Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 September 1995 and 3 October 1995
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 relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of inspection: 31/01/09 Date of signature: 16/03/94
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PX-200- Molecular formula (if other than submission substance): same as submission substance- Molecular weight (if other than submission substance): same as submission substance- Smiles notation (if other than submission substance): same as submission substance- InChl (if other than submission substance): same as submission substance- Structural formula attached as image file (if other than submission substance): same as submission substance- Substance type: white powder- Physical state: solid- Analytical purity: not stated- Impurities (identity and concentrations): not stated- Composition of test material, percentage of components: not stated- Isomers composition: not stated- Purity test date: not stated- Lot/batch No.: P-3- Expiration date of the lot/batch: not stated- Radiochemical purity (if radiolabelling): not stated- Specific activity (if radiolabelling): not stated- Locations of the label (if radiolabelling): not stated- Expiration date of radiochemical substance (if radiolabelling): not stated- Stability under test conditions: not stated- Storage condition of test material: room temperature- Other: not stated

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Charles River (UK) Ltd., Margate, Kent, UK.- Age at study initiation: five to eight weeks- Weight at study initiation: males = 142 to 155 g, females = 129 to 140 g.- Fasting period before study: overnight fast immediately before dosing and for two hours after dosing- Housing: solid floor polypropylene cages- Diet: ad libitum- Water: ad libitum- Acclimation period: at least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): 19 to 23°C- Humidity (%): 48 to 59%- Air changes (per hr): approximately 15 changes per hour- Photoperiod (hrs dark / hrs light): 12 hours continuous light followed by 12 hours continuous darkIN-LIFE DATES: From: Day 1 To: Day 14

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE- Concentration in vehicle: not stated- Amount of vehicle (if gavage): 10 ml/kg - the volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.- Justification for choice of vehicle: - Lot/batch no. (if required): not stated- Purity: not statedMAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - the volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.DOSAGE PREPARATION (if unusual): not applicableCLASS METHOD (if applicable)- Rationale for the selection of the starting dose: not applicable
Doses:
2000 mg/kg for range finding study and main study.
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight
Statistics:
Determination of LD50

Results and discussion

Preliminary study:
There were no deaths or clinical signs of toxicity.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
No signs of systemic toxicity were noted during the study.
Body weight:
All animals showed expected gain in bodyweight during the study.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
- Organ weights: not recorded- Histopathology: not determined- Potential target organs: none- Other observations: none

Any other information on results incl. tables

The acute oral median lethal dose (LD50) of the test material, PX-200, in the Sprague-Dawley CD strain rate was found to be greater than 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the test material, PX-200, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bw.
Executive summary:

The method followed that in the OECD Guidelines for Testing of Chemicals No. 401 "Acute Oral Toxicity" and Method B1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material as a suspension in arachis oil B.P. at a dose level of 2000 mg/kg bw. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross pathological examination.

there were no deaths. No signs of systemic toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

The acute oral median lethal dose (LD50) of the test material, PX-200, in the Sprague-Dawley CD strain rate was found to be greater than 2000 mg/kg bw.