Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test animals

Species:
other: Rat, Spraque-Dawley

Administration / exposure

Vehicle:
other: Methylcellulose

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 500 mg/kg bw
95% CL:
4 100 - 6 300
Remarks on result:
other: Slope of the mortality curve:9.4

Any other information on results incl. tables

Mortality

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 2

Male: 6400 mg/kg bw; Number of animals: 5; Number of deaths: 5

Male: 8000 mg/kg bw; Number of animals: 5; Number of deaths: 2

Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 1

Female: 6400 mg/kg bw; Number of animals: 5; Number of deaths: 3

Female: 8000 mg/kg bw; Number of animals: 5; Number of deaths: 4

Clinical signs

Signs of toxicity related to dose levels:

Shortly after dosing in the majority of animals: pilo-erections, hunched poisture, wadding, lethargy, decreased respiratory rate and pallor of the extremities.

The signs were accompanied by:

-ptosis in one male at 5000 mg/kg and in three females at 8000 mg/kg

- increased salivation in all rats at 5000 mg/kg

- comatose like condition in one male rat at 5000 mg/kg

Recovery was generally complete by day seven, except for one male dosed 5000 mg/kg pilo-erection was still observed on day 15. A bodyweight loss was recorded on day 8 for one male dosed at 5000 mg/kg, and the body gains for the remaining animals on day 8 and 15. Mortalities occured within ine hour to three days of dosing.

Gross pathology

Effect on organs:

Autopsy amongst the rats that died, revealed haemorrhage or congestion of the lungs and pallor of the liver, spleen and kidneys. Congestion of the stomach was also observed in one male rat at 6400 mg/kg.

Applicant's summary and conclusion

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