Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
14.01.-15.09.2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented in vitro study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
enucleated eye test
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: (S)1-Phenylpropylamin (CAS 3789-59-1)

Test animals / tissue source

Species:
rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes

Results and discussion

In vivo

Results
Irritation parameter:
other: corneal swelling [%]
Basis:
mean
Time point:
other: 240 min
Score:
98.2

Applicant's summary and conclusion

Conclusions:
Following assessment of the data for all endpoints, the test material was considered to have the potential to cause ocular irritancy in vivo.