Registration Dossier
Registration Dossier
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EC number: 272-683-5 | CAS number: 68908-82-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable 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: Modified Draize Test
- Principles of method if other than guideline:
- Draize Test: Food Drug Cosmetic Law J. 10: 722, 1955
- GLP compliance:
- no
- Remarks:
- study pre-dates introduction of GLP
Test material
- Reference substance name:
- η-1H-indol-3-yl-α,α,ε-trimethyl-1H-indole-3-heptanol
- EC Number:
- 267-434-2
- EC Name:
- η-1H-indol-3-yl-α,α,ε-trimethyl-1H-indole-3-heptanol
- Cas Number:
- 67860-00-8
- Molecular formula:
- C26H32N2O
- IUPAC Name:
- 8,8-di(1H-indol-3-yl)-2,6-dimethyloctan-2-ol
- Reference substance name:
- Indole
- EC Number:
- 204-420-7
- EC Name:
- Indole
- Cas Number:
- 120-72-9
- Molecular formula:
- C8H7N
- IUPAC Name:
- 1H-indole
- Reference substance name:
- 7-hydroxycitronellal
- EC Number:
- 203-518-7
- EC Name:
- 7-hydroxycitronellal
- Cas Number:
- 107-75-5
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 7-hydroxy-3,7-dimethyloctanal
- Reference substance name:
- 1-(1H-indol-1-yl)-3,7-dimethyloctane-1,7-diol
- Cas Number:
- 1642782-49-7
- Molecular formula:
- C18H27NO2
- IUPAC Name:
- 1-(1H-indol-1-yl)-3,7-dimethyloctane-1,7-diol
- Reference substance name:
- Unknown constituents
- IUPAC Name:
- Unknown constituents
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
- Specific details on test material used for the study:
- Indolene Liquid (Solution of 50% Castor Oil of the Schiff's base between hydroxycitronellal and indol)
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml of the test material (50%, 15% and 5%).
Solvent: Neantine - Duration of treatment / exposure:
- 14 days
- Observation period (in vivo):
- Observations of the eyes are made immediately and 1, 24, 48, 72 hours, 7 and 14 days later.
- Number of animals or in vitro replicates:
- 3 rabbits per concentration group
- Details on study design:
- This modified Draize test for eye irritation consists of a single instillation of 0.1 ml of the test material into one eye of three rabbits per concentration group. The untreated eyes serve as controls.
Scoring of the eyes is carried out according to Draize's method. The dose response, especially for the estimation of the minimal irritating and maximal non-irritating concentration, and the course as well as the duration of eye irritation are investigated. On the basis of this data the safety margin for every preparation or raw material tested is estimated taking into account the concentrations for consumer use.
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:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Single application of 50% Indolene in Castor Oil caused moderate conjunctival redness and mild conjunctiva chemosis of the rabbit eye disappearing during 1 week. No alteration of the cornea or iris could be observed macroscopically. Thus, the material is considered non-irritating to the eye.
- Executive summary:
A single instillation of 0.1 ml of 50% Indolene into one eye each of three rabbits, with the other eye serving as control, resulted in moderate redness and mild chemosis of the conjunctiva. These changes were reversible in seven days. Thus, 50% Indolene is non-irritating to the eye.
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