glutaraldehyde safety - summary (H)

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From:"Keith Ryan" <KPR@wpo.nerc.ac.uk> (by way of Marvin Hanna)
To:histonet@histosearch.com
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Hello all

Many thanks to all who responded on and off-line to my request for
information.  I hope I acknowledged each one individually.

My quest was to find the real reason for lowering the UK exposure
limit.  I won't summarise the replies but: (1) pulmonologists at one
hospital are thinking that long term, low level exposure to
formaldehyde and glutaraldehyde may cause idiopathic pulmonary
fibrosis, (2) I was told of a serious skin burn caused by a splash.

I have now heard from the UK Health & Safety Commission's Advisory
Committee on the Toxicity of Substances (ACTS).  I have copy from: HSE
Review 1997, published 1999, section C58 (consisting of 4 pages).
Quotes from this are below.

The official reason for lowering the exposure limit is that it has
not been possible to set a no-observed adverse effect level for
glutaraldehyde with regard to the induction of asthma.

Carcinogenicity is not supported by the available good-quality
evidence to date.
________________________________________

Glutaraldehyde must be labelled under the Chemicals (Hazard
Information and Packaging for supply) Regulations 1994 (CHIP) as
Toxic, Corrosive, Sensitising and Dangerous for the Environment.

Several thousand tonnes are imported into the UK each year.  It is
primarily used as a biocide and disinfectant in the health care,
off-shore, paper-making and agricultural sectors.

... it is estimated that a considerable number of (health care)
workers are intermittently exposed, given the widespread use in that
sector. Similarly, ....... for several hundred workers in the
manufacture of glutaraldehyde solutions.

...... available exposure data relates mainly to use in the health
care sector....... suggests that under normal operational conditions
short term exposures are generally less than 0.2 ppm.  This can be
exceeded during the cleaning of endoscopes ...... or the wiping of
surfaces.

HEALTH EFFECTS - ANIMAL STUDIES.
Glutaraldehyde is acutely toxic to rats by inhalation, oral and
dermal routes.  The principal effects are due to its irritant
properties.

Glutaraldehyde is clearly a skin sensitiser in rabbits, guinea pigs,
rats and mice.

Glutaraldehyde is clearly mutagenic in vitro, in bacterial and
mammalian cells. ............. No firm conclusions can be drawn from
the available evidence on chromosomal aberrations, but glutaraldehyde
clearly causes sister chromatid exchange (SCE) and unscheduled DNA
synthesis (UDS) in mammalian cells.

.......... However, the clearly negative results of recent,
good-quality bone marrow cytogenetics and peripheral blood
micronucleus tests, together with those of the liver UDS assay,
provide reassurance that the genotoxic effects shown in vitro are
unlikely to be expressed in vivo.

No reports of carcinogenicity studies of glutaraldehyde by the
inhalation or dermal routes of administration are currently available.
 A recent oral study provided no convincing evidence ... in rats .....
drinking water for up to two years.

No significant effects on reproduction were reported in a modern two
generation study ...........  There were no indications of significant
gonadal effects  in 13 weeks inhalation studies carried out in rats or
mice, or in a lethal assay in mice.

HUMAN DATA
Glutaraldehyde is irritant to to human skin at concentrations of
2-10%, but not 0.5%.  Higher concentrations have not been
investigated.

There is substantial evidence that glutaraldehyde is a skin
sensitiser in humans.  Concentrations as low as 0.13% have induced
allergic contact dermatitis.  The majority of cases have been reported
in health or funeral workers.

A fair body of evidence ............. indicates that glutaraldehyde
has the potential to cause occupational asthma.

........... several workplace studies with exposure data in which no
cases of asthma have been found among contemporary workers. .....
However, superimposed on these data are other reports of sensory
irritation and / or asthma in endoscopy nurses where the reported
levels of exposure overlap with those in the above studies.
................... From the data available, it has not been possible
to determine a NOAEL (no-observed adverse effect level) for the
induction of asthma.

No information is available in genotoxicity  in humans.

The only available mortality study is of limited value, but does not
provide any evidence that glutaraldehyde caused cancer or increased
mortality in glutaraldehyde production workers.

On the basis of the very limited information available, it does not
appear that glutaraldehyde causes reproductive toxicity in humans.

REFERENCE: Glutaraldehyde: Criteria document for an occupational
exposure limit EH/65/32. HSE Books ISBN 0 7176 1443 3.
_________________________________________________

Dr. Keith Ryan
Marine Biological Association of the UK
The Laboratory
Citadel Hill
Plymouth
Devon PL1 2PB
England

Tel. ++44 (0)1752 633249
Tel. ++44 (0)1752 633279
The 279 number has an answering machine

Fax ++44 (0)1752 633102

e-mail: kpr@wpo.nerc.ac.uk




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