Result card

  • SAF8: What kind of environmental risks are there when using uPA/PAI-1, Oncotype DX, or MammaPrint®?

What kind of environmental risks are there when using uPA/PAI-1, Oncotype DX, or MammaPrint®?

Authors: Iris Pasternack, Emilio Chiarolla, Narine Sahakyan, Leonor Varela

Internal reviewers: Pseudo100 Pseudo100, Pseudo163 Pseudo163, Pseudo169 Pseudo169, Pseudo219 Pseudo219, Pseudo90 Pseudo90, Pseudo94 Pseudo94

The search results for {SAF7} were used as the basis for this section. IP performed additional searches in PubMed and Google (10 March 2012) using the search terms, environment, ground water, endocrine disruptor, developmental toxin, reproductive toxin and cholinesterase inhibitor, combined with formaldehyde. No pertinent results were identified.

Further information was searched from EU Chemical agencies web page and the REACH (Registration, Evaluation, Authorisation and Restriction of Chemical Substances) web page. Starting in the late nineties new horizontal chemicals legislation was developed, and in 2007, REACH came into force. REACH’s primary aim is “to ensure a high level of protection of human health and the environment”. In the coming decade, REACH will place the burden of proof on industry, which must collect or generate the data necessary to ensure the safe use of chemicals. This data will be publicly available through the central database held at the European Chemicals Agency and will help to close the current information gap on chemicals. REACH also provides rules for phasing out and substitution of the most dangerous chemicals.

Since little was found in the above-mentioned sources, IP screened several MSDS for information on the ecotoxicity of formaldehyde.

T = Any procedure using formaldehyde

I = NA

C = NA

O = Environmental hazards

Formaldehyde 10%:

  • ecotoxicity: not available
  • BOD5 and COD: not available
  • biodegradation: possibly hazardous short term degradation products are not likely; however, long-term degradation products may arise
  • toxicity of the products of biodegradation:  they are less toxic than the product itself


Formaldehyde 4 %:

  • ecotoxicity: 96 h LC50 134 mg/litre rainbow trout; bacterial toxicity threshold (Pseudomonas putina) 14 mg/litre
  • biodegradation: biodegradable in water; degradation half-life in daylight 3 h
  • bio-accumulation: not bio-accumulative


Regarding toxicity to the aquatic environment, the following guidance is given on the disposal of formaldehyde waste. Place formaldehyde waste in a chemically compatible container with a sealed lid and label clearly. Complete a hazardous waste tag and call EH&S (486 – 3613). All biological materials preserved in formaldehyde must also be disposed of in this manner, not in medical waste containers. Drain disposal of dilute aqueous solutions containing formaldehyde is permitted to the limit of 100 g of solute per laboratory per day (for example, 1 litre of 10%formalin, or 10 litres of 1% formalin). This limit applies only as long as no other hazardous chemical is present in the solution.


Pasternack I et al. Result Card SAF8 In: Pasternack I et al. Safety In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (, Italy ; 2013. [cited 7 February 2023]. Available from: