Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.16 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEC
- Value:
- 10.8 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.16 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEC
- Value:
- 10.8 mg/m³
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
- Value:
- 18 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEC
- Value:
- 18 mg/m³
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43.2 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEL
- Value:
- 216 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.54 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- other: NOAEL
- Justification:
- Dermal exposure:
There are no dermal studies available.
For dermal exposure we taken that:
-the average weight of rabbits is 2.4kg
-the dose is applied over an area which is approximately 10% of the total body surface=0.24 kg
corrected dermal NOAEL= oral NOAEL
5000 mg/kg bw/day x 0.24 kg =
NOAELrat = 1200 mg/kg bw/day
The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be
NOAELin mg/cm2 = ((dose in mg/kg bw)x (average animal weight in kg)) / Treated surface in cm2)
NOAELtest* 2.4/127= NOAELmodified
NOAELmodified =1200mg/kg*2.4 kg/127cm2=22.68 mg/cm2
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Conclusion
In studies in rats, mice, guinea-pigs and hamsters that used radioactive tracer techniques, no intestinal absorption or translocation of ingested talc to the liver or kidneys was detected (Wehner et al., 1977; Phillips et al., 1978).
No translocation of talc into the ovaries was detected after single or multiple intravaginal applications of talc to rabbits (Phillips et al., 1978) or monkeys (Wehner et al., 1985, 1986).
There are no indications that orally or inhalation administered talc is absorbed by rats, mice, hamsters or guinea pigs.
Talc administered into the pleural space of rats is distributed systemically throughout the body.
Talc elimination of radioactivity was determined in the urine and faeces and thereforeTalc (Mg3H2(SiO3)4) has no bioaccumulation potential.
Exposure to talc does not lead to any relevant dermal absorption. Therefore designation with an “H” is not necessary.
There is no information that would justify a designation of talc with “Sa” or “Sh” (for substances which cause sensitization).
Nor can a classification of talc into a category for germ cell mutagens be justified on the basis of the available data.
There was no evidence of carcinogenic activity in male or female B6C3F1 mice.
A bioassay using rats was performed by the NTP to determine the carcinogenic potential of non-asbestiform, cosmetic-grade micro-talc following exposure by inhalation, and it was concluded there was some evidence of carcinogenic activity in male F344/rats, and clear evidence of carcinogenic activity in female F344/N rats. The rats were exposed to 6 mg/m3 (MMAD 2.7 ± 1.9 μm) or 18 mg/m3 (MMAD 3.2 ± 1.9 μm) talc for 6 h/day, 5 days/wk, for 113wks (males) or 122 wks (females).Concerns have been raised about this study, including concerns that micronized talc having a significantly smaller particle size distribution than cosmetic talc was used, aerosol concentrations were not properly controlled, proper procedures for dose selection were not followed resulting in the MTD being exceeded at both concentrations tested, and particle overload in the lungs was most likely the cause of the adverse effects reported.
The talc used in the this study was a commercially available microtalc whose dimensions of < 10 µm were distinctly finer than the cosmetic powder normally used.
Therefore, the study is not conclusive with regard to a possible carcinogenicity of large talc platelets or talc fibres.
There are conclusive but not suffcient data for the classification of substance Talc (Mg3H2(SiO3)4) with regard to carcinogenicity.
Not classifiable as a human carcinogen. /Talc containing no asbestos fibers/ [American Conference of Governmental Industrial Hygienists TLVs and BEIs. Threshold Limit Values for Chemical Substances and Physical Agents and Biological Exposure Indices.,, 2008, p. 54
It is concluded that talc not containing asbestos or asbestiform fibres is safe in the present practices of use.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.08 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEC
- Value:
- 10.8 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.08 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEC
- Value:
- 10.8 mg/m³
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
- Value:
- 18 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEC
- Value:
- 18 mg/m³
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.6 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 216 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.27 mg/cm²
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- other: NOAEL
- Justification:
- Dermal exposure:
There are no dermal studies available.
For dermal exposure we taken that:
-the average weight of rabbits is 2.4kg
-the dose is applied over an area which is approximately 10% of the total body surface=0.24 kg
corrected dermal NOAEL= oral NOAEL
5000 mg/kg bw/day x 0.24 kg =
NOAELrat = 1200 mg/kg bw/day
The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be
NOAELin mg/cm2 = ((dose in mg/kg bw)x (average animal weight in kg)) / Treated surface in cm2)
NOAELtest* 2.4/127= NOAELmodified
NOAELmodified =1200mg/kg*2.4 kg/127cm2=22.68 mg/cm2
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 160 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 600 mg/kg bw/day
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 160 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 600 mg/kg bw/day
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Talc (Mg3H2(SiO3)4)
General population
Humans differ in sensitivity due to a number of biological factors (such as age, gender, genetic composition and nutritional status). The intraspecies variation in humans is greater than in the more homogeneous experimental animal population
The data from animal studies are the starting point for risk characterisation.The default assumption in general is that humans are more sensitive than experimental animals.The traditional default AF (Assessment factor) suggested for interspecies extrapolation is 5 for workers and 10 for general population should be applied to the concentration/dose descriptor.
A lower default factor is generally suggested for the worker population, because the very young and very old are not part of this population.
To cover the intra-species variation, the default AF (Assessment factor) of 10 for general population was applied to the concentration/dose descriptor (NOAEL or NOAEC).
There are no dermal studies available.
For dermal exposure we taken that:
-the average weight of rabbits is 2.4kg
-the dose is applied over an area which is approximately 10% of the total body surface=0.24 kg
corrected dermal NOAEL= oral NOAEL
5000 mg/kg bw/day x 0.24 kg =
NOAELrat = 1200 mg/kg bw/day
The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be
NOAELin mg/cm2 = ((dose in mg/kg bw)x (average animal weight in kg)) / Treated surface in cm2)
NOAELtest* 2.4/127= NOAELmodified
NOAELmodified =1200mg/kg*2.4 kg/127cm2=22.68 mg/cm2
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.