Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
400 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
352.63 mg/m³
Explanation for the modification of the dose descriptor starting point:

The sub-chronic oral NOAEL of 400 mg/kg bw/d of benzyl alcohol (CAS 100-51-6) as a surrogate for benzyl benzoate (CAS 120-51-4) is used.


Corrected NOAEC = 352.63 mg/m³ (400 x 1/0,38 x 5/5 x50/100 x 6.7/10)

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
not required: already accounted for in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value (worker)
AF for the quality of the whole database:
1
Justification:
default value (worker)
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
70.5 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation for subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value (rat study used as starting point)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value (workers)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The sub-chronic oral NOAEL of 400 mg/kg bw/d of benzyl alcohol (CAS 100-51-6) as a surrogate for benzyl benzoate (CAS 120-51-4) is used.



Systemic inhalation:
Long-term
The sub-chronic oral NOAEL of 400 mg/kg bw/d of benzyl alcohol (CAS 100-51-6) as a surrogate for benzyl benzoate (CAS 120-51-4) is used.
Corrected NOAEC = 352.63 mg/m³ (400 x 1/0,38 x 5/5 x50/100 x 6.7/10)
Application of assessment factors of 1 (default value for dose-response relationship), 2 (for duration: extrapolation from a sub-chronic study to chronic exposure), 2.5 (for interspecies differences), 5 (for intraspecies differences; default values for workers), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall assessment factor of 25. Application of the overall assessment factor to the corrected starting point gives a DNEL value of 14.1 mg/m³.
Bioavailability: animal experiment oral/inhalation: 50/100



Acute/short-term
Short-term DNEL is derived from long-term DNEL by the use of a factor 5.



Local
Long term and short term local inhalation DNEL values are not proposed in the absence of any identified hazard.


Systemic dermal:
Long-term
The sub-chronic oral NOAEL of 400 mg/kg bw/d of benzyl alcohol (CAS 100-51-6) as a surrogate for benzyl benzoate (CAS 120-51-4) is used.
The long term dermal DNEL value was derived using default ECHA assessment factors. Application of assessment factors of 1 (for dose response), 2 (extrapolation from a subchronic to chronic exposure), 4 (allometric scaling), 2.5 (additional interspecies differences) and 5 (intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall AF of 100 and a DNEL of 4.0 mg/kg bw/d.



Acute/short-term
Benzyl benzoate is not classified for dermal toxicity.



Local
Long-term
Benzyl benzoate is not classified as a skin irritant or sensitiser.
Acute/short-term
Benzyl benzoate is not classified as a skin irritant or sensitiser.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.48 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
124.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

The sub-chronic oral NOAEL of 400 mg/kg bw/d of benzyl alcohol (CAS 100-51-6) as a surrogate for benzyl benzoate (CAS 120-51-4) is used.


Corrected NOAEC = 124.2 mg/m³ (400 x 1/1,15 x 50/100 x 5/7)

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation for subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
not required: already accounted for in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value (general population)
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.4 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:
 

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.42 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
285.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

285.7 mg/kg (400 x 5/7)


5/7 = exposition animals/exposition general population [days].

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation for subchronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value for rats
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.42 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
400 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
285.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

285.7 mg/kg (400 x 5/7)


5/7 = exposition animals/exposition general population [days].

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
extrapolation from subchronic study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
default value (rat study used as starting point)
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
10
Justification:
default value
AF for the quality of the whole database:
1
Justification:
default value
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The sub-chronic oral NOAEL of 400 mg/kg bw/d of benzyl alcohol (CAS 100-51-6) as a surrogate for benzyl benzoate (CAS 120-51-4) is used.


Systemic inhalation:
Long-term
The sub-chronic oral NOAEL of 400 mg/kg bw/d of benzyl alcohol (CAS 100-51-6) as a surrogate for benzyl benzoate (CAS 120-51-4) is used.
Corrected NOAEC = 124.2 mg/m³ (400 x 1/1,15 x 50/100 x 5/7)
Application of assessment factors of 1 (default value for dose-response relationship), 2 (for duration: extrapolation from a sub-chronic study to chronic exposure), 2.5 (for interspecies differences), 10 (for intraspecies differences; default values for the general population), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall assessment factor of 50. Application of the overall assessment factor to the corrected starting point gives a DNEL value of 2.48 mg/m³.
Bioavailability: animal experiment (oral)/inhalation: 50/100.



Acute/short-term
Short-term DNEL is derived from long-term DNEL by the use of a factor 5.



Local
Long term and short term local inhalation DNEL values are not proposed in the absence of any identified hazard.


 


Systemic dermal:
Long-term
The sub-chronic oral NOAEL of 400 mg/kg bw/d of benzyl alcohol (CAS 100-51-6) as a surrogate for benzyl benzoate (CAS 120-51-4) is used.
Corrected NOAEL: 285.7 mg/kg (400 x 5/7)
5/7 = exposition animals/exposition general population [days].
Application of assessment factors of 1 (for dose response), 2 (extrapolation from a subchronic to chronic exposure), 4 (allometric scaling), 2.5 (additional interspecies differences) and 10 (intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall AF of 200 and a DNEL of 1.42 mg/kg bw/d.



Acute/short-term
Short-term DNEL is derived from long-term DNEL by the use of a factor 5.



Local
Long-term
Benzyl benzoate is not classified as a skin irritant or sensitiser.
Acute/short-term
Benzyl benzoate is not classified as an irritant or sensitiser.



Oral systemic:
Long-term
The sub-chronic oral NOAEL of 400 mg/kg bw/d of benzyl alcohol (CAS 100-51-6) as a surrogate for benzyl benzoate (CAS 120-51-4) is used.
Corrected NOAEL = 285.7 mg/kg (400 x 5/7)
5/7 = exposition animals/exposition general population [days].
Application of assessment factors of 1 (for dose response), 2 (extrapolation from a subchronic to chronic exposure), 4 (allometric scaling), 2.5 (additional interspecies differences) and 10 (intraspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall AF of 200 and a DNEL of 1.42 mg/kg bw/d.



Acute/short-term
Benzyl benzoate is not classified for oral toxicity.