Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.837 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC technical report No.110: Guidance on Assessment Factors to Derive a DNEL and ECETOC workshop report No.20: Workshop on Guidance on Assessment Factors to Derive a DNEL.
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEC
Value:
22.039 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalatory NOAEC: 25 mg/kg bw/day *(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.) = 22.039 mg/m3
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation
AF for other interspecies differences:
1
Justification:
Based on ECETOC technical report No.110 and Workshop report No.20
AF for intraspecies differences:
3
Justification:
worker, Based on ECETOC technical report No.110 and Workshop report No.20
AF for the quality of the whole database:
2
Justification:
NOAEC is derived from NOAEL value. The predicted NOAEL value for Ligustral/Cyclal C/Trigustral is derived from a read-across WoE of HMPCC (key study RL2, supporting studies RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.521 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC technical report No.110: Guidance on Assessment Factors to Derive a DNEL and ECETOC workshop report No.20: Workshop on Guidance on Assessment Factors to Derive a DNEL.
Overall assessment factor (AF):
48
Modified dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = 25 mg/kg bw/day * (ABSoral/ABSdermal)=25 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL is used
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human in dermal route, Allometric scaling is 4
AF for other interspecies differences:
1
Justification:
Based on ECETOC technical report No.110 and Workshop report No.20
AF for intraspecies differences:
3
Justification:
worker, Based on ECETOC technical report No.110 and Workshop report No.20
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for Ligustral/Cyclal C/Trigustral is derived from a read-across WoE of HMPCC (key study RL2, supporting studies RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

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:
0.543 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC technical report No.110: Guidance on Assessment Factors to Derive a DNEL and ECETOC workshop report No.20: Workshop on Guidance on Assessment Factors to Derive a DNEL.
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEC
Value:
10.86 mg/m³
Explanation for the modification of the dose descriptor starting point:
Inhalation NOAEC: 25 mg/kg bw/day * (1/1.15 m3/kg/d)*(ABSoral/ABSinh.) = 10.86 mg/m3
AF for dose response relationship:
1
Justification:
NOAEC is used
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation
AF for other interspecies differences:
1
Justification:
Based on ECETOC technical report No.110 and Workshop report No.20
AF for intraspecies differences:
5
Justification:
General population, Based on ECETOC technical report No.110 and Workshop report No.20
AF for the quality of the whole database:
2
Justification:
NOAEC is derived from NOAEL value. The predicted NOAEL value for Ligustral/Cyclal C/Trigustral is derived from a read-across WoE of HMPCC (key study RL2, supporting studies RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.312 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC technical report No.110: Guidance on Assessment Factors to Derive a DNEL and ECETOC workshop report No.20: Workshop on Guidance on Assessment Factors to Derive a DNEL.
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Dermal NOAEL = 25 mg/kg bw/day * (ABSoral/ABSdermal)=25 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL is used
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human in dermal route, Allometric scaling is 4
AF for other interspecies differences:
1
Justification:
Based on ECETOC technical report No.110 and Workshop report No.20
AF for intraspecies differences:
5
Justification:
General population, Based on ECETOC technical report No.110 and Workshop report No.20
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for Ligustral/Cyclal C/Trigustral is derived from a read-across WoE of HMPCC (key study RL2, supporting studies RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.312 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC technical report No.110: Guidance on Assessment Factors to Derive a DNEL and ECETOC workshop report No.20: Workshop on Guidance on Assessment Factors to Derive a DNEL.
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEL
Value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAEL= 100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NAOEL is used
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human in oral route, Allometric scaling is 4
AF for other interspecies differences:
1
Justification:
Based on ECETOC technical report No.110 and Workshop report No.20
AF for intraspecies differences:
5
Justification:
General population, Based on ECETOC technical report No.110 and Workshop report No.20
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for Ligustral/Cyclal C/Trigustral is derived from a read-across WoE of HMPCC (key study RL2, supporting studies RL2). The default assessment factor of 1 is increased to 2 to account for uncertainty in the quality of the whole database, based on the available studies. This modification should be sufficient to account for any uncertainty in the read across approach.
AF for remaining uncertainties:
1
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