Registration Dossier

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

Referenceopen allclose all

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).

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.

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
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
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
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
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:
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 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).

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.