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:
1974
Report Date:
1974

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Santoflex IP

Test animals

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
corn oil
Duration of exposure:
24 h
Doses:
5010, 7940 mg/kg
No. of animals per sex per dose:
1 to 2 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: Clinical signs

Any other information on results incl. tables

Mortality: none

5010 mg/kg: m 0/1, f -, combined: 0/1

7940 mg/kg: m 0/1, f 0/1, combined: 0/2

Clinical signs: Reduced appetite and activity for three to five days.

Gross autopsy:

Survivors (14 days): Viscera appeared normal.

Applicant's summary and conclusion