Registration Dossier
Registration Dossier
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EC number: 213-424-8 | CAS number: 947-04-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-01-15 - 1985-01-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Dodecane-12-lactam
- EC Number:
- 213-424-8
- EC Name:
- Dodecane-12-lactam
- Cas Number:
- 947-04-6
- Molecular formula:
- C12H23NO
- IUPAC Name:
- 1-azacyclotridecan-2-one
- Test material form:
- solid
- Details on test material:
- Dodecane-12-lactam of Hüls AG, purity > 99.9 %; main impurity cyclododecanone ca. 100 ppm
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small white Russian, Chbb-SPF
- Details on test animals or tissues and environmental conditions:
- - Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1-2.4 kg
- Environmental conditions:
room temperature: 20°C (+/- 1°C);
humidity: 60% (+/- 5%);
Air change: 15 times/hour;
Light: 12 hour light/dark rhythm;
feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
water: tap water ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: identical animals, left eyes remained untreated
- Amount / concentration applied:
- 0.1 gram, finely ground in a mortar, undiluted
- Duration of treatment / exposure:
- not rinsed - no removal of test substance
- Observation period (in vivo):
- - Postexposure observation period: 3 weeks
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6 days after treatment - Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- - Tool used to assess score: Na 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:
- 7.17
- Max. score:
- 110
- Reversibility:
- fully reversible within: 6 days
- 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 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0.28
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 1.17
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritant / corrosive response data:
- A slight corneal opacity was noted in one female at 24 hrs, that diminished in severity at 48 hrs already, and was completely reversible at 72 hours. 5/6 animals showed a slight reddening of parts of the iris at 24 hours; this effect was completely resolved at 48 hours. Very slight to slight conjunctival redness started at 1 hour after instillation, and was most prominent at 24 hours (grades 1-3 for redness, 0-2 for swelling), diminished in severity by 48 hours (grades 0-2 for redness, 0-1 for swelling) and was only seen in 2/6 animals at 72 hours (grade 1 redness, no swelling). Conjunctival effects were completely reversible within 6 days.
AVERAGE SCORE
- Cornea: 0.11
- Iris: 0.28
- Conjuntivae (Redness): 1.17
- Conjuntivae (Chemosis): 0.56
- Overall irritation score: 7.17/110 - Other effects:
- no further information
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- According to the study, the test item lauryl lactam showed no 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 lauryl lactam was administered undiluted into eyes or eyelid sacs of male and female rabbits. According to the study, the test item lauryl lactam showed no irritant effect on the eyes and mucosa of male and female rabbits.
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