Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD guidelines No. 420 “Acute Oral Toxicity – Fixed Dose Method” and in accordance with GLP.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Principles of method if other than guideline:
Guideline followed.
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report)
- Physical state: White powder
- Analytical purity: 99.5%
- Storage condition of test material: Room temperature in the dark.

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, UK.
- Age at study initiation: 8-12 weeks (All the females were nulliparous and non-pregnant)
- Weight at study initiation: Animal No. 1- 164 g; Animal No. 2-157 g; Animal No. 3-171 g; Animal No. 4-174 g; Animal No. 5-167 g.
- Fasting period before study: overnight fasting immediately before dosing.
- Housing: The animals were housed in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.


MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bodyweight

DOSAGE PREPARATION (if unusual): The test item was freshly prepared , as required as a suspension in arachis oil with in two hours of dosing.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test item, 2000 mg/kg bodyweight was chosen as a starting dose on single animal.
In the absence of mortality or evident toxicity at a dose level of 2000 mg/kg, an additional group of 4 animals was treated with 2000 mg/kg bodyweight.
Doses:
Single dose of 2000 mg/kg bodyweight.
No. of animals per sex per dose:
4 female animals for single fixed dose of 2000 mg/kg bodyweight.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 min, 1, 2 and 4 hour after dosing and subsequently once daily for 14 days. Morbidity and mortality checks were made twice daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
None

Results and discussion

Preliminary study:
No mortality or evident toxicity observed at a dose level of 2000 mg/kg bodyweight.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality or sign of evident toxicity observed
Mortality:
No mortality
Clinical signs:
No signs of systemic toxicity observed
Body weight:
All animals showed expected gains in bodyweight over the observation period.
Gross pathology:
No abnormalities noted
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater that 2000mg/kg bodyweight.
Executive summary:

The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat following OECD TG No. 420. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of the test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

Mortality: There were no deaths.

Clinical observations: There were no signs of systemic toxicity.

Bodyweight: All animals showed expected gains in bodyweight.

Necropsy: No abnormalities were noted at necropsy.

CONCLUSION: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater that 2000 mg/kg bodyweight