Last update Nov. 7, 2023

Benzalkonium Chloride

Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

Benzalkonium chloride is a quaternary ammonium antiseptic and disinfectant used to clean the skin, mucous membranes (oral, vaginal) and wounds, in seborrheic dermatitis, as a spermicide, and as a preservative in medicines, as a disinfectant of surgical material and in cleaning products. Topical application in solutions or creams: cutaneous, oral and vaginal.

Benzalkonium chloride was not detected in the plasma or milk of women using tampons containing this disinfectant. (Johnson 1989)

Minimal levels, probably of no clinical significance, have been detected in milk samples from women using household disinfectants containing benzalkonium chloride (more if used frequently and in aerosol form). No problems in infants were described. (Zheng 2022)

Systemic absorption through the skin is negligible or below the limit of quantitation. (DeLeo 2021)

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With regard to occupational risks for breastfeeding mothers (INSHT 2022, UN 2011, EC Regulation 2008), there are only two Hazard phrases (old R-phrases, currently H-phrases for hazard) or precaution statements (P-phrases) that should appear on the product’s safety data sheet:

  • H362 (R64): "May cause harm to breast fed children"
  • P263: "Avoid contact during pregnancy/while nursing”

Three other H-phrases that should be considered during breastfeeding are related to the carcinogenic, mutagenic or cumulative strength of a product:

  • H350 (ant.R45 y R49): «May cause cancer»
  • H351 (ant. R40): “Suspected of causing cancer"
  • H370 (ant. R39): «Causes damage to organs».
  • H371 (ant. R68): "May cause damage to organs”
  • H372 (ant R48): «Causes damage to organs through prolonged or repeated exposure».
  • H373 (ant. R33):" May cause damage to organs through prolonged or repeated exposure”

Based on the absence of these phrases in the safety data sheet of this product (cita1 aaaa, cita2 aaa..), it would not be necessary to remove a breastfeeding mother from her job, and it would be enough for the company to meet legal requirements regarding the maximum levels of environmental exposure and for the employee to follow recommended rules of caution (gloves, hand and face washing, change of clothes, etc.)

Spermicides containing benzalkonium chloride are considered compatible with breastfeeding. (Serfaty 2015).

Do not apply to the breast or clean well before breastfeeding; avoid ingestion by the infant, as it is very caustic and can cause severe digestive lesions. (Civan 2016) 

Collectively, data indicate that there are no safety concerns regarding use of products that contain Benzalkonium Chloride under the current concentration restrictions, even when utilized at maximal permitted levels. (Choi 2018)

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With regard to occupational risks for breastfeeding mothers (INSHT 2022, UN 2011, EC Regulation 2008), there are only two Hazard phrases (old R-phrases, currently H-phrases for hazard) or precaution statements (P-phrases) that should appear on the product’s safety data sheet:

  • H362 (R64): "May cause harm to breast fed children"
  • P263: "Avoid contact during pregnancy/while nursing”

Three other H-phrases that should be considered during breastfeeding are related to the carcinogenic, mutagenic or cumulative strength of a product:

  • H350 (ant.R45 y R49): «May cause cancer»
  • H351 (ant. R40): “Suspected of causing cancer"
  • H370 (ant. R39): «Causes damage to organs».
  • H371 (ant. R68): "May cause damage to organs”
  • H372 (ant R48): «Causes damage to organs through prolonged or repeated exposure».
  • H373 (ant. R33):" May cause damage to organs through prolonged or repeated exposure”

Based on the absence of these phrases in the safety data sheet of this product (Quimipur 2019), it would not be necessary to remove a breastfeeding mother from her job, and it would be enough for the company to meet legal requirements regarding the maximum levels of environmental exposure and for the employee to follow recommended rules of caution (gloves, hand and face washing, change of clothes, etc.)

Alternatives

  • Chlorhexidine ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Benzalkonium Chloride in other languages or writings:

Tradenames

Main tradenames from several countries containing Benzalkonium Chloride in its composition:

References

  1. Zheng G, Schreder E, Sathyanarayana S, Salamova A. The first detection of quaternary ammonium compounds in breast milk: Implications for early-life exposure. J Expo Sci Environ Epidemiol. 2022 Sep;32(5):682-688. Abstract Full text (link to original source)
  2. DeLeo PC, Tu V, Fuls J. Systemic absorption of benzalkonium chloride after maximal use of a consumer antiseptic wash product. Regul Toxicol Pharmacol. 2021 Aug;124:104978. Abstract Full text (link to original source)
  3. Quimipur. Cloruro de Benzalconio. Ficha de seguridad toxicológica. 2019 Full text (in our servers)
  4. Choi SM, Roh TH, Lim DS, Kacew S, Kim HS, Lee BM. Risk assessment of benzalkonium chloride in cosmetic products. J Toxicol Environ Health B Crit Rev. 2018;21(1):8-23. Abstract
  5. Civan HA, Gulcu D, Erkan T. Corrosive Esophagitis with Benzalkonium Chloride in a Two Days Old Neonate. Pediatr Gastroenterol Hepatol Nutr. 2016 Sep;19(3):207-209. Epub 2016 Sep 29. Abstract Full text (link to original source)
  6. Serfaty D. Contraception des femmes allaitantes : place des spermicides. [Contraception in breastfeeding women: place for spermicides]. J Gynecol Obstet Biol Reprod (Paris). 2015 Jan;44(1):18-27. Abstract
  7. Johnson W Jr. Final report on the safety assessment of benzalkonium chloride. J Am Coll Toxicol. 1989;8:589–625. Full text (link to original source) Full text (in our servers)

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