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Cidex (Glutaraldehyde) Disinfectant withdrawn over safety fears

BBC News 22jan02

The product is used to disinfect fragile surgical instruments

A commonly used disinfectant in the NHS is to be withdrawn after staff reported skin problems and asthma. Cidex, made by Johnson and Johnson, is to be taken off the UK market on May 1 this year.

Cidex is one of the brand names for Glutaraldehyde, a toxic colourless, oily liquid also available as an aqueous solution. Glutaraldehyde is harmful if inhaled or swallowed and irritating to eyes and respiratory tract. It can also cause severe damage to the skin and eyes.

Exposure limits

Cidex is used by most NHS hospitals to kill viruses on surgical instruments which are too fragile to be heat-treated.

It is used in decontamination units throughout the country and is the most commonly used disinfectant in endoscopy departments.

But the UK's Health and Safety Executive (HSE) raised concerns over the use of the disinfectant after the reports of health problems from staff exposed to it during the decontamination process.

In 1999, the HSE published guidance limiting how much Glutaraldehyde workers should be exposed to.

The chemical hit the headlines 14 months ago when thousands of people were called for medical tests after possible exposure to a faulty batch.

'Good for nurses'

Jon Richards, of the health workers union Unison said the move was good news for nurses' health.

He said: "Too many nurses have been lost to the NHS and many valuable years of experience wasted, because of exposure to glutaraldehyde.

"There is no `safe' level of exposure and no place for it in hospitals today.

"It is well known that it can irritate the skin, eyes, throat and lungs. I am delighted to hear that it will be withdrawn from hospitals."

He said Unison had campaigned for years to get the substance banned.

"We have taken many claims for compensation for nurses who have had their careers needlessly cut short and their lives blighted by asthma and other health problems, through working with glutaraldehyde in operating theatres."


National Toxicology Program  TR 490

GLUTARALDEHYDE
CAS No. 111-30-8
Chemical Formula: C5H8O2 Molecular Weight: 100.13
Synonyms: 1,3-Diformylpropane; glutaral; glutardialdehyde; glutaric dialdehyde; 1,5-pentanedial; 1,5-pentanedione; potentiated acid glutaraldehyde
Trade names: Cidex; Sonacide

ABSTRACT

Glutaraldehyde is used in large volume in a variety of industries as a disinfectant, preservative, fixative and cross-linking agent, and as a chemical intermediate in the synthesis of pharmaceuticals and pesticides. Glutaraldehyde was nominated by the National Cancer Institute, the Occupational Safety and Health Administration, and the National Institute of Environmental Health Sciences for carcinogenicity studies because of potential occupational exposure. Male and female F344/N rats and B6C3F mice were exposed to 1 glutaraldehyde (25% aqueous solution) (approximately 93% pure) by inhalation for 2 years. In vitro genetic toxicology studies were conducted in Salmonella typhimurium, L5178Y mouse lymphoma cells, and cultured Chinese hamster ovary cells; in vivo studies were conducted to measure sex-linked recessive lethal mutations in Drosophila melanogaster, chromosomal aberrations and micronucleated erythrocytes in mouse bone marrow, and micronucleated erythrocytes in mouse peripheral blood. The results of 13-week inhalation studies with glutaraldehyde were reported previously (NTP, 1993).

2-YEAR STUDY IN RATS

Groups of 50 male and 50 female F344/N rats were exposed to 0, 250, 500, or 750 ppb glutaraldehyde vapor by inhalation, 6 hours per day, 5 days per week, for 104 weeks. Survival of 500 and 750 ppb female rats was less than that of the chamber controls. Mean body weights of all exposed groups of male rats and 500 and 750 ppb female rats were generally less than those of the chamber controls. Some female rats exposed to 750 ppb were thin to emaciated at the time they were killed moribund. Increased incidences of nonneoplastic nasal lesions occurred primarily within the anterior section of the nose in 500 and 750 ppb rats and to a lesser extent in 250 ppb rats. The more significant lesions included hyperplasia and inflammation of the squamous and respiratory epithelia and squamous metaplasia of the respiratory epithelium.

2-YEAR STUDY IN MICE

Groups of 50 male and 50 female B6C3F mice were 1 exposed to 0, 62.5, 125, or 250 ppb glutaraldehyde vapor by inhalation, 6 hours per day, 5 days per week, for 104 weeks. Survival of exposed mice was similar to that of the chamber controls. Mean body weights of female mice exposed to 250 ppb were generally less than those of the chamber controls throughout the study. Incidences of squamous metaplasia of the respiratory epithelium were increased in 250 ppb males and females and 125 ppb females. Incidences of hyaline degeneration of the respiratory epithelium were increased in all exposed groups of females. The incidence of inflammation of the nose was marginally increased in 250 ppb females.

GENETIC TOXICOLOGY

In genetic toxicity studies, glutaraldehyde was mutagenic with and without S9 metabolic activation in S. typhimurium strains TA100, TA102, and TA104. Glutaraldehyde was mutagenic in mouse L5178Y lymphoma cells in the absence of S9 and induced sister chromatid exchanges in cultured Chinese hamster ovary cells with and without S9. No increase in chromosomal aberrations was induced by glutaraldehyde in cultured Chinese hamster ovary cells with or without S9 at one laboratory; at another laboratory, chromosomal aberrations were induced in the absence of S9 only. Glutaraldehyde did not induce sex-linked recessive lethal mutations in germ cells of male D. melanogaster treated as adults by feeding or injection or treated as larvae by feeding. In vivo, glutaraldehyde induced a significant increase in chromosomal aberrations in mouse bone marrow cells 36 hours after a single intraperitoneal injection. In a subset of the 36-hour chromosomal aberrations test, there was a small increase in the number of micronucleated bone marrow polychromatic erythrocytes, which was judged to be equivocal. Additional short-term (3-day) and subchronic (13-week) micronucleus tests in mice, using the intraperitoneal or inhalation routes, respectively, yielded negative results.

CONCLUSIONS

Under the conditions of these 2-year inhalation studies, there was no evidence of carcinogenic activity* of glutaraldehyde in male or female F344/N rats exposed to 250, 500, or 750 ppb. There was no evidence of carcinogenic activity in male or female B6C3F mice exposed to 62.5, 125, or 250 ppb. 1 Incidences of nonneoplastic lesions of the nose were significantly increased in male and female rats and mice.

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