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EC number: 268-544-3 | CAS number: 68123-13-7
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Basic Blue 991
- Author:
- American College of Toxicology
- Year:
- 2 007
- Bibliographic source:
- International Journal of Toxicology, 26(Suppl. 2):51–63, 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The reporductive effects of basic blue 99 were evaluated on sprague dawley CD rats on the 6th to the 15th gestation days
- GLP compliance:
- no
Test material
- Reference substance name:
- 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride
- EC Number:
- 268-544-3
- EC Name:
- 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride
- Cas Number:
- 68123-13-7
- Molecular formula:
- C19H20BrN4O2.Cl
- IUPAC Name:
- 3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride
- Reference substance name:
- Basic Blue 99
- IUPAC Name:
- Basic Blue 99
- Details on test material:
- - Name of test material (as cited in study report):Basic blue 99- Molecular formula (if other than submission substance): C19-H20-Br-N4-O2.Cl- Molecular weight (if other than submission substance): 451.75 g/mol- Substance type:Organic- Physical state:Solid- Impurities (identity and concentrations):-Purity-63%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- - M/F ratio per cage:No data- Length of cohabitation:- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancyNo data- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.No data- Further matings after two unsuccessful attempts: [no / yes (explain)]No data- After successful mating each pregnant female was caged (how):No data- Any other deviations from standard protocol:Analytical verification of dosesYes/NoNo dataDetails on analytical verification of dosesNo data
- Duration of treatment / exposure:
- 20 days
- Frequency of treatment:
- Doses were given on 6th to the 15th gestation days.
- Details on study schedule:
- No data
Doses / concentrations
- Remarks:
- Doses / Concentrations:50 mg/ kg/dayBasis:nominal in water
- No. of animals per sex per dose:
- 29 pregnant females
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No DETAILED CLINICAL OBSERVATIONS: NoBODY WEIGHT: Yes
- Oestrous cyclicity (parental animals):
- No details
- Litter observations:
- weight of the placenta, uterus, fetuses, dams, body weight gain, and sex of the fetuses were recorded.
- Postmortem examinations (parental animals):
- On day 20 the rats were killed and cesarean sections were performed.
- Postmortem examinations (offspring):
- HISTOPATHOLOGY / ORGAN WEIGTHS:Yes
- Reproductive indices:
- The number of implantation sites, resorptions, living fetuses, and the number of corpora lutea were counted in each dam. The weight of the placenta, uterus, fetuses, dams, body weight gain, and sex of the fetuses were recorded.
- Offspring viability indices:
- No dams died
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Test animals had no differences in mean body weight gain in the course of gestation as compared to controls.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Test animals had no differences in mean body weight gain in the course of gestation as compared to controls.
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- organ weights and organ / body weight ratios
- reproductive function (oestrous cycle)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Yes. The weight of the placenta, uterus, fetuses, dams, body weight gain, and sex of the fetuses were recorded.
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- other: The organ weights of dams and theeffects on the body weights.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no treatment related effects. Based on the effects it is concluded that Basic Blue 99 at 50 mg/kg did not cause embryotoxic or teratogenic effects under the test conditions
- Executive summary:
The reporductive effects of basic blue 99 were evaluated on sprague dawley CD rats on the 6th to the 15th gestation days.50mg/kg.Controls animals were dosed with distilled water vehicle. The parameters checked includeimplantation sites, resorptions, living fetuses, and the number of corpora lutea.The weight of the placenta, uterus, fetuses, dams, body weight gain, and sex of the fetuses were recorded.Test animals had no differences in mean body weight gain in the course of gestation as compared to controls.There were no treatment related effects and 50mg/kg can be concluded as NOEL.
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