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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Name of test material (as cited in study report: T-7479
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: Cleae colourless liquid
- Analytical purity: treated as 100% pure
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers compositon:
- Purity test date:
- Lot/batch no.:
- Expiration date of the lot/batch: 23 March 2002
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material: At room temperature in the dark
- Other:

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 10 weeks old
- Weight at study initiation:
- Fasting period before study: overnight
- Housing:- Diet (e.g. ad libitum): Altromin (code VRF 1), Lage Germany
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: 5 Days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/_ 3 deg C.
- Humidity (%): 30 to 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Undiluted
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Expected to be low toxicity
Doses:
1 dose
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations twice daily,
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Body weights on days 1, 8 and 15. Clinical signs daily until the last day. Necrospsy was performed on study termination
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
Lethargy, hunched posture and/or piloerection were noted amound all animals between days 1 and 7.
Body weight:
Body weight and body weight gains were similar to controls.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 > 2000 mg/kg, male and female
Executive summary:

The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.1 tris "Acute toxicity-Oral, Acute Toxic Class Method" and OECD No. 423, "Acute Oral Toxicity-Acute Toxic Class Method" T-7479 was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occured. Lethargy, hunched posture and/or piloerection were noted among all animals between days 1 and 7. The mean body weight gain shown by the animals over the study period was considered to be norma.l No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of T-7479 in Wistar rats was established to exceed 2000 mg/kg body weight.