg/kg of dibasic lead phthalate
- No. of animals per sex per dose:
- 3 male and 3 female rats
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights were recorded when the animals arrived in the laboratories, then daily for five consecutive days prior to the experiment and daily during the experiment. At the termination of the experiment the animals were sacrificed and subjected to gross necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Signs of chemically related toxicity, gastrointestinal examination
Results and discussion
- Preliminary study:
- Range Finding Test-The oral administration of doses of dibasic lead phthalate ranging from 250 to 2000 mg/kg to male and female rats produced neither lethality nor consistent grossly observable evidence of acute or delayed onset toxicity. The behaviors of dosed animals were indistinguishable from those of control animals. All animals receiving dibasic lead phthalate in the range finding test gained body weight during the observation period.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: Since there were no signs of systemic or local toxicity associated with the 2000 mg/kg dose, it can be concluded that the "Lowest Observable Effect Level" (LOEL) is also greater than 2000 mg/kg.
- Mortality:
- All animals survived to the scheduled termination of the experiment.
- Clinical signs:
- other: There were no grossly observable signs of chemically related toxicity.
- Gross pathology:
- The oral administration of 2000 mg/kg of dibasic lead phthalate to male and female rats produced no grossly observable evidence of toxicity. Gastric rugae were closely examined (in a blind fashion) during necropsy and there was no evidence of a treatment-related change. One male dosed with 2000 mg/kg exhibited the presence of a yellow fluid in the gastrointestinal tract.
- Other findings:
- - Organ weights:
- Histopathology:
- Potential target organs:
- Other observations: The behavior of dosed animals was indistinguishable from those of control animals.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information These results show that dibasic lead phthalate affords no acute toxicological hazard as defined by the Department of Transportation (Federal Register, 1990) and therefore requires no special consideration during transport. Criteria used for interpretation of results: other: US Department of Transportation (Federal Register, 1990)
- Conclusions:
- The results of this experiment lead to the conclusion that the acute LD50 value for dibasic lead phthalate in both male and female rats is greater than 2000 mg/kg. Further, since there were no signs of systemic or local toxicity associated with the 2000 mg/kg dose it can be concluded that the "Lowest Observable Effect Level" (LOEL) is also greater than 2000 mg/kg. These results show that dibasic lead phthalate affords no acute toxicological hazard as defined by the Department of Transportation (Federal Register, 1990) and therefore requires no special consideration during transport.
- Executive summary:
This acute, oral toxicity study was conducted to assess the toxicological potential of dibasic lead phthalate in adult male and female rats in order to insure compliance with Department of Transportation regulations covering the transport of poisonous materials. The test material was suspended in 0.25% sodium carboxymethylcellulose and administered in volume doses of 1 ml/kg to young adult male and female Sprague Dawley derived rats. During the range finding test, groups of two males and two females received 250, 500, 1000, or 2000 mg/kg doses of dibasic lead phthalate. Animals were observed for signs of systemic toxicity and after 14 days they were subjected to complete gross necropsy which included visual examination of the mucosal surface of the gastrointestinal tracts. During the estimation of the acute oral LD50 value, groups of three male and three female rats received oral doses of 2000 mg/kg of dibasic lead phthalate. Animals were weighed and observed daily for 14 days then they were sacrificed and subjected to complete necropsy.
There was no evidence of either local or systemic toxicological consequences associated with the oral administration of dibasic lead phthalate. Body weight gains of dosed animals were similar to those of concurrent controls and there were no gross pathological findings that could be attributed to the administration of dibasic lead phthalate. Therefore, the acute oral LD50 value of dibasic lead phthalate in male and female rats is greater than 2000 mg/kg and the Lowest Observable Effect Level (LOEL) is also greater than 2000 mg/kg.
It is concluded that dibasic lead phthalate affords no acute toxicological hazard as defined by the Department of Transportation and requires no special consideration during transport.
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