Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 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
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Adopted 17 Dec. 2001
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 177 +/- 6.7 g
- Fasting period before study: yes
- Housing: transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet (e.g. ad libitum): ssniff R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 10. June To: 25. June 2003

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Tylose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 %
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: homogenity, stability

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual):
the test item was suspended in tylose and distributed homogeneously by means of a magnetic stirrer

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to toxicity data of related compounds
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (2 x 3 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Symptoms: twice daily
Body weight: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred
Clinical signs:
Feces was discolored by compound one day after the administration, no symptoms of toxicity were observed
Body weight:
not impaired
Gross pathology:
no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this OECD 423 study with female rats the LD50 of the test item is greater than 2000 mg/kg bw.
Executive summary:

Acute oral testing of the test item in famels rat yielded a LD50 greater than 2000 mg/kg be. After administration of 2000 mg/kg bw neither deaths nor symptoms occurred. Only the feces was discolored by the test compound on day 2 of the study. Development of body weight was not impaired. All animals were killed at the end of the observation period. They showed no macroscopically visible changes.