Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1948-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented and scientifically accpetable. Study conducted before the advent of GLP.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1948
Report Date:
1948

Materials and methods

Principles of method if other than guideline:
Single dermal dose
4 or 5/dose level, male albino Rabbits
14-day observation period
Deaths recorded, used to calculate LD50
Procedures detailed in original bound volumes and replicated in publications
GLP compliance:
no
Remarks:
Conducted pior to the advent of GLP.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No additional details.

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS

- Age at study initiation: Not identified.
- Weight at study initiation: See Table 1 Below

Administration / exposure

Type of coverage:
other: Dermal
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The application of undiluted diisobutyl carbinol to the truck of rabbits under an imprevious sheeting "Vinylite" for 24 hours.
Duration of exposure:
24 Hours
Doses:
2.52, 5.0, 10.0, 20.0 mL/Kg.
No. of animals per sex per dose:
4 animals @ 2.5mL/Kg
5 animals @ all other doses
Control animals:
no
Details on study design:
Single dermal dose
4/low dose levle, 5/all other dose levels, male albino rabbits
24 hour exposure
14-day observation period
Deaths recorded, used to calculate LD50
Procedures detailed in original bound volumes and replicated in publications.
The application of undiluted diisobutyl carbinol to the trunk of rabbits under an imprevious sheeting for 24 hours also produced erratic mortalities
at dosage levels differing by 100?%. Four of 5 rabbits diedat levels of 10 and 20 ml./kg. The R.F. LD50 is 5.66 (2.51 to 12.8) ml./kg. Marked erythema and in
some instances necrosis of the skin were noted. Livers showed varying degrees of congestion and the kidneys were usually pale. There appears to be a wide
variation in individual susceptibility to the action of this compound both by oral dose and skin penetration.
Statistics:
probit method used to calcluate LD50.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 5.66 mL/kg bw
Based on:
test mat.
95% CL:
ca. 2.51 - ca. 12.8
Mortality:
1/4 @ 2.52 mL/Kg
2/5 @ 5.0 mL/Kg
4/5 @ 10.0 mL/Kg
4/5 @ 20 mL/Kg
Clinical signs:
marked erythema
necrosis
Body weight:
See Talbe 1 for Body Weight changes in 14 days.
Gross pathology:
Liver showed varying degrees of congestion and the kidneys were usually pale.
Other findings:
not applicable

Any other information on results incl. tables

No additional informations or results.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 is 5.66 (2.51 to 12.8) mL./Kg. Marked erythema and in some instances necrosis of the skin were noted. Livers showed varying degrees
of congestion and the kidneys were usually pale. There appears to be a wide variation in individual susceptibility to the action of this compound both by oral dose and skin penetration.