Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited but acceptable documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Principles of method if other than guideline:
other: acute oral toxicity study
GLP compliance:
no
Test type:
other: acute oral toxicity study
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Santocure MOR, Lot no. NC 01-001

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
5010, 6310, 7940 mg/kg bw
No. of animals per sex per dose:
2 to 3 per dose and sex
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 940 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Signs of intoxication: reduced appetite and activity (one to three days in survivors), increasing weakness, collapse and death

Any other information on results incl. tables

Mortality:

5010 mg/kg bw: m (0/2), f (0/3)

6310 mg/kg bw: m (0/3), f (0/2)

7940 mg/kg bw: m (0/2), f (1/3) ( time of mortality: 2 days)

Signs of intoxication: reduced appetite and activity (one to three days in survivors), increasing weakness, collapse and death

Gross autopsy decedents: hemorrhagic lungs and liver and acute gastrointestinal inflammation

survivors (7 days): viscera appeared normal

Applicant's summary and conclusion

Executive summary:

LD50 rat: higher than 7940 mg/kg bw