Registration Dossier

Diss Factsheets

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:
2013

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

Constituent 1
Chemical structure
Reference substance name:
2,2-Difluoroethanamine
EC Number:
671-709-6
Cas Number:
430-67-1
Molecular formula:
C2H5F2N
IUPAC Name:
2,2-Difluoroethanamine

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.