Talc (Mg3H2(SiO3)4)

Endpoint summary

Description of key information

Skin irritation

Talc by virtue of the fact that it is a desiccant and abrasive could cause some drying of the skin by frequent and prolonged exposure to the product. Occasionally, very slight erythema has been reported; such effects were rapidly reversible. Talc is not considered a skin irritant. From occupational physicians, case reports for the working environment are available describing dryness or degenerative eczema of the skin in workers with chronic contact. These reactions may be avoided by skin care. On this basis this end point is waived and skin irritation / corrosivity classification of Talc deemed to be non-irritant .

 

Eye irritation

Talc (Mg3H2(SiO3)4) powder (dust) is not expected to exhibit chemically induced eye irritation. Talc was not irritating to the eyes of rabbits in one ocular irritation study which is briefly summarized in the IUCLID dataset on talc (European Commission. IUCLID Dataset. Substance ID: 14807-96-6 (Talc).2002) However, as nuisance dust as with any foreign particulate matter entering the eye, transient corneal abrasions can occur when Talc dust comes in direct contact with the eye during administration. On this basis, this end point is waived. It is not considered as being scientifically justified that animal testing should be carried out just to prove that Talc (Mg3H2(SiO3)4) dust is only classed as a particulate irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Remarks:

Data waiving based on inherent physico-chemical substance properties and ubiquitous nature of this compound.

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Remarks:

Data waiving based on inherent physico-chemical substance properties and ubiquitous nature of this compound.

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation

Talc by virtue of the fact that it is a desiccant and abrasive could cause some drying of the skin by frequent and prolonged exposure to the product. Occasionally, very slight erythema has been reported; such effects were rapidly reversible. Talc is not considered a skin irritant. From occupational physicians, case reports for the working environment are available describing dryness or degenerative eczema of the skin in workers with chronic contact. These reactions may be avoided by skin care. On this basis this end point is waived and skin irritation / corrosivity classification of Talc deemed to be non-irritant .

 

Eye irritation

Talc (Mg3H2(SiO3)4) powder (dust) is not expected to exhibit chemically induced eye irritation. Talc was not irritating to the eyes of rabbits in one ocular irritation study which is briefly summarized in the IUCLID dataset on talc (European Commission. IUCLID Dataset. Substance ID: 14807-96-6 (Talc).2002) However, as nuisance dust as with any foreign particulate matter entering the eye, transient corneal abrasions can occur when Talc dust comes in direct contact with the eye during administration. On this basis, this end point is waived. It is not considered as being scientifically justified that animal testing should be carried out just to prove that Talc (Mg3H2(SiO3)4) dust is only classed as a particulate irritant.

Justification for classification or non-classification

 Based on the hazard assessment of Talc (Mg3H2(SiO3)4), in section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99) and according to the criteria described in Directive 67/548 and in the CLP Regulation:

 

Directive 67/548

Skin Corrosivity C R35 Causes severe burns R34 Causes burns Skin Irritation Xi R38 Irritating to skin R43 May cause sensitization by skin contact Eye Irritation (Ocular Lesions) Xi R36 Irritating to eyes R37 irritating to respiratory system R41 Risk of serious damage to eyes

CLP

Skin Corrosivity H314 Skin Corr 1A Causes severe skin burns and eye damage H314 Skin Corr 1B Causes severe skin burns and eye damage Skin Irritation H315 Skin Irrit. 2 Causes skin irritation H317 Skin Sens. 1 May cause an allergic skin reaction Eye Irritation (Ocular Lesions) Xi H319 Eye Irrit. 2 Causes serious eye irritation H318 Eye Dam. 1 Causes serious eye damage H335 STOT SE 3 May cause respiratory irritation

 

  

It is concluded that the substanceTalc (Mg3H2(SiO3)4)does not meet the criteria to be classified for human health hazards for Skin Irritation Eye Irritation and Respiratory irritation