Registration Dossier
Registration Dossier
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EC number: 620-464-3 | CAS number: 1003859-14-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to EU / OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amine
- EC Number:
- 620-464-3
- Cas Number:
- 1003859-14-0
- Molecular formula:
- C8H9ClF2N2
- IUPAC Name:
- [(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The degree of irritation observed at the one hour observation time point was greater than score of 1. Hence the treated eye of test animals was rinsed with physiological saline solution.
- Observation period (in vivo):
- 72h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- >= 1 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h-72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h-72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24h-72h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2+3
- Time point:
- other: 24h-72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24h-72h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 24h-72h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 24h-72h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- other: discharge
- Basis:
- animal #1
- Time point:
- other: 24h-72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- other: discharge
- Basis:
- animal: 2+3
- Time point:
- other: 24h-72h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
Any other information on results incl. tables
There were no corneal effects observed in the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item applied to the rabbits’ eye mucosa, caused conjunctival irritant effects at one hour which were reduced at 48 hours after application. The effects were fully reversible within 72 hours. There were no corneal effects observed in the study.
The study result triggers the following classification/labelling:
- EU Directive 1999/45/EC (as amended): None
- Regulation (EC) No 1272/2008 (CLP): None
- GHS (rev. 5) 2013: None
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