Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan to Feb 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

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 material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: 38
- Purity: 100 %
- Expiration date of the lot/batch: 2003-03-12

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS:
- Source: Harlan-Winkelmann GmbH (Borchen, Germany)
- Age at study initiation: 9-11 weeks
- Weight at study initiation: 157-176 g
- Fasting period before study: 16-24 hours
- Housing: in groups
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: demineralized water with the aid of 2 % Cremophor EL
Details on oral exposure:
RATIONALE FOR THE SELECTION OF THE STARTING DOSE:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
ADMINISTRATION
- Application volume: 10 mL/kg bw
- Post dose observation period: 14 days

EXAMINATIONS
- Clinical observations were made several times on the day of dosing and at least once a day during the 14 day observation period. Body weights were recorded immediately prior to dosing and on days 7 and 14. Gross pathological examination was carried out on all animals.
Statistics:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: cut-off level according to OECD TG 423, Annex 2d
Mortality:
All 6 animals survived the treatment.
Clinical signs:
No clinical signs were observed.
Body weight:
Body weight development was not affected.
Gross pathology:
No gross pathological findings were observed.
Other findings:
No

Any other information on results incl. tables

NOEL: 2000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Executive summary:

A single oral dose of 2000 mg/kg bw of the test item formulated in demineralized water and 2 % Cremophor EL was tolerated by female rats without mortalities, clinical signs, effects on weight gain and gross pathological findings. According to OECD TG 423 the LD50 cut-off value of KGD 1409 is > 5000 mg/kg bw for rats (GHS Category 5 / unclassified).