Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: publication, which meets basic scientific principles, also published in the peer-rewieved handbook Fragrance Raw materials monographs
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Fragrance Raw materials monographs - benzylidene acetone
Author:
Opdyke, D.L.J.
Year:
1973
Bibliographic source:
Food and Cosmetics Toxicology Volume 11, Issue 6, December 1973, Page 1021

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
This publication lists the characteristics of benzylidene acetone, which include it to be a sensitiser in humans (Maximisation test) and a skin irritant in rabbits and humans.
GLP compliance:
no
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Benzylidene acetone (synonyms: 4-Phenyl-3-buten-2-one, benzalacetone)
- Molecular formula: C6H5-CH=CH-CO-CH3
- Substance type: organic
- Physical state: solid

In vivo test system

Test animals

Species:
human
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
25 volunteers

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2 %
No. of animals per dose:
25 human volonteers
Details on study design:
No details given, other than according to the maximisation test of Kligman (1966).
Challenge controls:
No details given, other than according to the maximisation test of Kligman (1966).
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
other: not given
Group:
test group
Dose level:
2 %
No. with + reactions:
12
Total no. in group:
25
Clinical observations:
sensitisation
Remarks on result:
other: Reading:

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
This publication lists the characteristics of benzylidene acetone, which include it to be a sensitiser in humans (Maximisation test) and a skin irritant in rabbits and humans.