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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

The skin irritation/corrosion of Cyclooctanone was tested in an OECD 404 study in one male rabbit. 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.

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

No data on eye damage/corrision is available, but based on the corrosive effects to the skin, Cyclooctanone should be classified for serious eye damage (Eye Dam. 1).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
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
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
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
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
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
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
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
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
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Time point:
other: 1/24/48/72 h
Score:
8
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the results for in vivo skin irritation/corrosion, Cyclooctanone should be classified as corrosive to the skin subcategory 1C (Skin Corr. 1C) according to CLP Regulation (EC) No. 1272/2008.

Based on the corrosive effects to the skin, Cyclooctanone should be classified for serious eye damage (Eye Dam. 1).