Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992/93
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1993

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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Laromer LR8869
- Physical state: liquid, yellowish
- Analytical purity: 99.8%
- Lot/batch No.: 1/92
- Stability under test conditions: proven by reanalysis
- Storage condition of test material: refrigerator, exclusion of light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: young adult
- Weight at study initiation: 178-190g
- Fasting period before study: 16h (water available ad lib.)
- Housing: single, in stainless steel wire mesh cages, type DK-III
- Diet (e.g. ad libitum): Kliba-lab-diet 343, ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: > 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Remarks:
DAB 9
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40g/100ml
- Justification for choice of vehicle: poor solubility of test substance in water

MAXIMUM DOSE VOLUME APPLIED: 5ml/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no acute toxicity expected due to chemical characteristics
Doses:
2000mg/kg
No. of animals per sex per dose:
3 males + 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observations: several times on the day of administration, thereafter: twice daily on workdays, daily on weekends
body weight: day 0, weekly thereafter and at the end of the study before the fasting period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
expected gain
Gross pathology:
no findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
Under the conditions of this study the median lethal dose after oral applications was found to be greater than 2000mg/kg b.w. for the male and female animals.
Executive summary:

The study was preformed to assess the range of mortality following oral administration of the test material, applied as a solution in olive oil DAB 9, to Wistar rats.

A group of 6 fasted animals (3males and 3females) was given a single oral dose of test material preparation in olive oil DAB 9 at a dose level of 2000mg/kg body weight.

Signs of toxicity have not been noted.

The expected body weight gain has been observed in the course of the study.

No mortality occured.

No abnormalities were noted at necropsy of animals sacrificed at the end of the study.