Registration Dossier
Registration Dossier
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EC number: 305-897-5 | CAS number: 95193-83-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from review article
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Repeated dose oral toxicity study of the test chemical
- Author:
- WHO
- Year:
- 2 016
- Bibliographic source:
- WHO Technical Report Series
- Reference Type:
- review article or handbook
- Title:
- Repeated dose oral toxicity study of the test chemical
- Author:
- European Commision
- Year:
- 2 004
- Bibliographic source:
- SCCNFP
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Combined repeated dose carcinogenicity study using rats was performed to determine the toxic nature of the test chemical
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
- EC Number:
- 305-897-5
- EC Name:
- 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
- Cas Number:
- 95193-83-2
- Molecular formula:
- C18H11NO5S to C18H8NO11S3.3Na
- IUPAC Name:
- trisodium hydrogen bis(2-(1,3-dioxo-5-sulfonato-2,3-dihydro-1H-inden-2-yl)quinoline-8-sulfonate)
- Details on test material:
- - Name of the test chemical: 1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts
- Molecular formula: C18H9NNa2O8S2
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Feed
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test chemical was mixed with feed at dose levels of 0%, 0.03%, 0.1%, 0.5%, 2.0%, 5.0% (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw per day, respectively)
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Feed
- Concentration in vehicle: 0%, 0.03%, 0.1%, 0.5%, 2.0%, 5.0% (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw per day, respectively)
- Amount of vehicle (if gavage): Not appilcable
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 30 months (in utero phase)
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0%, 0.03%, 0.1%, 0.5%, 2.0%, 5.0% (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw per day, respectively)
- No. of animals per sex per dose:
- 70 males and 70 females
- Control animals:
- not specified
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Not specified
- Cage side observations checked in table [No.?] were included. Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
- Time schedule: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: Not specified
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
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: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
- Time schedule for examinations: Not specified
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
HAEMATOLOGY: Not specified
- Time schedule for collection of blood: Not specified
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined. Not specified
CLINICAL CHEMISTRY: Not specified
- Time schedule for collection of blood: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined. Not specified
URINALYSIS: Not specified
- Time schedule for collection of urine: Not specified
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- Parameters checked in table [No.?] were examined. Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Not specified
IMMUNOLOGY: Not specified
- Time schedule for examinations: Not specified
- How many animals: Not specified
- Dose groups that were examined: Not specified
- Parameters checked in table [No.?] were examined. Not specified
OTHER: Not specified - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, absolute and relative organ weight was measured
HISTOPATHOLOGY: Yes, organs were observed for tissue damage and tumors (carcinogenic effects) - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight reductions in body weight were noted at at the two highest dose levels (2% and 5%)
- 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:
- no effects observed
- 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
- Description (incidence and severity):
- Changes in absolute and relative organ weights at the two highest dose levels (2% and 5%) were noted
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- Carcinogenicity was not observed during the study
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No observed adverse effect level (NOAEL) for the test chemical in a 30 months chronic-carcinogenicity study using male and female rats was considered to be 250 mg/Kg/day.
- Executive summary:
Combined repeated dose-carcinogencity study was performed to determine the toxic nature of the test chemical. The study was performed for 30 months using 70 male and 70 female rats per dose group. The test chemical was mixed with feed at dose level of 0%, 0.03%, 0.1%, 0.5%, 2% or 5% (equivalent to 0, 15, 50, 250, 1000 or 2500 mg/kg bw per day, respectively). The animals were exposed to the test chemical in the in utero phase. The treated animals were observed for changes in clinical signs, body weight changes, opthalmology, organ weight changes, histopathology and carcinogenic effects. There were slight reductions in body weight and changes in absolute and relative organ weights at the two highest dose levels (2% and 5%). No other treatment related effects were noted. Based on the details of the study, the No observed adverse effect level (NOAEL) for the test chemical in a 30 months chronic-carcinogenicity study using male and female rats was noted to be 250 mg/Kg/day.
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