2-methylbutan-1-ol

Acute Toxicity: dermal

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

Test material information

Constituent 1

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:

2-methylbutan-1-ol

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:

other: Erythema, edema or necrosis of the skin was observed at the application site.

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