Registration Dossier
Registration Dossier
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EC number: 700-776-7 | CAS number: -
Toxicological information
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: according GLP and guideline, purity of the test article not documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of mono-[(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl]-5,12-dihydroquino[2,3-b]acridine-7,14-dione and di-[(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl]-5,12-dihydroquino[2,3-b]acridine-7,14-dione and 5,12-dihydroquino[2,3-b]acridine-7,14-dione
- EC Number:
- 700-776-7
- Molecular formula:
- C29H17O4N3 (unspecified isomers) / C38H22O6N4 (unspecified isomers) / C20H12O2N2
- IUPAC Name:
- Reaction mass of mono-[(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl]-5,12-dihydroquino[2,3-b]acridine-7,14-dione and di-[(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl]-5,12-dihydroquino[2,3-b]acridine-7,14-dione and 5,12-dihydroquino[2,3-b]acridine-7,14-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate
- Age at study initiation: 4 weeks
- Weight at study initiation: male 156 - 188g, female 108-141g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 12 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): daily
- Storage temperature of food: stored in brown glass bottles and stored at ambient temperature
VEHICLE
The control article and vehicle for the test article was 0.5% (w/v) aqueous methylcel lulose. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis of test formulations
The analyses detailed below were carried out.
Stability and homogeneity
Stability and homogeneity were determined at HUK.
Achieved concentration
Analysis of achieved concentration was performed at HUK on samples formulated in weeks 1 and 3. - Duration of treatment / exposure:
- 28d
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The following dose levels were selected by the sponsor on the basis of an LD50 study performed by the client
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: day 1, weekly intervall
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: week 4
- Anaesthetic used for blood collection: Yes
- Animals fasted: Yes
- How many animals: all
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: week 4
- Animals fasted: Yes
- How many animals: all
URINALYSIS: Yes
- Time schedule for collection of urine: week 4 and week 7
- Metabolism cages used for collection of urine: No data
- Animals fasted: Yes
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
adrenals brain
kidneys liver
testes pancreas
ovaries seminal vesicles
HISTOPATHOLOGY: Yes
adrenals brain (including brain stem)
eyes (with optic nerves) femur (bone marrow)
heart kidneys
liver lungs (with mainstem bronchi)
ovaries pancreas
pituitary seminal vesicles
spleen stomach
testes thyroids (with parathyroids)
urinary bladder all gross lesions - Statistics:
- Data were processed, where appropriate, to give group mean values and standard deviations.
Some tables and appendices presented in the report are computer generated.
For each parameter, the analysis was performed using a two way analysis of variance (ANOVA). Where differences were found at the 5% level of significance each treated group was compared against the control group for the given sex, using the t-test.
For haematology and clinical chemistry parameters, parametric or non-parametric methods were used where appropriate. Where ANOVA could not be performed because of variance heterogeneity, the Kruskal-Wallis test was carried out for each sex; where this was significant at the 5% level of significance, pairwise Wilcoxon Rank Sum tests were performed to compare each treated group with the control group.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- Pink faeces characteristic of the test article were noted for all treated groups from day 2 of dosing and throughout the treatment period. The pink colouration was not observed from day 2 of the treatment-free phase.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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