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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983-10-18 to 1983-10-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclododecanone
EC Number:
212-595-6
EC Name:
Cyclododecanone
Cas Number:
830-13-7
Molecular formula:
C12H22O
IUPAC Name:
cyclododecanone
Details on test material:
cyclododecanone of Hüls AG, purity > 99.5 %

Test animals

Species:
rabbit
Strain:
other: small white Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.3 - 2.7 kg
- Number of animals: 3 males, 3 females
Environmental conditions:
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%)
- Air change: 15 times/hour
- Light: 12 hour light/dark rhythm
- Diet: K4 complete feed for rabbits (Ssniff, Soest, Germany) ad libitum
- Water: tap water ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: paraffin oil
Controls:
no
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
1, 24, 48, 72 hours, 6, 8 and 10 days after  patch removal
Number of animals:
6
Details on study design:
ADMINISTRATION/EXPOSURE 
- Preparation of test substance: 0.5 g ground in mortar, wetted with  paraffin oil
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with deionized water
- Post exposure period: 10 days
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and  Appendix VI of 79/831/EEC
- Examination time points: 1, 24, 48, 72 hours, 6, 8 and 10 days after  patch removal; evaluation based on readings 1-4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
1.04
Max. score:
8
Reversibility:
fully reversible within: 10 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.83
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0.83/4
- Edema: 0.17/4
- irritation index: 1.04/8
REVERSIBILITY: complete within 10 days
Other effects:
OTHER EFFECTS: slight eschar formation (days 6-8)

Any other information on results incl. tables

no further information

Applicant's summary and conclusion

Conclusions:
According to the outcome of the study with rabbits cyclododecanone is not classified as a skin irritant according to present EU legislation.
Executive summary:

Skin irritation properties of cyclododecanone were tested with rabbits. The substance showed only very slight irritating effects on skin. Therefore according to present EU legislation cyclododecanone is not classified as a skin irritant.