manufacture, processing and use of stainless steel - International ...

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Sensitisation No animal studies are available. Investigations of the involvement of stainless steel in allergic skin responses in humans fall into two categories: investigations of the potential of stainless steel to elicit skin responses in subjects previously sensitised to nickel; and investigations of the potential of stainless steel to induce hypersensitivity in non-sensitised subjects. Induction of hypersensitivity is the only toxicological property considered when deciding whether a substance or preparation should be classified as a skin sensitiser. Patch-testing studies have been conducted which have investigated the potential of stainless steels to elicit skin responses in subjects previously sensitised to nickel. The findings of these studies, in conjunction with results from nickel-release experiments, indicate that the ability of stainless steels to elicit skin responses in nickel-sensitised individuals depends upon the bioavailability of nickel. The results show that prolonged skin contact with stainless steel grades AISI 304, AISI 316L, AISI 317 and AISI 430 is unlikely to elicit skin responses in nickel-sensitised individuals. In contrast, the high-sulphur grade AISI 303 may, with prolonged skin contact, have the potential to elicit skin responses in nickel-sensitised subjects. With regard to the induction of hypersensitivity, there are few data are available for stainless steels. In one small study, stainless steel grades AISI 317, AISI 304 and one unspecified martensitic or ferritic grade failed to induce hypersensitivity in nonnickel-sensitised subjects as a result of skin contact. No information is available concerning the potential of AISI 303 to induce hypersensitivity as a result of skin contact. Given the extremely large population that is exposed to stainless steels, either by prolonged or intermittent skin contact, or as a result of stainless steel surgical implants, it is highly notable that so few reports of suspected sensitisation reactions are available. Consideration against classification criteria: The classification criteria for skin sensitisation are concerned with the induction of hypersensitivity as result of skin contact, not the potential to elicit a skin response in previously sensitised subjects. No animal studies are available. Data from a single human study provide no evidence to indicate that the three stainless steels tested induce hypersensitivity as result of skin contact. There is no toxicological basis for classifying stainless steels as sensitising by skin contact. 23
Prolonged exposure Information on the effects of prolonged exposure to metallic stainless steel come from a number of animal implantation studies, where implantation of stainless steel items into muscle or sub-cutaneous tissue has resulted in a local response, characterised by inflammatory and fibrotic changes. These changes are considered to be a typical, non-specific local response to foreign material. Human data on the effects of prolonged exposure to metallic stainless steel are limited to a few case-reports in which local and/or distal effects have been reported in subjects who have received prosthetic implants made from stainless steel. However, these reports have not provided consistent evidence of an association between stainless steel and the reported changes over and above a non-specific response to implanted materials. Further, given the wide use of stainless steel in prosthetic devices, surgical and dental, it is highly significant that only a small number of cases have been reported. Consideration against classification criteria: Only limited animal and human data are available. These provide no evidence that prolonged exposure to metallic stainless steels has any serious detrimental effect on health. There is no basis for classifying metallic stainless steels for effects arising from repeated or prolonged exposure. Carcinogenicity The only data relating to the carcinogenicity of metallic stainless steel comes from a single animal study in which i.m. implantation of stainless steel rods failed to increase tumour development in mice. No standard animal carcinogenicity studies have been conducted with metallic stainless steel using recommended protocols, although this is not surprising given the problems that would be faced exposing animals to the test material. There are no data available regarding the carcinogenicity of metallic stainless steels in humans. Consideration against classification criteria: The available data provide no basis for classifying metallic stainless steels for carcinogenicity. Mutagenicity No data are available relating to the mutagenicity of metallic stainless steel, although this is not unexpected given the difficulties that would be encountered in conducting tests using currently available methods. Consideration against classification criteria: In the absence of any data, there is no basis for classifying metallic stainless steels for mutagenicity. 24
Page 1 and 2: MANUFACTURE, PROCESSING AND USE OF
Page 3 and 4: 3.2 GRINDING OF STAINLESS STEEL ...
Page 5 and 6: Within the review, each section is
Page 7 and 8: Results from a single intra-muscula
Page 9 and 10: studies are often based on small nu
Page 11 and 12: The toxicological database for fume
Page 13 and 14: PEFR peak expiratory flow rate PSD
Page 15 and 16: Table 1.1 Identity of stainless ste
Page 17 and 18: There are several different systems
Page 19 and 20: method have been used in some of th
Page 21 and 22: grade was tested, an austenitic sta
Page 23 and 24: pick-up of nickel and chromium when
Page 25 and 26: Human data Patch-testing studies Se
Page 27 and 28: does not allow any conclusions to b
Page 29 and 30: Schriver et al. (1976) reported a c
Page 31 and 32: Other studies reviewed in this sect
Page 33 and 34: Human data on the effects of prolon
Page 35: Exposure to stainless steel powder
Page 39 and 40: In view of the chemical/physical pr
Page 41 and 42: Figure 2.1 Production of stainless
Page 43 and 44: Table 2.1 Manufacture of stainless
Page 45 and 46: 2.3 Toxicokinetics Toxicokinetics i
Page 47 and 48: survey, there was no evidence of an
Page 49 and 50: The "exposure" variable used by the
Page 51 and 52: Table 2.2 Epidemiological studies o
Page 53 and 54: Consideration against classificatio
Page 55 and 56: 3 STAINLESS STEEL PROCESSING This s
Page 57 and 58: Arc voltage or arc length Arc volta
Page 59 and 60: 3.1.2 Information on exposure Weldi
Page 61 and 62: Reference Akesson & Skerfving (1985
Page 63 and 64: Table 3.2 Elemental composition of
Page 65 and 66: These levels decreased, although ch
Page 67 and 68: treatment group and no effects were
Page 69 and 70: esponses in terms of irritancy, fib
Page 71 and 72: MMA/SS) at approximately 400 mg/m 3
Page 73 and 74: Exposure measure 60 Welders a (n=52
Page 75 and 76: was relatively heterogeneous. No de
Page 77 and 78: used included respiratory symptoms,
Page 79 and 80: Keskinen et al. (1980) reported on
Page 81 and 82: Positive results were reported with
Page 83 and 84: Welding method Electrode Base metal
Page 85 and 86: A significant increase in chromatid
Page 87 and 88:
treated with MIG/SS fume. One lung
Page 89 and 90:
The mortality experiences of the tw
Page 91 and 92:
Moulin et al. 1993b Mortality was s
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Moulin 1997 A meta-analysis involvi
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Table 3.3. Epidemiological studies
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“are known, and in this study too
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Bonde et al. (1990) investigated fe
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out stainless steel welding in the
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contact. The available human data p
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Effects on reproduction No studies
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Table 3.4 Grinding of stainless ste
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Reference Process Work piece materi
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No deaths occurred in any treatment
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Human data No studies are available
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mg of dust per animal. In another t
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(Observed 8, Expected 4.7, SMR 170,
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Table 3.5 Epidemiological studies o
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Carcinogenicity The carcinogenicity
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Toxicokinetics and toxicity Informa
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112 APPENDIX 1 22.7.94 Official Jou
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Escales F, Galante J, Rostoker W. B
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IARC. Monographs on the evaluation
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Malmqvist KG, Johansson GI, Bohgard
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Simonato L, Fletcher AC, Andersen A
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Bondemark L, Kurol J, Wennberg A. O
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Furon D, Hilderbrand HF. Research i
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Hooftman RN, Arkesteyn CW, Roza P.
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Koshi K, Yagami T. Chromosomes of c
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Merritt K, Brown SA. Release of hex
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Pereira ML. Studies on the permeabi
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Stern RM . Detecting a possible inc
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Toyoshima M, Sato A, Taniguchi M, I
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