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EC number: 238-877-9 | CAS number: 14807-96-6
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Pulmonary deposition, translocation and clearance of inhaled neutron-activated talc in hamsters.
- Author:
- Wehner AP, Wilderson CL, Cannon WC, Buschbom RL, and Tanner TM.
- Year:
- 1 977
- Bibliographic source:
- Fd Cosmet Toxicol. 1977;15:213-224.
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To determine the deposition, distribution, and clearance of talc, 44 female Syrian golden hamsters received a single 2-h nose-only exposure to a neutron-activated talc aerosol and sub-groups of 4 animals were then killed at 11 different intervals from 15 min to 132 days after exposure.
The talc tested was a commercial baby powder. Nine unexposed control animals were used; four were killed on the day the test animals were exposed and five were killed on the final day of the study. The aerosol exposure system had 7 tiers of exposure ports, and the talc aerosol was passed through a cyclone elutriator to remove particles that were larger than ~10 μm in diameter; the activity median aerodynamic diameter was 6.4-6.9 μm. The mean aerosol concentration was 40 and 75 μg/l at the 15-30 and 60-90 min sampling periods, respectively. In the presentation of the results, the γ-ray counts from the controls were expressed as μg talc equivalent, and the γ-ray counts of the exposed animals were not corrected for control values. - GLP compliance:
- no
Test material
- Reference substance name:
- Talc (Mg3H2(SiO3)4)
- EC Number:
- 238-877-9
- EC Name:
- Talc (Mg3H2(SiO3)4)
- Cas Number:
- 14807-96-6
- Molecular formula:
- H2Mg3O12Si4
- IUPAC Name:
- Talc (Mg3H2(SiO3)4)
- Test material form:
- solid
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- hamster, Syrian
- Strain:
- other: female Syrian golden hamsters
- Details on species / strain selection:
- 44 female Syrian golden hamsters
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- 44 female Syrian golden hamsters
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Photoperiod: 12 hours dark/light cycle
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Vehicle:
- other: neutron-activated talc aerosol
- Duration and frequency of treatment / exposure:
- a single 2-h nose-only exposure to a neutron-activated talc aerosol
Doses / concentrationsopen allclose all
- Dose / conc.:
- 40 mg/m³ air
- Dose / conc.:
- 75 mg/m³ air
- No. of animals per sex per dose / concentration:
- 44 female Syrian golden hamsters
- Control animals:
- yes
- no
- Positive control reference chemical:
- no data
- Details on study design:
- The talc tested was a commercial baby powder. Nine unexposed control animals were used; four were killed on the day the test animals were exposed and five were killed on the final day of the study. The aerosol exposure system had 7 tiers of exposure ports, and the talc aerosol was passed through a cyclone elutriator to remove particles that were larger than ~10 μm in diameter; the activity median aerodynamic diameter was 6.4-6.9 μm. The mean aerosol concentration was 40 and 75 μg/l at the 15-30 and 60-90 min sampling periods, respectively. In the presentation of the results, the γ-ray counts from the controls were expressed as μg talc equivalent, and the γ-ray counts of the exposed animals were not corrected for control values.
Variations among animals killed at the same time were attributed to variations in aerosol concentration at different tiers. The mean pulmonary talc content in the lungs of test animals at various time intervals was 33.08 (15 min after exposure), 24.08 (100 min), 42.70 (4 h), 18.75 (21 h), 21.30 (2 days), 21.03 (after 4 days), 13.85 (after 8 days), and 8.95μg (after 18 days); the mean for the day 0 control animals was 1.78 μg. The biological half-life of the talc deposited in the lungs was 7-10 days. At the time of termination of the final group, i.e. 132 days, there was no statistically significant difference in the talc burden of the lungs of test (3.70 μg) and control (2.30 μg) animals. The amount of talc in the liver, kidneys, and lungs was also determined; the only statistically significant differences compared to controls in any of these organs were found in the liver; there was a decrease at 4 h compared to day 0 controls, an increase at day 36 compared to both day 0 and day 132 controls, and an increase on day 68 compared to day 132 controls. - Details on dosing and sampling:
- The mean pulmonary talc content in the lungs of test animals at various time intervals was 33.08 (15 min after exposure), 24.08 (100 min), 42.70 (4 h), 18.75 (21 h), 21.30 (2 days), 21.03 (after 4 days), 13.85 (after 8 days), and 8.95μg (after 18 days); the mean for the day 0 control animals was 1.78 μg. The biological half-life of the talc deposited in the lungs was 7-10 days. At the time of termination of the final group, i.e. 132 days, there was no statistically significant difference in the talc burden of the lungs of test (3.70 μg) and control (2.30 μg) animals. The amount of talc in the liver, kidneys, and lungs was also determined; the only statistically significant differences compared to controls in any of these organs were found in the liver; there was a decrease at 4 h compared to day 0 controls, an increase at day 36 compared to both day 0 and day 132 controls, and an increase on day 68 compared to day 132 controls.
- Statistics:
- Analysis of the data using the Kruskal-Wallis test
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- In an inhalation study with hamsters, neutron-activated cosmetic talc was administered in concentrations of 40 to 75 mg/m3 for 2 hours. The purity was 95 mass percent. 20 to 80 µg corresponding to 6% to 8% of the amount inhaled were deposited in the alveolar region per animal. Clearance was absolutely complete after only 4 months. No transition to other organs, such as the liver, kidneys or ovaries, was observed
- Details on distribution in tissues:
- Analysis of the data using the Kruskal-Wallis test showed that there were no significant differences among the mean talc burden values for the liver, kidneys, and ovaries, including the control values, and that there was no significant trend, indicating there was no translocation of talc to these tissues.
- Details on excretion:
- no translocation from the respiratory tract to other tissues was found in this study, and the clearance of talc from the lungs was complete within 4 months after exposure.
Metabolite characterisation studies
- Metabolites identified:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: no bioaccumulation potential based on study results
In an inhalation study with hamsters, neutron-activated cosmetic talc was administered in concentrations of 40 to 75 mg/m3 for 2 hours. The purity was 95 mass percent. 20 to 80 µg corresponding to 6% to 8% of the amount inhaled were deposited in the alveolar region per animal. Clearance was absolutely complete after only 4 months. No transition to other organs, such as the liver, kidneys or ovaries, was observed - Executive summary:
To determine the deposition, distribution, and clearance of talc, 44 female Syrian golden hamsters received a single 2-h nose-only exposure to a neutron-activated talc aerosol and sub-groups of 4 animals were then killed at 11 different intervals from 15 min to 132 days after exposure.
The talc tested was a commercial baby powder. Nine unexposed control animals were used; four were killed on the day the test animals were exposed and five were killed on the final day of the study. The aerosol exposure system had 7 tiers of exposure ports, and the talc aerosol was passed through a cyclone elutriator to remove particles that were larger than ~10μm in diameter; the activity median aerodynamic diameter was 6.4-6.9μm. The mean aerosol concentration was 40 and 75μg/l at the 15-30 and 60-90 min sampling periods, respectively. In the presentation of the results, theγ-ray counts from the controls were expressed asμg talc equivalent, and theγ-ray counts of the exposed animals were not corrected for control values.
Variations among animals killed at the same time were attributed to variations in aerosol concentration at different tiers. The mean pulmonary talc content in the lungs of test animals at various time intervals was 33.08 (15 min after exposure), 24.08 (100 min), 42.70 (4 h), 18.75 (21 h), 21.30 (2 days), 21.03 (after 4 days), 13.85 (after 8 days), and 8.95μg (after 18 days); the mean for the day 0 control animals was 1.78μg. The biological half-life of the talc deposited in the lungs was 7-10 days. At the time of termination of the final group, i.e. 132 days, there was no statistically significant difference in the talc burden of the lungs of test (3.70μg) and control (2.30μg) animals. The amount of talc in the liver, kidneys, and lungs was also determined; the only statistically significant differences compared to controls in any of these organs were found in the liver; there was a decrease at 4 h compared to day 0 controls, an increase at day 36 compared to both day 0 and day 132 controls, and an increase on day 68 compared to day 132 controls.
Analysis of the data using the Kruskal-Wallis test showed that there were no significant differences among the mean talc burden values for the liver, kidneys, and ovaries, including the control values, and that there was no significant trend, indicating there was no translocation of talc to these tissues.
As noted, no translocation from the respiratory tract to other tissues was found in this study, and the clearance of talc from the lungs was complete within 4 months after exposure.
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