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EC number: 200-350-6 | CAS number: 57-83-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Test system |
Substance |
Application |
Test concentration |
End point/Effect |
Literature |
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In vitro |
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Salmonella Typhimurium TA97, 98, 100, 1535 |
|
With or without preincubation or metabolic activation: hamster or rat liver S-9, Aroclor 1254 (10 or 30%) |
100-10000 µg/plate (test material solvent: DMSO) |
Ames Negative |
Zeiger, E., Anderson, B. Haworth, S., Lawlor, T.and Mortelmans, K.;Salmonell Mutagenicity Tests:IV. Result from the Testing of 300 Chemicals; Environ. Mol.Mutagen. 11(Suppl.12):1-158, 1988 |
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E ColiWP2 UVRA |
|
With or without Preincubation or Metabolic Activation: rat , hamster or mouse liver, S-9 or S-9, Aroclor 1254 (10 or 30%) |
0.3-333.3 µg/plate (test material solvent: DMSO or acetone) |
Ames Negative |
Dunkel, V.C., Zeiger, E., Brusick, D., Mccoy, E., Mcgregor, D., Mortelmans, K., Rosenkranz, H.S. and Simmon,V.F.; Reproducibility of microbial mutagenicity assays:tests with Salmonella Typhimurium and Escherichia Coli using a standardized protocol; Environ. Mol. Mutagen. 6 (Suppl. 2): 1-254,1984 |
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Escherichia coli polA (W3119 vs P3478) |
|
|
|
Rec-assay, DNA effects (bacterial DNA repair) No conclusion |
Mutat Res 87:211-297,1981 |
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Human embryonicfibroblasts orrenal epithelia |
Progesterone |
|
1 µg/L |
Two-fold increase the number of chromosomal aberrations |
Serova, I.A. & Kerkis, Y.J. (1974)Cytogenetic effect of some steroidhormones and change in activity of lysosomal enzymes in vitro (Russ.) Genetica 10, 142-149) |
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Human lymphocytesfrom healthywoman |
Progesterone |
|
0.1-100 µg/mL |
No chromosoma effects |
Stenchever, M.A, Jarvis, J.A. &Kreger, N.K. (1969) Effect of selected estrogens and progestinson humanchromosomes in vitro.Obstet. Gynecol.34, 249-251. |
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Humankidney cells |
|
|
100 µg/L |
DNA Inhibition |
Canadian Journal of Genetics and Cytology (National Research Council of, Publication Sales and Distribution,ON K1A OR6,) V.1-1959-, vol 10, pg 299,1968. |
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Mouse-embryo cells |
|
|
1 mg/L |
Cytogenetic analysis |
Doklady Akademii Nauk SSSR.Proceedings of the Academy of Sciences of the. For English translation, see DBIOA and DKBSA (V/O)Mezhdunarodnaya Kniga 113095,) V.1 -1933-, vol 282, pg 173, 1985 |
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Human lymphocytes |
|
|
12 mg/L//22H |
Cytogenetic analysis |
Mutation Research. (Elsevier Science Pub. B.V., POB 211,1000 AE Amsterdam, Netherlands) V.1, 1964-, vol 651,pg 40, 2008 |
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Rat hepatocytes,strain indicator:THY Incorp |
|
No metabolicactivation |
4-15 µg/ml,test materialsolvent DMSO |
Unschedule DNA Synthesis Negative |
Oshiro, Y, Bawierz, Ps and Piper,CE; absence of a genotoxic response from steroids in the rat primary hepatocyte unscheduled DNA synthesis assay; Environ.Mutagen. 8 (5):461-465, 1986] |
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Primary rathepatocytes (male) |
Progesterone |
Two experiments |
0.00128 up to10 µg/ml |
Highest concentration causedcytotoxicity. No unscheduled DNA synthesis or S-phase syntesis was induced |
Schering Pharma Research ReportNo. A091. Study to evaluate the potential of Progesterone to induce unscheduled DNA synthesis in isolated rat hepatocytes in vitro, dated. |
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Primary rathepatocytes (female) |
Progesterone |
Two experiments according toGLP |
Experiment 1:0.33, 1.0, 5.0,10.0 or 15.0µg/mlExperiment 2:1.0, 3.0, 5.0,7.0, 9.0 or11.0 µg/ml |
Highest concentration causedcytotoxicity. No concentration dependent reproducible increase in the number of nuclear grain counts were observed |
Schering Pharma Research Report No. A425.Evaluation of the Report: Unscheduled DNA synthesis in primary hepatocytes of rats in vitro with progesterone (Zk 4.981),dated 11 Jan 1993. |
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rat liver cells,female |
Progesterone |
|
|
No induction ofDNA repair |
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work)., p. V6 139 (1974) |
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Human cells |
|
|
|
Sister chromatid exchange SCE (No conclusion) |
Mutat Res 297:101-180,1993 |
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Human lymphocytes |
|
|
20 mg/L |
Sister chromatid exchange |
Mutation Research. (Elsevier Science Pub. B.V.,POB 211, 1000 AE Amsterdam, Netherlands) V.1-1964-, vol 191, pg 121, 1987. |
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Human lymphocytes |
|
|
8 mg/L/22H |
In vitromicronucleolus test |
Mutation Research. (Elsevier Science Pub. B.V.,POB 211, 1000 AEAmsterdam,Netherlands) V.1, 1964-, vol 651, pg 40, 2008 |
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Human fibroblasts |
|
|
12 mg/L |
In vitromicronucleolus test |
Mutation Research. (Elsevie Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands)V.1, 1964-, vol 651, pg 40, 2008 |
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Mouse (BALB/c- 3T3) cells |
|
|
|
Cell transformation Negative |
Mutat Res 114:283-385,1983 |
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Syrian hamster embryo (SHE) cells |
|
|
|
Cell transformation,clonal assayNegative |
Mutat Res 114:283-385,1983 |
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Fischer rat embryo(RLV/1706)cells |
|
|
|
Cell transformation,viral enhanced Positive |
Mutat Res 114:283-385,1983 |
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Rat embryo |
|
|
2600 µg/L |
Morphologicaltransformation |
JNCI, Journal of the National Cancer Institute. (DC) V.61-79, 1978-87. For publisher information, see JNCIEQ., vol 67, pg 1303, 1981. |
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Mousefibroblasts |
|
|
80 µg/L |
Morphologicaltransformation |
JNCI, Journal of the National Cancer Institute. (DC) V.61-79, 1978-87.For publisher information,see JNCIEQ., vol 67, pg 1303, 1981 |
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Hamster-embryo |
|
|
30 mg/L |
Morphologicaltransformation |
Carcinogenesis (). (Univ. Press, Pinkhill House, Southfield Road, Eynsham, Oxford,) V.1- 1980 -, vol 16, pg 1329, 1995. |
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Syrian hamster embryo cells |
Progesterone |
|
Dose that did not induce chromosomalaberrations. |
Induction of celltransformation |
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work).,p. V6 139 (1974) |
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Baby rat kidney cells infected with human papilloma virus -16 carrying the Ha-ras-1 oncogene |
Progesterone |
|
|
Induction of cell transformation |
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). p. V6 139 (1974) |
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Human sperm |
|
|
|
Positive / sperm morphology |
Mutat Res 115:73-148,1983 |
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Mouse sperm |
|
|
|
Negative / sperm morphology |
Mutat Res 115:73-148,1983 |
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Mouse fibroblasts |
-S9, 20 days |
0.01 mg/L |
Morphological transformation |
Environmental and Molecular Mutagenesis.(R.Liss, Inc., 41 E. 11th, New York, NY10003)V.10- 1987-, vol 37, pg 231, 2001 |
in vivo |
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Female SD RatHepatocytes |
Progesterone |
Intragastric (gavage) Dose Regimen: partial hepatecto my after 3 days, rats killed 2 days later |
100 mg/kg bw |
In vivo micronucleolus Positive |
Martelli, A, Mereto, E, Ghia, M, Orsi, P, Allavena, A, Depascalis, C.Rand Brambilla, G;Induction of micronuclei and ofenzyme-altered foc in the liver of female rats exposed to progesterone and three synthetic progestins; Mutat.Res. 419(1-3) 33-41, 1998 |
Male dog or femaleChinese hamster |
Progesterone |
Intramuscular orsubcutaneous |
1-25 mg/animal, 7 daysa week for 6 weeks(intramuscular application) or 1 -100mg/animal, thriceweekly for 4 weeks |
ChromosomalAbnormalities(stickness, clumping,condensation), aneuploidy,polyploidy in meiotic germcells. |
Williams, D.L.,Runyan, J.W.& Hagen, A.A.(1968)Meiotic chromosomealterations produced by progesterone.Williams, D.L.,Hagen, A.A. &Runyan, J.W. Jr &(1971) Chromosomealterations producedin germ cells of dogs by progesterone. J.lab. clin. Med. 77, 417-429.Williams, D.L., Runyan,J.W. Jr. & Hagen, A.A.(1972) Progesterone-induced alteration of oogenesis in the Chinese hamsters. J. lab. clin. Med. 79, 972-977. |
Han Wistar Rat, 3 male and 3 female |
Progesterone |
Daily administration for 14 d Gavage |
100 mg/kg/d |
Slight to moderate apathy and atactic gait. No DNA adducts detected
|
Schering Research Report No. AG18,DNA adduct analysis in liver of male and female rats after daily intragastric administration of chlormadinine acetate, megestrol acetate, drospirenone, ethinylestradiol, norethisterone acetate, gestodene, estradiol orprogesterone over a period of 14 days, dated 23. Aug. 1996. |
Dog |
|
Intraarterial |
100 µg/L |
Cytogenetic Analysis |
Nature. (Nature Subscription Dept., POB 1018, Manasguan, NJ 08736) V.1- 1869-,vol 220, pg 1145,1968. |
Mouse |
|
Oral |
1060 mg/kg |
DNA damage |
Medical ScienceResearch. (ElsevierApplied SciencePub. Ltd., Crown House,,Barking,Essex IG118JU, UK) V.15 -1987-, vol 15, pg 703, 1987. |
Mouse |
|
Subcutaneous |
200 mg/kg |
Unscheduled DNA synthesis |
Journal of Endocrinology.(Biochemical Soc.Book Depot, POB 32,Colchester, CCO2 8HP,) V.1 -1939-, vol 60, pg 167, 1974 |
Mouse |
|
Subcutaneous |
200 mg/kg |
DNA inhibition |
Journal ofEndocrinology.(Biochemical Soc.Book Depot, POB 32,, Colchester, CO2 8HP,)V.1-1939-, vol 60, pg167, 1974 |
Rabbit |
|
Intravenous |
100 µg/L |
DNA damage |
Nippon Naibumpi Gakkai Zasshi.Journal of the Endocrine Society.(NaibumpiGakkai, c/oFuritsu Ika Daigaku, Kojinbashi Nishizume-Sagaru,Kamigyo-ku, Kyoto602, Japan)V.1-1925-, vol 51, pg1043, 1975. |
Rhesus monkey, female |
Progesterone
|
Daily treatment for 12 weeks. Subcutaneous |
0.5, 5.0 or 50.0 µg/ml |
No increase in Erythrocyte micronucleous formation |
Schering Report No.3930, Testing of ZK9.471, ZK 5.931, ZK18.206 and ZK4.981 for mutageniceffects in a micronucleus test on female rhesus monkeysafter 12 weeks administration,dated 17 Jul. 1979. |
Short description of key information:
A study in Wistar rats with application of 100 mg Progesterone per gavage showed no DNA adducts. Furthermore, no increase in erythrocyte micronucleous formation was detected in female rhesus monkeys. Further data is based on the result of a literature search (references are stated in the tables). There is a large amount of in vitro as well as in vivo studies reported in the literature for various endpoints with both, positive and negative results.
Endpoint Conclusion:
Justification for classification or non-classification
Various in vitro and in vivo test systems for investigation of genotoxic properties of progesterone have led to contradictive results.
Different publications show mutagenic effects in vivo and in vitro. A standard micronucleus assay in monkeys and DNA adduct analysis in rats from Schering AG did not indicate any genotoxic potential. Therefore, there are no sufficient evidences available to classify the endogenous substance progesterone as genotoxic.
Progesterone is not classified according to German legislation (TRGS-905).
Classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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