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:
study report
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 96/54/EG, B.1tris (Akute-toxische-Klassen-Methode)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: rat, Hsd Cpb:WU

Administration / exposure

Vehicle:
other: Methocel - K4M Premium

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Mortality:
Male: 25 mg/kg bw; Number of animals: 3; Number of deaths: 0
Male: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 200 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 3
Clinical signs:
Signs of toxicity related to dose levels: 2000 mg/kg: lateral position, motor excitation, dyspnea and death within a few minutes after application. 200 mg/kg: abdominal and dorsal position, locomotor disturbance and dyspnea 25 mg/kg: locomotor disturbance
Gross pathology:
Effects on organs: At pathology all rats which died showed mild local changes in the gastro intestinal tract. All rats which were sacrified at the end of the study showed no macroscopic abnormalities.

Applicant's summary and conclusion

Executive summary:

The LD50 of the substance is in the range 200 -2000 mg/kg bw.