Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: FDA data
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
FDA Pharm Class
Author:
FDA
Year:
2018
Bibliographic source:
FDA Pharm Class http://www.accessdata.fda.gov/spl/data/8af16d2c-b12c-40fe-add6-f0d6ce8bbfdb/8af16d2c-b12c-40fe-add6-f0d6ce8bbfdb.xml

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other:
Version / remarks:
the followed guideline is not specified
Principles of method if other than guideline:
the followed guideline is not specified
GLP compliance:
not specified
Type of study:
other: the followed guideline is not specified
Justification for non-LLNA method:
the followed guideline is not specified

Test material

1
Chemical structure
Reference substance name:
Cinchocaine
EC Number:
201-632-1
EC Name:
Cinchocaine
Cas Number:
85-79-0
Molecular formula:
C20H29N3O2
IUPAC Name:
2-butoxy-N-[2-(diethylamino)ethyl]quinoline-4-carboxamide
Test material form:
solid: particulate/powder

Results and discussion

In vivo (non-LLNA)

Results
Key result
Remarks on result:
other: FDA chemical allergen

Applicant's summary and conclusion

Conclusions:
DIBUCAINE Pharmacologic Class Indexing Food and Drug Administration
DIBUCAINE standardized chemical allergen
Executive summary:

DIBUCAINE Pharmacologic Class Indexing Food and Drug Administration

DIBUCAINE standardized chemical allergen