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:
The study was conducted between 22 October 2015 and 13 November 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Deviations:
not specified
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor Batch/Lot no. PW2
- Expiration date of the lot/batch:
- Purity test date:06 October 2015

RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

OTHER SPECIFICS:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Raleigh NC, USA
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 wks
- Weight at study initiation: 188 - 208 g
- Fasting period before study: yes, 16-20h
- Housing: individually in stainless steel wire bottom cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: > 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but not reported
- Humidity (%): controlled but not reported
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 October 2015 To: 13 November 2015

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2.0 g/10 mL
- Amount of vehicle (if gavage): 2.0 mL
- Justification for choice of vehicle: to assist dosing by gavage
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED: 2.0 mL/rat

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Observed at 15 min, 1, 2 and 4 h and then once daily for 14 days. Bodyweights recorded pretest, weekly and at termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
other: pharmacological effects

Results and discussion

Preliminary study:
One female rate dosed at 2000 mg/kg - No adverse effects.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
None
Clinical signs:
None
Body weight:
All five animals gained weight by study termination
Gross pathology:
Gross necropsy of all animals revealed no observable abnormalities

Applicant's summary and conclusion

Interpretation of results:
other: The oral LD50 of RD14153 is >2000 mg/kg body weight
Conclusions:
The oral LD50 of RD14153 is greater than 2000 mg/kg.
Executive summary:

The study was designed to examine the potential toxicity of RD14153 when administered orally to Sprague-Dawley rats. the study was conducted according to the guidelines OECD 425 and OPPTS 870.1100.

Initially a single female rat was dosed orally with RD14153 at 2000 mg.kg bodyweight. The animal survived and subsequently 4 further femae rats were dosed at 2000 mg/kg bodyweight.The rats were observed at 15 mins 1, 2 and hours post dose and once daily for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Bodyweights were recorded immediately pre-test, weekly and at termination.All animals were examined for gross pathology.

All animals survived a single dose of 2000 mg/kg bodyweight. there were no ablnormal physical signs, all five rats gained in bodyweight and gross pathology of all animals revealed no observable abnormalities.

The oral LD50 of RD14153 is greater than 2000 mg/kg.