Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From September 17 to October 03, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (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
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: Hsd:Sprague Dawley (SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH Gartenstrasse 27 D-33178 Borchen
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation (mean): 188.3 g
- Housing: in transparent macrolon cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet: ssniff R/M-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least five days
- Randomization procedure: Computer generated algorithm (archived with raw data) Randomization schemes 2002.0512

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C (except short lasting deviations due to disturbances of air condition)
- Humidity (%): 50 ± 20 % (except short lasting deviations due to disturbances of air condition)
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Tylose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20 % suspension in tylose

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The acute oral toxicity of the test substance was tested only at a dose level of 2000 mg/kg body weight (limit test) according to toxicity data of related compounds.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time the animals were weighed weekly.
- Necropsy of survivors performed: yes. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the whole study.
Clinical signs:
The following clinical signs were observed in the animals starting 30 – 60 minutes hour after the administration of the test substance:
uncoordinated gait, squatting posture, and irregular respiration.
Urine was discolored red on day 1 and later on up to day 3 discolored dark as well as feces.
From day 4 until the end of the study no symptoms were observed.
Body weight:
One animal showed a slight body weight reduction in the second week of the study. Development of body weight was not impaired in the other animals.
Gross pathology:
The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

Method

The test substance was tested for its Acute Oral Toxicity according to a the OECD guideline 423.

Observations

No lethality occurred after application of 2000 mg/kg body weight. Besides unspecific symptoms the animals showed impairments of motility and respiration starting 30 – 60 minutes after application. Additionally urine was discolored reddish on day one. Later on up to day 3 urine was

discolored dark as well as feces. From day 4 until the end of the study no symptoms were observed. One animal showed a slight body weight reduction in the second week of the study. Development of body weight was not impaired in the other animals. All animals were killed at the end of the observation period. They showed no macroscopically visible changes.

 

Conclusion

LD50 > 2000 mg/kg bw.