Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
not available
Molecular formula:
C12 H16 Cl NO2 HCl
IUPAC Name:
not available
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Specific details on test material used for the study:
2-(ter-butylamino)-1-(3-chloro-4-hydroxyphenyl)ethanone HCl

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
animal: #1 #2 #3
Time point:
other: 1-24-48-72 hours
Score:
0
Max. score:
4
Reversibility:
other: no observed effects
Irritant / corrosive response data:
no observed effects

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The product showed no irritant/corrosive effects