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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- chronic toxicity: inhalation
- 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:
- Animal experiments with talc.
- Author:
- Wagner JC, Berry G, Cooke TJ, Hill RJ, Pooley FD, Skidmore JW
- Year:
- 1 977
- Bibliographic source:
- in: Walton WH (Ed.) Inhaled particles IV, Pergamon Press, Oxford, 647–654
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- GLP compliance:
- not specified
- Limit test:
- 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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Two groups of 12 male and 12 female Wistar-derived rats, 6–8 weeks
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: mean particle size, 25 μm
- Details on inhalation exposure:
- Two groups of 12 male and 12 female Wistar-derived rats, 6–8 weeks of age, were exposed by inhalation to a mean respirable dust concentration of 10.8 mg/m3 Italian talc (grade 0000; ready milled; mean particle size, 25 μm in diameter; containing 92% talc, 3% chlorite, 1% carbonate minerals and 0.5–1% quartz) for 7.5 hours per day on 5 days a week for 6 or 12 months (cumulative exposures, 8200 and 16 400 mg/m3 × h, respectively).
Ten days after the end of each exposure period, six rats per group were killed; 12 rats per group died and two rats per group were unaccounted for; the remaining four rats per group were killed 1 year after the end of the exposure period. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- periods of 3, 6 and 12 months.
- Frequency of treatment:
- Exposure times were 7.5 hours per day and 5 days per week.
Doses / concentrations
- Dose / conc.:
- 10.8 mg/m³ air
- No. of animals per sex per dose:
- 12 male and 12 female Wistar rats
- Control animals:
- yes
- Details on study design:
- Two groups of 12 male and 12 female Wistar-derived rats, 6–8 weeks of age, were exposed by inhalation to a mean respirable dust concentration of 10.8 mg/m3 Italian talc (grade 0000; ready milled; mean particle size, 25 μm in diameter; containing 92% talc, 3% chlorite, 1% carbonate minerals and 0.5–1% quartz) for 7.5 hours per day on 5 days a week for 6 or 12 months (cumulative exposures, 8200 and 16 400 mg/m3 × h, respectively).
Ten days after the end of each exposure period, six rats per group were killed; 12 rats per group died and two rats per group were unaccounted for; the remaining four rats per group were killed 1 year after the end of the exposure period. - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- animals (6/cage) were exposed to talc dust; SFA chrysotile controls were treated similarly
at each time frame; untreated controls were used; some animals were killed 10 days or 1
yr after final exposure, and the remainder lived until natural death
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Minimal fibrosis was observed. Talc exposure led to distinct fibrosis that was comparable with that after exposure to chrysotile in the parallel group. A lung adenoma was detected in one of 24 animals treated with talc
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 10.8 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: increased mortality (50%; 6 and 12 months), fibrosis as the exposure period progressed, 1/24 animals with lung adenoma
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Wistar rats were treated with “Italian talc” (about 92% talc, 0.5–1% quartz, “asbestos-free”) in a respirable dust fraction of 10.8 mg talc/m3 for periods of 3, 6 and 12 months. Exposure times were 7.5 hours per day and 5 days per week. High mortality in the two groups with 6- and 12-month periods of treatment was striking; 50% of the animals died during treatment in both groups. Talc exposure led to distinct fibrosis that was comparable with that after exposure to chrysotile in the parallel group. A lung adenoma was detected in one of 24 animals treated with talc
Applicant's summary and conclusion
- Conclusions:
- Wistar rats were treated with “Italian talc” (about 92% talc, 0.5–1% quartz, “asbestos-free”) in a respirable dust fraction of 10.8 mg talc/m3 for periods of 3, 6 and 12 months. Exposure times were 7.5 hours per day and 5 days per week. High mortality in the two groups with 6- and 12-month periods of treatment was striking; 50% of the animals died during treatment in both groups. Talc exposure led to distinct fibrosis that was comparable with that after exposure to chrysotile in the parallel group. A lung adenoma was detected in one of 24 animals treated with talc
- Executive summary:
In rats exposed by inhalation to 10.8 mg/m3 Italian talc (grade 00000; ready milled; mean particle size, 25 µm) for 3 months, minimal fibrosis was observed, the degree of which did not change during the observation period after exposure. Animals that were exposed for 1 year had minimal to slight fibrosis, the degree of which had increased to moderate within 1 year after cessation of exposure.
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