Cyclododecane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-10-11 to 1983-10-24

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

Test material information

Constituent 1

Reference substance name:

Cyclododecane

EC Number:

206-033-9

EC Name:

Cyclododecane

Cas Number:

294-62-2

Molecular formula:

C12H24

IUPAC Name:

cyclododecane

Details on test material:

Test substance: cyclododecane of Hüls AG, purity ca. 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/female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.3-2.6 kg
- Diet: ad libitum Ssniff K4
- Water: ad libitum, tab water
- Number of animals: 3 per sex
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 °C
- Humidity (%): 60 % +/-5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/light

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: paraffin oil

Controls:

not required

Amount / concentration applied:

ADMINISTRATION/EXPOSURE 
- Preparation of test substance: : 0.5 g undiluted, ground in mortar, wetted with  paraffin oil

Duration of treatment / exposure:

4 hour(s)

Observation period:

Postexposure period: 13 days

Number of animals:

3 males
3 females

Details on study design:

ADMINISTRATION/EXPOSURE 
- Area of exposure: approximately 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Postexposure period: 13 days
- Removal of test substance: rinsed with aqua dest after removal of patch
EXAMINATIONS
- Scoring system: OECD Test Guideline
- Examination time points: 1, 24, 48, 72 hours, 6, 8, 10, 13 days after  removal of patch; first 4 readings evaluated

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h

Score:

2.38

Max. score:

8

Reversibility:

fully reversible within: 13 days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

1.56

Max. score:

4

Reversibility:

fully reversible within: 13 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.61

Max. score:

4

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

AVERAGE SCORE
- Irritation index: 2.38/8
- Erythema: x = 1.56
- Edema: x = 0.61
REVERSIBILITY: complete by end of observation period

Other effects:

no other effects

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information but not classified Criteria used for interpretation of results: other: Regulation EC No 1272/2008 (CLP)

Conclusions:

Under the test conditions slightly irritations to the rabbit skin were observed for the substance cyclododecane..

Executive summary:

The acute skin irritation properties of Cyclododecane were estimated according to OECD Guideline 404. A dose of 500 mg test item per animal was applied to the shorn, intact dorsal skin of 3 male and female rabbits under occlusive conditions for 4 hours. After removal of the patches the treated skin areas were rinsed with water and dried. The results were assessed 1, 24, 48 and 72 hr after patch removal. Under the test conditions slightly irritations to skin were observed.