Registration Dossier
Registration Dossier
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EC number: 204-555-1 | CAS number: 122-57-6
Endpoint summary
Administrative data
Description of key information
Acute toxicity oral: publication and GESTIS Database; LD50(rat) = 2030 mg/kg; LD50 (rat) = > 5000 mg/kg
Acute toxicity dermal: publication, LD50 (rabbit) = > 3000 mg/kg
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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).
- 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: Peer reviewed database
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No information on test guideline is available.
- GLP compliance:
- not specified
- Remarks:
- result of this entry is based on a reviewed article - information on GLP is not specified
- Test type:
- other: no further information available
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Control animals:
- not specified
- Preliminary study:
- Not reported.
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 030 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- LD50 (oral, rat) = 2030 mg/kg
- Executive summary:
A LD50 (oral, rat) of 2030 mg/kg for banzalacetone was reported in GESTIS database (Original source: Toxicological Data, compiled by the National Institute of Health (NIH), USA, selected and distributed by Technical Database Services (TDS), New York, 2009.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 030 mg/kg bw
- Quality of whole database:
- Reliable peer reviewed data, sufficient for weight of evidence approach.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- 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).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 000 mg/kg bw
- Quality of whole database:
- Reliable peer reviewed data.
Additional information
Acute toxicity: oral
A 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 rats (Levenstein, 1972a). In addition, the acute dermal LD50 was reported as > 3 g/kg in the rabbit (Levenstein, 1972b).
The acute oral LD50 of 2030 mg/kg was reported in GESTIS database.
Acute toxicity: inhalation
No data are available for this endpoint. However, the test substance has a low vapour pressure [0.0134 hPa est. with MPBPVPWIN v 1.43 (EPI Suite v 4.1)], so the potential for the generation of inhalable forms is low; also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.
Acute toxicity: dermal
A 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 rats (Levenstein, 1972a). In addition, the acute dermal LD50 was reported as > 3 g/kg in the rabbit (Levenstein, 1972b).
Justification for classification or non-classification
The substance does not meet the criteria for classification and labelling regarding oral and dermal toxicity in accordance with Regulation (EC) No 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
