Registration Dossier
Registration Dossier
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EC number: 215-363-2 | CAS number: 1324-11-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 - 16 Dec 1977
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- 10 female rats used (instead of 5 males and 5 females)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- dibromodibenzo[b,def]chrysene-7,14-dione
- EC Number:
- 215-363-2
- Cas Number:
- 1324-11-4
- Molecular formula:
- C24H10Br2O2
- IUPAC Name:
- dibromodibenzo[b,def]chrysene-7,14-dione
- Test material form:
- solid
- Details on test material:
- Vat Orange 1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: ca 8 weeks
- Weight at study initiation: 102 - 112 g
- Fasting period before study: 16
- Housing: 5/cage
- Diet: Altromin 1324 ad libitum
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- 25 % solutions in deionised water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% (w/v)
- Amount of vehicle (if gavage): 20 mL/kg bw - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weight: weekly; clinical signs&death: frequently first day; thereafter twice daily
- Necropsy of survivors performed: yes - Statistics:
- N/A
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- 5000 mg/kg bw; Number of animals: 10; Number of deaths: 0
- Clinical signs:
- crouch position, discolouration of feces (yellowish)
- Body weight:
- bodyweight was not affected by the treatment
- Gross pathology:
- no effect observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 (oral, gavage) is above 5000 mg/kg bw in female rats. The substance is not classifiable according to CLP criteria.
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