Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-02-05 to 2008-03-04
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Sponsor and E010005910

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: +-20% of 226g
- Fasting period before study: 4 hours
- Housing: uspended solid-floor polypropylene cages furnished with woodflake
- Diet (e.g. ad libitum): Certified rat and mouse diet ad libitum, except for a fasting period of 4 hours prior to dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 300 mg active ingriedient/kg bodyweight, 50 mg active ingredient/kg bodyweight
- Amount of vehicle (if gavage): 10 ml active ingredient/kg bodyweight
- Justification for choice of vehicle: The test material did not dissolve/suspend in distilled water

MAXIMUM DOSE VOLUME APPLIED: 10 ml active ingredient/kg bodyweight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: There was an absence of data regarding the toxicity of the test material.
Doses:
300 mg active ingriedient/kg bodyweight and 50 mg active ingredient/kg bodyweight
No. of animals per sex per dose:
1 for 300 mg active ingriedient/kg bodyweight
6 for 50 mg active ingredient/kg bodyweight
All were females.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Once a day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Clinical signs and body weight examinations were performed.

Results and discussion

Preliminary study:
One mouse given a dosage level of 300 mg active ingredient/kg bodyweight. Hunched posture was noted at 4 hours, and at 1 day signs of systemic toxicity noted were hunched posture, lethargy, pilo-erection, dehydration, decreased respiratory rate and pallor of the extremities. The animal was killed in extremis one day after dosing. Patchy pallor of the liver was noted at necropsy. Based on this information, a dose level of 79 mg/kg bodyweight was selected for investigation.
Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 79 - <= 471 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 50 - <= 300 mg/kg bw
Based on:
act. ingr.
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the observation period.
Body weight:
All animals showed expected gains in bodyweight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Based on this information, a dose level of 79 mg/kg® bodyweight was selected for investigation.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The test substance was classified as a category 3 for acute oral toxicity according to GHS criteria.