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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
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
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- 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
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- Nanomaterial photocatalytic activity
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- Endpoint summary
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- Environmental data
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- 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
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- Toxicological Summary
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- Specific investigations
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- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
Since progesterone is a naturally occurring hormone in humans, no relevant tumorigenic potential has to be assumed for this compound. However, also during the handling of progesterone it has to be kept in mind that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.
Key value for chemical safety assessment
Justification for classification or non-classification
Classified according to German legislation (TRGS-905) for gestagenic steroids as Carc. Cat. 3 (EEC criteria).
Classified as Category 3, R40 according to Directive 67/548/EEC.
Classified as Category 2 according to Regulation (EC) 1272/2008/EC (CLP).
Additional information
Carcinogenicity Animal Data
Test system |
Substance |
Application |
Test concentration |
End point/Effect |
Literature |
16 ovariectomized C3H mice with mouse tumor virus [MTV+] |
Progesterone |
Intramuscular weekly intravaginal applications of 1% solution of DMBA |
0.2 mg twice weekly |
Incidence of squamous- cell carcinomas increased from 5/15 to 9/16; no change in the incidence of mixed carcinomas (3/8 to 4/16) |
Glucksmann, A & Cherry, C.P. (1962) The effect of castration and of additional hormonal treatments on the induction of cervical and vulval tumours in mice. Br. J. Cancer 16, 634-652. |
C3H female mouse [MTV+] |
Progesterole in peanut oil |
Subcutaneous 5 times/week/19 weeks |
2.5 mg
|
Incidence of breast tumors induced by 3- methyl-cholanthrene to 23/23, compared with 5/24 for 3- methylcholanthrene alone & 2/25 for progesterole alone. |
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work)., p. V6 139 (1974) |
BALB/C mouse |
Progesterone |
Subcutaneous implantation, 18 months treatment |
59-900 µg/day |
Ovarian granulosa cell tumors were found in 27/83 balb/c mice; most of them measuring less than 0.5 mm in diameter. One microscopic tumor occurred among 33 control mice killed after 18 months. |
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work)., p. V6 141 (1974) |
BALB/C mouse |
Progesterone |
Subcutaneous Implantation, 18 months treatment |
18-900 µg/day |
Sarcomas of the endometrial stroma in 15/142 mice after 18 months. No tumors in the 33 control animals |
Lipschütz, A., Iglesias, R, Panasevich, V.I. & Salinas, S. (1967). Granulosa-cell tumors induced in mice by progesterone. Br. J. Cancer 21, 144-152; Lipschütz, A., Iglesias, R, Panasevich, V.I. & Salinas, S. (1967). Pathological changes induced in the uterus of mice withnthe prolonged administration of progesterone and 19-nor- contraceptives. Br. J. Cancer 21, 160-165. |
Neonatal female Balb/cfC3H mouse [MTV+] |
Progesterone |
Subcutaneous |
100 µg/day, alone or in combination with 5 or 20 µg/day Oestradiol 17β |
Persistent vaginal cornification in all 32 mice treated with progesterone alone; simultaneous administration reduced occurrence of vaginal cornification significantly. Mammary tumor incidence was enhanced by progesterone alone (23/32) or in combination with oestradiol (5 µg, 20/32; 20 µg, 33/44), when compared to control animals /5/17). Age of onset was significantly lower in mice given progesterone. |
Jones, L.A. & Bern, H.A. (1977) Long-term effects of neonatal treatment with progesterone, alone or in combination with estrogen, on the mammary gland and reproductive tract of female BALB/cfC3H mice. Cancer Res. 37, 67-75. |
Female C3HXA hybrid mouse [MTV+] |
|
Implantation (subcutaneous) every 28 days during 104 weeks) |
14 mg pellets |
Breast carcinomas significantly earlier age higher incidence (88% at 70 week) than among 58 untreated control mice (62% at 93 week). No mammary tumors in 27 progestrone- treated, intact males. |
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 141(1974) |
27 C3H mice [MTV-] |
Progesterone |
42 weeks |
|
No induction of tumors |
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work)., p. V6 139 (1974) |
Mouse |
|
Subcutaneous |
|
Tumors : mammary gland; ovaries; uterus |
IARC Monographs on the Evaluation of the carcinogenic Risk of Chemicals to Humans, International Agency for Research on Cancer,,, P. V6 135 Y74]/[IARC Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans, International Agency for Research on Cancer, Lyon, France, P. V21 491 Y79 |
BALB/cCrgl female mouse |
Progesterone |
Subcutaneous, 5 days after birth |
100 µg/ 0.02 ml sesame oil |
Induction of genital tract lesions in 15/24 mice [MTV-] at about 1.5-2 years of age. No lesions in control animals. |
Jones, H.A. & Wong, L.M. (1977) Cervicovaginal and mammary gland abnormalities in old BALB/cCrgl mice treated neonatally with progesterone. J.Toxicol. Environ. Health´3, 360 -361. |
13 CBA mouse with mouse tumor virus |
Progesterone |
Subcutaneous, weekly until death |
10 mg |
Mice were given an intrauterine implantation of 0.1 mg 3-methylcholanthrene, mice were ovariectomized. At week 20-29, 2 sarcomas of the uterine horn in 4 mice, 2 sarcomas in 4 other mice that died at 40- 49 weeks. In control mice only receiving MCA, 5 adenocarcinomas, 2 squamos carcinomas and 1 sarcoma were observed. |
Kaslaris, E. & Jull, J.W. (1962) The induction of tumours following the direct implantation of four chemical carcinogens into the uterus of mice and the effect of strain and hormones thereon. B. J. Cancer 16, 479-483. |
C57BL6 mouse |
Progesterone |
Every 3 weeks for 9 weeks |
15 mg after local application of MCA |
Increased incidence of vaginal-cervical invasive squamous- cell carcinomas, from 6/50 with MCA alone to 45/50. |
Muñoz, N. (1973) Effect of herpesvirus type 2 and hormonal imbalance on the uterine cervix of the mouse. Cancer Res. 33, 1504 -1508. |
AXC rat |
Progesterone |
Implantation (subcutaneous) 40 weeks |
20 mg /100 g body wt |
An INCR incidence of liver cell carcinomas induced by N-2 - fluorenyldiacetamide observed in intact male rats (11/11 VS 7/12), in castrated males (5/13 VS 1/9) & in ovariectomized females (4/12 vs 0/14) |
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-present. (Multivolume work). p. V6 142 (1974) |
Female AXC rat
|
Progesterone /and/or diethylstilbestrol (DES) plus irradiation |
Intramuscular implantation |
20 mg / plus irradiation |
Development of mammary tumors inhibited by progesterone. Incidence reduced from 12/21 with DES & irradiation to 1/21 with DES & progesterone + irradiation; incidence 0/11 with progesterone & irradiation. |
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-present. (Multivolume work)., p. V6 142 (1974) |
AXC rat, hysterectomized and ovariectomized |
Progesteron |
Subcutaneous injection or implantation |
2 mg (injection) 20 mg (implantation) |
No affection of incidence of mammary tumors induced by simultaneous administration of DES by 82 weeks of age (18/39 or 17/33 vs. 21/38). |
Segaloff, A. (974) The role of the ovary in estrogen production of mammary cancer in the rat. Cancer Res 34, 2708-2710. |
Female SD rat |
Progesterone |
Subcutaneous, i.g. installation of 20 mg DMBA at 55 days |
1.25 mg in 0.05 mL sesame oil, 5 days of age |
Tumor development in 23/30 animals by 190 days of age. Incidence was similar to that in controls given DMBA only. (20/33). Local number of adeno- carcinomas was higher in progesterone- treated rats (44 vs 27). |
Shellabarger, C.J & Soo, V.A. (1973) Effects of neonatally administered sex steroids on DMBA-induced mammary neoplasia in rats. Cancer Res 33, 1567-1569. |
Female rat |
Progesterone |
Subcutaneous |
0.3 mg, three times weekly for 21 weeks |
Increase of latent period of induction of mammary tumors from 37 to 50 weeks. No change in tumor incidence. |
Cutts, J.H. (1964) Estrone- induced mammary tumors in the rat. II. Effect of alterations in the hormonal environment on tumor induction, behaviour and growth. Cancer Res., 24, 1124-1130. |
Rat |
Progesterone |
Intramuscular |
1 mg twice weekly |
Retardation of app. 4 times the induction of sarcomas of the cervix and vagina produced by local administration of DMBA weekly for life; induction of papillomas was promoted by 19 weeks; progesterone alone did not increase the effects of the carcinogen in ovariectomized animals; when given with oestrogen, the incidence but not the latent period of tumor induction was restored to that of intact females. |
Glucksmann, A & Cherry, C.P. (1968) The effect of oestrogens, testosterone and progesterone on the induction of cervico-vaginal tumours in intact and castrate rats. Br. J. Cancer, 22, 545-562. |
SD Rat |
Progesterone |
Subcutaneous |
3 mg twice weekly for 28 weeks |
Reduction of age at onset of mammary tumors induced by 30 mg DMBA given intragastrically at 50 days of age (52 vs. 115 days) and increased the number of tumors per rat when compared to controls. Mammary tumor incidence not affected (19/20 vs. 16/20). |
Jabara, A.G. & Maritz, J.S. (1973) Effetcts of hypothyroidism and progesterone on mammary tumours induced by DMBA in Sparague-Dawley rats. Br. J. Cancer, 28, 161-172. |
SD Rat |
Progesterone |
Subcutaneous |
4 mg daily for 20 days |
Injection before and after a single iv injection of 5 mg DMBA resulted in a lowered incidence (from 100 to 20) and almost complete inhibition of the tumors for 4 months after the DMBA injection. No mammary tumors appeared in rats treated with progesterone in combination with oestradiol benzoate (5 µg/day) during the same period |
Kledzik, G.S., Bradley, C.J. & Meites, J. (1974) Reduction of carcinogen-induced mammary cancer incidence in rats by early treatment with hormones or drugs. Cancer Res. 34, 2953- 2956. |
Female Beagle dog |
Progesterone |
Subcutaneous,
74 weeks |
0.08-22.5 mg daily |
Endometrial hyperplasia; no tumors in animals killed 24 hr after last dose, but fibro-adenomatous nodules occurred in 2/5 dogs given highest doses |
IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work)., p. V6 141 (1974) |
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