Registration Dossier

Diss Factsheets

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:
1997

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

Constituent 1
Chemical structure
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%

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:
Haemorrhagic lung, dark liver and dark kidneys
Body weight:
The body weight gains of the surviving animals was reported to be normal.
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.