Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 Feb - 03 Apr 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 2001
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
adopted 2002
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nosan No. 8147
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solution
Details on test material:
- Name of test material (as cited in study report): GSID 3056-1
- Physical state: solid, brownish
- Analytical purity: 60.8 area-% (HPLC; analytical report 11L00523)
- Lot/batch No.: 1470 VB04
- Storage condition of test material: room temperature
- Stability under storage conditions over the study period: guaranteed by the sponsor (sponsor holds this responsibility)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: approximate mean of 170 g
- Fasting period before study: at least 16 hours
- Housing: single housing in Makrolon cages Type III
- Diet: VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): fully air-conditioned room

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: test item was soluble in olive oil

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION
The test item was ground with mortar and pestle, and stirred with a high speed homogenizer and a magnetic stirrer; to delete air bubbles the test item preparation was stored at room temperature for approximately 1 hour.

CLASS METHOD
- Rationale for the selection of the starting dose: the starting dose of 2000 mg/kg bw was requested by the sponsor; as no mortality occurred in the first group of 3 female animals, the experiment was repeated with another 3 female animals.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females in the first group and 3 females in the second group tested
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed several times on the day of administration and daily thereafter on workdays, body weights were determined shortly before administration, weekly thereafter and on the last day of observation.
- Necropsy of survivors performed: the animals were sacrificed on the last day of observation (CO2-inhalation) and subjected to gross pathology; no histological examinations were performed.
Statistics:
Calculations were performed using Microsoft Excel 2003 and checked with a calculator.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
No mortality occurred during the observation period.
Clinical signs:
No clinical signs were observed during clinical examinations.
Body weight:
The mean body weight of the test groups increased throughout the study period within the normal range.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

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