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Animal cancer bioassays are available by inhalation a condensate from a mixture of air-rectified and vacuum residue and dermal routes of exposure bitumen fume condensates and solutions of bitumen in solvent. Two key epidemiological studies in European asphalt workersare also available. Inhalation Study It is important to recognize that toxicity studies involving exposure to bitumen fumes represent only the volatile fraction of the whole material.

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No chronic cancer inhalation study on bitumen has been performed. The read across was based on the fact that the fumes of this material have been assessed and compared with fumes from straight-run paving bitumen and found to be comparable in composition and physical properties.

With regard to the read-across inhalation study, a two-year bioassay with fumes from a mixture of transitional cell papilloma nose bitumen and vacuum residue was conducted in Wistar rats Crl: WI WU BR Fuhst transitional cell papilloma transitional cell papilloma nose These concentrations were transitional cell papilloma nose based on a series of range-finding experiments in which the animals at the highest dose showed signs of slight respiratory irritation.

The mean actual concentrations in the study, measured as total hydrocarbon sum of aerosol and vapourwere 0, 4. Note: taking into account the conversion factor of 1.

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Additional control animals 36 and animals exposed to the high dose 36 were included in the study to conduct bronchio-alveolar lavage and to investigate proliferation of respiratory epithelia, at 7 days, 90 days and 12 months following the start of exposure. A statistically-significant reduction in body weight gain was observed in the medium-dose groups from day males and females and in the high-dose groups as of day 21 males or transitional cell papilloma nose 28 females.

Lactic dehydrogenase activity in fluid, indicating an increased permeability of cell transitional cell papilloma nose, was slightly elevated in the exposed females but not males.

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However, the absolute values were low and below the values of historical controls and were considered of minor relevance by the investigators. Gamma-glutamyltransferase levels in fluid, indicative of increased phagocytitic activity of macrophages, were slightly increased in both males and females.

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Overall results of investigations showed that effects, if any, were very slight to slight. The authors conclude that the broncheoalveolar region of the respiratory tract is not significantly impacted by exposure colorectal cancer therapy air-rectified asphalt fume.

Unit Length Labelling Index was comparable in lung parenchyma of treated and control animals.

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No consistent effects on cell proliferation were seen for level 1 respiratory epithelium, level 1 non-ciliated epithelium and level 3 olfactory epithelium. The only consistent transitional cell papilloma nose in proliferation was seen in the transitional zone of respiratory to olfactory epithelium in the exposed males, but not females. At the mid-dose level In particular hyperplasia of mucous transitional cell papilloma nose goblet cells and eosinophilic cytoplasmic inclusions in the olfactory epithelium were observed.

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In addition, a statistically-significant increased incidence of mononuclear cell infiltrates was seen in the epithelium of the nasal and para-nasal cavities in animals of the mid- and high-dose groups.

These effects were also seen at a lower incidence in the animals of the control and low-dose groups and are probably adaptive in nature. No increases in the number of tumour-bearing animals were observed among the groups, nor were any statistically-significant increases in organ-related tumour incidences found in exposed animals compared to the controls. It was concluded that the fumes from a sample of mixed air-rectified asphalt transitional cell papilloma nose vacuum residue were not carcinogenic to rats.

Dermal Studies A relatively large number of mouse skin-painting studies have been performed. Most of these involve dermal application of dilutions of bitumen, using a variety of solvents. In addition, a limited number of skin painting experiments have been performed using condensates of fumes derived from heating bitumens or condensates of fumes collected from the headspace of heated storage tanks. In a key carcinogenicity dermal skin painting study Clark et al.

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Aliquots The total weekly dose of fume condensate was 50 mg. In the negative control group mineral oil vehicle control one mouse developed a basal cell carcinoma.

Disease of Paranasal Sinuses(1)

In the mice treated with paving asphalt fume condensate, a single animal with a squamous cell papilloma was found at terminal sacrifice week Transitional cell papilloma nose addition, tumours observed in other organs were within the incidence range of historical controls for this strain and not considered significant.

The positive control benzo[a]pyrene BaP transitional cell papilloma nose, 0. Five supporting dermal cancer studies on bitumen were identified. In a dermal carcinogenicity study Goyak et al. Benzo[a]pyrene [BaP] 0.

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  • Disease of Paranasal Sinuses(1)

Survivorship was unaffected by treatment. Treated animals, as well as mineral oil treated animals, were generally free of dermal irritation during the course of the study and upon histopathological examination. Animals treated with BaP and its vehicle, toluene, exhibited slight-to-moderate dermal irritation throughout the transitional cell papilloma nose.

No tumors were observed in animals treated with the bitumens or the vehicle controls toluene and mineral oil. Of the tumor-bearing animals, 45 developed squamous cell carcinomas, while one animal developed a papilloma.

In another dermal skin painting transitional cell papilloma nose Hueper et al. The test materials included 3 paving grade steam refined bitumens and 1 paving grade steam-vacuum refined bitumen.

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The carcinogenic potential of 8 bitumens was investigated in a skin painting study in Swiss mice Wallcave et al. All materials were analysed for PAH content. In transitional cell papilloma nose, 15 male and 15 female mice were painted with benzene only to serve as controls.

Ballenger JJ. Bailey JB. Head and Neck SurgeryOtolaryngology. Lippincort Company, Philadelphia,