Purified Talc

(BAN, rINN)
Synonyms: E553(b); Mastek; Powdered Talc; Purified French Chalk; Talc; Talco (esteatita); Talco purificado; Talcum; Talcum Purificatum; Talk; Talkas; Talkki; Talkum.
Cyrillic synonym: Очищенный Тальк.

💊 Chemical information

CAS — 14807-96-6.

Pharmacopoeias.

In Chin., Eur., Int., Jpn, US, and Viet.

Ph. Eur. 6.2

(Talc; Purified Talc BP 2008). A powdered, selected, natural, hydrated, magnesium silicate. Pure talc has the formula Mg 3 Si 4 O 10 (OH) 2 ; it may contain varying amounts of associated minerals. A light, homogeneous, white or almost white powder, greasy to the touch (non-abrasive). It should be free from asbestos. Practically insoluble in water, in alcohol, and in dilute solutions of acids and of alkali hydroxides.

USP 31

(Talc). A powdered, selected, natural, hydrated magnesium silicate. It may contain variable amounts of associated minerals among which chlorites (hydrated aluminium and magnesium silicates), magnesite (magnesium carbonate), calcite (calcium carbonate), and dolomite (calcium and magnesium carbonate) are predominant. A very fine, white or greyish-white, unctuous crystalline powder, which adheres readily to the skin, and is free from grittiness.

💊 Adverse Effects and Precautions

Contamination of wounds or body cavities with talc is liable to cause granulomas and it should not be used for dusting surgical gloves. Inhalation of talc can cause respiratory irritation; prolonged exposure may produce pneumoconiosis. The most common adverse effects of talc pleurodesis are chest pain and fever. More serious complications that can occur include empyema, pneumonitis, dyspnoea, hypoxaemia, pulmonary oedema, pulmonary embolism, acute respiratory distress syndrome, and respiratory failure. Cardiovascular complications such as tachycardia, myocardial infarction, hypotension, hypovolaemia, and asystolic arrest have also occurred in patients treated with talc pleurodesis. However, the role of talc in serious complications is not always clear as the underlying condition of patients with malignant pleural effusion and the procedure itself are likely to be contributing factors. Talc is liable to be heavily contaminated with bacteria, including Clostridium tetani, Cl. welchii, and Bacillus anthracis. When used in dusting powders or to treat pneumothorax and pleural effusions, it should be sterilised.

Abuse.

Adverse pulmonary and ocular effects have been associated with the presence of talc in abused substances. It may be present as an excipient in oral medications that are crushed then dissolved and injected, or it may have been purposely added as a filler to the abused substance. When injected intravenously, the insoluble talc particles can embolise in small pulmonary vessels causing occlusion and pulmonary hypertension. The particles may also then migrate into the pulmonary interstitium, inducing a foreign-body reaction and fibrosis. Irregular nodules can develop in the lungs, which may coalesce to form conglomerate masses.1 Talc retinopathy is described as deposits of crystalline talc embolising in the retinal microvasculature after intravenous injection.2-4 Pulmonary granulomas5 and talc retinopathy6 have also been described after nasal inhalation of abused substances containing talc.
1. Gotway MB, et al. Thoracic complications of illicit drug use: an organ system approach. Radiographics 2002; 22 (suppl): S119–S135
2. Martidis A, et al. Talc embolism: a static retinopathy. Am J Ophthalmol 1997; 124: 841–3
3. Fraser-Bell S, Capon M. Talc retinopathy. Clin Experiment Ophthalmol 2002; 30: 432–3
4. El-Jabali F, Cohen S. Talc retinopathy. N Engl J Med 2006; 354: e11. Available at: http://content.nejm.org/cgi/reprint/354/12/ e11.pdf (accessed 27/09/07
5. Johnson DC, et al. Foreign body pulmonary granulomas in an abuser of nasally inhaled drugs. Pediatrics 1991; 88: 159–61
6. Kumar RL, et al. Crystalline retinopathy from nasal ingestion of methamphetamine. Retina 2006; 26: 823–4.

Carcinogenicity.

A review by a working group of the International Agency for Research on Cancer concluded that there was inadequate evidence to confirm whether purified talc was carcinogenic in humans but there was sufficient evidence to confirm that talc containing asbestiform fibres was carcinogenic to man.1There have been suggestions of a link between the use of talc and ovarian cancer2 but although a case-controlled study suggested an approximate doubling of the risk among women after perineal use of talc the working group noted that information was not available on the asbestos content of the talcs.1 Further case-controlled studies have also reported a positive association between perineal talc use and ovarian cancer, although others have found no association. A large prospective cohort study3 that included 78 630 women found little support for an association overall, although from an analysis by histological subtype there appeared to be a modest increase in the risk for serous invasive cancer. A meta-analysis4 that included this cohort study and 15 case-controlled studies did find a positive association between any exposure to perineal talc and the risk of developing ovarian cancer (relative risk 1.33; 95% confidence interval 1.16 to 1.45). However, the authors highlighted possible selection bias and confounding factors that may have resulted in a false-positive association. There was a lack of a clear dose-response relationship, different results for hospital-based and population-based patients, and the timing of exposure to talc in relation to cancer diagnosis was not always known. An analysis of epidemiological studies in workers involved in milling the raw mineral (not containing asbestos-like fibres) found no evidence of an increased risk of lung cancer; there was some evidence of an excess among miners or other industrial workers exposed to talc, but these populations were also exposed to other potential carcinogens.5
1. IARC/WHO. Silica and some silicates. IARC monographs on the evaluation of the carcinogenic risk of chemicals to humans volume 42 1987. Available at: http://monographs.iarc.fr/ENG/ Monographs/vol42/volume42.pdf (accessed 27/09/07
2. Longo DL, Young RC. Cosmetic talc and ovarian cancer. Lancet 1979; ii: 349–51
3. Gertig DM, et al. Prospective study of talc use and ovarian cancer. J Natl Cancer Inst 2000; 92: 249–52
4. Huncharek M, et al. Perineal application of cosmetic talc and risk of invasive epithelial ovarian cancer: a meta-analysis of 11,933 subjects from sixteen observational studies. Anticancer Res 2003; 23: 1955–60
5. Wild P. Lung cancer risk and talc not containing asbestiform fibres: a review of the epidemiological evidence. Occup Environ Med 2006; 63: 4–9.

Effects on the lungs.

Acute respiratory failure has occurred in patients treated with talc pleurodesis, given either as a slurry or by insufflation. In a series of 338 patients treated with insufflation, 4 developed acute respiratory failure and 3 of them died.1 In another series2 of 78 patients who underwent 89 procedures using slurry or insufflation, respiratory complications developed after 24 procedures including acute respiratory distress syndrome after 8 procedures in 7 patients of whom 1 died. In a debate based on these and other reports, including some series in which there were no respiratory complications, it was argued3that although the risk of acute respiratory distress is small the use of talc for pleurodesis should be abandoned in favour of other drugs such as tetracyclines or bleomycin, or mechanical abrasion of the pleura. The opposing view4 was that there were many possible causes for acute respiratory distress in these cases, and that talc was still the best pleurodesis agent available. In a prospective randomised comparison in patients with malignant pleural effusion,5 respiratory complications were more common with insufflation than slurry. The authors noted that the role of talc in causing acute respiratory complications of pleurodesis is unclear and further study is needed. It has been suggested that acute respiratory distress syndrome after talc pleurodesis may be related to the talc particle size. There were no such reactions in a study6 of 558 patients given largeparticle (mean size 24.5 μm) talc insufflation, and the authors suggested that reported cases appeared to occur in countries where talc products contained higher concentrations of small particles (less than 5 μm). For other effects on the lungs, see under Abuse, above and Infant Skin Care, below.
1. Campos JRM, et al. Respiratory failure due to insufflated talc. Lancet 1997; 349: 251–2
2. Rehse DH, et al. Respiratory failure following talc pleurodesis. Am J Surg 1999; 177: 437–40
3. Light RW. Talc should not be used for pleurodesis. Am J Respir Crit Care Med 2000; 162: 2024–6
4. Sahn SA. Talc should be used for pleurodesis. Am J Respir Crit Care Med 2000; 162: 2023–4
5. Dresler CM, et al. Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion. Chest 2005; 127: 909–15
6. Janssen JP, et al. Safety of pleurodesis with talc poudrage in malignant pleural effusion: a prospective cohort study. Lancet 2007; 369: 1535–9.

Infant skin care.

The routine use of non-medicated powders in the skin care of infants can be hazardous and their use should be discouraged.1,2 Talc acts as a pulmonary irritant and inhalation of baby-powders by infants has caused severe respiratory difficulties and several deaths have been reported. Careful respiratory monitoring is indicated in children suspected of inhaling talcum powder as the onset of symptoms may be delayed for several hours.1 There have also been reports of umbilical granulomas resulting from contamination of umbilical stumps with talcum powder used for skin care.2
1. Pairaudeau PW, et al. Inhalation of baby powder: an unappreciated hazard. BMJ 1991; 302: 1200–1
2. Sparrow SA, Hallam LA. Talc granulomas. BMJ 1991; 303: 58.

💊 Uses and Administration

Purified talc is used in massage and as a dusting powder to allay irritation and prevent chafing. It is usually mixed with starch, to increase absorption of moisture, and zinc oxide. Talc used in dusting powders should be sterilised. Purified talc is used as a lubricant and diluent in making tablets and capsules and to clarify liquids. Sterile purified talc is also used as a sclerosant after drainage of malignant pleural effusion and for recurrent spontaneous pneumothorax. It is administered into the pleural cavity as a slurry or by aerosol (insufflation). Doses of about 5 g may be used for pleural effusion and 2 g for pneumothorax.

Pleural effusions.

Talc is used as a sclerosant to achieve pleurodesis in the management of benign and malignant pleural effusions and recurrent spontaneous pneumothorax.1-4 It is generally given into the pleural space as a slurry via intercostal tube, or by insufflation (talc poudrage) at thoracoscopy. Most reports have used a dose of 2 to 5 g, but doses have ranged from 1 to 10 g. A study5 of talc pleurodesis in patients with malignant pleural effusion found both slurry and insufflation to be equally effective. The most common adverse effects associated with this use of talc are pain and fever. Other reported effects have included local infection and empyema, cardiovascular complications, and respiratory failure (see also Effects on the Lungs, above).
1. Kennedy L, Sahn SA. Talc pleurodesis for the treatment of pneumothorax and pleural effusion. Chest 1994; 106: 1215–22
2. de Campos JRM, et al. Thoracoscopy talc poudrage: a 15 year experience. Chest 2001; 119: 801–6
3. Antunes G, et al. British Thoracic Society. BTS guidelines for the management of malignant pleural effusions. Thorax 2003; 58 (suppl 2): ii29–ii38. Also available at: http://www.brit-thoracic.org.uk/Portals/0/Clinical%20Information/ Pleural%20Disease/Guidelines/PleuralDiseaseMalignantPE.pdf (accessed 28/07/08
4. Henry M, et al. British Thoracic Society. BTS guidelines for the management of spontaneous pneumothorax. Thorax 2003; 58 (suppl 2): ii39–ii52. Also available at: http://www.brit-thoracic.org.uk/Portals/0/Clinical%20Information/ Pleural%20Disease/Guidelines/PleuralDiseaseSpontaneous.pdf (accessed 28/07/08
5. Dresler CM, et al. Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion. Chest 2005; 127: 909–15.

💊 Preparations

BP 2008: Talc Dusting Powder.

Proprietary Preparations

USA: Sclerosol. Multi-ingredient: Arg.: Dr Selby; Austral.: ZSC; Austria: Cutimix; Herposicc; Prurimix; Rombay; Belg.: Aloplastine; Braz.: Pasta d’Agua†; Pomaderme; Talco Alivio†; Chile: Hansaplast Footcare; Cz.: Cutimix†; Prurimix†; Fr.: Aloplastine; Eryange†; Poudre du Marcheur; Indon.: Minos; Yanthi Baby & Bath Powder; Israel: Pedisol; Malaysia: Rowarolan; Mex.: Hipoglos; NZ: Grans Remedy; Lamisil Odor Eze; Philipp.: Johnson’s Baby Double Protection Powder; Pol.: Pedipur; Port.: Cuidaderma; Spain: Amniolina; Ictiomen; Pomada Infantil Vera†; Switz.: Tanno-Hermal; Turk.: Cinkos; USA: Columbia Antiseptic Powder; Venez.: Hipoglos con Hidrocortisona†; Hipoglos†.
Published January 19, 2019.