Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-03-03 to 1999-04-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
(1996)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: as specified in section 1.1 and 1.2

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Weight at study initiation: males: 169 g; females: 181 g (200 mg/kg bw group) and 177 g (2000 mg/kg bw group)
- Fasting period before study: yes, at least 16 hours before administration
- Housing: single housing in stainless steel wire mesh cages
- Diet: ad libitum, standard laboratory diet (Kliba-Labordiaet, Klingentalmuehle AG, Kaiseraugst, Switzerland)
- Water: ad libitum, tap water
- Acclimation period: at least one week

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % Tylose CB 30.000 in aqua bidest.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 and 20 g/100 mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and the composition no pronounced acute oral toxicity was expected. Therefore a starting dose of 2000 mg/kg body weight has been chosen.
Doses:
200 and 2000 mg/kg bw
No. of animals per sex per dose:
200 mg/kg body weight: 3 males, 3 females
2000 mg/kg body weight: 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 1 resp. 14 days
- Frequency of observations and weighing:
Individual body weight determination shortly before administration (day 0), weekly thereafter and at the end of the study (before fasting period); additionally animals that died or were sacrificed moribund.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Mortality:
All animals of the 2000 mg/kg dose group were found dead 1 day after application.
No mortality occurred in the 200 mg/kg dosing group.
Clinical signs:
Signs of toxicity were not noted.
Body weight:
The expected body weight gain was observed in the course of the study.
Gross pathology:
Necropsy findings of the animals that died were edema in all lobes of the lung and effusion in the thoracic cavity.
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information