Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
and EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeder: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 282 ± 5 g
females: 198 ± 3 g
- Fasting period before study: overnight
- Housing: one to seven of the same sex / cage during acclimation period and 3 rats of the same sex and group / cage
during the treatment period in polycarbonate cages with stainless steel lid (48 x 27 x 20 cm)
- Diet (e.g. ad libitum): ad libitum, pellets by SSNIFF Spezialdiäten GmbH, Germany
- Water (e.g. ad libitum): ad libitum, drinking water, filtered
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 C
- Humidity (%): 30-70 %
- Air changes (per hr): 12 / hour (filtered, non-recycled air)
- Photoperiod (hrs dark / hrs light): 12/12 h

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: MC (methylcellulose) 0.5 %
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg / ml vehicle suspension
- Amount of vehicle (if gavage): 10 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 10 ml / kg

Doses:
2000 mg / kg bodyweight
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations : frequently during the hours administration following then once a day
weighing: days 1, 8 and 15
- Necropsy of survivors performed: yes (macroscopic examination).
- Other examinations performed: none.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
1 of 3 males (day 2)
Clinical signs:
-hypoactivity, piloerection, dyspnoea (males)
-none in females
Body weight:
Reversible loss of BW.
Gross pathology:
No abnormality.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU