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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
Study period:
16 Jan 1959 -10 Feb 1959
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1959
Report date:
1959

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Test material was applied to shaved occluded skin of male rabbits for 24 hours. Surviving rabbits were observed for 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbutan-1-ol
EC Number:
205-289-9
EC Name:
2-methylbutan-1-ol
Cas Number:
137-32-6
Molecular formula:
C5H12O
IUPAC Name:
.
Constituent 2
Reference substance name:
2-methyl-1-butanol
IUPAC Name:
2-methyl-1-butanol
Details on test material:
No additional information available.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
Male albino New Zealand strain rabbits, 3 to 5 months of age and averaging 2.5 kg in weight were used. Rabbits were procured locally and maintained on Rockland rabbit ration.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Rabbits were immobilized during the 24-hour skin contact period. Vinylite sheeting was used to retain the dose in contact with the clipped skin of the trunk
Duration of exposure:
24 hours
Doses:
2.5 and 5 ml/kg
No. of animals per sex per dose:
4 males/dose
Control animals:
not specified
Details on study design:
Test material was applied to the shaved abdomen of 4 rabbits for each dose level. The application site was occluded with Vinylite sheeting for the 24 hour exposure period. Surviving rabbits were observed for the 14-day observation period.
Statistics:
The moving average method of' calculating the LD50 was used.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3.54 mL/kg bw
Based on:
test mat.
Mortality:
There was no mortality in rabbits dosed dermally with 2.5 ml/kg. At 5.0 ml/kg, all animals died. One rabbit died on the day of test material application and the remaining died on days 1, 3 or 4 after application.
Clinical signs:
Erythema, edema or necrosis of the skin was observed at the application site.
Body weight:
Body weight gains of rabbits dosed dermally with 2.5 ml/kg ranged from -166 to +450 g over the 14 day observation period.
Gross pathology:
Rabbits that died had hemorrhage under the skin, mottled or pale livers and kidneys and lung hemorrhage.
Other findings:
No additional information available.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 was 3.54 ml/kg. for undiluted 2 -methylbutanol
Executive summary:

The acute dermal toxicity of 2 -methylbutanol was determined in albino New Zealand rabbits. The dermal LD50 was 3.54 ml/kg. for undiluted 2 -methylbutanol

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