Registration Dossier
Registration Dossier
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EC number: 671-709-6 | CAS number: 430-67-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex 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:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,2-difluoroethan-1-amine
- EC Number:
- 671-709-6
- Cas Number:
- 430-67-1
- Molecular formula:
- C2H5F2N
- IUPAC Name:
- 2,2-difluoroethan-1-amine
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 30µl
- Duration of treatment / exposure:
- 10s
- Observation period (in vivo):
- 240min
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Mean maximum corneal swelling
- Basis:
- mean
- Time point:
- other: 75 min
- Remarks on result:
- other: value 0%; ICE Class I;in vitro eye irritation in the isolated chicken eyes test
- Irritation parameter:
- other: Mean maximum corneal swelling
- Basis:
- mean
- Time point:
- other: 240 min
- Remarks on result:
- other: value 0%; ICE Class I;in vitro eye irritation in the isolated chicken eyes test
- Irritation parameter:
- other: Mean maximum corneal opacity
- Basis:
- mean
- Remarks on result:
- other: value 2; ICE Class III;in vitro eye irritation in the isolated chicken eyes test
- Irritation parameter:
- other: Mean fluorescein retention
- Basis:
- mean
- Remarks on result:
- other: value 3; ICE Class IV;in vitro eye irritation in the isolated chicken eyes
- Irritant / corrosive response data:
- Based on this in vitro eye irritation in the isolated chicken eyes test , the test item is not classified as a severe irritant and not classified as non-irritant.It is concluded that an in vivo study is required for classification.
Applicant's summary and conclusion
- Interpretation of results:
- other: see conclusions
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on this in vitro eye irritation in the isolated chicken eyes test , the test item is not classified as a severe irritant and not classified as non-irritant.It is concluded that an in vivo study is required for classification.
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