Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 423
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rat, Sprague-Dawley Hsd:(SD)

Administration / exposure

Vehicle:
other: Suspension in 20 % Tylose

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 6; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
Im Verlauf der Studie ist kein Tier gestorben. Ab 30 Min.
bis 1 h p.a. traten folgende unspezifischen Symptome auf:
Hockstellung, gestelzter und unkoordinierter Gang,
unregelmäßige Atmung, eingezogene Flanken, Hyperaktivität,
verengte Lidspalten, gesträubtes Fell und gelbliche
Verfärbung der Einstreu. Ab dem 7. Tag p.a. waren die
Effekte reversibel.

2 Tiere zeigten am Ende der Studie einen leichten
Körpergewichtsverlust. Bei den anderen Tieren war die
Körpergewichtsentwicklung nicht beeinflusst.

"ENGLISH"

No animal died in the course of the study. The following
unspecific symptoms occurred from 30 min to 1 h p.a.
Crouched posture, high-legged and uncoordinated gait,
irregular breathing, contracted flanks, hyperactivity,
narrowed eyelids, piloerection and yellow discoloration of
the bedding. The effects were reversible from the 7th day.

2 animals exhibited a slight loss in body weight at the end
of the study. There was no influence on the body-weight

gain of the other animals.
Gross pathology:
Effects on organs:
Bei der Sektion der Tiere am Ende der Studie wurden keine
makroskopisch sichtbaren Effekte festgestellt.

"ENGLISH"

No macroscopically visible effects were determined during
the necropsy of the animals at the end of the study.

Applicant's summary and conclusion

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