Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.17 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
DNEL value:
158.7 mg/m³
Explanation for the modification of the dose descriptor starting point:
Required as route is from oral exposure to inhalation exposure and data on longterm oral exposure only is available.
AF for dose response relationship:
1
Justification:
Not required as NOAEC used
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not required for concentrations
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
5
Justification:
Standard default for workers
AF for the quality of the whole database:
2
Justification:
NOAEL based on read across data
AF for remaining uncertainties:
1
Justification:
None known
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:
0.9 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Absorption through ingestion considered to be equivalent to absorption through the skin as a worse case assessment.
AF for dose response relationship:
1
Justification:
Not required, NOAEL used
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
5
Justification:
Standard default for workers
AF for the quality of the whole database:
2
Justification:
NOAEL based on read across data
AF for remaining uncertainties:
1
Justification:
None known
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.78 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC
DNEL value:
78.26
Explanation for the modification of the dose descriptor starting point:
Required as route is from oral exposure to inhalation exposure and data on longterm oral exposure only is available.
AF for dose response relationship:
1
Justification:
Not required, NOAEC used
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not required, concentration used in dose descriptor
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
10
Justification:
Standard default for general population
AF for the quality of the whole database:
2
Justification:
NOAEC based on read across data
AF for remaining uncertainties:
1
Justification:
None known
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:
0.45 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Modified dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No long-term dermal exposure data available, only oral exposure data.
AF for dose response relationship:
1
Justification:
Not required, NOAEL used
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Standard default for rat to human
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
10
Justification:
Standard default for general population
AF for the quality of the whole database:
2
Justification:
NOAEL based on read across data
AF for remaining uncertainties:
1
Justification:
None known
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.45 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Modified dose descriptor starting point:
NOAEL
DNEL value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
Not required, NOAEL used
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Standard default for rat to human
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
10
Justification:
Standard default for general population
AF for the quality of the whole database:
2
Justification:
NOAEL based on read across data
AF for remaining uncertainties:
1
Justification:
None known
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

To address toxicological endpoints as part of the REACH registration of Benzyl Salicylate (Target Substance) it is proposed to read-across to Cyclohexyl Salicylate, Ethylhexyl salicylate and Methyl salicylate (Source Substances).

The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.

The Target Substance and Source Substances have been characterised using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling, it can be seen that the substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific.

For classification and labelling purposes this indicates that the structural analogues are relatively harmless and would not be classified in accordance with Regulation (EC) No 1272/2008 (CLP). The registration substance is considered to have similar properties and is therefore not classified in accordance with CLP.