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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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