Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
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-referenceopen allclose all
Reason / purpose:
reference to same study
Reference
Endpoint:
acute toxicity: oral
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
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
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. In addition it is stated, that the acute oral LD50 was > 5 g/kg in the rats (Levenstein, 1972a).
GLP compliance:
no
Test type:
other: not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
no details given
Doses:
no details given, however an LD50 of < 5000 mg/kg is given
No. of animals per sex per dose:
no data
Statistics:
Not reported.
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
The acute oral LD50 was reported as > 5 g/kg in the rat ( Levenstein, 1972a).
Interpretation of results:
other: EU GHS criteria not met
Conclusions:
The acute oral LD50 was reported as > 5 g/kg in the rat ( Levenstein, 1972a).
Executive summary:

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 (Opdyke, 1973, Fragrance raw materials monographs - benzylidene acetone). Moreover, the acute oral LD50 was reported as > 5 g/kg in the rat (Levenstein, 1972a).

Reason / purpose:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
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
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
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
Species:
human
Strain:
other: not applicable
Details on test animals and environmental conditions:
no details given, as the primary publication is not available
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
other: 2 % concentration in petrolatum
Controls:
other: the untreated skin served as control
Amount / concentration applied:
not given
Duration of treatment / exposure:
not given
Observation period:
not given
Details on study design:
Tested in a 2 % concentration in petrolatum it produced no irritation in a 48 hr closed-patch test in 25 human subjects (Kligman, 1972).
Irritation parameter:
other: qualitative result
Remarks on result:
other: Tested in a 2 % concentration in petrolatum it produced no irritation in a 48 hr closed-patch test in 25 human subjects (Kligman, 1972).
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Tested in a 2 % concentration in petrolatum it produced no irritation in a 48 hr closed-patch test in 25 human subjects (Kligman, 1972).
Interpretation of results:
other: EU GHS criteria not met
Conclusions:
Tested in a 2 % concentration in petrolatum it produced no irritation in a 48 hr closed-patch test in 25 human subjects (Kligman, 1972).
Executive summary:

The test item is also characterised in a publication, which lists the characteristics of benzylidene acetone, which include it to be a sensitiser in humans (Maximisation test) and a skin irritant in rabbits and not irritating in humans (Opdyke, 1973, Fragrance raw materials monographs - benzylidene acetone).

In there it is stated that Benzylidene acetone tested in a 2 % concentration in petrolatum produced no irritation in a 48 hr closed-patch test in 25 human subjects (Kligman, 1972).

Reason / purpose:
reference to same study
Reference
Endpoint:
skin irritation: in vivo
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
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
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
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no details given, as the primary publication is not available
Type of coverage:
not specified
Preparation of test site:
other: intact or abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin served as control
Amount / concentration applied:
not given
Duration of treatment / exposure:
not given
Observation period:
not given
Number of animals:
not given
Details on study design:
Benzylidene acetone applied full strength to intact or abraded rabbit skin was mildly irritating (Levenstein, 1972b).
Irritation parameter:
other: qualitative result
Remarks on result:
other: mildly irritating
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Benzylidene acetone applied full strength to intact or abraded rabbit skin was mildly irritating (Levenstein, 1972b).
Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
Benzylidene acetone applied full strength to intact or abraded rabbit skin was mildly irritating (Levenstein, 1972b).
Executive summary:

The test item is also characterised in a publication, which lists the characteristics of benzylidene acetone, which include it to be a sensitiser in humans (Maximisation test) and a skin irritant in rabbits and not irritating in humans (Opdyke, 1973, Fragrance raw materials monographs - benzylidene acetone).

In there it is stated that Benzylidene acetone applied full strength to intact or abraded rabbit skin was mildly irritating (Levenstein, 1972b).

Reason / purpose:
reference to same study
Reference
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
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
Reason / purpose:
reference to same study
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
Justification for non-LLNA method:
Old publication where LLNA wasn't standard procedure yet.
Species:
human
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
25 volunteers
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2 %
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2 %
No. of animals per dose:
25 human volunteers
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
Key result
Reading:
1st reading
Group:
test group
Dose level:
2 %
No. with + reactions:
12
Total no. in group:
25
Clinical observations:
sensitisation
Remarks on result:
other: Reading: other: not given. Group: test group. Dose level: 2 %. No with. + reactions: 12.0. Total no. in groups: 25.0. Clinical observations: sensitisation.
Group:
negative control
Remarks on result:
not measured/tested
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
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.
Executive summary:

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.

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

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. In addition it is stated, that the acute dermal LD50 was > 3 g/kg in the rabbit (Levenstein, 1972b).
GLP compliance:
no
Test type:
other: not specified

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

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Details on dermal exposure:
no data available
Duration of exposure:
no data
Doses:
not specified, however a LD50 value of > 3 g/kg is given
No. of animals per sex per dose:
no data
Details on study design:
no data

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
The acute dermal LD50 was reported as > 3 g/kg in the rabbit ( Levenstein, 1972b).

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS criteria not met
Conclusions:
The acute dermal LD50 was reported as > 3 g/kg in the rabbit ( Levenstein, 1972b).
Executive summary:

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 (Opdyke, 1973, Fragrance raw materials monographs - benzylidene acetone). Moreover, the acute dermal LD50 was reported as > 3 g/kg in the rabbit (Levenstein, 1972b).