Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Test system

Substance

Application

Test concentration

Toxicity

Reference

Mouse embryos

Progesterone

Injection on day 15 of gestation into amnionic sac or subcutaneous on days 15, 16 or 17

3.5 mg

Induction of 61% mortality (13 % in control animals), or 65% after subcutaneous injection

Petrelli, E.A. & Forbes, T.R. (1964) Toxicity of progesterone to mouse fetuses. Endocrinology 75, 145- 46.

Mouse

 

Subcutaneous

100 mg/kg (1D preg)

Effects on fertility (Other measures of fertility

Archives of Toxicology, Supplement. (Springer-Verlag New York, Inc., Service

Center, 44 Hartz Way, Secaucus, NJ 07094) No.1-1978-, vol 4, pg 248, 1980.

Mouse

 

Subcutaneous

20 mg/kg (6-9D preg)

Effects on fertility (post-implantation

mortality); effects on embryo or fetus

(fetotoxicity

Oyo Yakuri. Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V.1- 1967-, vol 15, pg 955, 1978.

Mouse

 

Subcutaneous

1500 µg/kg (3D pre)

Maternal effects (uterus, cervix, vagina

Journal of Reproduction and Fertility (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-, vol 5, pg 331, 1963.

Mouse

 

Implant

3 mg/kg (5D pre)

Maternal effects (uterus, cervix, vagina

Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1- 1970-, vol 16, pg 357,   

1977.

Rat

 

Oral

25 mg/kg (1D pre)

Effects on fertility (mating performance)      

Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282)  V.1- 1950-, vol 5, pg 282, 1954.

Rat

 

Oral

180 mg/kg (9D male)

Paternal effects (prostate, seminal vessicle, Cowper's gland, accessory glands)

 

Proceedings of the Society for Experimental    Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04-, vol 100, pg 540, 1959.

Rat

 

Oral

50 mg/kg (1D pre)

Effects on fertility (mating performance)      

Acta Endocrinologica, Supplementum

(Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) No.1- 1948-, vol 28, pg 18, 1956.

Rat

 

Oral

700 mg/kg (14D pre)

Maternal effects (Uterus, cervix, vagina)

Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950-, vol 24, pg 284, 1973.

Rat

 

Dermal

240 mg/kg (30D male)

Paternal effects (prostate, seminal vessicle, Cowper's gland, accessory glands; prostate, seminal vessicle, Cowper's gland, accessory glands)                                        

Steroids. (Holden-Day Inc., 4432 Telegraph Ave., Oakland, CA 94609) V.1- 1963-, vol 10, pg 687, 1967.

Rat

 

Subcutaneous

7 mg/kg (10-16D preg)

Effects on fertility (abortion)

Journal of Physiology. (Cambridge Univ. Press, 

32 E. 57th St., New York, NY 10022) V.1- 1878-,

vol 164, pg 138, 1962.

Rat

 

Subcutaneous

188 mg/kg (30D pre)

Maternal effects (menstrual cycle changes or disorders)

 

Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04-, vol 108, pg 3, 1961.

Rat

 

Subcutaneous

20 mg/kg (23D preg)

Maternal effects (parturition; postpartum); effects on newborn (growth statistics)

Proceedings of the Society for Experimental Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04-, vol 145, pg 1047, 1974.

Rat

 

Intramuscular

900 ug/kg (6-14D preg)

Effects on fertility (post-implantation

mortality)

 

Folia Biologica (Krakow). (Ars Polona, 1001, 00-068 Warsaw 1, Poland) V.1- 1953-, vol 16, pg 343, 1968.

Rat

 

Intramuscular

200 mg/kg (48D male

Paternal effects (testes, epididymis, sperm duct; prostate, seminal vessicle, Cowper's gland, accessory glands; other effects on male

Indian Journal of Experimental Biology. Publications & Information Directorate, CSIR, Hillside Rd., New Delhi 110 012, India) V.1-1963-, vol 5, pg 45, 1967.

Rat

 

Intracerebral

250 µg/kg (1D pre)                             

Effects on fertility (other measures of

fertility

Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-, vol 27, pg 445, 1971.

Rat

 

Parenteral

8750 µg/kg (7D pre

Maternal effects (uterus, cervix, vagina)

Journal of Experimental Medicine. (Rockefeller 

Univ. Press, 1230 York Ave., New York, NY 10021) V.1- 1896-, vol 102, pg 347, 1955.

Rat

 

Implant

250 µg/kg (2D post)

Maternal effects (postpartum)

Biology of Reproduction. (Soc. for the Study of

Reproduction, 309 W. Clark St., Champaign, IL 1820) V.1- 1969-, vol 7, pg 109, 1972.

Rat

 

Implant

30 mg/kg (24D pre)

Maternal effects (ovaries, fallopian tubes)

Biology of Reproduction. (Soc. for the Study of

Reproduction, 309 W. Clark St., Champaign, IL 61820) V.1- 1969-, vol 2, pg 315, 1970.

52 rabbits exposed to vaginal strings containing 3-Methylcholanthrene

Progesterone

Subcutaneous injection, twice weekly for 20 months

10 mg

 

No incidence of vaginal tumors occurring within incidences being 5/23 in controls compared

with 4/30 in treated animals.

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).

Rabbit

 

Subcutaneous

50 ug/kg (5D pre)

Maternal effects (uterus, cervix, vagina)

Anatomical Record. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1- 1906/08-, vol 142, pg 469, 1962.

Rabbit

 

Subcutaneous

50 µg/kg (1D pre)

Effects on fertility (other measures of fertility)

Acta Endocrinologica, Supplementum (Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) No.1- 1948-, vol 73, pg 3, 1963.

Rabbit

 

Subcutaneous

70 mg/kg (14D male)

Paternal effects (spermatogenesis; other effects on male)

Nature. (Nature Subscription Dept., POB 1018, Manasguan, NJ 08736) V.1- 1869-, vol 204, pg 261, 1964.

Rabbit

 

Subcutaneous

300 µg/kg (2D pre/1D pre)

Effects on fertility (pre-implantation mortality)

 

American Journal of Obstetrics and Gynecology. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920-, vol 117, pg 167, 1973.

Rabbit

 

Subcutaneous

100 µg/kg (1D pre)

Maternal effects (ovaries, fallopian tubes)

Journal of Physiology. (Cambridge Univ. Press, 32 E. 57th St., New York, NY 10022) V.1- 1878-, vol 181, pg 568, 1965.

Rabbit

 

Oral

1 mg/kg (1D pre/1D preg)

Effects on fertility (other measures of

fertility)

Endocrinology (Baltimore). (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21203) V.1- 1917-, vol 79, pg 939, 1966.

Rabbit

 

Dermal

500 µg/kg (1D pre)

Effects on fertility pre-implantation   

mortality)

Steroids. (Holden-Day Inc., 4432 Telegraph Ave., Oakland, CA 94609) V.1- 1963-, vol 7, pg 341, 1966.

Rabbit

 

Intramuscular

8 mg/kg (2-9D preg)

Effects on fertility (pre-implantation mortality)

Australian Journal of Biological Sciences.     

(Commonwealth Scientific and Industrial Research Organization, 314 Albert St., E. Melbourne, Vic. 3002, Australia) V.6- 1953-, vol 28, pg 291, 1975.

Rabbit

 

Intramuscular

8 mg/kg (2-9D preg)

Maternal effects (postpartum)

Journal of Animal Science. (American Soc. of Animal Science, 309 W. Clark St., Champaign, IL 61820) V.1- 1942-, vol 42, pg 131, 1976.

Rabbit

 

Intramuscular

2500 mg/kg (2D pre)

Effects on fertility (female fertility index; pre-implantation mortality); specific developmental abnormalities (other developmental abnormalities)

Biology of Reproduction. (Soc. for the Study of

Reproduction, 309 W. Clark St., Champaign, IL 61820) V.1- 1969-, vol 14, pg 451, 1976.

Rabbit

 

Intrauterine

684 µg/kg (14D pre/1-10D)

Effects on Fertility (pre-implantation mortality)

American Journal of Obstetrics and Gynecology. 

(C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920-, vol 109, pg 536, 1971                                      

Dog

 

Subcutaneous

16 mg/kg (5D pre)

Maternal Effects (uterus, cervix, vagina)

Contraception. (Geron-X, Inc., POB 1108, Los   

Altos, CA 94022) V.1- 1970-, vol 12, pg 529,   

1975.

Dog

 

Implant

360 mg/kg (34W pre)

Effects on fertility (other measures of fertility)

Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950-, vol 36, pg 373, 1981.

Dog

 

Implant

600 mg/kg (60W pre)

Maternal effects (breasts, lactation)

Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950-, vol 36, pg 373, 1981.

Pig

 

Subcutaneous

40 mg/kg (16D pre)

Maternal effects (ovaries, fallopian tubes)

Journal of Reproduction and Fertility (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-, vol 19, pg 541, 1969.

Pig

 

Subcutaneous

1667 µg/kg (1D pre)

Effects on fertility (other measures of fertility)

Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-, vol 17, pg 227, 1968.

Guinea Pig

 

Intramuscular

1480 mg/kg (70D male)

Paternal effects (testes, epididymis, sperm duct); effects on fertility (mating  performance)

Nature. (Nature Subscription Dept., POB 1018, Manasguan, NJ 08736) V.1- 1869-, vol 209, pg 1322, 1966.

Hamster

 

Subcutaneous

240 ug/kg (1D pre)

Effects on fertility (other measures of

fertility) 

Proceedings of the Society for Experimental

Biology and Medicine. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1903/04-, vol 169, pg 189, 1982.

Hamster

 

Subcutaneous

2 mg/kg (1D pre)

Maternal effects (uterus, cervix, vagina)

Journal of Reproduction and Fertility. Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-, vol 42, pg 341, 1975.

Hamster

 

Subcutaneous

80 mg/kg (1D preg)

Maternal effects (parturition); Effects on newborn (live birth index)

Biology of Reproduction. (Soc. for the Study of

Reproduction, 309 W. Clark St., Champaign, IL 61820) V.1- 1969-, vol 6, pg 281, 1972.

Hamster

 

Subcutaneous

32 mg/kg (1D pre)

Effects on fertility (female fertility index)

Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-,

vol 16, pg 499, 1968.

Hamster

 

Parenteral

2400 ug/kg (3D pre)

Effects on fertility (mating performance)

Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-, vol 37, pg 269, 1974.

Monkey

 

Inhalation

30 µg/kg/30M (60D male)

Paternal effects (spermatogenesis; testes, epididymis, sperm duct)

Biology of Reproduction. (Soc. for the Study of

Reproduction, 309 W. Clark St., Champaign, IL 61820) V.1- 1969-, vol 22, pg 935, 1980.

Monkey

 

Inhalation

4 µg/kg (10D pre)

Effects on fertility (other measures of

fertility)

Nature. (Nature Subscription Dept., POB 1018, Manasguan, NJ 08736) V.1- 1869-, vol 270, pg 32, 1977.

Monkey

 

Subcutaneous

900 µg/kg (9D pre)

Effects on fertility (other measures of fertility)                            

 

Endocrinology (Baltimore). (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21203) V.1- 1917-, vol 90, pg 257, 1972.

Monkey

 

Intramuscular

12 mg/kg (8D pre)                              

Effects on fertility (other measures of

fertility

Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950-, vol 39 (Suppl), pg 419, 1983.

Monkey

 

Intravaginal

85410 µg/kg (52W pre)

Maternal effects (uterus, cervix, vagina); effects on fertility (other measures of fertility)

Contraception. (Geron-X, Inc., POB 1108, Los Altos, CA 94022) V.1- 1970-, vol 20, pg 339, 1979.

Women

 

Oral

200 mg/kg (20D pre)

TDLo

Maternal effects (uterus, cervix, vagina)

American Journal of Obstetrics and Gynecology. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63146)

 V.1- 1920-, vol 85, pg

427, 1963.

Woman

 

Oral

120 mg/kg (20D pre)

Effects on fertility (other measures of fertility)                      

 

Vitamins and Hormones. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1943-, vol 17, pg 307, 1959.

Woman

 

Oral

100 mg/kg (20D pre)

Maternal effects (uterus, cervix, vagina)

Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282) V.1- 1950-, vol 16, pg 158, 1965.

Woman

 

Oral

120 mg/kg (20D pre)

Maternal effects (menstrual cycle changes or disorders); effects on fertility (female fertility index; other measures of fertility)  

Acta Endocrinologica, Supplementum       

(Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) No.1- 1948-, vol 28, pg 18, 1956.

Woman

 

Parenteral

32 mg/kg (3W pre)

Maternal effects (menstrual cycle changes or disorders)

American Journal of Obstetrics and Gynecology. 

(C.V. Mosby Co., 11830 Westline Industrial Dr.,St. Louis, MO 63146) V.1- 1920-, vol 76, pg 626, 1958.

Woman

 

Intravaginal

210 mg/kg (3W pre)

Maternal effects (menstrual cycle changes or disorders) 

American Journal of Obstetrics and Gynecology. 

(C.V. Mosby Co., 11830 Westline Industrial Dr.,St. Louis, MO 63146) V.1- 1920-, vol 76, pg 626, 1958.

Woman

 

Intravaginal

475 ug/kg (1Y pre)

Maternal effects (menstrual cycle changes or disorders)

 

Contraception. (Geron-X, Inc., POB 1108, Los

Altos, CA 94022) V.1- 1970-, vol 13, pg 559,   

1976.

Man

 

Intramuscular

50 mg/kg (70D male)

Paternal effects (spermatogenesis; breast development)                                   

 

Annals of the New York Academy of Sciences.   New York Academy of Sciences, 2 E. 63rd St., New York, NY 10021) V.1- 1877-, vol 71, pg 649, 1958.

Man

 

Intramuscular

15 mg/kg (21D male)

Paternal effects (impotence)                   

Annals of the New York Academy of Sciences.   New York Academy of Sciences, 2 E. 63rd St., New York, NY 10021) V.1- 1877-, vol 71, pg 649, 1958.

 Mouse  
Parental   

TDLo 250000 µg/kg/5 days-I Maternal Effects (Oogenesis;

Ovaries, fallopian tubes)

Teratology, The International

Journal of Abnormal Development. (Alan R. Liss, Inc., 41 E. 11th St.,, NY 10003) V.1- 1968 -.

Vol 34, pg 29, 1986
 
 Mouse  Intraperitoneal
277.5 mg/kg/5D-I
Maternal effects (ovaries, fallopian
tubes)

Teratology, The International

Journal of Abnormal

Development. (Alan R. Liss, Inc., 41 E. 11th St.,, NY 10003) V.1- 1968-,

Vol 34, pg 29, 198


Short description of key information:
Corresponding to the progestogenic efficacy of the compound repeated exposure to pharmacologically active doses may result in disturbances of endogenous hormone production and consequently to reversible inhibition of fertility in men and women.

Effects on developmental toxicity

Description of key information
Progesterone is the naturally occurring hormone for maintenance of pregnancy. Therefore, no teratogenic potential has to be assumed. However, progestogens exerted embryolethal effects in animal experiments. In addition, it should be prudently assumed that after intake of large doses the compound might be transferred into the milk of breast-feeding women and might lead to a disturbance of the development of the infant.
Additional information

Test system

Substance

Application

Test concentration

Toxicity

Reference

Mouse

 

Subcutaneous

240 mg/kg (14-16D preg

Effects on newborn (biochemical and metabolic; delayed effects)

Developmental Pharmacology and Therapeutics. (S. Karger Pub., Inc., 79 Fifth Ave., New York,

NY 10003) V.1- 1980-, vol 10, pg 385, 1987.

Rat

Progesterone

Subcutaneous injection

5-200 mg/day on days 15-20 of gestation

No abnormalities of external or internal genitalia.

Revesz, C., Chappel, C.I. & Gaudry, R. (1960) Masculinization of female fetuses in the rat by progestational compounds. Endocrinology 66, 140-144.

Rat

 

Subcutaneous

420 mg/kg (15-17D preg)

Effects on embryo or fetus (fetal death)

Endocrinology (Baltimore). (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21203) V.1- 1917-, vol 75, pg 145, 1964.

Rat

 

Subcutaneous

9 mg/kg (15-20D preg)

Specific developmental abnormalities

urogenital system)

 

Journal of Reproduction and Fertility.

(Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960-, vol 5, pg 331, 1963.

Rat

 

Subcutaneous

1 mg/kg (9D preg

Effects on newborn (behavioral)

Bulletin of Experimental Biology and Medicine

(English Translation). Translation of BEBMAE.  

Plenum Pub. Corp., 233 Spring St., New York,  

NY 10013) V.41- 1956-, vol 74, pg 1255, 1972.

Rat

 

Intramuscular

110 mg/kg (1-22D preg)

Effects on newborn (delayed effects)

Journal of Clinical Investigation. (Rockefeller Univ. Press, 1230 York Ave., New York, NY 10021) V.1- 1924-, vol 41, pg 710, 1962.

Rat

 

Intramuscular

30 mg/kg (1-6D preg)                           

Effects on embryo or fetus (fetotoxicity

Folia Biologica (Krakow). (Ars Polona, POB 1001, 00-068 Warsaw 1, Poland) V.1- 1953-, vol 16, pg 343, 1968.

Rat

 

Parenteral

36300 µg/kg (7-17D preg

Specific developmental abnormalities (central nervous system); Effects on newborn (biochemical and metabolic)

 

Brain Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1-1966-, vol 170, pg 194, 1979.

Rat

 

Parenteral

60 µg/kg (16-19D preg)              

Specific developmental abnormalities (blood and lymphatic system)

Bulletin of Experimental Biology and Medicine (English Translation). Translation of BEBMAE.  

(Plenum Pub. Corp., 233 Spring St., New York, NY 10013) V.41- 1956-, vol 82, pg 1561, 1976.

Rat

 

Parenteral

36300 µg/kg (7-17D preg

Specific developmental abnormalities (central nervous system); effects on Newborn (biochemical and metabolic)

Brain Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1-1966-, vol 170, pg 194, 1979.

Rabbit

Progesterone

Injection on days 1-4 of gestation

1 mg/day

No discernible effect on 6.5 days-old blastocytes

Adams, C.E., Hay, M.F. & Lutwak-Mann, C. (1961) The action of various agents upon the rabbit embryo. J. Embryol exp. Morphol. 9, 468-491.

Rabbit (10)

Progesterone

Injection on days 8-16 of gestation

30 mg/kg/day

Virilization of the fetuses (increase in anourethral distance in both sexes) and an excess of males (F:M = 1.78:2.07).

Piotrowski, J. (1969) Experimental studies on the effect of some steroid hormones on the development of the rabbit fetus. II (Pol.). Przegl. Lek., 25, 322-324.

Pig

 

Intramuscular

18333 µg/kg (15-25D preg

Specific developmental abnormalities urogenital system)

Biology of Reproduction. (Soc. for the Study of

Reproduction, 309 W. Clark St., Champaign, IL 61820) V.1- 1969-, vol 52, pg 1389, 1995.

Guinea Pig

 

Subcutaneous

86 mg/kg (18-60D preg)

Specific developmental abnormalities (urogenital system)

Fertility and Sterility. (American Fertility Soc., 608 13th Ave. S, Birmingham, AL 35282)          V.1- 1950-, vol 19, pg 606, 1968.

Female Guinea pig (7)

Progesterone

Subcutaneous injection from day 18 after mating until day 60

1 mg/animal

No masculinisation.

Foote, D.W., Foote, W.C. & Foote, L.H. (1968) Influence of certain natural and synthetic steroids in genital development in guinea pigs. Fertil. Steril. 19, 606-615.

Macca mulatta (Rhesus) monkey

Progesterone

Intramuscular

50 mg, 5 days a week from day 24-28 of gestation until term

No change in duration of pregnancy and no abnormalities in offspring.

Wharton, L.R. & Scott, R.B. (1964) Experimental production of genital lesions with norethindrone. Am. J. Obstet. Gynecol. 89, 701-715.

Woman

 

Oral

113 mg/kg (6-32W preg)

Specific developmental abnormalities urogenital system)

 

Journal of Clinical Endocrinology and

Metabolism. (Williams & Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.12- 1952-, 

ol 19, pg 1369, 1959.

Woman

 

Parenteral

600 µg/kg (67-71D preg)

Specific developmental abnormalities urogenital system)

 

Mayo Clinic Proceedings. (Room 1035, Plummer Bldg., Mayo Clinic, Rochester, MN 55905) V.39 1964-, vol 33, pg 200, 1958.

Woman

 

Unreported

386 mg/kg (18-34W preg)

Specific developmental abnormalities urogenital system)

 

AMA Journal of Diseases of Children. (Chicago, IL) V.91-99, 1956-60. For publisher information, see AJDCAI., vol 95, pg 9, 1958.

Justification for classification or non-classification

Corresponding to the progestogenic efficacy of the compound repeated exposure to pharmacologically

active doses may result in disturbances of endogenous hormone production and consequently to reversible inhibition of fertility in men and women. Progesterone is the naturally occurring hormone for maintenance of pregnancy. Therefore, no teratogenic potential has to be assumed. However, progestogens exerted embryolethal effects in animal experiments. In addition, it should be prudently assumed that after intake of large doses the compound might be transferred into the milk of breast-feeding women and might lead to a disturbance of the development of the infant.

Classified according to German legislation (TRGS-905) as Repr. (F) Cat. 1 and Repr. (E) Cat. 2 (EEC criteria).

Classified as Category 1A according to Regulation (EC) 1272/2008 (CLP).

According to the Directive 67/548 EEC progesterone is classified:

Category 1; R60 - May impair fertility.

Category 2; R61 - May cause harm to the unborn child.

R64 - May cause harm to breastfed babies

Additional information