Registration Dossier
Registration Dossier
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EC number: 500-281-4 | CAS number: 98362-33-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-11-21 to 1985-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
- EC Number:
- 500-281-4
- EC Name:
- 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
- Cas Number:
- 98362-33-5
- Molecular formula:
- Exact identification is not feasible
- IUPAC Name:
- Copolymer of neodecanoic acid oxiranylmethyl ester and 4-methylbenzenesulfonic acid
- Test material form:
- liquid: viscous
- Details on test material:
- Yellowish liquid, high viscosity
Content: 100%
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: 2.0 - 2.5 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 mL undiluted test item
- Duration of treatment / exposure:
- 72 hours after application, the treated eyes were rinsed with warm physiological saline
- Observation period (in vivo):
- - Postexposure observation period: 6 days
- 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:
- 1.42
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- 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
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0.06
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24; 48; 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0
- Iris: 0
- Conjuntivae (Redness): 0.06
- Conjuntivae (Chemosis): 0
- Overall irritation score: 1.42/110 - Other effects:
- no further information
Any other information on results incl. tables
A slight conjunctiva redness and discharge was observed 1 hour after administration at all animals. At 24 hours after administration only 1 male rabit showed slight conjunctiva redness. At 48 hours all animals were free of signs.
Applicant's summary and conclusion
- Conclusions:
- According to results of the study, the test item 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 of the test item
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid
lauryl lactam was administered undiluted into eyes or eyelid sacs of male and female rabbits.
A slight conjunctiva redness and discharge was observed 1 hour after administration at all animals. At 24 hours after administration only 1 male rabit showed slight conjunctiva redness. At 48 hours all animals were free of signs.
According to the study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.
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