Cyclooctanone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09.11.1987 to 19.11.1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclooctanone

EC Number:

207-940-2

EC Name:

Cyclooctanone

Cas Number:

502-49-8

Molecular formula:

C8H14O

IUPAC Name:

cyclooctanone

Test material form:

solid

Test animals

Species:

rabbit

Strain:

other: Little white Russians, Chbb-SPF

Details on test animals or test system and environmental conditions:

SOURCE ANIMAL
- Source:
Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Sex:
male
- Weight at study initiation:
2.2 kg
- Diet (e.g. ad libitum):
ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

test item was liquified via heating

Amount / concentration applied:

0.5 cm³

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48,72 h and 6 days

Number of animals:

1

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1 h

Score:

4

Reversibility:

not fully reversible within: 6 days

Remarks on result:

other: necrosis

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

4

Reversibility:

not fully reversible within: 6 days

Remarks on result:

other: necrosis, calloused skin around application site

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

48 h

Score:

4

Reversibility:

not fully reversible within: 6 days

Remarks on result:

other: necrosis with scabs

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

72 h

Score:

4

Reversibility:

not fully reversible within: 6 days

Remarks on result:

other: necrosis with scabs

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 6 d

Score:

4

Reversibility:

not fully reversible within: 6 days

Remarks on result:

other: necrosis with scabs

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

4

Reversibility:

not fully reversible within: 6 days

Remarks on result:

probability of severe irritation

Results 7

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

animal #1

Time point:

other: 1/24/48/72 h

Score:

8

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

Based on the results in the study and according to EC Regulation No 1272/2008 the test material should be classifeid as skin corrosive category 1C.

Executive summary:

One male rabbit was exposed to a 4 hour application of 0.5 cm³ of undiluted Cyclooctanone to 6 cm² of clipped dorsal skin. The application site was examined 1, 24, 48, 72 h and 6 days after treatment. Corrosive responses were identified with severe erythema to slight eschar formation, severe oedema accompainied with necrosis from 1 hour up to 6 days after a 4 hour treatment. After 1 hour of treatment no necrosis was detected.

The primary skin irritation index was 8 and the test material was considered to be corrosive to the skin.

According to CLP Regulation (EC) No 1272/2008 the test material should be classified as skin corrosive category 1C.