Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 Aug 2010 - 07 Sep 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study Analytical purity not given, responsibility of the sponsor.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
yes
Remarks:
Analytical purity not given, responsibility of the sponsor
GLP compliance:
yes (incl. certificate)
Remarks:
Department of Health of the United Kingdom, 2009
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HiPeaK
- Physical state: white powder
- Analytical purity: not given, responsibility of the sponsor
- Lot/batch No.: 9086
- Storage condition of test material: RT in the dark under nitrogen
- Expiry date: 23 Dec 2011

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 168 - 181 g
- Fasting period before study: overnight
- Housing: in groups of up to four
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/mL for pre-test and 200 mg/mL for main experiment
- Amount of vehicle (if gavage): 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the abscence of data regarding the toxicity, 300 mg/kg bw was chosen as starting dose for a preliminary experiment
Doses:
300 mg/kg bw for pre-test and 2000 mg/kg bw for main experiment
No. of animals per sex per dose:
pre-test 300 mg/kg bw: 1 animal
main experiment 2000 mg/kg bw: 5 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: cage side observations twice daily, weighing on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs: 0.5, 1, 2 and 4 hours after dosing and daily thereafter

Results and discussion

Preliminary study:
300 mg/kg bw: no mortalities, hunched posture 0.5, 1 and 2 hours after dosing, no signs after 4 hours
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities
Clinical signs:
No signs of systemic toxicity
Body weight:
Normal body weight gain
Gross pathology:
No abnormal findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of HiPeaK was estimated to be >2000 mg/kg bw. Therefore no classification according to DSD or CLP is required.