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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: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study.
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
- Specific details on test material used for the study:
- “Italian talc” (about92% talc, 3% chlorite, 1% carbonate minerals and 0.5–1% quartz)
Italian talc (grade 00000; ready milled; mean particle size, 25 μm;
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
Young healthy male and nulliparous, non pregnant, female rats [strain: Wistar Crl:WI] (Full-Barrier), were used in this study.
At the beginning of the study, the age of the animals was 8-9 weeks. The range of the body weight was:
Females: 144.32 to 216.48 g, (mean: 180.40 g, ± 20%= 36.08 g)
Males: 211.18 to 316.77 g, (mean: 263.98 g, ± 20%= 52.80 g).
ENVIRONMENTAL CONDITIONS
After an adequate acclimatisation period (at least five days), the animals were barrier maintained (full-barrier) in air conditioned rooms under the following conditions: temperature: 22 ± 3 °C, relative humidity: 55 ± 10%, artificial light, sequence being 12 hours light, 12 hours dark, air change: 10 x / hour, free access to Altromin 1324 maintenance diet, free access to tap water, sulphur acidified to a pH of approximately 2.8 (drinking water, municipal residue control, microbiol. controlled periodically), housed individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- In a feeding study in 16 male and 16 female Wistar rats, talc was added to the diet; this resulted in an amount taken up of 100 mg/day and animal. After feeding had been carried out for 101 days, the animals were observed until death and subsequently examined histopathologically. One of the animals treated with talc showed a leiomyosarcoma of the stomach. Sarcomas, which were however not associated with the talc treatment, were found in the uterus of two animals
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 101 days
- Frequency of treatment:
- 7 days per week
Doses / concentrations
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 16 male and 16 female Wistar rats
- Control animals:
- yes, plain diet
- Details on study design:
- In a feeding study in 16 male and 16 female Wistar rats, talc was added to the diet; this resulted in an amount taken up of 100 mg/day and animal. After feeding had been carried out for 101 days, the animals were observed until death and subsequently examined histopathologically. One of the animals treated with talc showed a leiomyosarcoma of the stomach. Sarcomas, which were however not associated with the talc treatment, were found in the uterus of two animals
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- General clinical observations were made twice a day except during weekend and holidays where observations were made only once, approximately at the same time each day and considering the peak period of anticipated effects after dosing
- Cage side observations checked in table were included.
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
WATER CONSUMPTION No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
NEUROBEHAVIOURAL EXAMINATION: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
ORGAN WEIGHT: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- No
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- One of the animals treated with talc showed a leiomyosarcoma of the stomach. Sarcomas, which were however not associated with the talc treatment, were found in the uterus of two animals
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No chronic pathological effect was associated with oral administration of Italian talc (92% pure; 100 mg per day on 101 days over 5 months) to rats
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
No chronic pathological effect was associated with oral administration of Italian talc (92% pure; 100 mg per day on 101 days over 5 months) to rats.
100 mg/day and animal: tumours in the stomach (1/16 animals with leiomyosarcoma) and in the uterus (2/16 animals with sarcomas, which were not attributed to treatment)
Applicant's summary and conclusion
- Conclusions:
- Under the condition of this study, for a period of101 days for male and female rats, the NOAEL of Talc In a feeding study was 100 mg/kg/day. No adverse effects were seen on general toxicity endpoints.
One of the animals treated with talc showed a leiomyosarcoma of the stomach. Sarcomas, which were however not associated with the talc treatment, were found in the uterus of two animals.
No chronic pathological effect was associated with oral administration of Italian talc (92% pure; 100 mg per day on 101 days over 5 months) to rats.
- Executive summary:
Groups of 16 male and 16 female Wistar-derived rats, 21–26 weeks of age, were fed 100 mg Italian talc (grade 00000; ready milled; mean particle size, 25 μm; containing 92% talc, 3% chlorite, 1% carbonate minerals and 0.5–1% quartz) per day per rat in the diet for 5 months (talc-containing diet was actually given for 101 days) and were then maintained on basal diet for life (average survival, 614 days). No differences in tumour incidence were noted between treated animals and eight male and eight female control animals fed basal diet throughout (average survival, 641 days)
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