Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
10-14 Jul 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
3 min and 60 min
Number of animals:
1

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
The test item caused full thickness necrosis after a 3 min-dermal exposure and therefore had to be classified as corrosive.