Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

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

Test animals

Species:
rat
Strain:
other: HanIbm: WIST (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Biological Research Laboratories.
- Age at study initiation: 8-10 weeks
- Weight at study initiation: Males: 206-216 g. Females: 171-190 g.
- Fasting period before study: Yes, overnight.
- Housing: Groups of three in Makrolon type-4 cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: One week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 40-66
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Justification for choice of vehicle: None given


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: None given.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Three
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical signs: four times per day on the day of treatment, and once daily thereafter. Body weights: Pre-administration and on Days 8 and 15.
- Necropsy of survivors performed: yes, on day 15 after observations.
- Other examinations performed: Macroscopic examination.
Statistics:
No statistical analysis as no deaths occurred.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths occurred.
Mortality:
No deaths occurred.
Clinical signs:
There were no clinical signs.
Body weight:
The body weights were in the expected range.
Gross pathology:
No abnormal findings.
Other findings:
No other findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a good quality acute toxic class method study (reliability score of 1), conducted to OECD 423 and GLP, the LD50 in rats for Wacker BS 1701 was greater than 2000 mg/kg bw as no deaths occurred at this dose.
Executive summary:

Two groups, each with three male or three female HanIbm: WIST (SPF) rats, were treated with Wacker BS 1701 at 2000 mg/kg bw by oral gavage. The test substance was diluted in corn oil at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2 -15. Mortality/viability was recorded together with clinical signs at the same time intervals. Body weights were recorded on Day 1 prior to administration and on Days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study, and there were no clinical signs, effects on body weight, or abnormal macroscopic findings. The LD50 was therefore not determined, but was greater than 2000 mg/kg bw.