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EC number: 947-945-3 | CAS number: -
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies on the reproductive, cytological and biochemical toxicity of Ginkgo Biloba in Swiss albino mice
- Author:
- Abdulaziz A. Al-Yahya, Abdulhakeem A. Al-Majed ∗, A.M. Al-Bekairi, O.A. Al-Shabanah, S. Qureshi
- Year:
- 2 006
- Bibliographic source:
- Journal of Ethnopharmacology 107 (2006) 222–228
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Effect of Ginkgo Biloba on reproductive parameters in Swiss albino mice.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene
- Cas Number:
- 37330-39-5
- Molecular formula:
- C(21)H(31-36)O
- IUPAC Name:
- Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source:Experimental Animal Care Center- Age at study initiation:6–8 weeks- Weight at study initiation: 25–28 g- Fasting period before study:Not available- Housing:Details not available- Diet (e.g. ad libitum):Purina chowdiet ad libitum- Water (e.g. ad libitum):ad libitum- Acclimation period:Not availableENVIRONMENTAL CONDITIONS- Temperature (°C):Standard conditions- Humidity (%):Standard conditions- Photoperiod (hrs dark / hrs light):12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:Aqueous suspension of Ginkgo biloba was administered by gastric intubation (oral) daily for a period of 90 days.
- Details on mating procedure:
- - M/F ratio per cage:1:3- Length of cohabitation:1 week- Proof of pregnancy:Not available- After successful mating each pregnant female was caged (how):individually- Any other deviations from standard protocol:each male mouse in the treated and control groups was caged with three females, which were allowed to stay with the male for 1 week. The female mice were necropsied 13 days following the mid-week of their caging and presumptive mating and the number of pregnant mice was recorded to determine percent fertility
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- Each male mouse in the treated and control groups was caged with three females, which were allowed to stay with the male for 1 week. The female miewere necropsied 13 days following the mid-week of their caging and presumptive mating and the number of pregnant mice wasrecorded to determine percent fertility.
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 25 mg/kg/day,50 mg/kg/day,100 mg/kg/dayBasis:actual ingested
- No. of animals per sex per dose:
- Study on reproductive parameters of male mice-group 1, control (tap water)-5 male micegroup 2, Ginkgo biloba-25 mg/kg/day-5 male micegroup 3, Ginkgo biloba-50 mg/kg/day-5 male micegroup 4,Ginkgo biloba-100 mg/kg/day-5 male miceStudy rate of pregnancy and mean implants per female-group 1, control (tap water)-5 male micegroup 2, Ginkgo biloba-25 mg/kg/day-10 male mice and 30 female mice matedgroup 3, Ginkgo biloba-50 mg/kg/day-10 male mice and 30 female mice matedgroup 4,Ginkgo biloba-100 mg/kg/day-10 male mice and 30 female mice mated
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:The dose of Ginkgo biloba was determined by (i) maximum tolerated dose (MTD) and (ii) human therapeutic dose with reference to the surface area rule. On basis of evaluated MTD (1.6 gm/kg), the doses of Ginkgo biloba selected were 25, 50 and 100 mg/kg/day corresponding to 1/64, 1/32 and 1/16, respectively.
Examinations
- Parental animals: Observations and examinations:
- REPRODUCTIVE ORGAN WEIGHT: Yes- Time schedule for examinations:last day of sub-chronic treatment-Organ weight-testes, caudae epididymis, seminal vesicles and prostate gland
- Oestrous cyclicity (parental animals):
- Not examined
- Sperm parameters (parental animals):
- Parameters examined in P male parental generations:spermatozoa motility, count and abnormalities
- Litter observations:
- Not applicable
- Postmortem examinations (parental animals):
- REPRODUCTIVE ORGAN WEIGHT: Yes
- Postmortem examinations (offspring):
- Not applicable
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
Reproductive function / performance (P0)
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
Effect on reproductive organ weight, sperm motility and count-significant increase in the mean weight of caudae epididymis at 50 and 100 mg/kg/day and prostate at 100 mg/kg/day of Ginkgo biloba. There was no significant effect of the treatment on either the sperm motility or the count.Effect on spermatozoa morphology-No significant effects observed.Effect on the rate of pregnancy and mean implants per female-decrease the rate of pregnancy and cause embryonic losses implantation.These changes were statistically significant at the higher dose (100 mg/kg/day).
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 25 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No effects reproductive organ weight, sperm motility and count,spermatozoa morphology.
- Remarks on result:
- other: no other details available
- Dose descriptor:
- LOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: significant increase in the mean weight of caudae epididymis and prostate.
- Remarks on result:
- other: no other details available
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no change in the dead implants per pregnant female mice.
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: decrease the rate of pregnancy and cause embryonic losses implantation.
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
Effect levels (P1)
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (P1)
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the subchronic study in mice the following is assessed-NOAEL-P Male-25 mg/kg bw/day.LOAEL-P-Male-50 mg/kg bw/day.NOAEL-P-Female-50 mg/kg bw/day.LOAEL-P-Female-100 mg/kg bw/day.
- Executive summary:
In 90 days subchronic study effect of Ginkgo Biloba was studied on reproductive parameters- spermatozoa motility, count and abnormalities and on rate of pregnancy and mean implants per female.Based on effecs observed the following NOAEL and LOAEL values were assessed-
NOAEL-P Male-25 mg/kg bw/day.
LOAEL-P-Male-50 mg/kg bw/day.
NOAEL-P-Female-50 mg/kg bw/day.
LOAEL-P-Female-100 mg/kg bw/day.
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