Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-05-16 to 2002-08-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD test under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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): CAVASOL W6 HP
- Physical state: solid powder
- Analytical purity: 95.9% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 63B001
- Expiration date of the lot/batch: 2003-02-28
- Stability under test conditions: stable
- Storage condition of test material: in original container, at room temperature, in the dark

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: approx. 6 weeks
- Weight at study initiation: males 153 - 168 g; females 140 - 152 g
- Fasting period before study: overnight (max. 20 hours
- Housing: standard laboratory conditions; groups of three animals in Makrolon type-4 cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
not used
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 male/3 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: at periodic intervals on the day 1 and once daily during day 2-15 examination for clinical signs/mortality; body weights were recorded on day 1 before administration and on days 8 and 15
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, mortality, body weights, necropsy
Statistics:
not possible, limit test

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality has been observed.
Clinical signs:
No clinical signs have been observed.
Body weight:
Males (mean): day 1: 163 g; day 8: 235 g; day 15: 277 g
Females (mean): day: 1 147 g; day 8: 183 g; day 15: 209 g
Gross pathology:
No findings noted.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (oral, rat) was determined to be > 2000 mg/kg bw.
Executive summary:

A group of three male and five female Wistar rats was treated with Cavsaol W6 HP at 2000 mg/kg by oral gavage. No deaths occurred during the study. General signs of toxicity were not observed. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy. The LD50 (oral, rat) was determined to be > 2000 mg/kg bw.