Registration Dossier
Registration Dossier
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EC number: 203-252-1 | CAS number: 104-92-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 September 1996- 7 November 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-bromoanisole
- EC Number:
- 203-252-1
- EC Name:
- 4-bromoanisole
- Cas Number:
- 104-92-7
- Molecular formula:
- C7H7BrO
- IUPAC Name:
- 1-bromo-4-methoxybenzene
- Details on test material:
- Purity= 98.75%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK.
- Age at study initiation: 8-10 weeks
- Weight at study initiation: The males weight ware: 229 to 242 g. The females weight were: 208 to 241 g.
- 5 days of acclimatisation before start of study.
-Free access of water and food with exception of an overnight fast immediately before dosing and for approximately 2-4 hr after dosing.
- Housing: Solid-floor polypropylene cages furnished with woodflakes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 ºC
- Humidity (%): 48-56 %
- Air changes (per hr): at least 15 changes per hr.
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
N/A
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw
DOSAGE PREPARATION (if unusual): N/A - Doses:
- 1000 mg/kg, 1414 mg/kg and 2000 mg/kg
- No. of animals per sex per dose:
- 5 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed or overt signs of toxicity 1/2, 1 ,2 and 4 hours after dosing and subsequently once daily for 14 days. Body weights recorded on days 0, 7, 14 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross lesions, body weight vhanges, macroscopic examination, mortality and any other toxicological effects. - Statistics:
- NDA
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 1 907 mg/kg bw
- Based on:
- test mat.
- Mortality:
- For dose of 1414 mg/kg -1/5 deaths
For dose of 2000 mg/kg- 3/5 deaths. - Clinical signs:
- other: Haemorrhagic lung, dark liver and dark kidneys
- Gross pathology:
- Abnormalities noted at necropsy of females that died during the study were haemorrhagic lung, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
- Other findings:
- N/A
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test substance p-Bromoanisole when administered by the oral route was 1907 mg/kg bw.
- Executive summary:
An acute oral study was perfomed on 8 -12 weeks female Sprague Dawley rats with dosage of 1000, 1414 and 2000 mg/kg. The test followed OECD guideline 401 and was performed to GLP standard.
At dose level of 1414 mg/kg bw only one mortality was observed
At dose level of 2000 mg/kg bw 3 mortality deaths were observed.
Therefore the LD50 females of the test substance p-Bromoanisole was determined to be greater 1907 mg/kg bw.
Male animals were considered not to be markedly more sensitive to the test material than the female animals.
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