Registration Dossier

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: GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
T-7145
IUPAC Name:
T-7145
Details on test material:
- Name of test material (as cited in study report: T-7145
- Physical state: Clea colorless liquid
- Analytical purity: Expected to be >99.5%
- Lot/batch no.: Lot 4
- Expiration date of the lot/batch: April 28, 2000
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: approx 6 weeks old
- Fasting period before study: overnight (max 20 hours)
- Housing:- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 21 C
- Humidity (%): approx 50%
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12 light/12 dark
IN-LIFE DATES: From: To: Females: July 13, 1999 to July 27, 1999; Males: July 15, 1999 to July 29, 1999

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (1.2 ml/kg)
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing:Observed twice daily; Weighed pre-administration, day 8, day 15, and death
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occured
Clinical signs:
No clinical signs of toxicity were noted
Body weight:
Weight gain was considered to be similar to that expected of normal untreated animals
Gross pathology:
No abnormalities were found at macroscopic post motem examination of the animals

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Oral LD50 exceeds 2000 mg/kg body weight Criteria used for interpretation of results: EU
Conclusions:
LD50 is greater than 2000 mg/kg and no classification is necessary.
Executive summary:

An assessment of acute oral toxicity of the test material was conducted according to Acute Toxic Class Method. Test material was administered by oral gavage at 2000 mg/kg body weight. No mortality, signs of clinical toxicity or macroscopic changes occurred. The oral LD50 of T-7145 was established to exceed 2000 mg/kg in Wistar rats. Under Guidelines in Commission Directive 93/21/EEC, T-7145 does not have to be classified and has no obligatory labelling requirement for oral toxicity.