Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 October 1997 - 13 November 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to international guideline and GLP.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Epyrron
- Physical state: Off white powder
- Composition of test material, percentage of components: Main Component 55%
Other: 22% & 18%
- Lot/batch No.: GV-1458 K1
- Expiration date of the lot/batch: 24 September 1998
- Stability under test conditions: Stable
- Storage condition of test material: 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, Sulzfeld, Germany
- Age at study initiation: 9 weeks
- Housing: Group housing (polycarbonate cages) 3 animals per sex
- Diet (e.g. ad libitum): Free access, standard pelleted laboratory animal diet (Carfil Quality BVBA, Oud-Turnhour, Belgium).
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 28 October 1997 To: 13 November 1997

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg


Doses:
2000 mg/kg (10 ml/kg) body weight
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability - Twice daily; Body Weight - Days 1 (pre-administration), 8 and 15; Clinical Signs - periodic intervals on day of dosing, and once daily thereafter, until day 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: Necropsy was performed at the end of the observation period and internal macroscopic abnormalities were recorded.
Statistics:
None performed

Results and discussion

Preliminary study:
Since the 2000 mg/kg limit test resulted in no adverse effects, or mortalities in the study group, no additional dose levels were required.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
There were no signs toxicity throughout the 15 day observation period. All male and females animals appeared normal throughout the observation period.
Body weight:
The body weight gained by animals over the study period was considered to be similar to that expected for normal untreated animals.
Gross pathology:
No abnormalities were observed at the macroscopic level for all animals necropsied at the conclusion of the 15-day observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance, when administered as supplied to 3 male and 3 female Wistar rats, indicates an acute oral LD50 greater than 2000 mg/kg.
Executive summary:

The oral LD50 value of the test substance in Wistar rats was established as greater than 2000 mg/kg body weight.