No. 1031 - Miljøstyrelsen

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110 CAS no Synonym Test Exposure route 107-46-0 HMDS subchronic toxicity inhalation, nose only 107-46-0 HMDS reproductive toxicity, one generation 107-46-0 HMDS uterotrophic assay; estrogenic and antiestrogenic activity Combined 540-05-9, 556-67-2, 541-02-6, 540-97-6, and 107-50- 6, or LMWS D3, D4, D5, D6, and D7 or LMWS Species / model Conc. Exposure period albino rat (♀,♂), Fisher 344, 5 groups, 30♂ and 30♀ / group or 20♂ and 20♀ / group inhalation rat (♀,♂), Crl:CD ® (SD)IGS BR, 4 groups, 24♂ and 24♀ / group oral immature rat (♀), Sprague-Dawley Gr.1: 0 mg/l, Gr.2: 0.14 ± 0.02 mg/l; Gr.3: 0.73 ± 0.2 mg/l; Gr 4: 3.42 ± 0.49 mg/l and Gr.5: 13.64 ± 1.47 mg/l Gr.1: 0 ppm, Gr.2: 100 ppm Gr.3: 1030 ppm and Gr 4: 5000 ppm HMDS: 600 and 1200 mg/kg/day; EE: 3 µg/kg/day; HMDS+EE: 1200 mg/kg/day + 3 µg/kg/day (EE) kinetics, distribution subcutaneous mice (♀), CD-1 Gr.1: 250 mg LMW cyclosiloxane mixture; Gr.2: DMPS-V three months, 6 hrs/day, 5 days/week 6 hrs/day, 28 consecutive days prior to mating 4 consecu-tive days beginning on PND 18 (SP), single dose once per day single exposure Result/Effects NOAEL / LOAEL no treatment related deaths, clinical signs, effect on body weight, food consumption, or hematology or clinical biochemistry parameters multifocal, subpleural, subacute to subchronic interstitial inflammation in lungs of all groups. After the recovery period an increase of these finding were still seen in Gr.5 slightly increased incidence and severity of testicular tubular atrophy in Gr.5 males slightly increased incidence of proteinaceous casts and severity of tubular regeneration in the kidneys in Gr.5 males all F0 animals survived transient effect on body weight gain and food consumption at 5000 ppm slight but not statistically significant effect on postnatal pup survival for the 500 ppm group 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 low molecular weight silicones persist in the organs of mice for at least one year after a single s.c. injection every organ examined (10 different) accumulated silicones individual cyclosiloxanes show different retention in tissues D5 and D6 appear to persist longer than D4 high levels of cyclosiloxanes in ovaries and moderately high in uterus EPA DCN/Ref. no data 86980000048 1997 not stated 86010000010 2000 not stated 84000000002 2001 not relevant Subbarao VK et al
111 CAS no Synonym 556-67-2, 541-02-6, 107-46-0 D4, D5, D6 Test Exposure route exposure assessment, interim, establishment of average daily dose (ADD) inhalation, dermal, oral Species / model Conc. Exposure period human, workers, consumers, general public three year analysis of potential exposure Various exposures Result/Effects NOAEL / LOAEL women are typically exposed to a greater diversity of personal care products individuals who are exposed from several sources seem to get the highest exposure female siloxane workers who use siloxane products high in D4 content and resides in the vicinity of a plant using these materials could experience a total base case ADD exposure for most other persons is smaller ADD: 0.71 (D4), 0.23 (D5), and 0.09 (D6) mg/kg/day occ. exposure, female workers: 0.5252 mg/kg/day consumers: 0.4784 mg/kg/day general public: 0.0217 mg/kg/day (residents in vicinity of a silicone plant) Mucification: A change produced in the vaginal mucosa of spayed experimental animals following stimulation with oestrogen; characterised by the formation of tall columnar cells secreting mucus. PND = postnatal day NK cells = natural killer cells AFC = Antibody Forming Cells KI = K(i) = Inhibition constant PROD = pentoxyresorufin O-dealkylase EE = ethinylestradiol ER = endoplasmatic reticulum PB= Phenobarbital 3-MC = 3-methylchlolanthrene PBPK model = physiologically-based pharmacokinetic model LMW = Low Molecular Weight LMWS = Low Molecular Weight Siloxanes DMPS-V = Low molecular weight linear siloxane mixture not relevent 1998 EPA DCN/Ref.
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Siloxanes - Consumption, Toxicity a
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Table of Contents PREFACE 5 SUMMARY
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Preface Siloxanes, the building blo
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8 products, clothes, health-care pr
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10 A possible estrogenic effect con
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Sammenfatning og konklusioner Denne
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Udledninger til miljøet Den væsen
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Prisen på alternativerne varierer
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1 Introduction 1.1 What are siloxan
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Cyclic siloxanes with other functio
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Curing of one-component RTV silicon
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Table 1.2 Consumption of silicones
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tion and export of siloxanes regist
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CAS No. Name Import average tonnes
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• Defoamers, flow control agents
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Besides their technical properties,
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paint, coatings and waxes in total
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Table 2.5 Siloxanes in imported, ex
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Fate of the siloxanes The siloxanes
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• Mouldmaking (reproduction of co
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The main source of releases of silo
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• Immunotoxicity studies. Human c
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LD 50 following dermal application
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cinogenic hazard associated with D5
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following repeated exposures, the l
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Table 4.1 PBT profiler results for
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5 Alternatives The use of some type
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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
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Page 109: 109 CAS no Synonym Test Exposure ro
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No. 1031 - Miljøstyrelsen

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