Cyclododecane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-10-11 to 1983-10-17

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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

other: Small white Russian

Details on test animals or tissues 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: 2.2-2.6 kg
- Number of animals: 3 per sex
- Water: ad libitum, tab water
- Diet: K4 Diet (Ssniff, Soest); ad libitum
- Controls: untreated eye
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

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

ADMINISTRATION/EXPOSURE 
- Preparation of test substance: grinding in mortar
- Vehicle: none
- Amount applied: 0.05 g undiluted

Duration of treatment / exposure:

72 hour(s)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

Comment: eyes not rinsed
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h

Score:

4.83

Max. score:

110

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.11

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.72

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea:  x = 0.11
- Iris:    x = 0
- Conjunctivae (Redness):   x = 0.72
- Conjunctivae (Chemosis):  x = 0.22
- Overall irritation score: 4.83/110

Other effects:

no other effects described

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 conditions of this study, the test item cyclododecane showed only slight irritant effect on the eyes and mucosa of male and female rabbits.

Executive summary:

To test the acute irritant effect on eyes and mucosa the test item cyclododecane was administered undiluted into eyes or eyelid sacs of 3 male and female rabbits. Under the conditions of this study, the test item cyclododecane showed only slight irritant effect on the eyes and mucosa of male and female rabbits.