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Administrative data

Description of key information

Only limited information is available concerning acute toxicity of Progesterone. On basis of the low acute toxicity of progesterone after single parenteral administration and the known oral LD50 values for this group of steroidal compounds no risk of acute poisoning has to be assumed after single uptake of progesterone.

Key value for chemical safety assessment

Additional information

Animal Data

Test system

Substance

Application

Test concentration

Toxicity

Reference

Rat

 

Intraperitoneal

 

LD50=327 mg/kg

Drugs in Japan (Ethical Drugs). (Yakugyo Jiho Co., Ltd., Tokyo, Japan), vol -, pg 1183, 1995

Mouse

 

Intravenous

 

LDLo=100 mg/kg

Convulsions or effect on seizure; ataxia dyspnea

 

Journal of Medicinal Chemistry, American Chemical Soc., Distribution Office Dept. 223, POB 57136, West End Stn., Washington, DC 20037) V.6- 1963-, vol 11, pg 117, 1968

Rat

 

Intraperitoneal

1 mg/kg

 

TDLo

Endocrine (estrogenic)

Toxicology and Applied Pharmacology. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1959-, vol 92, pg 368, 1988.

Rat

 

Intraperitoneal

16 mg/kg

 

TDLo

Behavioral (general anesthetic)

Clinical Pharmacology and Therapeutics. American Society for Clinical Pharmacology and Therapeutics, St. Louis Mo Mosby-Year Book) V.1- 1960-, vol 14, pg 727, 1976

Rat

 

Intraperitoneal

20 mg/kg

 

TDLo

Behavioral (alteration of classical conditioning)        

Neuropsychopharmacology. (Elsevier Science, 655 Avenue of the Americas, New York, NY 10010) V.1- 1987-, vol 29, pg 1597, 2004.

Rat

 

Subcutaneous

2.5 mg/kg

TDLo

Behavioral (Changes in psychophysiological     

tests); effects on fertility (mating performance)

Hormones and Behavior. (Academic Press, Inc., 1

E. First St., Duluth, MN 55802) V.1- 1969-, vol

49, pg 105, 2006        

Rat

 

Intramuscular

1 mg/kg

TDLo

Kidney, ureter, bladder (other changes in urine

composition); nutritional and gross metabolic (changes in Na) 

European Journal of Pharmacology. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1967-, vol 454, pg 131, 2002

Mouse

 

Intraperitoneal

5 mg/kg

TDLo

Behavioral (change in motor activity, alteration of classical conditioning)

Neuropsychopharmacology. (Elsevier Science, 655

Avenue of the Americas, New York, NY 10010) V.1- 1987-, vol 23, pg 276, 2000

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.