Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC, B1
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Rat (Sprague-Dawley)

Administration / exposure

Vehicle:
other: Distilled water

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 671 mg/kg bw
95% CL:
>= 547 - <= 925
Remarks on result:
other: Slope of the mortality curve: 7.4
Mortality:
Male: 320 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 500 mg/kg bw; Number of animals: 5; Number of deaths: 0
Male: 800 mg/kg bw; Number of animals: 5; Number of deaths: 3
Female: 320 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 500 mg/kg bw; Number of animals: 5; Number of deaths: 2
Female: 800 mg/kg bw; Number of animals: 5; Number of deaths: 4
Clinical signs:
Signs of toxicity related to dose levels:
Pilo-erection was observed in all rats within five minutes
of dosing and throughout the remainder of Day 1. This
persisted and was accompanied on Day 1 and/or later
intervals by:
abnormal body carriage, abnormal gait and pallor of the
extremities in all rats;
lethargy and decreased respiratory rate in all rats dosed at
500 mg/kg and the majority of rats at 320 and 800 mg/kg;
clonic convulsions in one male treated at 320 mg/kg, one
male and two females at 500 mg/kg and two males and three
females at 800 mg/kg;
Slight bodyweight loss was recorded for all rats that died,
while surviving rats achieved anticipated bodyweight gains
throughout the study as judged by external appearance and
behaviour was complete by Day 5.
Gross pathology:
Effects on organs:
No treatment related macroscopic findings were observed for
rats which died during the study or which were killed on Day
15.

Applicant's summary and conclusion

Interpretation of results:
other: harmful