Registration Dossier
Registration Dossier
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EC number: 281-682-9 | CAS number: 84012-38-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ruscus aculeatus, Liliaceae.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, J.H. Dermal Toxicity. Appraisal of Safety of Chemicals in Foods, Drugs and Cosmetics. 46-59; 1959
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ruscus aculeatus, ext.
- EC Number:
- 281-682-9
- EC Name:
- Ruscus aculeatus, ext.
- Cas Number:
- 84012-38-4
- Molecular formula:
- not applicable
- IUPAC Name:
- Ruscus aculeatus, ext.
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3 males and 3 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 7.3
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.3
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 7.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- All animals blinked excessively and rubbed the treated eye upon instillation of the compound.
No corneal opacity or iritis was observed.
Conjunctival redness occurred in all animals at one hour and in four animals at 24 hours.
Chemosis appeared in all animals at 1 hour only.
Discharge occurred in 4 animals at 1 hour only.
NO eye irritation was evident in any animal by 48 hours.
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