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
Report Date:
1973

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 14

Test animals

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
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:
> 5 010
Remarks on result:
other: Clinical signs: reduced appetite and activity (survivors), increasing weakness, collapse and death (decents); gross autopsy:hemorrhagic areas of the lung, liver, spleen, and kidney discoloration, gastrointestinal inflammation (decents)

Any other information on results incl. tables

Mortality:

time of mortality: 8 days

5010 mg/kg: 0/1 male

7940 mg/kg: 1/1 male, 0/1 female, combinded: 1/2

Signs of intoxication: reduced appetite and activity (four to seven days in survivors), increasing weakness, collapse and death (decent)

Gross autopsy:

Decent: hemorrhagic areas of the lung, liver, spleen, and kidney discoloration, gastrointestinal inflammation

Survivors (14 days): Viscera appeared normal

Applicant's summary and conclusion

Executive summary:

LD50 rabbit: >5010 mg/kg