What is ToxRe?

ToxRe is an innovative and independent scientific risk management and liability exposure consultancy group. We are specialised in re-evaluating and re-interpreting available safety studies concerning (new) intermediates, chemicals, phamaceuticals, etc. and subsequently in re-assessing the potential product, occupational and/or environ-mental liability exposure as well as the sustainability and the investment quality of companies and/or manufacturers intending to produce and launch (new) chemical, pesticidal, biochemical, biotechnical, nutritional and/or pharmaceutical products.

ToxRe’s name
The name “ToxRe” grew out of practical day-to-day experience in the following fields:
* Re-evaluation of available toxicity studies,
* Re-interpretation of toxicological end-points,
* Regulatory affairs and/or support,
* Re-registrations (including REACH),
* Re-assessment of occupational and environmental safety issues,
* Re-assessment of potential liability exposures,
* Response by "trouble shooting",
* Re-insurance assistance.

ToxRe’s risk management experience
is drawn upon chemical and pharmaceutical companies and their investors seeking high quality scientific advice on the safety of their synthesizing operations, occupational and environmental safety and any subsequent potential liability exposure.

ToxRe’s reports
on the liability exposure and the sustainability of companies are strictly confidential and are written in a concise style using the language of the financial services industry.

ToxRe has direct links
* to international organisations active in the field of human toxicology and environ-mental protection (BIT, IARC, WHO, FAO, JECFA, JMPR, Codex Alimentarius Commission, etc.);
* international institutions active in the sustainability field (UNEP, OECD, etc.);
* international regulatory authorities (EPA, FDA, etc.);
* medium sized companies and multinationals seeking global regulatory approvals and liability re/insurance coverage for their new molecules;
* national and international bankers, investors and re/insurance companies favouring environmentally safe and sustainable industrial clients.

ToxRe’s consultancy services
aim to provide high-quality “second opinions” concerning the safety and tolerance aspects of (new) chemical substances, (new) pharmaceuticals and (new) chemical processes as well as the potential liability exposure of (start-up) chemical companies and related industries. Such high-quality information may help to ease the health claims burden and to improve the quality of human life and of environmental health (click here for a graphical animation).

Safety and liability concerns
As has been shown many times in the past, (new) biologically active chemical substances (and related synonyms or Brands®) may be a greater risk to human life and/or environmental health than originally estimated. A higher degree of hazard may represent a higher health risk to employee’s, end-users, consumers and to the environment. Such higher health risks might result in a potentially higher liability exposure for the manufacturer (and a higher financial risk to investors).

Growing interest in safety
Manufacturers and investors are becoming increasingly interested in obtaining a reliable profile of the liability exposure and sustainability of their prospective industrial clients and partners who are developing, synthesising, handling, launching and marketing new chemical, biochemical, biotechnical and pharmaceutical products.

Adverse consequences underestimated
Unfortunately, financial carriers still tend to underestimate the potential adverse effects of exposing humans and the environment to chemicals. Inevitably, financial carriers also tend to underestimate the potential liability exposure of multinational or smaller companies, as proven by the many chemical- and pharmaceutical products, hormones, agro-chemicals, pesticides, additives, etc. that have been criticised, banned and/or withdrawn from the market over recent years.

Some examples of liability from the past (*):

Thalidomide Sleeping tablet: Birth defects after intake by pregnant mothers.

Diethylstilboestrol (DES)

Development of infertile female offspring or vaginal cancers after intake by pregnant mothers (second generation defects)
TCDD

Contaminant: Skin acne and general adverse human health effects after accidental release in Seveso, Italy.

Methylisocyanate

 

Mass poisoning and death after accidental release and human inhalation exposure in Bhopal, India. Massive insurance claims ongoing up to day.
3 (N phenylamino) 1,2 propanediol Toxic Oil Syndrome, Spain. Serious health problems and death after consumption of olive oil probably contaminated by PAP.
Crude oil Pollution of Alaska's coastal region after accidental release by the Exxon Valdez oil tanker.
Organophosphorus and Mercury-based pesticides Pollution of the river Rhine in 1988 when a fire was estinguished and 15,000 m3 contaminated water found its way into the Rhine at a chemical complex near Basle, Switzerland.
Cyanides Pollution of the Hungarian Rivers Szamos, and Tisza by the accidental discharge of 100 thousand m3 cyanide-rich waste, following the rupture of a reservoir of a metal extraction factory located in the Baia Mare area in Romania, on January 30th, 2000.
Temafloxacin Anti-bacterial, withdrawn: haematotoxicity.
Alpidem Somnifer, withdrawn: hepatotoxic.
Flosequinan Vasodilator for the treatment of heart failure: increased risk of mortality.
Terfenadine Anti-allergic: cardiotoxic.
2,4,6-Trichloranisole (TCA) Contaminant: cork-taste in wine.
Troglitazone Anti-diabetic, withdrawn: hepatotoxic.
Mibefradil Anti-hypertensive, withdrawn: cardiotoxic as a consequence of drug-drug interaction.
Dexfenfluramin Anti-obesive drug often combined with phentermine (Fen-Phen): heart valve injury.
Sertindole Anti-schizophrenia, withdrawn: cardiotoxicity.

Grepafloxacine

Trovafloxacin

Anti-bacterial, withdrawn: cardiotoxicity.

Anti-bacterial, withdrawn: hepatotoxic.

Bromfenac

Rofecoxib, valdecoxib

Analgesic, withdrawn: hepatotoxicity.

Analgesics, withdrawn: serious cardiovascular risks; serious unpredictable skin reactions.

Cerivastatin Anti-lipid, withdrawn: muscle damage, rhabdomyolysis, nephrotoxic.
Acrylamide Spontaneous production of this carcinogen contaminant during frying and baking of certain starch food products.
Conjugated equine oestrogens Oral hormone replacement for menopausal women: breast cancer and cardiovascular injury events as reported by the Women’s Health Initiative.

(*) References available on request.

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