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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1983
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
Reference substance name:
Cyclododecatrien-(1,5,9)
IUPAC Name:
Cyclododecatrien-(1,5,9)
Details on test material:
Cyclododecatrien-(1,5,9) of Hüls AG, purity > 99.5%

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
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: 2.3 - 2.5 kg
- Number of animals: 3 per sex
- Controls: untreated eye
- Number of animals: 3 males, 3 females
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
- Water: tap water ad libitum
Environmental conditions:
- Room temperature: 20°C (+/- 1°C);
- Humidity: 60% (+/- 5%);
- Air change: 15 times/hour;
- Light: 12 hour light/dark rhythm;

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: identical animals, left eyes remained untreated
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
Comment: not rinsed
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data  sheet
- Tool used to assess score: sodium fluorescein / ophthalmic lamp

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:
other: complete after 6 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.17
Max. score:
4
Reversibility:
other: complete after 6 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: complete after 6 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.5
Max. score:
3
Reversibility:
other: complete after 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.22
Max. score:
4
Reversibility:
other: complete after 6 days
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 0.17
- Iris: 0
- Conjunctivae (Redness): 0.50
- Conjunctivae (Chemosis): 0.22
- Overall irritation score: 3/110
Other effects:
REVERSIBILITY: complete after 6 days

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulation EC 1272/2008 (CLP)
Conclusions:
Under the conditions of the study, the test item 1,5,9 -cyclododecatrien showed no irritant effects on eyes and mucosa of male and female rabbits which leads to no classification according to 67/548/EEC and according CLP regulation (1272/2008).
Executive summary:

To test the acute irritant effect on eyes and mucosa the test item 1,5,9 -cyclododecatriene was administered undiluted into eyes or eyelid sacs of 3 male and 3 female rabbits (OECD 405 guideline study). According to the study, the test item 1,5,9 -cyclododecatriene showed no irritant effect ont he eyes and mucisa of male and female rabbits.