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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
24.7 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
175 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
308.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

No studies are conducted for the target substance or relevant read-across substances via inhalation route. Thus, the most reliable NOAEL was selected from a repeated dose toxicity study (oral) conducted for the read-across substance (sodium fluoride). Lower NOAELs presented in the data set are not used as dose descriptor starting points as they are from studies where no adverse effects were observed i.e. these NOAELs were selected based on the highest concentration tested.

AF for dose response relationship:
1
Justification:
the starting point for the DNEL calculation is a derived NOAEC
AF for differences in duration of exposure:
1
Justification:
oral chronic study
AF for other interspecies differences:
2.5
Justification:
default AS for other interspecies differences
AF for intraspecies differences:
5
Justification:
differences for workers
AF for the quality of the whole database:
1
Justification:
default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
175 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
175 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No studies are conducted for the target substance or relevant read-across substances via dermal route. Thus, the most reliable NOAEL was selected from a repeated dose toxicity study (oral) conducted for the read-across substance (sodium fluoride). Lower NOAELs presented in the data set are not used as dose descriptor starting points as they are from studies where no adverse effects were observed i.e. these NOAELs were selected based on the highest concentration tested.

AF for dose response relationship:
1
Justification:
the starting point for the DNEL calculation is a derived NOAEL
AF for differences in duration of exposure:
1
Justification:
chronic oral study
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
default assessment factor
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.1 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):
25
Dose descriptor starting point:
NOAEL
Value:
175 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
152 mg/m³
Explanation for the modification of the dose descriptor starting point:

No studies are conducted for the target substance or relevant read-across substances via inhalation route. Thus, the most reliable NOAEL was selected from a repeated dose toxicity study (oral) conducted for the read-across substance (sodium fluoride). Lower NOAELs presented in the data set are not used as dose descriptor starting points as they are from studies where no adverse effects were observed i.e. these NOAELs were selected based on the highest concentration tested.

AF for dose response relationship:
1
Justification:
the starting point for the DNEL calculation is a derived NOAEC
AF for differences in duration of exposure:
1
Justification:
chronic to chronic
AF for other interspecies differences:
2.5
Justification:
default AS for other interspecies differences, i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
AF for intraspecies differences:
10
Justification:
differences for general population
AF for the quality of the whole database:
1
Justification:
default assessment factor
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
DNEL (Derived No Effect Level)
Value:
1.75 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):
100
Dose descriptor starting point:
NOAEL
Value:
175 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
175 mg/kg bw/day
AF for dose response relationship:
1
Justification:
the starting point for the DNEL calculation is a derived NOAEC
AF for differences in duration of exposure:
1
Justification:
chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
difference between metabolic rate scaling and body weight scaling for rats and humans
AF for other interspecies differences:
2.5
Justification:
default AS for other interspecies differences, i.e. toxicokinetic differences not related to metabolic rate (small part) and toxicodynamic differences (larger part)
AF for intraspecies differences:
10
Justification:
differences for general population
AF for the quality of the whole database:
1
Justification:
default assessment factor
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