3-methylbut-2-en-1-ol

Acute Toxicity: dermal

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: Comparable to guideline study with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

; reduced animal number (3 animals per dose and sex instead of 5 animals per dose and sex)

Principles of method if other than guideline:

Male and female rats were treated with two doses of test material; the test material was applied uniformly to the clipped skin of the back and flank of each animal. The application site was covered with an aluminium foil, which was secured in position with adhesive tape. After an exposure period of 24 hours, the bandage was removed and the application site was gently washed with warm water and dried with pulp.
Following treatment, the animals were regularly examined for mortality, clinical signs of toxicity and local changes over an observation period of 14 days. All rabbits that died during the observation period as well as the surviving animals, which were sacrificed at the end of the observation period, were subjected to necropsy.

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted.

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

3-methylbut-2-en-1-ol

EC Number:

209-141-4

EC Name:

3-methylbut-2-en-1-ol

Cas Number:

556-82-1

Molecular formula:

C5H10O

IUPAC Name:

3-methylbut-2-en-1-ol

Details on test material:

- Name of test substance: 3-Methylbut-2-en-1-ol (Prenol)
- Analytical purity: ca. 99 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Wiga, Sulzfeld, Germany
- Average weight at study initiation: males: 260 g; females: 180 g
- Diet: Herilan MRH-Kraftfutter (H. Eggersmann, Rinteln/Weser, Germany), ad libitum
- Water: ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The substance was applied undiluted at dosages of 2000 and 4000 mg/kg bw onto the clipped flank or back skin of the animals (area: about 42 sqcm). The treated skin area was covered with a aluminium wrap which was fixed with an adhesive tape. The dressing was removed 24 hrs after application of the test substance. Subsequently, the remaining test substance was removed with warm water or a water/Lutrol (polyethyleneglycol) mixture.

Duration of exposure:

24 h

Doses:

2000 and 4000 mg/kg bw

No. of animals per sex per dose:

3 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: The animals were weighed prior to exposure of the test material, on day 4, 6, 11 and on day 13. In both groups the animals were observed for clinical signs and mortality on working days.
- Necropsy performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Mortality:

No deaths occurred at both dose groups.

Clinical signs:

other: Slight apathy, staggering, irregular breathing, slight local skin irritation, which was reversible during the post observation period.

Gross pathology:

All examined animals were without abnormal findings.