Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9 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:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
220.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

As a repeated dose inhalation toxicity study is not available, the NOAEL from the oral 90 -day study in the rat was used to derive the modified dose descriptor starting point. A NOAEC of 220.4 mg/m³ was derived taking into account the respiratory volume of a rat and a worker for a relevant duration (/0.38*0.67) and the oral NOAEL of 250 mg/kg bw/d. In the absence of specific data, it was assumed that inhalation absorption is twice that of oral absorption.

AF for dose response relationship:
1
Justification:
not required as starting point is a NOAEC
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
not required - already taken into account in modification of dose descriptor starting point
AF for other interspecies differences:
2.5
Justification:
default ECHA value
AF for intraspecies differences:
5
Justification:
default ECHA value for workers
AF for the quality of the whole database:
1
Justification:
Default for acceptable database
AF for remaining uncertainties:
1
Justification:
No additional factor required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
2.5 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:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In the absence of specific data, oral absorption is considered to be equivalent to dermal absorption.

AF for dose response relationship:
1
Justification:
not required as starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
The starting point is derived from a study in the rat
AF for other interspecies differences:
2.5
Justification:
default ECHA value
AF for intraspecies differences:
5
Justification:
default ECHA value for workers
AF for the quality of the whole database:
1
Justification:
Default for acceptable database
AF for remaining uncertainties:
1
Justification:
No additional factor required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Inhalation DNEL values

Systemic Long-term

The sub-chronic oral NOAEL of 250 mg/kg bw/d is corrected for the extent of inhalation absorption (100%) and oral absorption (50%) and breathing rate (/0.38 *0.67) to give a corrected (inhalation) starting point (NOAEC) of 220.4 mg/m³. 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 9 mg/m³.

Systemic Acute/short-term

Benzyl acetate is of low systemic toxicity following oral exposures and is not classified for acute oral, dermal or inhalation toxicity. The substance is not corrosive or sensitising to the skin following dermal contact. Inhalation exposure is unlikely based on the physico-chemical properties of the test material. An acute systemic DNEL is therefore not required.

Local

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

Dermal DNEL values

Systemic Long-term

The long term systemic dermal DNEL value was derived from the dermal NOAEL of 250 mg/kg bw/d established in a 90 day study in rats; correction for route-to route extrapolation is not therefore required. 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 sub-chronic 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 2.5 mg/kg bw/d. In the absence of specific data, oral and dermal absorption are assumed to be equivalent.

Systemic Acute/short-term

Benzyl acetate is of low systemic toxicity following oral exposures and is not classified for acute oral, dermal or inhalation toxicity. The substance is not corrosive or sensitising to the skin following dermal contact. An acute systemic DNEL is therefore not required.

Local

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

Eyes

No hazard is identified as benzyl acetate is not an eye irritant.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.2 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:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
108.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

As a repeated dose inhalation toxicity study is not available, the NOAEL from the oral 90 -day study in the rat was used to derive the modified dose descriptor starting point. A NOAEC of 108.7 mg/m³ was derived taking into account the respiratory volume of a rat (/1.15) and the NOAEL of 250 mg/kg bw/d. It was assumed that inhalation absorption is twice that of oral absorption.

AF for dose response relationship:
1
Justification:
not required as starting point is a NOAEC
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
not required - already taken into account in modification of dose descriptor starting point
AF for other interspecies differences:
2.5
Justification:
default ECHA value
AF for intraspecies differences:
10
Justification:
default ECHA value for general population
AF for the quality of the whole database:
1
Justification:
Default for acceptable database
AF for remaining uncertainties:
1
Justification:
No additional factor required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

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:
1.3 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:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In the absence of specific data, oral and dermal absorption are assumed to be equivalent.

AF for dose response relationship:
1
Justification:
not required as starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
The starting point is derived from a study in the rat
AF for other interspecies differences:
2.5
Justification:
default ECHA value
AF for intraspecies differences:
10
Justification:
default ECHA value for general population
AF for the quality of the whole database:
1
Justification:
Default for acceptable database
AF for remaining uncertainties:
1
Justification:
No additional factor required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.3 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:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of the starting point is not required as it is derived from an oral study.

AF for dose response relationship:
1
Justification:
not required as starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
The starting point is derived from a study in the rat
AF for other interspecies differences:
2.5
Justification:
default ECHA value
AF for intraspecies differences:
10
Justification:
default ECHA value for general population
AF for the quality of the whole database:
1
Justification:
Default for acceptable database
AF for remaining uncertainties:
1
Justification:
No additional factor required
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Inhalation DNEL values

Systemic Long-term

The sub-chronic oral NOAEL of 250 mg/kg bw/d is corrected for the extent of inhalation absorption (100%) and oral absorption (50%) and

breathing rate (/1.15) to give a corrected (inhalation) starting point (NOAEC) of 108.7 mg/m³. 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 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 2.2 mg/m³.

Systemic Acute/short-term

Benzyl acetate is of low systemic toxicity following oral exposures and is not classified for acute oral, dermal or inhalation toxicity. The substance is not corrosive or sensitising to the skin following dermal contact. Inhalation exposure is unlikely based on the physico-chemical properties of the test material. An acute systemic DNEL is therefore not required.

Local

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

Dermal DNEL values

Systemic Long-term

The long term systemic dermal DNEL value was derived from the dermal NOAEL of 250 mg/kg bw/d established in a 90 day study in rats; correction for route-to route extrapolation is not therefore required. 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 sub-chronic 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 1.3 mg/kg bw/d.

Systemic Acute/short-term

Benzyl acetate is of low systemic toxicity following oral exposures and is not classified for acute oral, dermal or inhalation toxicity. The substance is not corrosive or sensitising to the skin following dermal contact. An acute systemic DNEL is therefore not required.

Local

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

Oral DNEL values

Systemic Long-term

The long term systemic dermal DNEL value was derived from the dermal NOAEL of 250 mg/kg bw/d established in a 90 day study in rats; correction for route-to route extrapolation is not therefore required. 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 sub-chronic 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 1.3 mg/kg bw/d.

Systemic Acute/short-term

Benzyl acetate is of low systemic toxicity following oral exposures and is not classified for acute oral, dermal or inhalation toxicity. The substance is not corrosive or sensitising to the skin following dermal contact. An acute systemic DNEL is therefore not required.

Eyes

No hazard is identified as benzyl acetate is not an eye irritant.