Pent-1-ene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12.7.1982-26.7.1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Fully documented, non GLP Study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

No stepwise approach was adopted. Only the average weight of the test animals is given, and not the weight at the beginning and end of the test.

Principles of method if other than guideline:

In addition to the stated guideline, the test substance was applied to damaged skin to investigate systemic effects.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pent-1-ene

EC Number:

203-694-5

EC Name:

Pent-1-ene

Cas Number:

109-67-1

Molecular formula:

C5H10

IUPAC Name:

pent-1-ene

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Pentene-1

Test animals

Species:

rabbit

Strain:

other: Russian (Albino)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: 10 - 11 months
- Weight: 2.7 - 2.9 kg
- Housing: single
- Diet (e.g. ad libitum): Standardized feed for test animals ALTROMIN
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 days
- gender: female

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1°C
- Humidity (%): 50 - 60 %
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

Observation after 1, 24, 48 and 72 hours

Number of animals:

3 female animals tested

Details on study design:

TEST SITE
- Area of exposure:
- % coverage: 100%
- Type of wrap if used: 6.25cm2 linen piece, covered by a synthetic self-adhesive strip; subsequently the patches were covered by a bandage (acrylastic)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM:
Values for erythema and eschar formation as well as oedema formation were averaged for all animals and summed up. The sum resulted from 16 averages and was divided by 8 to obtain the primary irritation index:
0.0 - 0.5: non irritating
0.6 - 3.0: slightly irritating
3.1 - 5.0: moderately irritating
5.1 - 8.0: strongly irritating

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

# animals 1-3; intact and scarified skin

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no effect

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

#animals 1-3; intact and scarified skin

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable as no effect

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythema or oedema formation was observed on any of the test animals at any observation time. Merely horny skin callus developed on the intact and scarified skin in the second observation period.

Other effects:

No systemic toxicity effects were observed after dermal application of the product.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, 1-pentene is not classified for skin irritation according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In a dermal irritation study performed similarly to the EU Method B4, 0.5 mL of test material was applied on intact and scarrified skin of 3 female Russian rabbits. Test sites were covered with an occlusive dressing for 4 hours. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after the removal of the patch.

No reaction on intact or scarrified skin was found. The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0 / 0.0 / 0.0 for erythema and oedema.

Based on the available data, the test item Pentene-1 was not skin irritant. No additional self-classification is proposed regarding skin irritation according to the Annex I of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.