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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

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
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reference
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
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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 dermal LD50 was > 3 g/kg in the rabbit (Levenstein, 1972b).
GLP compliance:
no
Test type:
other: not specified
Species:
rabbit
Strain:
not specified
Sex:
not specified
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
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).
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).

Reason / purpose for cross-reference:
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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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 or test system 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 for cross-reference:
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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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 or test system 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 for cross-reference:
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 for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
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 chemical
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

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

Test material

Constituent 1
Chemical structure
Reference substance name:
4-phenylbutenone
EC Number:
204-555-1
EC Name:
4-phenylbutenone
Cas Number:
122-57-6
Molecular formula:
C10H10O
IUPAC Name:
4-phenylbut-3-en-2-one
Constituent 2
Reference substance name:
benzylidene acetone
IUPAC Name:
benzylidene acetone
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:
human
Strain:
other: not applicable
Details on test animals or test system and environmental conditions:
no details given, as the primary publication is not available

Test system

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).

Results and discussion

In vivo

Resultsopen allclose all
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).

Applicant's summary and conclusion

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).