No. 1031 - Miljøstyrelsen

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104 CAS no Synonym Test Exposure route 556-67-2 D4 dose-response study inhalation, whole body 556-67-2 D4 subacute toxicity, pilot study on effects on liver size and hepatic enzyme induction 556-67-2 D4 subacute toxicity, effects on liver size and hepatic enzyme induction 556-67-2 D4 subacute toxicity; induction of rat hepatic microsomal cytochrome P450, UDPglucoronosyltransferase, and epoxid hydrolase inhalation, whole body inhalation, whole body inhalation, whole body Species / model Conc. Exposure period rat (♀), Fisher 344 1, 7, 30, 70, 150, 300, 500, 700 and 900 ppm 6 hours/day; 5 days rat (♀,♂), Fisher 70 and 700 ppm 28 days, 6 hours/day; 5 days/week rat (♀,♂), Fisher 344 rat (♀,♂), Fisher 344 556-67-2 D4 subchronic toxicity inhalation albino rat (♀,♂), Fisher 344, 4 groups, 10 ♀/10 ♂ / group 556-67-2 D4 subchronic toxicity, range finding study for chronic study inhalation, nose only albino rat (♀,♂), Fisher 344, 4 groups, Gr.2, 3, 4: 20 ♀/20 ♂ / group; Gr.5: 30 ♀/30 ♂ / group 70 and 700 ppm 28 days, 6 hours/day; 5 days/week 70 and 700 ppm 28 days, 6 hours/day; 5 days/week ≤1000 ppm, repeated dose (2.78, 5.13, 8.62 and 14.21 mg/l) ≤990 ppm, repeated dose (0.42, 1.48, 5.91 and 10.87 mg/l) 20 days (♂), 21 days (♀), 6 hours/day; 5 days/week 3 months, 6 hours/day; 5 days/week Result/Effects NOAEL / LOAEL dose-dependent increase in liver size and induction of PROD activity achieving a max response between 300 and 900 ppm hepatic conc. of D4 may reach levels saturating CYP2B1/2 activity induction of CYP2B1/2 enzymes is an early and sensitive biochemical response to D4 exposure in rat max can be achieved following 5 days repeated inhalation of approx. 500 ppm D4 D4 is a Phenobarbital-like inducer of rat hepatic cytochrome P450 enzymes dose and time dependent liver enlargement in ♀ rats, maximum by day 7 induction of several metabolizing enzymes, primarily CYP2B1 D4 induces hepatic cytochrome P450 enzymes biochemical response similar to phenobarbital rapid but revesible increase in liver size induction of several metabolizing enzymes, primarily CYP2B1 D4 induces hepatic cytochrome P450 enzymes biochemical response similar to phenobarbital D4 induces CYP enzymes and epoxide hydrolase in a manner similar to Phenobarbital - i.e. D4 is a PB-like inducer of hepatic microsomal enzymes in the Fisher 344 rat. reduced food consumption reduced body weight and body weight gain thymic atrophy vaginal mucification reduction in corpora lutea score slight reduction in body weight and food intake at 990 ppm. slight dose related increase in abs. and rel. liver weight (♀ most sensitive) slight reduction in thymus and ovarian weight in ♀ at the highest 2 doses ovarian atrophy and vaginal mucification in ♀ at 990 ppm EPA DCN/Ref. no data 86990000029 1999 no data 86970000723 1996 no data 86970000725 1997 no data McKim JM et al 1997 no data 86950000155 1995 no data 86950000153 1995
105 CAS no Synonym Test Exposure route 556-67-2 D4 subchronic toxicity and splenic antibody cell response 556-67-2 D4 genetic toxicity, Ames test 556-67-2 D4 genetic toxicity, SCE assay 556-67-2 D4 genetic toxicity, chromosome abberations 556-67-2 D4 single generation study (range-finding study for 2 gen. study) 556-67-2 D4 reproductive toxicity, range-finding (test reproducibility of EPA, 3) 556-67-2 D4 reproductive toxicity, range-finding 556-67-2 D4 reproductive toxicity, range-finding study 556-67-2 D4 reproductive toxicity, range-finding study inhalation, whole body in vitro salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 Species / model Conc. Exposure period rat (♀,♂), Fisher 7, 20, 60, 180 and 540 ppm in vitro chinese hamster ovary cells (CHO) inhalation, whole body rat (♀,♂), Sprague-Dawley inhalation rat (♀,♂), Sprague-Dawley; 2 groups, 20 F 0 ♀/20 F 0 ♂ / group inhalation, whole body inhalation, whole body inhalation, whole body vapour inhalation, whole body vapour rat (♀,♂), Sprague-Dawley; 2 groups, 22 F 0 ♀/22 F 0 ♂ / group rat (♀), Sprague Dawley, 22 ♀ / group rat (♂), Sprague- Dawley. 22 / group rat (♂), Sprague- Dawley. 40 / group maximum dose = 5 mg/plate with or without S9 ≤0.003 mg/ml with and without S9 28 days, 6 hours/day; 5 days/week 700 ppm 5 days, 6 hours/day 70 and 700 ppm 28 days, 6 hours/day 700 ppm ≥28 days, 6 hours/day 70, 300, 500, and 700 ppm 70, 300, 500, and 700 ppm Result/Effects NOAEL / LOAEL statictically significant increase in liver weight and liver to body weight (♂ at 540 ppm; ♀ at 20-540 ppm) no alterations in immune system AFC response no data no mutagenicity was detected in salmonella thyphimurium (negative) no data no significant dose-related increases in chromosomal aberration frequencies (negative) 6 hours/day for 70 at least days prior to mating 6 hours daily for 70 days prior to mating 500 and 700 ppm 6 hours daily for 70 days prior to mating <strong>No</strong> significant, treatment-related increases in chromosomal aberrations were detected (negative) treatment related reduction in mean body weight (♀,♂) shortly after exposure initiation and late in gestation (♀) statistically significant reduction in mean live litter size at 700 ppm accompanied by a decreased number of uterine implantations treatment related reduction in mean body weight (♀,♂) shortly after exposure initiation and late in gestation (♀) statistically significant reduction in mean live litter size at 700 ppm accompanied by a decreased number of corpora lutea and uterine implantations maternal toxicity in F0 females at 300, 500 and 700 ppm statistically significant reduction in mean live litter size and implantation site at 700 ppm increased liver and thyroid weights at 700 ppm slight statistically insignificant reductions in pup survival (% per litter) at 700 ppm on PND 0 and during PND 0-4 interval decrease in mean pup body weights on PND 1 and PND 4 at 700 ppm relative to control toxicity demonstrated in F0 males at 700 ppm by clinical signs and reduces mean body weight gain and food consumption during the first week no adverse effects on F1 pups at 500 and 700 ppm EPA DCN/Ref. no data 86980000040 1997 no data Vergnes JS et al 2000 no data Vergnes JS et al 2000 no data Vergnes JS et al 2000 no data 86960000398 1995 no data 86970000023 1995 no data 86970000847 1997 no data 86980000049 1997 500 ppm (F0 toxicity) 700 ppm (F1) 86980000061 1997
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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
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
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Page 107 and 108: 107 CAS no Synonym Test Exposure ro
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Page 111: 111 CAS no Synonym 556-67-2, 541-02
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No. 1031 - Miljøstyrelsen

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