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EC number: 200-554-5 | CAS number: 63-05-8
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
- Principles of method if other than guideline:
- - Principle of test:
Thirty-day old female rats received corn oil or androstenedione (in corn oil) at one of four concentrations (5.0, 10.0, 30.0 or 60.0 mg/kg body weight) by gavage for two weeks prior to mating, during the mating period and until gestation day (GD) 19. Caesarean sections were performed on GD 20.
- Parameters analysed / observed:
number of corpora lutea, the number of implantation sites, and the number and position of resorption sites and fetuses (dead or alive); gravid uterus weight;
viable fetuses examined individually for any gross external morphological effects, sex, weight, crown-rump length, and anogenital distance, any externally visible abnormalities, skeletal anomalies, soft-tissue anomalies;
serum hormones levels: Androstenedione, Estradiol, LH, FSHTestosterone, Progesterone - GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Androst-4-ene-3,17-dione
- EC Number:
- 200-554-5
- EC Name:
- Androst-4-ene-3,17-dione
- Cas Number:
- 63-05-8
- Molecular formula:
- C19H26O2
- IUPAC Name:
- androst-4-ene-3,17-dione
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Steraloids, Newport, RI
- Purity: >99%
Test animals
- Species:
- rat
- Strain:
- other: CD-CRL:CD-BR, VAF+
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc. (Wilmington, MA)
female (n = 250; 49 days old; 150–175 g)
male (n = 91; 56 days old; 175–200 g)
- Housing:
females: singly during the pre-mating dosing period and from GD 0 until GD 20
- Diet (e.g. ad libitum): Purina Rodent Chow 5002M (Purina Mills, Inc., Richmond, IN), ad libitum
males: singly, except during mating period
mating period: two female rats + one male rat
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approx 1 wk
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64–79 °F
- Humidity (%): 40–70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Dosing solutions were stable for >35 days as determined by HPLC analysis. All solutions of androstenedione were prepared and used according to the results of the stability tests. The dosing solutions were only utilized after HPLC analysis confirmed that the solutions were within the prescribed concentrations (±10%).
VEHICLE
- Amount of vehicle (if gavage):
0.3 ml corn oil /100 g bw: control, 5.0, 10.0 or 30.0 mg/kg bw/d dose groups
0.6 mL/100 g bw: double dose control or ‘‘00’’ control, 60 mg/kg bw/d dose group - Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1:2
- Length of cohabitation: 15 h/day, 5 days/week for up to 3 weeks or until mating occurred
-females that did not mate at the end of the week were re-mated with a different randomly selected
- At the end of the three-week mating period, females that did not mate (n = 3) were necropsied.
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- - males: not exposed
- females: 2 weeks prior to mating, during the mating period (up to 3 weeks) and from GD 0 through GD 19 - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 5 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 10 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 60 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- The distribution of the animals among 0 control, 00 control, 5, 10, 30 and 60 mg/kg dose groups were 39, 29, 39, 29, 33 and 40, respectively.
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Estrous cyclicity was evaluated in 20 randomly selected animals from the 30 mg/kg and 60 mg/kg treatment groups monitored daily during the two week pre-mating exposure period
- Ovaries and uterine content:
- - corpora lutea, number of implantation sites, and number and position of resorption sites and fetuses (dead or alive)
- gravid uterus was removed in toto and weighed - Blood sampling:
- Blood was collected from the inferior vena cava of all pregnant females, serum hormone (Androstenedione, Estradiol, LH, FSH, Testosterone, Progesterone) and gonadotrophin levels were determined by radioimmunoassay
- Fetal examinations:
- gross external morphological effects
anogenital distance
skeletal anomalies
soft-tissue anomalies - Statistics:
- A p value of =0.05 was considered statistically significant. For the parameters feed and fluid consumption, number of corpora lutea, implants, alive, males and females alive and estrous cyclicity data, an Analysis of Variance (ANOVA) followed by a protected least significance difference (LSD) test (one-tail, if ANOVA p < 0.05) was used to compare the two control groups as well as each control group with their respective treatment group(s). For the parameters implantation efficiency and percent early, late, and total (early + late) resorptions, the data were transformed using a Freeman–Tukey Arc–Sine Transformation followed by an ANOVA and a protected LSD test as discussed above.
An Analysis of Covariance (ANCOVA) followed by a protected LSD (two-tail, if the ANCOVA p < 0.05) test was used to compare the control with each treated group for the parameters adult organ weights, and mean body weight gain and gravid uterine weight of pregnant females. The ANCOVA adjusted the body weight gain
and the gravid weight by day 0 dam weight, and the organ weight by the final dam weight. For both the fetal weight and crown rump measurements, a Nested ANOVA followed by a protected LSD test (p < 0.05) was used to compare the control and treated groups. A Fisher's Exact Test was used to compare the treated groups with the control for the incidence of specific soft-tissue variations in fetuses, and clinical external signs in female rats and day 20 fetuses.
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- endocrine findings
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no specific effect on fetal parameters
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1: Serum endocrine parameters (mean ± SEM) from day 20 pregnant rats a
| Dose levels (mg/kg) | |||||
| 0 (19) | 00 (21) | 5.0 (25) | 10.0 (27) | 30.0 (24) | 60.0 (27) |
Androstenedione b | 1.67 ± 0.14 | 1.65 ± 0.16 | 1.53 ± 0.10 | 1.64 ± 0.11 | 1.75 ± 0.10 | 1.67 ± 0.11 |
Estradiol c | 61.68 ± 3.51 | 50.60 ± 3.96 | 56.09 ± 4.30 | 54.29 ± 3.59 | 62.61 ± 4.51 | 57.08 ± 3.24 |
LH d,b | 1.06 ± 0.07 | 1.12 ± 0.04 | 1.28 ± 0.10 | 1.30 ± 0.15 | 1.08 ± 0.06 | 1.07 ± 0.07 |
FSH b | 5.92 ± 0.38 | 6.13 ± 0.31 | 6.53 ± 0.32 | 6.26 ± 0.27 | 6.53 ± 0.37 | 5.81 ± 0.26 |
Testosterone b | 0.47 ± 0.06 | 0.59 ± 0.08 | 0.48 ± 0.06 | 0.48 ± 0.04 | 0.52 ± 0.06 | 0.46 ± 0.05 |
Progesterone b | 16.68 ± 1.99 | 16.15 ± 2.50 | 15.57 ± 1.78 | 15.53 ± 1.80 | 17.04 ± 1.79 | 16.82 ± 1.34 |
( ) = number of litters.
a If the p value is not given then p > 0.10.
b Data expressed in ng/ml.
c Data expressed in pg/ml.
d Data transformed using a log transformation.
Table 2: Estrous cycle measurements during 14-day pre-mating period (day, mean ± SEM)
| Dose levels (mg/kg) | |||
| 0 (20) | 00 (20) | 30.0 (20) | 60.0 (20) |
Regular cycle (4–5 days) | 2.05 ± 0.17 | 2.20 ± 0.17 | 2.05 ± 0.17 | 1.65 ± 0.18 |
Irregular cycle (2,3,6–10 days) | 0.25 ± 0.12 | 0.25 ± 0.14 | 0.10 ± 0.07 | 0.30 ± 0.15 |
Highly irregular cycle (11–13 days) | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.05 ± 0.05 | 0.00 ± 0.00 |
Acyclic (14 days) | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 | 0.00 ± 0.00 |
Number of estrous stages observed | 3.30 ± 0.13 | 3.45 ± 0.15 | 3.20 ± 0.14 | 2.85 ± 0.15* |
( ) = number of animals per group. *Indicates statistically significant difference from the ‘‘00’’ control group; p </= 0.05.
Table 3: Mean feed and fluid consumption and body weight gain during pre-mating (days 0–14) and gestation (days 0–20) a
| Dose levels (mg/kg) | |||||
| 0 | 00 | 5.0 | 10.0 | 30.0 | 60.0 |
Feed consumption (g ± SEM) | ||||||
0–14 b | 229.3 ± 2.7 | 207.4 ± 2.3 | 231.7 ± 3.0 | 225.0 ± 2.9 | 229.2 ± 2.7 | 211.9 ± 1.7 |
0–20 c | 399.2 ± 6.0 | 344.7 ± 6.2 | 396.9 ± 6.2 | 397.3 ± 7.0 | 402.6 ± 5.8 | 358.6 ± 4.3 |
Fluid consumption (ml ± SEM) | ||||||
0–14 b | 387.8 ± 9.7 | 376.0 ± 10.6 | 375.0 ± 10.1 | 356.5 ± 10.9 | 390.8 ± 8.1 | 363.7 ± 7.0 |
0–20 c | 727.7 ± 16.8 | 650.9 ± 24.0 | 698.5 ± 17.4 | 711.3 ± 24.6 | 732.3 ± 18.8 | 655.3 ± 14.2 |
Mean body weight gain (g ± SEM) | ||||||
0–14 b, d | 34.4 ± 1.7 | 31.8 ± 1.4 | 34.1 ± 1.5 | 34.5 ± 1.7 | 37.5 ± 1.6 | 38.6 ± 1.3 |
0–20 c, d | 138.4 ± 4.6 | 132.0 ± 7.1 | 133.6 ± 4.3 | 134.5 ± 4.7 | 134.2 ± 5.2 | 131.9 ± 4.7 |
a If p value not given p > 0.10.
b n = 47, 38, 39, 30, 41 and 57 animals for the 0, 00, 5.0, 10.0, 30.0 and 60 mg/kg dose groups, respectively.
c n = 39, 29, 39, 29, 33 and 40 animals for the 0, 00, 5.0, 10.0, 30.0 and 60 mg/kg dose groups, respectively.
d Total weight gain minus gravid uterine weight.
Table 4: Analysis of maternal and reproductive necropsy findings a
Dose level (mg/kg) | ||||||
0 (39) | 00 (29) | 5.0 (39) | 10.0 (29) | 30.0 (33) | 60.0 (40) | |
No. (%) of pregnant females | ||||||
37 (95) | 27 (93) | 38 (97) | 28 (97) | 32 (97) | 38 (95) | |
Corpora lutea (Mean ± SEM) | ||||||
16.27 ± 0.29 | 16.19 ± 0.52 | 16.03 ± 0.46 | 16.86 ± 0.39 | 16.03 ± 0.41 | 16.13 ± 0.38 | |
Implants/litter (Mean ± SEM) | ||||||
15.27 ± 0.30 | 14.89 ± 0.70 | 14.03 ± 0.66 | 14.86 ± 0.58 | 14.44 ± 0.52 | 14.21 ± 0.57 | |
Implantation efficiency (%, Mean ± SEM) | ||||||
94.14 ± 1.34 | 90.47 ± 3.45 | 86.88 ± 3.09 | 88.12 ± 2.91 | 89.63 ± 2.56 | 87.63 ± 3.04 | |
Early + late deaths/litter (%, Mean ± SEM) | ||||||
3.96 ± 0.84 | 6.50 ± 3.69 | 2.55 ± 0.69 | 7.14 ± 2.10 | 9.53 ± 3.21 | 4.20 ± 0.89 | |
Viable fetuses/litter (Mean ± SEM) | ||||||
14.68 ± 0.32 | 14.44 ± 0.73 | 13.61 ± 0.62 | 13.79 ± 0.62 | 13.44 ± 0.61 | 13.61 ± 0.56 | |
Total number of fetuses (litters) | ||||||
Male | 276 (37) | 195 (26) | 273 (38) | 176 (28) | 221 (31) | 264 (38) |
Female | 267 (37) | 195 (26) | 244 (38) | 210 (28) | 209 (31) | 253 (37) |
Viable fetuses/litter (Mean ± SEM) | ||||||
Male | 7.46 ± 0.32 | 7.22 ± 0.53 | 7.18 ± 0.43 | 6.29 ± 0.51 | 6.91 ± 0.44 | 4.50 ± 0.52 |
Female | 7.22 ± 0.39 | 6.95 ± 0.39 | 6.42 ± 0.37 | 7.50 ± 0.49 | 6.53 ± 0.42 | 7.10 ± 0.62 |
Anogenital distance (Mean ± SEM) | ||||||
Male | 3.40 ± 0.02 | 3.40 ± 0.03 | 3.40 ± 0.02 | 3.34 ± 0.03 | 3.38 ± 0.02 | 3.45 ± 0.02 |
Female | 1.68 ± 0.01 | 1.73 ± 0.02 | 1.69 ± 0.01 | 1.66 ± 0.02 | 1.74 ± 0.02 | 1.76 ± 0.01 |
Sex distribution (%) | ||||||
Male | 50.83 | 50 | 52.8 | 45.6 | 51.4 | 51.06 |
Female | 49.17 | 50 | 47.2 | 44 | 48.6 | 48.94 |
Fetal body weight (g, Mean ± SEM) | ||||||
Males | 3.80 ± 0.02 | 3.70 ± 0.02 | 3.76 ± 0.02 | 3.75 ± 0.03 | 3.74 ± 0.03 | 3.73 ± 0.03 |
Females | 3.63 ± 0.02 | 3.54 ± 0.02 | 3.56 ± 0.02 | 3.56 ± 0.03 | 3.62 ± 0.02 | 3.59 ± 0.02 |
Fetal crown-rump length (cm, Mean ± SEM) | ||||||
Males | 4.02 ± 0.01 | 3.99 ± 0.01 | 4.01 ± 0.01 | 4.01 ± 0.01 | 4.00 ± 0.01 | 3.99 ± 0.01 |
Females | 3.94 ± 0.01 | 3.92 ± 0.01 | 3.91 ± 0.01 | 3.93 ± 0.01 | 3.94 ± 0.01 | 3.91 ± 0.01 |
No. runts (litters with runts) | ||||||
Males | 1 (1) | 2 (2) | 1 (1) | 2 (2) | 2 (2) | 5 (5) |
Females | 3 (3) | 0 (0) | 2 (2) | 2 (2) | 0 (0) | 4 (4) |
a If the p value is not given then p > 0.10.
Table 5: Representative incidence of specific fetal soft-tissue variations *
Dose level (mg/kg) | 0 | 0 | 5 | 10 | 30 | 60 |
No. fetuses (litters) examined | 236 (35) | 196 (26) | 225 (36) | 194 (28) | 214 (31) | 232 (37) |
Hydroureter, severe | 6 (5) | 7 (5) | 5 (5) | 10 (6) | 4 (4) | 10 (7) |
Hydroureter, moderate | 0 (0) | 24 (12) | 0 (0) | 0 (0) | 0 (0) | 13 (11) |
Enlarged renal pelvis, moderate | 6 (3) | 8 (7) | 14 (8) | 8 (5) | 12 (10)* | 12 (9) |
Enlarged ureter at kidney, severe | 12 (7) | 16 (8) | 11 (7) | 10 (6) | 4 (4) | 9 (7) |
Enlarged ureter at kidney, moderate | 16 (12) | 15 (8) | 23 (14) | 20 (12) | 17 (13) | 18 (14) |
Kidney, ectopic | 1 (1) | 0 (0) | 1 (1) | 1 (1) | 1 (1) | 3 (3) |
Anophthalmia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (1) |
( ) = number of litters.
*p 6 0.05.
Table 6A: Absolute organ weights for selected maternal organs (g, mean ± SEM)
Dose level (mg/kg) | ||||||
0 (31) | 00 (26) | 5.0 (33) | 10.0 (28) | 30.0 (32) | 60.0 (33) | |
Heart | 0.913 ± 0.016 | 0.882 ± 0.014 | 0.909 ± 0.011 | 0.902 ± 0.015 | 0.892 ± 0.015 | 0.942 ± 0.034 |
Liver | 14.531 ± 0.241 | 14.282 ± 0.238 | 13.987 ± 0.280 | 14.215 ± 0.288 | 14.237 ± 0.276 | 14.647 ± 0.243 |
Spleen | 0.710 ± 0.065 | 0.609 ± 0.016 | 0.621 ± 0.023 | 0.647 ± 0.019 | 0.611 ± 0.014 | 0.604 ± 0.012 |
Adrenal | ||||||
Rt. | 0.035 ± 0.002 | 0.033 ± 0.001 | 0.035 ± 0.001 | 0.032 ± 0.001 | 0.032 ± 0.001 | 0.030 ± 0.001 |
Lft. | 0.037 ± 0.002 | 0.033 ± 0.001 | 0.036 ± 0.001 | 0.033 ± 0.001 | 0.032 ± 0.001 | 0.030 ± 0.001 |
Both | 0.072 ± 0.003 | 0.066 ± 0.002 | 0.071 ± 0.002 | 0.065 ± 0.002 | 0.064 + 0.002 | 0.060 ± 0.002 |
Ovary | ||||||
Rt. | 0.077 ± 0.003 | 0.072 ± 0.002 | 0.074 ± 0.002 | 0.070 ± 0.002 | 0.076 ± 0.003 | 0.074 ± 0.003 |
Lft. | 0.072 + 0.002 | 0.071 ± 0.003 | 0.070 ± 0.0021 | 0.072 ± 0.002 | 0.071 ± 0.002 | 0.070 ± 0.003 |
Both | 0.150 + 0.004 | 0.143 ± 0.003 | 0.144 ± 0.0042 | 0.142 ± 0.003 | 0.147 ± 0.004 | 0.144 ± 0.005 |
Brain | 1.898 ± 0.014 | 1.879 ± 0.021 | 1.888 ± 0018 | 1.925 ± 0.016 | 1.910 ± 0.016 | 1.889 ± 0.016 |
( ) = number of organs examined.
Table 6B: Organ to brain weight ratios for selected maternal organs (g, mean ± SEM)
Dose level (mg/kg) | ||||||
0 (31) | 00 (26) | 5.0 (33) | 10.0 (28) | 30.0 (32) | 60.0 (33) | |
Heart | 0.481 ± 0.008 | 0.470 ± 0.008 | 0.482 ± 0.006 | 0.469 ± 0.008 | 0.468 ± 0.008 | 0.498 ± 0.016 |
Liver | 7.659 ± 0.144 (25)a | 7.625 ± 0.155 | 7.458 ± 0.156 | 7.390 ± 0.150 | 7.463 ± 0.150 (26)a | 7.776 ± 0.133 (27)a |
Spleen | 0.373 ± 0.032 | 0.325 ± 0.008 | 0.392 ± 0.012 | 0.337 ± 0.011 | 0.320 ± 0.006 | 0.320 ± 0.006 |
Adrenal | ||||||
Rt. | 0.018 ± 0.001 | 0.018 ± 0.001 | 0.018 ± 0.001 | 0.017 ± 0.001 | 0.017 ± 0.001 | 0.016 ± 0.001** |
Lft. | 0.019 ± 0.001 | 0.018 ± 0.001 | 0.019 ± 0.001 | 0.017 ± 0.001* | 0.017 ± 0.001* | 0.016 ± 0.001** |
Both | 0.037 ± 0.001 | 0.036 ± 0.001 | 0.037 ± 0.001 | 0.034 ± 0.001* | 0.034 + 0.001* | 0.032 ± 0.001** |
Ovary | ||||||
Rt. | 0.041 ± 0.001 | 0.038 ± 0.001 | 0.039 ± 0.002 | 0.037 ± 0.001 | 0.040 ± 0.002 | 0.039 ± 0.002 |
Lft. | 0.038 + 0.001 | 0.038 ± 0.002 | 0.037 ± 0.001 | 0.037 ± 0.001 | 0.0378 ± 0.001 | 0.037 ± 0.002 |
Both | 0.079 + 0.002 | 0.076 ± 0.002 | 0.076 ± 0.002 | 0.074 ± 0.002 | 0.077 ± 0.002 | 0.076 ± 0.002 |
( ) = number of organs examined.
* Significantly different than the ‘‘0’’ control group, p </= 0.05.
** Significantly different than the ‘‘00’’ control group, p </= 0.05.
a Indicates that six livers were transferred to another protocol.
Applicant's summary and conclusion
- Executive summary:
Thirty-day old female rats received corn oil or androstenedione (in corn oil) at one of four concentrations (5.0, 10.0, 30.0 or 60.0 mg/kg body weight) by gavage for two weeks prior to mating, during the mating period and until gestation day (GD) 19. Caesarean sections were performed on GD 20. No dose related changes were observed in serum androstenedione, estradiol, LH, FSH, testosterone or progesterone. A statistically significant decrease in estrous cycle length was observed in the 60.0 mg/kg dose group only. Feed and fluid consumption, mean body weight gain, organ weight and fetal parameters were not affected by androstenedione treatment. At the doses given, androstenedione had no specific effect on the development of individual bones or soft tissues.
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