4-pentylcyclohexanone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 12 until February 26, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted February 24, 1987

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-pentylcyclohexanone

EC Number:

406-670-4

EC Name:

4-pentylcyclohexanone

Cas Number:

61203-83-6

Molecular formula:

C11H20O

IUPAC Name:

4-pentylcyclohexan-1-one

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAVO-lvanovas, Kisslegg
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: mean 2.87 (2.77 - 2,98) kg
- Housing: kept separately in cages type KK 017
- Diet: ad libitum, acidified, fully demineralized water from an automatic drinking device
- Water: ad libitum, Altromin Standard Diet TPF 2113
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 38-56
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3 (1m and 2f )

Details on study design:

TEST SITE
- Area of exposure: 24 hours before the start of the study the backs and flanks of the animals were cautiously shaved with an electronic clipper so that the skin stayed intact.
- Type of wrap: The application sites were wrapped with polyethylene foil which was kept in place by leather sleeve.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: After 4 hours of occlusive exposure the patches were removed and any test material left was wiped off.

OBSERVATION TIME POINTS
The rabbits were investigated for skin alterations, behavior, and general condition 1 hour after removal of the patches, and then daily for a period of further 14 days.
All rabbits were weighed before start of the study and on days 5, 8, 11 and 15.

SCORING SYSTEM:
- Method of calculation: Skin changes at the application site were evaluated according to the DRAIZE and OECD recommendations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Other effects:

- Other adverse local effects:
Single application of 0.5 mL test item to the intact dorsal skin of rabbits led to irritation of the skin.
Beginning from day 2, and then up to day 7 of the study, erythema and edema were observed. They were followed by other irritation symptoms i.e. formation of large scales and smaller scales from day 5 up to day 12.

- Other adverse systemic effects:
No signs of systemic toxicity were detected. The body weight development was normal. All rabbits survived the 15 day observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008.

Executive summary:

A study was performed according to OECD 404 under GLP conditions. To test for primary skin irritation the test item was applied to intact skin (for a 4 hour period under occlusive conditions) of rabbits. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for a further 14 days. The skin irritation test revealed slight irritation. Beginning at the second reading, up to day 7 of the study, erythema and edema occurred (max. score 1), which from day 5 up to 12 were followed by other irritation symptoms, i.e. formation of large scales and smaller scales. Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008.