Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 May to 10 June 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken at GLP accredited laboratory to internationally accepted guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): BPS-MAE
- Physical state: White shiny solid
- Lot/batch No.: G130324
- Storage condition of test material: Room temperature in the dark.
- Other: Date received 25 April 2003

Test animals

Species:
rat
Strain:
other: CD(Crl:CD(SD)IGS BR)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory rat supplier
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: Yes
- Housing: The animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by International Product Supplies Limited, Wellingborough, Northants, UK was allowed throughout the study
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
DMSO
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test material was toxic, 2000 mg/kg was chosen as the
starting dose.
Doses:
One dose of 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 1/2 hour, 1 hour, 2 hours, 4 hours and once daily for 14 days
- Frequency of observations and weighing: Prior to dosing and at 7 and fourteen days
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examination of major organs.

Results and discussion

Preliminary study:
No preliminary study.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
There were no deaths or signs of systemic toxiity.

All animals showed expected gains in bodyweight over the
study period.
Gross pathology:
Effects on organs:
No abnormalities were noted at necropsy.
Other findings:
- Other observations: No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated as being greater than 2500 mg/kg bodyweight.