Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.308 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):
20
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
6.17 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
ECHA REACH Guidance. An assessment factor of 4 was used, as the NOAEL was based on an OECD 422 resulting in a longer exposure than a subacute 28d study.
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehyde type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF.
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.88 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):
5
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
4.41 mg/m³
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehyde type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF.
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.22 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Dose descriptor:
NOAEC
Value:
4.41 mg/m³
AF for dose response relationship:
20
Justification:
ECHA REACH Guidance.
AF for differences in duration of exposure:
4
Justification:
ECHA REACH Guidance. An assessment factor of 4 was used, as the NOAEL was based on an OECD 422 resulting in a longer exposure than a subacute 28d study.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
AF for other interspecies differences:
1
Justification:
ECHA REACH Guidance.
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.88 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEC
Value:
4.41 mg/m³
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
AF for other interspecies differences:
1
Justification:
ECHA REACH Guidance.
AF for intraspecies differences:
1
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
5
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.89 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):
80
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
71.43 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

5 mg/kg/d observed in an oral toxicity study adapted to account for only 7% dermal absorption.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
ECHA REACH Guidance. An assessment factor of 4 was used, as the NOAEL was based on an OECD 422 resulting in a longer exposure than a subacute 28d study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehydes type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF.
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.57 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):
20
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
71.43 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

5 mg/kg/d observed in an oral toxicity study adapted to account for only 7% dermal absorption.

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance. An assessment factor of 4 was used, as the NOAEL was based on an OECD 422 resulting in a longer exposure than a subacute 28d study.
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehydes type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF.
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
215 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance R8, page 125 footnote 17:
17 In some papers it is suggested that the LLNA EC3 value is close enough to the human NOAEL and that therefore it can be used as a surrogate for the NOAEL (19, 26, 28)
AF for differences in duration of exposure:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
There are both reliable human and LLNA data on Bourgeonal, the LLNA EC3 being the lowest threshold it is chosen as a conservative point of departure for deriving the DNEL and as recommended by the guidance, no AF for interspecies differences is thus needed.
AF for other interspecies differences:
1
Justification:
ECHA REACH Guidance.
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
215 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance R8, page 125 footnote 17:
17 In some papers it is suggested that the LLNA EC3 value is close enough to the human NOAEL and that therefore it can be used as a surrogate for the NOAEL (19, 26, 28)
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
There are both reliable human and LLNA data on Bourgeonal, the LLNA EC3 being the lowest threshold it is chosen as a conservative point of departure for deriving the DNEL and as recommended by the guidance, no AF for interspecies differences is thus needed.
AF for other interspecies differences:
1
Justification:
ECHA REACH Guidance.
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
54.4 µg/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):
40
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
2.18 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
ECHA REACH Guidance. An assessment factor of 4 was used, as the NOAEL was based on an OECD 422 resulting in a longer exposure than a subacute 28d study.
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehydes type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF.
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.22 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):
10
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
2.17 mg/m³
Explanation for the modification of the dose descriptor starting point:

ECHA REACH Guidance.

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehydes type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF.
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.22 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Value:
2.17 mg/m³
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance.
AF for differences in duration of exposure:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
AF for other interspecies differences:
1
Justification:
ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.22 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Value:
2.17 mg/m³
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
AF for other interspecies differences:
1
Justification:
ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.

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:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
160
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
35.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

5 mg/kg/d observed in an oral toxicity study adapted to account for only 7% dermal absorption.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
ECHA REACH Guidance. An assessment factor of 4 was used, as the NOAEL was based on an OECD 422 resulting in a longer exposure than a subacute 28d study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehydes type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF.
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.79 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):
40
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

5 mg/kg/d observed in an oral toxicity study adapted to account for only 7% dermal absorption.

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance.
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehydes type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF..
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
107.5 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance R8, page 125 footnote 17:
17 In some papers it is suggested that the LLNA EC3 value is close enough to the human NOAEL and that therefore it can be used as a surrogate for the NOAEL (19, 26, 28)
AF for differences in duration of exposure:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
There are both reliable human and LLNA data on Bourgeonal, the LLNA EC3 being the lowest threshold it is chosen as a conservative point of departure for deriving the DNEL and as recommended by the guidance, no AF for interspecies differences is thus needed.
AF for other interspecies differences:
1
Justification:
ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
107.5 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance R8, page 125 footnote 17:
17 In some papers it is suggested that the LLNA EC3 value is close enough to the human NOAEL and that therefore it can be used as a surrogate for the NOAEL (19, 26, 28)
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance.
There are both reliable human and LLNA data on Bourgeonal, the LLNA EC3 being the lowest threshold it is chosen as a conservative point of departure for deriving the DNEL and as recommended by the guidance, no AF for interspecies differences is thus needed.
AF for other interspecies differences:
1
Justification:
ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 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):
160
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
4
Justification:
ECHA REACH Guidance. An assessment factor of 4 was used, as the NOAEL was based on an OECD 422 resulting in a longer exposure than a subacute 28d study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehydes type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF.
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26.88 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):
40
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance.
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA REACH Guidance. An assessment factor of 4 was used, as the NOAEL was based on an OECD 422 resulting in a longer exposure than a subacute 28d study.
AF for other interspecies differences:
1
Justification:
Bourgeonal is part of a certain family of chemicals (p-tert-Butyldihydrocinnamic aldehydes type) on which there is an extensive amount of studies that can be used to characterise and compare the differences in toxicokinetic and toxicodynamic of those chemicals between a wide variety of species (rat, mouse, rabbit, human, etc...). For instance, such a comparative study has been done on the very closely related p-t-Butyl-alpha-methylhydrocinnamic aldehyde (CAS 80 -54 -6, EC 201 -289 -8), clearly showing that the rat is the most sensitive species and as such the most susceptible to its toxicological effects.
As the study used to select the point of departure has been done on rats, there is no need for further AF.
AF for intraspecies differences:
10
Justification:
ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance.
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population