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

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There are no data available regarding the carcinogenicity of metallic stainless steels in humans. Effects on reproduction No studies are available which have investigated the effect of metallic stainless steel on reproduction, either in animals or in humans. 1.2 Metallic stainless steel: powder There is no relevant published information available on metallic stainless steel in the powdered form. The chemical structure of stainless steel powder is anticipated to be the same as for metallic stainless steel in the massive form. According to the European Powder Metallurgy Association (EPMA), there are three main particle size ranges for stainless steel powders: Powder type/application Particle diameter (µm) Median Range Pressing and sintering 70 20-150 Metal injection moulding 15 5-40 Filtration from 20µm upwards Source: EPMA (personal communication) With the three main powder types, at least some of the particles fall within the inhalable 8 range. With metal injection moulding powders, some of the particles are also likely to be within the respirable range. Currently, stainless steel powder production represents a small section of metallic stainless steel production. In the EU, annual production of stainless steel powder intended for sintering is estimated to be less than 5000 tonnes; this represents less than 0.1% of total stainless steel production for the EU. 8 ‘Inhalable’ dust is the fraction of airborne material which enters the nose and mouth during breathing and is therefore available for deposition in the respiratory tract; ‘respirable’ dust is the fraction of airborne material which penetrates to the gas exchange region of the lung (Health and Safety Executive 1997). As an approximation, particle diameter for inhalable particles is generally
Exposure to stainless steel powder may occur during the manufacturing process and during use in plasma spraying operations. As some powders are inhalable, and some may also be respirable, stainless steel powders present the potential for inhalation exposure in the occupational setting. No exposure data are available. The intrinsic toxicological properties of stainless steel in the powdered form are considered to be the same as for stainless steel in the massive form. Consequently, there is unlikely to be any identifiable hazard specifically associated with this form of metallic stainless steel. 1.3 Hazard assessment This section contains a summary of data on the health effects of metallic stainless steel, reviewed in the preceding sections. Data relating to each toxicological endpoint are then evaluated against the criteria contained in Annex VI of Directive 92/32/EEC, amending Directive 67/548/EEC. The purpose of this evaluation is to establish how, based on currently available data, metallic stainless steels would be classified if they were substances. Currently, stainless steels are classified in the EU according to the Preparations Directive (88/379/EEC). According to the conventional method contained within the Preparations Directive, stainless steels which contain nickel at a concentration of 1% or more are classified as category 3 carcinogens (R40) and skin sensitisers (R43). Acute toxicity No studies have been conducted in animals or humans which have investigated the acute toxicity of metallic stainless steels, or the potential of stainless steels to cause skin or eye irritation. However, given the resistance of stainless steels to corrosion due to the presence of the passive film, the findings of leaching studies and the lack of positive results in human patch-testing studies, none of these effects would be expected to occur. This view is supported by the absence of any reports of acute toxicity associated with exposure to metallic stainless steel. The absence of such data is even more notable given the extremely large number of individuals who are exposed to stainless steel on a regular basis, for example in cooking utensils, other domestic appliances, wristwatches, clothes fasteners and prosthetic devices. Consideration against classification criteria: No studies have been conducted in animals to provide any evidence concerning the acute toxicity of metallic stainless steel, or regarding irritancy to the skin or eyes. Further, there are no human data available. However, in view of the widespread human exposure to metallic stainless steel, human experience provides no reasonable basis for classifying metallic stainless steel for acute toxicity, or for irritancy to the skin or eyes. 22
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: Human data on the effects of prolon
Page 37 and 38: Prolonged exposure Information on t
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
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A significant increase in chromatid
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treated with MIG/SS fume. One lung
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The mortality experiences of the tw
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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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