Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
calculation (if not (Q)SAR)
Remarks:
Migrated phrase: estimated by calculation
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: Authoritative data base
Title:
Danish QSAR study for CAS No.: 99-03-6
Author:
Danish (Q)SAR Database
Year:
2016
Bibliographic source:
Database developed by National Food Institute, Technical University of Denmark, with support from the Danish Environmental Protection Agency, the Nordic Council of Ministers and the European Chemicals Agency.

Materials and methods

Principles of method if other than guideline:
The predicton is done using Danish (Q)SAR Database
GLP compliance:
no
Type of study:
other: Allergic contact dermatitis (ACD) in guinea pig and human

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:

- Name of test material: 3’-aminoacetophenone
- Molecular formula: C8H9NO
- Molecular weight: 135.16 g/mol
- Substance type: Organic
- Physical state: Liquid

In vivo test system

Test animals

Species:
other: guinea pig and human
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: no data
Vehicle:
no data
Concentration / amount:
no data
Challengeopen allclose all
Route:
other: no data
Vehicle:
no data
Concentration / amount:
no data
No. of animals per dose:
no data
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Clinical observations:
not sensitising
Remarks on result:
other: Reading: 1st reading. Group: test group. Clinical observations: not sensitising.

Any other information on results incl. tables

not sensitising

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be negative on guinea pig and human for 3'-aminoacetophenone. Thus it can be concluded that the substance 3'-aminoacetophenone has negative skin sensitization effects and based on the CLP criteria for classification it can be classified as not sensitizing to skin.
Executive summary:

Based on the QSAR prediction done using the Danish (Q)SAR Database, the skin sensitization was estimated to be negative on guinea pig and human for 3'-aminoacetophenone. Thus it can be concluded that the substance 3'-aminoacetophenone has negative skin sensitization effects and based on the CLP criteria for classification it can be classified as not sensitizing to skin.