Registration Dossier

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
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 dermal toxicity study
GLP compliance:
no
Test type:
other:
Limit test:
no

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
not specified
Vehicle:
corn oil
Duration of exposure:
24 h
Doses:
3160, 5010, 7940 mg/kg bw
No. of animals per sex per dose:
1 to 2 animals per dose
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 for one to three days

Any other information on results incl. tables

Mortality: no mortality in any of the treated animals

Signs of intoxication: reduced appetite and activity for one to three days

Gross autopsy (14 days): viscera appeared normal

Applicant's summary and conclusion

Executive summary:

LD50 rabbit: higher than 7940 mg/kg bw