No. 1031 - Miljøstyrelsen

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50 less potent than EE, and many times less potent than the weak phytoestrogen CE (EPA DCN 86990000059 1999). In the same assay HMDS showed no measurable effect on uterine weight when tested as an agonist. When co-administered together with EE, HMDS produced a slight, but statistically significant reduction in absolute uterine weight. The biological relevance of this could not be assessed in the present study (EPA DCN 86990000059 1999). 3.3 Conclusion Only few siloxanes are described in the literature with regard to health effects, and it is therefore not possible to make broad conclusions and comparisons of the toxicity related to short chained linear and cyclic siloxanes based on this evaluation. Data is primarily found on the cyclic siloxanes D4 and D5 and the small linear HMDS. The three siloxanes have a relatively low order of acute toxicity by oral, dermal and inhalatory routes and do not require classification for this effect. They are not shown to be irritating to skin or eyes and are also not found sensitizing by skin contact. Data on respiratory sensitization have not been identified. Subacute and subchronic toxicity studies show that the liver is the main target organ for D4 which also induces hepatocellular enzymes. This enzyme induction contributes to the elimination of the substance from the tissues. Primary target organ for D5 exposure by inhalation is the lung. D5 has a similar enzyme induction profile as D4. Subacute and subchronic inhalation of HMDS affects in particular the lungs and kidneys in rats. <strong>No</strong>ne of the investigated siloxanes show any signs of genotoxic effects in vitro or in vivo. Preliminary results indicate that D5 has a potential carcinogenic effect. D4 is considered to impair fertility in rats by inhalation and is classified as a substance toxic to reproduction in category 3 with the risk phrase R62 ('Possible risk of impaired fertility'). The results of a study to screen for estrogen activity indicate that D4 has very weak estrogenic and antiestrogenic activity and is a partial agonist (enhances the effect of the estrogen). It is not uncommon for compounds that are weakly estrogenic to also have antiestrogenic properties. Comparison of the estrogenic potency of D4 relative to ethinylestradiol (steroid hormone) indicates that D4 is 585,000 times less potent than ethinylestradiol in the rat stain Sprague-Dawley and 3.7 million times less potent than ethinylestradiol in the Fisher-344 rat strain. Because of lack of effects on other endpoints designated to assess estrogenicity, the estrogenicity as mode of action for the D4 reproductive effects has been questioned. An indirect mode of action causing a delay of the LH (luteinising hormone) surge necessary for optimal timing of ovulation has been suggested as the mechanism. Based on the reviewed information, the critical effects of the siloxanes are impaired fertility (D4) and potential carcinogenic effects (uterine tumours in females) (D5). Furthermore there seem to be some effects on various organs
following repeated exposures, the liver (D4), kidney (HMDS) and lung (D5 and HMDS) being the target organs. A possible estrogenic effect contributing to the reproductive toxicity of D4 is discussed. There seems however to be some indication that this toxicity may be caused by another mechanism than estrogen activity. Effects which based on the reviewed literature do not seem to be problematic are acute toxicity, irritant effects, sensitization and genotoxicity. 51
Page 1 and 2: Siloxanes - Consumption, Toxicity a
Page 3 and 4: Table of Contents PREFACE 5 SUMMARY
Page 5: Preface Siloxanes, the building blo
Page 8 and 9: 8 products, clothes, health-care pr
Page 10 and 11: 10 A possible estrogenic effect con
Page 13 and 14: Sammenfatning og konklusioner Denne
Page 15 and 16: Udledninger til miljøet Den væsen
Page 17 and 18: Prisen på alternativerne varierer
Page 19 and 20: 1 Introduction 1.1 What are siloxan
Page 21 and 22: Cyclic siloxanes with other functio
Page 23 and 24: Curing of one-component RTV silicon
Page 25 and 26: Table 1.2 Consumption of silicones
Page 27 and 28: tion and export of siloxanes regist
Page 29 and 30: CAS No. Name Import average tonnes
Page 31 and 32: • Defoamers, flow control agents
Page 33 and 34: Besides their technical properties,
Page 35 and 36: paint, coatings and waxes in total
Page 37 and 38: Table 2.5 Siloxanes in imported, ex
Page 39 and 40: Fate of the siloxanes The siloxanes
Page 41 and 42: • Mouldmaking (reproduction of co
Page 43 and 44: The main source of releases of silo
Page 45 and 46: • Immunotoxicity studies. Human c
Page 47 and 48: LD 50 following dermal application
Page 49: cinogenic hazard associated with D5
Page 53 and 54: Table 4.1 PBT profiler results for
Page 55 and 56: 5 Alternatives The use of some type
Page 57 and 58: Name of alternative Neopentylglycol
Page 59 and 60: 5.1.7 Summary and general experienc
Page 61 and 62: Table 5.2 Identified alternatives t
Page 63 and 64: References Allan, R.B., Kochs, P. &
Page 65 and 66: EPA DCN 86970000024. 1996. Pharmaco
Page 67 and 68: EPA, August 2003. Siloxane D5 in Dr
Page 69 and 70: 69 Annex 1 Siloxanes listed in the
Page 71 and 72: 71 INCI name CAS No EINECS/ ELINCS
Page 79 and 80: Declared name CAS No. ACRYLATES / D
Page 81 and 82: Annex 3 Siloxanes in the Danish Pro
Page 83 and 84: Tonnes siloxanes Import Production
Page 89 and 90: tonnes siloxanes Import Production
Page 91 and 92: Annex 5 Siloxanes in cleaning and m
Page 93 and 94: tonnes siloxanes Import Production
Page 95 and 96: Annex 7 Database screening for deca
Page 97 and 98: Inhalation No relevant data found O
Page 99 and 100: PhysProp 2003. PHYSPROP DEMO-databa
Page 101 and 102:
10 CAS no Synonym Test Exposure rou
Page 103 and 104:
103 CAS no Synonym Test Exposure ro
Page 105 and 106:
Page 107 and 108:
Page 109 and 110:
Page 111:
111 CAS no Synonym 556-67-2, 541-02
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No. 1031 - Miljøstyrelsen

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