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.
|