Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.341 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
813.03 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
408.547 mg/m³
Explanation for the modification of the dose descriptor starting point:

The FC-770 NOAEC (813,030 mg/m3 ) was modified, as per ECHA guidance, by multiplying by 6 hours/8 hours and then by 6.7 m3/10 m3 to give a corrected inhalation dose descriptor = 408,547 mg/m3.  

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
AF for other interspecies differences:
1
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
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:
3.3 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):
300
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
other: NOAEC
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

ECHA states that, β€œin general, dermal absorption will not be any higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral to dermal extrapolation.”  Therefore, the oral NOAEL (1,000 mg/kg/day) was used as the corrected dermal NOAEL.  

AF for dose response relationship:
1
AF for differences in duration of exposure:
6
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
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

No additional DN(M)ELs for FC-770 were/could be calculated for this human exposure pathway because either the pathway was not identified in the exposure scenarios or there were no available/adequate data to calculate the DNEL.

Dermal DN(M)EL for Acute/short-term exposure - systemic effects

Inhalation DN(M)EL for Acute/short-term exposure - systemic effects

Dermal DN(M)EL for Acute/short-term exposure - local effects

Inhalation DN(M)EL for Acute/short-term exposure - local effects

Dermal DN(M)EL for Long-term exposure - local effects

Inhalation DN(M)EL for Long-term exposure - local effects

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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

No additional DN(M)ELs for FC-770 were calculated for the general population because exposure pathways for the general population were not identified.

Dermal DN(M)EL for Acute/short-term exposure - systemic effects

Inhalation DN(M)EL for Acute/short-term exposure - systemic effects

Oral DN(M)EL for Acute/short-term exposure - systemic effects

Dermal DN(M)EL for Acute/short-term exposure - local effects

Inhalation DN(M)EL for Acute/short-term exposure - local effects

Dermal DN(M)EL for Long-term exposure - systemic effects

Inhalation DN(M)EL for Long-term exposure - systemic effects

Oral DN(M)EL for Long-term exposure - systemic effects

Dermal DN(M)EL for Long-term exposure - local effects

Inhalation DN(M)EL for Long-term exposure - local effects