Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.92 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):
100
Dose descriptor starting point:
NOAEL
Value:
218 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
192.2 mg/m³
Explanation for the modification of the dose descriptor starting point:
Oral to inhalation extrapolation taking into account a standard assessment factor of 2 for differences in absorption.
AF for dose response relationship:
1
Justification:
According to guideline
AF for differences in duration of exposure:
4
Justification:
Standard assessment factor intrapolated to reflect a study duration of 42 days.
AF for interspecies differences (allometric scaling):
1
Justification:
Included in route-to-route extrapolation.
AF for other interspecies differences:
2.5
Justification:
According to guideline
AF for intraspecies differences:
5
Justification:
According to guideline
AF for the quality of the whole database:
2
Justification:
DNEL derived based on read-across data
AF for remaining uncertainties:
1
Justification:
According to guideline
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:
0.545 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):
400
Dose descriptor starting point:
NOAEL
Value:
218 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
218 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral-to-dermal extrapolation taking into account a standard assessment factor of 1 for differences in absorption.
AF for dose response relationship:
1
Justification:
According to REACH guideline
AF for differences in duration of exposure:
4
Justification:
Standard assessment factor intrapolated to reflect a study duration of 42 days.
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Justification:
According to REACH guideline
AF for remaining uncertainties:
2
Justification:
DNEL derived based on read-across data
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

WORKERS

 

Long-term systemic effects via inhalation route

 

Starting point: NOAEL = 218 mg/kg bw/d.

This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.

 

Correction of the starting point:

 

NOAEC = 218 mg/kg bw/d * (1/0.38 m3/kg bw) * (6.7 m3/10 m3) = 384 mg/m3

 

Assessment factor for oral-to-inhalation extrapolation: 2

 

NOAEC = 384 mg/m3* (1/2) = 192 mg/m3

 

 

Long-term systemic effects via dermal route

 

Starting point: NOAEL = 218 mg/kg bw/d.

This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.

 

Correction of the starting point not required.

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.474 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):
200
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
Value:
94.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
Oral to inhalation extrapolation taking into account a standard assessment factor of 2 for differences in absorption.
AF for dose response relationship:
1
AF for differences in duration of exposure:
4
AF for interspecies differences (allometric scaling):
1
Justification:
Included in route-to-route extrapolation.
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
Justification:
DNEL derived based on read-across data
AF for remaining uncertainties:
1
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:
0.273 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):
800
Dose descriptor starting point:
NOAEL
Value:
218 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
218 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Oral-to-dermal extrapolation taking into account a standard assessment factor of 1 for differences in absorption.
AF for dose response relationship:
1
Justification:
According to REACH guideline
AF for differences in duration of exposure:
4
Justification:
Standard assessment factor intrapolated to reflect a study duration of 42 days.
AF for interspecies differences (allometric scaling):
4
Justification:
According to REACH guideline
AF for other interspecies differences:
2.5
Justification:
According to REACH guideline
AF for intraspecies differences:
10
Justification:
According to REACH guideline
AF for the quality of the whole database:
1
Justification:
According to REACH guideline
AF for remaining uncertainties:
2
Justification:
DNEL derived based on read-across data
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:
0.273 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):
800
Modified dose descriptor starting point:
NOAEL
Value:
218 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
4
Justification:
Standard assessment factor intrapolated to reflect a study duration of 42 days.
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2
Justification:
DNEL derived based on read-across data
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

GENERAL POPULATION

 

Long-term systemic effects via inhalation route

 

Starting point: NOAEL = 218 mg/kg bw/d.

This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.

 

Correction of the starting point:

 

NOAEC = 218 mg/kg bw/d * (1/1.15 m3/kg bw) = 189.6 mg/m3

 

Assessment factor for oral-to-inhalation extrapolation: 2

 

NOAEC = 190 mg/m3* (1/2) = 94.8 mg/m3

 

 

Long-term systemic effects via dermal route

 

Starting point: NOAEL = 218 mg/kg bw/d.

This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.

 

Correction of the starting point not required.

 

 

Long-term systemic effects via oral route

 

Starting point: NOAEL = 218 mg/kg bw/d.

This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.

 

Correction of the starting point not required.