1,2-epoxybutane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: basic data given, comparable to guideline/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Principles of method if other than guideline:

according to Draize: Appraisal of the safety of chemicals in foods, drugs and cosmetics. In dermal toxicity pp. 46 - 59, 1959.
Austin, Tex.: Association of food and drug officials of the United Staates, Texas, State Department of Health.

GLP compliance:

no

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Animal species: Rabbit / White Vienna (2 females), breeder: Gaukler, Germany
Animal weights: 3.1 resp. 3.02 kg
Type of cage: Cage made of stainless steel with wire mesh walk floor, floor area about 40 cm x 51 cm
No. of animals per cage: 1
Animal identification: Ear tattoo
Room temperature: 20 - 26°C
Relative humidity: about 30 - 70%
Day/night rhythm: 12 h / 12 h
Bedding: No bedding in the cages, saw dust in the waste trays
Diet: Ovator Sokikanin 4 mm, Duesseldorf, Germany
Drinking water: About 250 ml per animal
Acclimatization period: About 8 days before the beginning of the study in the laboratory, same housing conditions as during the study

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

Application area: 2.5 x 2.5 cm
Volume applied: Coating of the test patch with the undiluted test substance
Appl. site: back or flank

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

2

Details on study design:

Removal of the test substance: no
Readings: 15 - 30 minutes after removal of the test patches and 24 h, 48 h, 8 d after beginning of application
Scoring according to Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 h

Score:

0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information