Pentene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 April to 25 May 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not applicable

Principles of method if other than guideline:

The test material was exposed to the shaved rabbit skin for 4 hours under semi-occluded condition. Observation made up to 7 days after the application of the substance.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Pentene

EC Number:

246-916-6

EC Name:

Pentene

Cas Number:

25377-72-4

Molecular formula:

C5H10

IUPAC Name:

pent-1-ene

Details on test material:

- Name of test material (as cited in study report): Pentene-1, N-amylene (as CAS No. 109-67-1)

- Physical state: Colourless liquid.

- Analytical purity: 94.4%

- Lot/batch No.: ST83/065

- Expiration date of the lot/batch: 1 October 1983.

- Stability under test conditions: Tested using infra-red spectra. The substance is judged to have been stable for the duration of the study. (Stabilities of formulations of the test substance) The stabilities of formulations of the test substance in corn oil or corn oil: Freund's Complete Adjuvant (1:1 v/v) were assessed by a panel of qualified chemists. These formulations were stable for at least one working day (7.5 h).

- Storage condition of test material: In the dark at ambient temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

4 hours.

Observation period:

Up to 7 days (observations were made at 30 minutes after the removal of the patch (i.e. approximately 4 hours after application) and at 24, 48 and 72 hours and 7 days after application).

Number of animals:

Three males and three females.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Other effects:

Not reported.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

There were no skin reactions following a 4 hour semi-occluded application of undiluted pentene-1 to rabbit skin. The material is therefore
not an irritant in this test.

Executive summary:

The test material, Pentene-1, is a fine chemical used in chemical syntheses. In the 4 hour skin irritancy test, the test material was not irritating to semi-occluded rabbit skin.

The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).

The test was conducted following to the similar methodologies as OECD testguideline 404 (1981). There are no information available regarding the testing facility therefore a reliability of 2 is assigned.