Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1983-11-11 to 1983-10-14
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:
Cyclododecanol
EC Number:
217-031-2
EC Name:
Cyclododecanol
Cas Number:
1724-39-6
Molecular formula:
C12H24O
IUPAC Name:
cyclododecanol
Details on test material:
TS: cyclododecanol of Hüls AG, purity > 99 %

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: 2.3-2.8 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 ground in mortar, wetted with  paraffin oil
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 hours
Number of animals:
3 males
3 females
Details on study design:
ADMINISTRATION/EXPOSURE 
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing
- Removal of test substance: washing with deionized water
- Post exposure period: 72 hours
EXAMINATIONS
- Scoring system: OECD; evaluation: VCI notes on safety data sheet and  Appendix VI of 79/831/EEC
- Examination time points: 1, 24, 48, and 72 hours after patch removal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
8
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0
- Edema: 0
- irritation index: 0/8
Other effects:
no other effects

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Conclusions:
Under the test conditions no irritations to skin were observed. Thus cyclododecanol is considered to be not irritating
Executive summary:

The acute skin irritation properties of Cyclododecanol 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 no irritations to skin were observed.