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EC number: 204-555-1 | CAS number: 122-57-6
Skin sensitisation
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-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:
- 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
- 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 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).
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance Raw materials monographs - benzylidene acetone
- Author:
- Opdyke, D.L.J.
- Year:
- 1 973
- 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
- Justification for non-LLNA method:
- Old publication where LLNA wasn't standard procedure yet.
Test material
- 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
- 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
Constituent 1
Constituent 2
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 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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
Applicant's summary and conclusion
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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