Extrapolation from results of animal studies to humans for the endpoint male fertility:
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| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
Bremerhaven
Wirtschaftsverlag NW
2003
|
| Series: | Schriftenreihe der Bundesanstalt für Arbeitsschutz und Arbeitsmedizin
Forschung ; 984 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Item Description: | Zsfassung in dt. u. franz. Sprache |
| Physical Description: | 153 S. graph. Darst. : 210 mm x 148 mm |
| ISBN: | 3897019671 |
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| adam_text | Contents
Abstract 11
Kurzreferat 13
Resume 15
1 Introduction 17
2 Effects on male fertility 19
2.1 General background 19
2.2 Types of Effects 20
2.2.1 Nomenclature 20
2.2.2 Types of Damage 21
2.2.3 Mode of Action 22
2.3 Influencing Factors 24
2.3.1 Type of Chemical/Mode of Action 24
2.3.2 Dose 24
2.3.3 Time after Exposure 25
2.3.4 Duration of Exposure 26
2.3.5 Species/Strain 27
2.3.6 Age 27
2.3.7 Reversibility 28
3 Animal Studies 30
3.1 Types of Studies 30
3.1.1 One or two Generation Reproduction Studies (OECD 415 or 416) 30
3.1.2 Guideline on Detection of Toxicity to Reproduction for Medicinal
Products 31
3.1.3 Reproductive Assessment by Continuous Breeding (RACB) 32
3.1.4 Alternative Reproductive Test (ART) 33
3.1.5 Male Dominant Lethal Test 34
3.1.6 Other Studies 34
3.2 Control Values, Variation and Statistical Power 34
3.3 Comparison of Different Endpoints and Study Designs 38
3.3.1 Description of Studies Analyzed 38
3.3.2 Sensitivity 41
3.3.3 Dose Response 53
3.3.4 Correlation of Endpoints 60
3.3.5 Influence of Duration of Exposure 64
3.3.6 Influence of Mode of Action 69
3.3.7 Comparison of Study Designs 69
3.4 Analysis of Individual Endpoints 70
3.4.1 Testis Weight 70
3.4.2 Epididymal Weight 72
3.4.3 Weight of Accessory Sex Organs 73
3.4.4 Histopathology 74
3.4.5 Sperm Count 76
3.4.6 Sperm Morphology 79
3.4.7 Sperm Motility 80
3.4.8 Hormone Levels/Endocrine Parameters 81
3.4.9 Sexual Function/Behavior 82
3.4.10 Fertility 82
4 Human Studies 86
4.1 Types of Studies 86
4.1.1 Cross Sectional Studies 86
4.1.2 Longitudinal Studies 86
4.2 Variability 86
4.3 Semen Analysis in Fertile and Infertile Men 88
4.3.1 Analysis of Individual Endpoints 90
4.3.2 Correlation of Endpoints and Conclusions 92
5 Species Differences 93
5.1 Within Different Animal Species 93
5.2 Animals to Humans 94
5.2.1 Qualitative Differences in Spermatogenesis in Laboratory Animals and
Man 94
5.2.2 Comparison of Effects in Animals and Humans 94
5.2.3 Quantitative Differences in Reproductive Parameters 95
5.2.4 Interspecies Extrapolation Factors (IEF) 96
5.2.5 Quantitative Assessment of Reproductive Risks based on Sperm
Counts 123
6 Evaluation 125
6.1 Hazard Identification 125
6.2 Risk Assessment 125
6.2.1 Sensitive Endpoints for Deriving NOAELs 125
6.2.2 Assessment Factors 128
7 Data gaps and Recommendations for Future Research 133
7.1 Data Analysis 133
7.1.1 Improve Database on Histopathology 133
7.1.2 Statistical Analysis 134
7.1.3 Effects on FrGeneration 134
7.2 Experiments 134
7.2.1 Additional Endpoints in Repeated Dose Toxicity Studies 134
7.2.2 Detection of Effects on Sexual Function/Behavior 135
7.2.3 Development of a Suitable Animal Model 135
7.2.4 Endpoints for Assessing Fertility 136
7.3 Female Fertility 137
8 Acknowledgement 138
9 References 139
List of Tables
Table 2 1: Nomenclature for effects on semen/ejaculate 21
Table 2 2: Examples of chemicals affecting different targets involved in
spermatogenesis 23
Table 2 3: Time course of effect of adriamycin (single i.v. dose of 10 mg/kg bw) on
reproductive endpoints in Wistar rats (SUTER et al., 1997) 26
Table 2 4: Duration of six seminiferous cycles in different species 27
Table 3 1: Variation and detectable differences for endpoints of male reproductive
toxicity in Fischer 344 rats (BLAZAK et al., 1985; MORRISSEY et al.,
1988b; ZENICKetal., 1994) 35
Table 3 2: Relative statistical power and detectable differences for endpoints of
male reproductive toxicity in subchronic toxicity studies with B6C3F1
mice (MORRISSEY et al., 1988b ) 35
Table 3 3: Relative statistical power and detectable differences of endpoints of
male reproductive toxicity in CD 1 mice in continuous breeding studies
(MORRISSEY, 1988a; MORRISSEY et al., 1989a) 36
Table 3 4: Detectable differences for endpoints of fertility in continuous breeding
studies with CD 1 mice (MORRISSEY et al., 1989a) 37
Table 3 5: Statistical power and minimum detectable effect for various parameters
in rabbit semen (WILLIAMS et al., 1990) 37
Table 3 6: Frequency of effects at different dose levels in studies on male fertility
in rats. Analysis of the data of TAKAYAMA et al., (1995) 16 studies with
4 weeks duration analyzed 42
Table 3 7: Factors for different sensitivity for endpoints of male reproductive
toxicity in the study of TAKAYAMA et al., (1995) (geometric mean of
LOAELx/LOAEL y). 16 studies with 4 weeks duration analyzed 43
Table 3 8: Comparison of LOAELs of different endpoints of male reproductive
toxicity with fertility in mice (GRAY et al., 1989) 46
Table 3 9: Frequency of effects at different dose levels in Continuous Breeding
Studies (CHAPIN et al., 1997a). 3 studies, where males were the
sex affected 47
Table 3 10: Frequency of effects at different dose levels in continuous breeding
studies with mice, analysis of the data of CHAPIN et al., (1997a), 41
studies analyzed 48
Table 3 11: Comparison of LOAELs of different endpoints in 41 continuous
breeding studies (CHAPIN et al., 1997a). Geometric mean of
LOAEL x/LOAEL y 50
Table 3 12: Analysis of publications for positive, negative or equivocal results on
endpoints tested (ULBRICH PALMER, 1995) 52
Table 3 13: Association of endpoints for male reproductive toxicity with male fertility
in 25 continuous breeding studies with CD mice. 10 studies showed
adverse effects on fertility (MORRISSAY, 1989b) 61
Table 3 14: Endpoints of male reproductive toxicity affected in 90 day studies with
F344 rats and B6C3F1 mice (MORRISSEY et al., 1988b) 62
Table 3 15: Sensitivity of reproductive endpoints in comparison to body weight in
F344 rats and B6C3F1 mice (MORRISSEY et al., 1988b) 62
Table 3 16: Endpoints of male reproductive toxicity affected for substances with
complete dataset (histopathology, organ weights, sperm analysis and
mating trial available, ULBRICH PALMER, 1995) 63
Table 3 17: LOAELS after 4 weeks exposure compared to 9 weeks exposure
(TAKAYAMAetal., 1995) 67
Table 3 18: Frequency of detection of effects depending on time of analysis
(ULBRICH and PALMER, 1995) 68
Table 3 19: Comparison of outcome of Short term and long term studies on male
reproductive toxicity (ULBRICH and PALMER, 1995) 68
Table 3 20: Comparison of male reproductive toxicity in 90 day studies with
Continuous Breeding studies in mice (CHAPIN et al., 1998) 70
Table 3 21: Methods in histopathology of the testes 76
Table 3 22: Quantification of parameters associated with fertility or infertility 84
Table 4 1: Estimates of variation within and between laboratories in assessment of
the most common semen variables (NEUWINGER et al., 1996) 87
Table 4 2: Estimates of the minimal number of participants to be examined in each
exposure group in order to detect a 25 % change of seminal
characteristics (BONDE et al., 1996) 88
Table 4 3: Results of semen analysis in fertile and infertile men 88
Table 4 4: Normal values of human semen according to WHO 89
Table 4 5: Frequency distributions of human sperm counts in fertile and infertile
men, (from MEISTRICH and BROWN, 1983) 90
Table 5 1: Number of studies with effects on different male reproductive endpoints
in F344 rats and B6C3F1 mice (MORRISSEY et al., 1988b) 93
Table 5 2: Comparison of effects in animals and humans (Clegg, 1994) 95
Table 5 3: Species differences in reproductive parameters 96
Table 5 4: IEF for sperm counts 100
Table 5 5: Threshold for effects of lead on different sperm parameters in
rabbit (MOORMAN et al., 1998) 103
Table 5 6: Sperm counts in workers exposed to lead and relationship to blood
lead concentrations (ALEXANDER et al., 1996) 104
Table 5 7: Studies with ethylene dibromide 106
Table 5 8: Studies with cyclophosphamide 107
Table 5 9: Studies with chlorambucil 111
Table 5 10: Studies with sulphasalazine 112
Table 5 11: Studies with cyproterone acetate 117
Table 5 12: lEFs for the most sensitive endpoints and comparison with results
from Meistrich from Table 5 4 118
Table 5 13: Scaling factors 120
Table 5 14: Influence of time of assessment after single X ray irradiation on IEF
(MEISTRICH and SAMUELS, 1985) 122
Table 6 1: Detection of changes in endpoints of male reproductive toxicity by
different testing protocols 128
Table 6 2: Assessment factors (oral application, VERMEIRE et al., 1999) 129
Table 6 3: Assessment factors depending on the completeness of the
database 131
List of Figures
Figure 3 1: Sensitivity of different endpoints of male fertility compared to body
weight (=1) after 4 weeks and 9 weeks application 44
Figure 3 2: Sensitivity of different endpoints of male fertility compared to body
weight (=1) in continuous breeding studies 51
Figure 3 3: Dose response for several parameters for the study of TAKAYAMA
(1995) 54
Figure 3 4: Time and dose dependency of effects of nitrazepam on male
reproduction in Sprague Dawley Rats 65
|
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| genre_facet | Literaturbericht |
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| indexdate | 2024-07-09T19:15:24Z |
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| isbn | 3897019671 |
| language | English |
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| physical | 153 S. graph. Darst. : 210 mm x 148 mm |
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| series2 | Schriftenreihe der Bundesanstalt für Arbeitsschutz und Arbeitsmedizin : Forschung |
| spelling | Mangelsdorf, Inge Verfasser aut Extrapolation from results of animal studies to humans for the endpoint male fertility I. Mangelsdorf ; J. Buschmann Bremerhaven Wirtschaftsverlag NW 2003 153 S. graph. Darst. : 210 mm x 148 mm txt rdacontent n rdamedia nc rdacarrier Schriftenreihe der Bundesanstalt für Arbeitsschutz und Arbeitsmedizin : Forschung 984 Zsfassung in dt. u. franz. Sprache Fertilität (DE-588)4071184-5 gnd rswk-swf Reproduktionstoxikologie (DE-588)4277009-9 gnd rswk-swf Längsschnittuntersuchung (DE-588)4034036-3 gnd rswk-swf Mann (DE-588)4037363-0 gnd rswk-swf Tiermodell (DE-588)4140660-6 gnd rswk-swf (DE-588)4167870-9 Literaturbericht gnd-content Reproduktionstoxikologie (DE-588)4277009-9 s Tiermodell (DE-588)4140660-6 s DE-604 Mann (DE-588)4037363-0 s Fertilität (DE-588)4071184-5 s Längsschnittuntersuchung (DE-588)4034036-3 s Buschmann, Jochen Verfasser aut Schriftenreihe der Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Forschung ; 984 (DE-604)BV011499960 984 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010387697&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Mangelsdorf, Inge Buschmann, Jochen Extrapolation from results of animal studies to humans for the endpoint male fertility Schriftenreihe der Bundesanstalt für Arbeitsschutz und Arbeitsmedizin Fertilität (DE-588)4071184-5 gnd Reproduktionstoxikologie (DE-588)4277009-9 gnd Längsschnittuntersuchung (DE-588)4034036-3 gnd Mann (DE-588)4037363-0 gnd Tiermodell (DE-588)4140660-6 gnd |
| subject_GND | (DE-588)4071184-5 (DE-588)4277009-9 (DE-588)4034036-3 (DE-588)4037363-0 (DE-588)4140660-6 (DE-588)4167870-9 |
| title | Extrapolation from results of animal studies to humans for the endpoint male fertility |
| title_auth | Extrapolation from results of animal studies to humans for the endpoint male fertility |
| title_exact_search | Extrapolation from results of animal studies to humans for the endpoint male fertility |
| title_full | Extrapolation from results of animal studies to humans for the endpoint male fertility I. Mangelsdorf ; J. Buschmann |
| title_fullStr | Extrapolation from results of animal studies to humans for the endpoint male fertility I. Mangelsdorf ; J. Buschmann |
| title_full_unstemmed | Extrapolation from results of animal studies to humans for the endpoint male fertility I. Mangelsdorf ; J. Buschmann |
| title_short | Extrapolation from results of animal studies to humans for the endpoint male fertility |
| title_sort | extrapolation from results of animal studies to humans for the endpoint male fertility |
| topic | Fertilität (DE-588)4071184-5 gnd Reproduktionstoxikologie (DE-588)4277009-9 gnd Längsschnittuntersuchung (DE-588)4034036-3 gnd Mann (DE-588)4037363-0 gnd Tiermodell (DE-588)4140660-6 gnd |
| topic_facet | Fertilität Reproduktionstoxikologie Längsschnittuntersuchung Mann Tiermodell Literaturbericht |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=010387697&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV011499960 |
| work_keys_str_mv | AT mangelsdorfinge extrapolationfromresultsofanimalstudiestohumansfortheendpointmalefertility AT buschmannjochen extrapolationfromresultsofanimalstudiestohumansfortheendpointmalefertility |