Registration Dossier
Registration Dossier
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EC number: 203-916-0 | CAS number: 111-86-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Octylamine
- EC Number:
- 203-916-0
- EC Name:
- Octylamine
- Cas Number:
- 111-86-4
- Molecular formula:
- C8H19N
- IUPAC Name:
- octan-1-amine
- Details on test material:
- Name of test material (as cited in study report):
1-Octanamine, not further specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- other: none
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): undiluted
- Duration of treatment / exposure:
- 24 h, not rinsed
- Observation period (in vivo):
- 24 h
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: table of Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 3.75
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Remarks on result:
- other: not evaluated in all animals
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not determinable
- Remarks:
- All animals were killed at 24 hours for humane reasons.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not determinable
- Remarks:
- All animals were killed at 24 hours for humane reasons.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not determinable
- Remarks:
- All animals were killed at 24 hours for humane reasons.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not determinable
- Remarks:
- All animals were killed at 24 hours for humane reasons.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not determinable
- Remarks:
- All animals were killed at 24 hours for humane reasons.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not determinable
- Remarks:
- All animals were killed at 24 hours for humane reasons.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not determinable
- Remarks:
- All animals were killed at 24 hours for humane reasons.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not determinable
- Remarks:
- All animals were killed at 24 hours for humane reasons.
- Irritant / corrosive response data:
- Severe conjunctival and corneal damage and necrosis in all animals
Any other information on results incl. tables
1-Octylamine was corrosive to the eye. All four animals exhibited severe conjunctival and corneal damage and necrosis.
All animals were killed at 24 h for humane reasons.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- N-octylamine is highly corrosive to the rabbit's eye
- Executive summary:
The eye irritating properties of n-octylamine were examined in a non-GLP study that was conducted and evaluated in accordance with OECD TG 405. Four rabbits received 0.1 mL of the undiluted test substance into the conjunctival sac of one eye without rinsing. Severe conjunctival (mean score 3 for redness and 3.75 for chemosis) and corneal damage (mean score 4) and necrosis was seen in all four animals at 24 hours after treatment, and all animals were killed at 24 hours for humane reasons (Biodynamics, 1985).
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