Registration Dossier
Registration Dossier
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EC number: 449-410-5 | CAS number: 18084-64-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - 4 instead of 3 animals
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 449-410-5
- EC Name:
- -
- Cas Number:
- 18084-64-5
- Molecular formula:
- C36H44N4
- IUPAC Name:
- 1,4,7,10-Tetrabenzyl-1,4,7,10-tetraazacyclododecane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye, which remained untreated, served as control.
- Amount / concentration applied:
- 0.1 mL (corresponded to 42-64 mg substance)
- Duration of treatment / exposure:
- test substance remained in the eye (eye was not rinsed)
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 2 males and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- 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:
- reddening
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: some animals showed reddening of conjunctivae, sclerae, membrana nictitans, and of the outer eyelid shortly after treatment; reddening of sclerae lasted until day 2.
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
One animal was killed for humane reasons 48 hours after application because a bolus of compound under the upper eyelid, which mechanically damaged the eye, could not be removed. Pathological examination of the animals revealed a mechanical damage of the cornea with inflammatory reaction.
Applicant's summary and conclusion
- Executive summary:
In a local tolerance test on the rabbit eye according to OECD TG 405 a single application of the test substance into the conjunctival sac provoked slight and transient irritation.
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