Norethindrone

Modify Date: 2024-01-02 12:50:43

Norethindrone Structure
Norethindrone structure
Common Name Norethindrone
CAS Number 68-22-4 Molecular Weight 298.419
Density 1.2±0.1 g/cm3 Boiling Point 447.0±45.0 °C at 760 mmHg
Molecular Formula C20H26O2 Melting Point 205-206 °C(lit.)
MSDS Chinese USA Flash Point 190.5±21.3 °C
Symbol GHS08
GHS08
Signal Word Warning

 Use of Norethindrone


Norethindrone is a female progestin approved by FDA for the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary amenorrhea.

 Names

Name norethisterone
Synonym More Synonyms

 Norethindrone Biological Activity

Description Norethindrone is a female progestin approved by FDA for the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary amenorrhea.
Related Catalog
Target

Progesterone Receptor[1]

In Vivo Norethindrone acetate could be a cost-effective alternative with relatively mild side effects in the treatment of symptomatic endometriosis. Subjects treated with norethindrone acetate obtain dysmenorrhea and noncyclic pelvic pain relief[1]. Norethindrone acetate alone is a well-tolerated, effective option to manage pain and bleeding for all stages of endometriosis. Post-Norethindrone acetate bleeding scores are improved regardless of prior hormonal regimen, and post-Norethindrone acetate pain scores improved in all patients except for those previously prescribed GnRH-agonist plus add-back[2]. Norethindrone acetate shows low acute toxicity in experimental animals and is consistent with the lack of toxicity seen in humans. Administration of norethindrone acetate alone to rodents at several multiples of the human dose results in no treatment related mortality, hematological changes, behavioral changes, or organ pathology[3]. Norethindrone acetate administration leads to significant and proportional reductions of the concentrations of triglycerides, cholesterol and phospholipids of plasma lipoproteins of density <1.006 of rats fed a high carbohydrate diet. Norethindrone acetate (0.1 mM) also significantly inhibits the incorporation of both palmitate and glycerol into triglycerides of isolated hepatocytes from fed rats[4].
Animal Admin Rats: Female Sprague-Dawley rats (200-210 g), 6 of which serve as controls, are individually caged in an animal room illuminated from 9:00 a.m. to 9:00 p.m. Each of the 7 rats receiving norethindrone acetate is fed 35 μg/day for 2 weeks. Water and the rat chow which is high in carbohydrate are available ad libitum[4].
References

[1]. Muneyyirci-Delale O, et al. Effect of norethindrone acetate in the treatment of symptomatic endometriosis. Int J Fertil Womens Med. 1998 Jan-Feb;43(1):24-7.

[2]. Kaser DJ, et al. Use of norethindrone acetate alone for postoperative suppression of endometriosis symptoms. J Pediatr Adolesc Gynecol. 2012 Apr;25(2):105-8.

[3]. Maier WE, et al. Pharmacology and toxicology of ethinyl estradiol and norethindrone acetate in experimental animals. Regul Toxicol Pharmacol. 2001 Aug;34(1):53-61.

[4]. Cheng DC, et al. Norethindrone acetate inhibition of triglyceride synthesis and release by rat hepatocytes. Atherosclerosis. 1983 Jan;46(1):41-8.

 Chemical & Physical Properties

Density 1.2±0.1 g/cm3
Boiling Point 447.0±45.0 °C at 760 mmHg
Melting Point 205-206 °C(lit.)
Molecular Formula C20H26O2
Molecular Weight 298.419
Flash Point 190.5±21.3 °C
Exact Mass 298.193268
PSA 37.30000
LogP 3.38
Vapour Pressure 0.0±2.5 mmHg at 25°C
Index of Refraction 1.577
Storage condition -20°C Freezer
Water Solubility chloroform: ≥50 mg/mL, clear, colorless

 MSDS


Section 1. Chemical Product and Company Identification
Norethindrone
Common Name/
Trade Name
Manufacturer
Commercial Name(s)
Synonym
Chemical Name
Chemical Family
Norethindrone

Section 4. First Aid Measures
Eye ContactCheck for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at
least 15 minutes. Get medical attention if irritation occurs.
Skin ContactWash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
Serious Skin ContactNot available.
InhalationIf inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
medical attention.
Serious InhalationNot available.
IngestionDo NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an
unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if
symptoms appear.
Serious IngestionNot available.

Section 5. Fire and Explosion Data
Flammability of the Product May be combustible at high temperature.
Auto-Ignition Temperature Not available.
Flash PointsNot available.
Flammable LimitsNot available.
Products of CombustionNot available.
Fire Hazards in Presence of Slightly flammable to flammable in presence of heat.
Various SubstancesNon-flammable in presence of shocks.
Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available.
Risks of explosion of the product in presence of static discharge: Not available.
of Various Substances
SMALL FIRE: Use DRY chemical powder.
Fire Fighting Media
and InstructionsLARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Not available.
Special Remarks on
Fire Hazards
Special Remarks on Explosion Not available.
Hazards

Section 6. Accidental Release Measures
Small SpillUse appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by
spreading water on the contaminated surface and dispose of according to local and regional authority
requirements.
Large SpillUse a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water
on the contaminated surface and allow to evacuate through the sanitary system.
Norethindrone

Section 7. Handling and Storage
PrecautionsKeep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk,
evaporate the residue under a fume hood. Ground all equipment containing material. Do not ingest. Do not
breathe dust. Wear suitable protective clothing. If ingested, seek medical advice immediately and show the
container or the label. Keep away from incompatibles such as oxidizing agents.
StorageKeep container tightly closed. Keep container in a cool, well-ventilated area.

Section 8. Exposure Controls/Personal Protection
Engineering ControlsUse process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below
recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to
airborne contaminants below the exposure limit.
Personal ProtectionSafety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
Personal Protection in Case of Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used
a Large Spillto avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist
BEFORE handling this product.
Exposure LimitsNot available.

Section 9. Physical and Chemical Properties
Physical state and appearance Solid. (Powdered solid.)OdorOdorless.
Bitter. (Slight.)
Taste
Molecular Weight298.4 g/mole
White.
Color
Not applicable.
pH (1% soln/water)
Boiling PointNot available.
Melting Point204°C (399.2°F)
Critical TemperatureNot available.
Specific GravityNot available.
Not applicable.
Vapor Pressure
Vapor DensityNot available.
Not available.
Volatility
Odor ThresholdNot available.
Water/Oil Dist. Coeff.The product is more soluble in oil; log(oil/water) = 3
Ionicity (in Water)Not available.
Dispersion PropertiesSee solubility in water, diethyl ether.
SolubilityPartially soluble in diethyl ether.
Very slightly soluble in acetone.
Insoluble in cold water.

Section 10. Stability and Reactivity Data
StabilityThe product is stable.
Not available.
Instability Temperature
Conditions of InstabilityExcess heat, incompatible materials
Incompatibility with various Reactive with oxidizing agents.
substances
Norethindrone
Not available.
Corrosivity
Special Remarks onNot available.
Reactivity
Special Remarks onNot available.
Corrosivity
Will not occur.
Polymerization

Section 11. Toxicological Information
Routes of EntryInhalation. Ingestion.
Toxicity to AnimalsAcute oral toxicity (LD50): 6000 mg/kg [Mouse].
Chronic Effects on HumansMUTAGENIC EFFECTS: Mutagenic for mammalian somatic cells.
DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Reproductive system/toxin/male
[SUSPECTED].
May cause damage to the following organs: the reproductive system.
Other Toxic Effects onSlightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.
Humans
Special Remarks onNot available.
Toxicity to Animals
Special Remarks onMay cause cancer.
Chronic Effects on HumansMay cause adverse reproductive effects(maternal and paternal effects, effects on male and female fertility) and
birth defects.
Special Remarks on otherAcute Potential Health Effects:
Toxic Effects on HumansSkin: May cause skin irritation.
Eyes: May cause eye irritation.
Inhalation: May cause respiratory tract irritation.
Ingestion: May cause gastrointestinal tract irritation. May affect endocrine system and skin (dermatitis), and
blood.

Section 12. Ecological Information
EcotoxicityNot available.
Not available.
BOD5 and COD
Possibly hazardous short term degradation products are not likely. However, long term degradation products may
Products of Biodegradation
arise.
Toxicity of the ProductsNot available.
of Biodegradation
Special Remarks on theNot available.
Products of Biodegradation

Section 13. Disposal Considerations
Waste DisposalWaste must be disposed of in accordance with federal, state and local environmental
control regulations.
Norethindrone

Section 14. Transport Information
DOT ClassificationNot a DOT controlled material (United States).
IdentificationNot applicable.
Not applicable.
Special Provisions for
Transport
DOT (Pictograms)

Section 15. Other Regulatory Information and Pictograms
California prop. 65: This product contains the following ingredients for which the State of California has found to
Federal and State
cause cancer, birth defects or other reproductive harm, which would require a warning under the statute:
Regulations
Norethindrone
California prop. 65: This product contains the following ingredients for which the State of California has found to
cause birth defects which would require a warning under the statute: Norethindrone
California prop. 65: This product contains the following ingredients for which the State of California has found to
cause cancer which would require a warning under the statute: Norethindrone
Illinois toxic substances disclosure to employee act: Norethindrone
Pennsylvania RTK: Norethindrone
Minnesota: Norethindrone
Massachusetts RTK: Norethindrone
California Director's list of Hazardous Substances: Norethindrone
CaliforniaCalifornia prop. 65: This product contains the following ingredients for which the State of California has found
Proposition 65to cause cancer which would require a warning under the statute: Norethindrone
Warnings
California prop. 65: This product contains the following ingredients for which the State of California has found
to cause birth defects which would require a warning under the statute: Norethindrone
Other RegulationsOSHA: Hazardous by definition of Hazard Communication Standard (29 CFR 1910.1200).
EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances.
WHMIS (Canada) Not controlled under WHMIS (Canada).
Other Classifications
DSCL (EEC)R40- Possible risks of irreversibleS2- Keep out of the reach of children.
effects.S36/37- Wear suitable protective clothing and
R60- May impair fertility.gloves.
S45- In case of accident or if you feel unwell,
seek medical advice immediately (show the
label where possible).
S53- Avoid exposure - obtain special
instructions before use.
Health Hazard
HMIS (U.S.A.)1 National Fire Protection
1 Flammability
1 Association (U.S.A.)
Fire Hazard
1 0 Reactivity
Health
Reactivity
0
Specific hazard
Personal Protection
E
WHMIS (Canada)
(Pictograms)
Norethindrone
DSCL (Europe)
(Pictograms)
TDG (Canada)
(Pictograms)
ADR (Europe)
(Pictograms)
Protective Equipment
Gloves.
Lab coat.
Dust respirator. Be sure to use an
approved/certified respirator or
equivalent.


SECTION 16 - ADDITIONAL INFORMATION
N/A

 Toxicological Information

CHEMICAL IDENTIFICATION

RTECS NUMBER :
RC8975000
CHEMICAL NAME :
19-Nor-17-alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-
CAS REGISTRY NUMBER :
68-22-4
BEILSTEIN REFERENCE NO. :
1915671
LAST UPDATED :
199612
DATA ITEMS CITED :
89
MOLECULAR FORMULA :
C20-H26-O2
MOLECULAR WEIGHT :
298.46
WISWESSER LINE NOTATION :
L E5 B666 OV MUTJ E FQ F1UU1 -A&F

HEALTH HAZARD DATA

ACUTE TOXICITY DATA

TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
SPECIES OBSERVED :
Human - woman
DOSE/DURATION :
42 mg/kg
TOXIC EFFECTS :
Endocrine - androgenic Skin and Appendages - dermatitis, other (after systemic exposure)
TYPE OF TEST :
LD50 - Lethal dose, 50 percent kill
ROUTE OF EXPOSURE :
Oral
SPECIES OBSERVED :
Rodent - mouse
DOSE/DURATION :
6 gm/kg
TOXIC EFFECTS :
Details of toxic effects not reported other than lethal dose value
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Intramuscular
SPECIES OBSERVED :
Rodent - rat
DOSE/DURATION :
30 mg/kg/15D-I
TOXIC EFFECTS :
Blood - changes in serum composition (e.g. TP, bilirubin, cholesterol) Biochemical - Metabolism (Intermediary) - lipids including transport
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
SPECIES OBSERVED :
Rodent - mouse
DOSE/DURATION :
163 mg/kg/78W-C
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria Reproductive - Tumorigenic effects - ovarian tumors
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Parenteral
SPECIES OBSERVED :
Rodent - mouse
DOSE/DURATION :
168 mg/kg/78W-C
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria Reproductive - Tumorigenic effects - ovarian tumors
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Implant
SPECIES OBSERVED :
Rodent - mouse
DOSE/DURATION :
166 mg/kg/77W-C
TOXIC EFFECTS :
Tumorigenic - equivocal tumorigenic agent by RTECS criteria Tumorigenic - increased incidence of tumors in susceptible strains
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
4 mg/kg
SEX/DURATION :
female 20 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
7143 ug/kg
SEX/DURATION :
male 25 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material, sperm morphology, motility, and count) Reproductive - Paternal Effects - impotence Reproductive - Paternal Effects - other effects on male
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
4200 ug/kg
SEX/DURATION :
female 21 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
37800 ug/kg
SEX/DURATION :
female 7-24 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
210 ug/kg
SEX/DURATION :
female 30 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant per # sperm positive females; # females pregnant per # females mated) Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
18 mg/kg
SEX/DURATION :
male 42 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material, sperm morphology, motility, and count) Reproductive - Paternal Effects - testes, epididymis, sperm duct Reproductive - Paternal Effects - impotence
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
18 mg/kg
SEX/DURATION :
male 42 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - breast development
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
28 mg/kg
SEX/DURATION :
female 5-25 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
63 mg/kg
SEX/DURATION :
female 10-39 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
2190 ug/kg
SEX/DURATION :
female 52 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
7 ug/kg
SEX/DURATION :
lactating female 1 day(s) post-birth
TOXIC EFFECTS :
Reproductive - Maternal Effects - postpartum
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
37800 ug/kg
SEX/DURATION :
female 7-24 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Implant
DOSE :
230 ug/kg
SEX/DURATION :
female 26 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant per # sperm positive females; # females pregnant per # females mated)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Unreported
DOSE :
131 ug/kg
SEX/DURATION :
female 52 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Unreported
DOSE :
4200 ug/kg
SEX/DURATION :
female 6-8 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - musculoskeletal system Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Unreported
DOSE :
14 mg/kg
SEX/DURATION :
female 6-39 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Unreported
DOSE :
12 mg/kg
SEX/DURATION :
female 6-20 week(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Newborn - behavioral
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Unreported
DOSE :
76 mg/kg
SEX/DURATION :
female 6-32 week(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Unreported
DOSE :
84 ug/kg
SEX/DURATION :
female 12 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - ovaries, fallopian tubes
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
50 mg/kg
SEX/DURATION :
female 5 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
28 mg/kg
SEX/DURATION :
male 14 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland, accessory glands
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
188 mg/kg
SEX/DURATION :
female 15-17 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus) Reproductive - Specific Developmental Abnormalities - skin and skin appendages Reproductive - Specific Developmental Abnormalities - musculoskeletal system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
100 mg/kg
SEX/DURATION :
female 17-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
20 mg/kg
SEX/DURATION :
female 6-9 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
50 mg/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant per # sperm positive females; # females pregnant per # females mated)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
60 mg/kg
SEX/DURATION :
female 12 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
17500 ug/kg
SEX/DURATION :
female 7 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant per # sperm positive females; # females pregnant per # females mated)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
400 ug/kg
SEX/DURATION :
female 10 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - ovaries, fallopian tubes
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
2 mg/kg
SEX/DURATION :
female 6-9 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
15 mg/kg
SEX/DURATION :
female 15-24 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
17500 ug/kg
SEX/DURATION :
female 15-21 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
500 ug/kg
SEX/DURATION :
female 2 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
15750 ug/kg
SEX/DURATION :
male 21 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - testes, epididymis, sperm duct Reproductive - Paternal Effects - prostate, seminal vesicle, Cowper's gland, accessory glands
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
5250 ug/kg
SEX/DURATION :
male 7 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - male fertility index (e.g. # males impregnating females per # males exposed to fertile nonpregnant females)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Parenteral
DOSE :
62500 ug/kg
SEX/DURATION :
female 15-19 day(s) after conception
TOXIC EFFECTS :
Reproductive - Maternal Effects - parturition Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Unreported
DOSE :
1500 ug/kg
SEX/DURATION :
female 30 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
80 mg/kg
SEX/DURATION :
female 8-15 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants) Reproductive - Effects on Embryo or Fetus - fetal death
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
200 mg/kg
SEX/DURATION :
female 6-7 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
360 ug/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
2 mg/kg
SEX/DURATION :
female 6-7 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
50 mg/kg
SEX/DURATION :
female 4 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in number of implants per female; total number of implants per corpora lutea)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
120 ug/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Parenteral
DOSE :
12 mg/kg
SEX/DURATION :
female 1-3 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - litter size (e.g. # fetuses per litter; measured before birth) Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Implant
DOSE :
6500 ug/kg
SEX/DURATION :
female 6-18 day(s) after conception
TOXIC EFFECTS :
Reproductive - Effects on Embryo or Fetus - fetotoxicity (except death, e.g., stunted fetus)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Intravaginal
DOSE :
6400 ng/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
TYPE OF TEST :
TCLo - Lowest published toxic concentration
ROUTE OF EXPOSURE :
Inhalation
DOSE :
30 ug/kg/30M
SEX/DURATION :
male 60 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material, sperm morphology, motility, and count) Reproductive - Paternal Effects - testes, epididymis, sperm duct
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Inhalation
DOSE :
18 ug/kg
SEX/DURATION :
female 10 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Inhalation
DOSE :
34 ug/kg
SEX/DURATION :
female 10 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Intramuscular
DOSE :
3 mg/kg
SEX/DURATION :
female 3 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - menstrual cycle changes or disorders
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Intramuscular
DOSE :
800 ug/kg
SEX/DURATION :
female 8 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Implant
DOSE :
186 ug/kg
SEX/DURATION :
female 1-31 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - abortion
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Unreported
DOSE :
270 ug/kg
SEX/DURATION :
male 45 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Paternal Effects - spermatogenesis (incl. genetic material, sperm morphology, motility, and count) Reproductive - Paternal Effects - other effects on male
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Intravaginal
DOSE :
2847 ug/kg
SEX/DURATION :
female 52 week(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - ovaries, fallopian tubes
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
39 mg/kg
SEX/DURATION :
female 8-20 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - post-implantation mortality (e.g. dead and/or resorbed implants per total number of implants) Reproductive - Effects on Embryo or Fetus - fetal death
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
150 ug/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
125 ug/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Oral
DOSE :
313 ug/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - mating performance (e.g. # sperm positive females per # females mated; # copulations per # estrus cycles)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Administration onto the skin
DOSE :
500 ug/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in number of implants per female; total number of implants per corpora lutea)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Administration onto the skin
DOSE :
500 ug/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
1250 ug/kg
SEX/DURATION :
female 5 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - female fertility index (e.g. # females pregnant per # sperm positive females; # females pregnant per # females mated)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
2500 ug/kg
SEX/DURATION :
female 5 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - uterus, cervix, vagina
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
15 mg/kg
SEX/DURATION :
female 5-7 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in number of implants per female; total number of implants per corpora lutea)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
37500 ng/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - mating performance (e.g. # sperm positive females per # females mated; # copulations per # estrus cycles) Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
5 mg/kg
SEX/DURATION :
female 1 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Fertility - other measures of fertility
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Unreported
DOSE :
300 ug/kg
SEX/DURATION :
female 1-3 day(s) after conception
TOXIC EFFECTS :
Reproductive - Fertility - pre-implantation mortality (e.g. reduction in number of implants per female; total number of implants per corpora lutea)
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Subcutaneous
DOSE :
86 mg/kg
SEX/DURATION :
female 18-60 day(s) after conception
TOXIC EFFECTS :
Reproductive - Specific Developmental Abnormalities - endocrine system Reproductive - Specific Developmental Abnormalities - urogenital system
TYPE OF TEST :
TDLo - Lowest published toxic dose
ROUTE OF EXPOSURE :
Parenteral
DOSE :
2400 ug/kg
SEX/DURATION :
female 3 day(s) pre-mating
TOXIC EFFECTS :
Reproductive - Maternal Effects - other effects Reproductive - Fertility - mating performance (e.g. # sperm positive females per # females mated; # copulations per # estrus cycles)
TYPE OF TEST :
Cytogenetic analysis

MUTATION DATA

TYPE OF TEST :
Cytogenetic analysis
TEST SYSTEM :
Mammal - species unspecified Cells - not otherwise specified
DOSE/DURATION :
100 ug/L
REFERENCE :
AJOGAH American Journal of Obstetrics and Gynecology. (C.V. Mosby Co., 11830 Westline Industrial Dr., St. Louis, MO 63146) V.1- 1920- Volume(issue)/page/year: 120,390,1974 *** REVIEWS *** IARC Cancer Review:Animal Sufficient Evidence IMSUDL IARC Monographs, Supplement. (WHO Publications Centre USA, 49 Sheridan Ave., Albany, NY 12210) No.1- 1979- Volume(issue)/page/year: 7,294,1987 TOXICOLOGY REVIEW COGYAK Clinical Obstetrics and Gynecology. (Lippincott/Harper, Journal Fulfillment Dept., 2350 Virginia Ave., Hagerstown, MD 21740) V.1- 1958- Volume(issue)/page/year: 16(4),37,1973 TOXICOLOGY REVIEW PCNAA8 Pediatric Clinics of North America. (W.B. Saunders Co., W. Washington Sq., Philadelphia, PA 19105) V.1- 1954- Volume(issue)/page/year: 8,413,1961 TOXICOLOGY REVIEW ARVPAX Annual Review of Pharmacology. (Palo Alto, CA) V.1-15, 1961-75. For publisher information, see ARPTDI. Volume(issue)/page/year: 5,447,1965 TOXICOLOGY REVIEW CMROCX Current Medical Research and Opinion. (Clayton-Wray Pub. Ltd., 1a High St., Alton, Hants., UK) V.1- 1972- Volume(issue)/page/year: 4,309,1976 TOXICOLOGY REVIEW ACEDAB Acta Endocrinologica, Supplementum (Copenhagen). (Periodica, Skolegade 12 E, DK-2500 Valby, Denmark) No.1- 1948- Volume(issue)/page/year: 51,671,1960

 Safety Information

Symbol GHS08
GHS08
Signal Word Warning
Hazard Statements H351
Precautionary Statements P281
Personal Protective Equipment Eyeshields;full-face particle respirator type N100 (US);Gloves;respirator cartridge type N100 (US);type P1 (EN143) respirator filter;type P3 (EN 143) respirator cartridges
Hazard Codes Xn
Risk Phrases R40
Safety Phrases S22-S36/37/39-S45
RIDADR 2811.0
WGK Germany 3
RTECS RC8975000
HS Code 2937290090

 Synthetic Route

 Customs

HS Code 2937290090

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 Synonyms

Mini-Pe
Noriday
Ethynylnortestosterone
Utovlan
sc4640
Anovule
estr-4-en-3-one, 17-ethynyl-17-hydroxy-, (17b)-
MFCD00067596
(17a)-17-Hydroxy-19-norpregn-4-en-20-yn-3-one
19-Nor-17a-ethynyl-17b-hydroxy-4-androsten-3-one
19-nor-17α-Ethynylandrosten-17β-ol-3-one
Menzol
ENT
(8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one
17α-Ethynyl-17β-hydroxyestr-4-en-3-one
19-nor-17α-Ethynyl-17β-hydroxy-4-androsten-3-one
Norethindrone
Primolut N
(17b)-17-ethynyl-17-hydroxyestr-4-en-3-one
19-Nortestosterone, 17-ethynyl-
Ethinylnortestosterone
Norfor
17a-Ethynyl-19-nortestosterone
(17α)-17-Hydroxy-19-norpregn-4-en-20-yn-3-one
19-Nor-17α-ethynyltestosterone
19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-, (17α)-
Estr-4-en-3-one, 17α-ethynyl-17-hydroxy-
Norgestin
17-Hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one
19-Nor-17a-ethynyltestosterone
Estr-4-en-3-one, 17-ethynyl-17-hydroxy-, (17β)-
EINECS 200-681-6
(8R,9S,10R,13S,14S,17R)-17-Ethinyl-17-hydroxy-13-methyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-on
17α-Ethynyl-17-hydroxy-4-estren-3-one
19-Nor-17-ethinyl testosterone
19-Nor-17α-pregn-4-en-20-yn-3-one, 17-hydroxy-
Triella
19-Nor-17a-ethynylandrosten-17b-ol-3-one
17α-Ethynyl-19-nortestosterone
17α-Ethynyl-17β-hydroxy-19-norandrost-4-en-3-one
Norpregneninolone
Norethindrone (USP)
norethisterone
(8R,9S,10R,13S,14S,17R)-17-éthynyl-17-hydroxy-13-méthyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tétradécahydro-3H-cyclopenta[a]phénanthrén-3-one
17β-Hydroxy-19-norpregn-4-en-20-yn-3-one
Gestest
NET
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