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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1983-10-11 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

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 / 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/female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.2-2.6 kg
- Diet: ad libitum Ssniff K4
- Water: ad libitum, tab water
- Number of animals: 3 per sex
- 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: ground in a mortar
- Amount of substance instilled: 0.05 g
- Vehicle: none, undiluted
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
3 females
Details on study design:
Comment: not rinsed
- Postexposure observation period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet and Appendix VI of 79/831/EEC
- Tool used to assess score: sodium fluorescein / ophthalmic lamp /  visual inspections

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
3
Max. score:
110
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.28
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjunctivae (Redness): 0.39 - Conjunctivae (Chemosis): 0.28
- Overall irritation score: 3.0/110
REVERSIBILITY: complete within 72 hours
Other effects:
no other effects

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the test item cyclododecanol showed only very slight irritant effects on the eyes and mucosa of male and female rabbits. These effects do not lead to classification and labelling according to the criteria of EC Directive 67/548/EEC and EC Regulation 1272/2008.
Executive summary:

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