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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.26 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
881.58 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant NOAEL is taken from the oral 2 -generation study in rats with sodium formate, which gave a NOAEL of 1000 mg/kg bw/d. For workers, the corrected inhalatory NOAEC would be [1000 mg/kg bw/d * (1/sRVrat) * (Oral absorbance in the rat/Inhalatory absorbance in humans) * (sRVhuman/wRV)] = [1000 mg/ kg bw/d * (1/0.38 m^3/kg bw/d) * (50%/100%) * (6.7m^3)/10m^3)]

This gives a modified NOAEC for assessment of the inhalatory effects of 881.58 mg/m^3.

AF for dose response relationship:
1
Justification:
Default value: a NOAEL from a reliable study is used as a starting point
AF for differences in duration of exposure:
2
Justification:
A default value of 2 is used to extrapolate from a sub-chronic study to long-term exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not required: already taken into account in adjustment of the starting point
AF for other interspecies differences:
2.5
Justification:
Default value for toxicokinetic and toxicodynamic interspecies differences
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Default value: good quality database
AF for remaining uncertainties:
1
Justification:
Default value: no signficant remaining uncertainties
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:
10 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL is based on the 2-generation oral study in rats with sodium formate. The value corresponded to a NOAEL of 1000 mg/kg bw/d. It is considered that the oral absorption is equal to the dermal absorption (default, worst-case assumption). This gives a modified dermal NOAEL of 1000 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
No adjustments are necessary as the starting point is from a NOAEL in a reliable study
AF for differences in duration of exposure:
2
Justification:
An assessment factor of 2 is used to extrapolate from a sub-chronic study to long-term exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default value: starting point is from a study in the rat
AF for other interspecies differences:
2.5
Justification:
Default value for toxicokinetics and toxicodynamics interspecies differences
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Default value: good qualuty database
AF for remaining uncertainties:
1
Justification:
Default value: no significant remaining uncertainties
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:
low hazard (no threshold derived)

Additional information - workers

The NOAEL of 1000 mg/kg bw/d from a reproductive/fertility study where dosing was conducted orally for at least 90 days is considered to be the relevant starting point for DNEL derivation.

Following the default assumption that inhalation absorption is twice the oral absorption, the inhalatory modified dose descriptor starting point of 881.58 mg/m3 is derived for workers based on 10 m3/8 hour period and 70 kg body weight.

Following the assumption that the dermal absorption is equal to the oral absorption, the modified dose descriptor starting point of 1000 mg/kg bw/day is relevant for dermal DNEL derivation.

The use of assessment factors according to REACH guidance is considered below:

Intraspecies differences (allometric scaling): a default assessment factor of 4 is used as starting point is derived from a rat study, where appropriate.

Intraspecies differences (remaining differences): a default assessment factor of 2.5 is used.

Interspecies differences: a default assessment factor of 5 is used for workers

Duration: an additional assessment factor of 2 is used long-term DNEL values as the starting point is derived from a subchronic study

Dose-response: a default assessment of 1 is used as the original study is reliable.

Database quality: a default assessment factor of 1 is used

Sodium formate is of low acute toxicity and is not classified for acute toxicity by any route of exposure. No hazard is identified and short-term systemic DNELs are not required.

Sodium formate is not a skin irritant or sensitiser. Local dermal DNELs are not required in the absence of any hazard.

Sodium formate is not a respiratory irritant or sensitiser. Local inhalation DNELs are not required in the absence of any hazard.

Long-term systemic dermal DNEL

The derivation of dermal DNEL values assumes dermal absorption is equal to oral absorption. Applying the overall assessment factor of 100 for workers to the modified starting point of 1000 mg/kg bw/d gives a DNEL value of 10.00 mg/kg bw/d.

Long-term systemic inhalation DNEL

The derivation of inhalation DNEL values assumes that the extent of inhalation absorption is twice that of oral absorption.

Applying the overall assessment factor of 25 for workers to the modified starting point of 881.58 mg/m3 gives a DNEL value of 35.26 mg/m3 (assuming a bodyweight of 70 kg and a breathing rate of 10 m3/8h).

Hazard for the eyes

Sodium formate is classified for eye irritation (category 2) according to CLP 1272/2008. Based on ECHA guidance on information requirements and chemical safety assessment, part E, Table 3-1, the hazard assessment is considered to be low.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.7 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):
50
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
434.78 mg/m³
Explanation for the modification of the dose descriptor starting point:

A NOAEL is based on the 2-generation oral study in rats with sodium formate. The value corresponded to a NOAEL of 1000mg/kg bw/d. For the general population, the corrected inhalatory NOAEC would be [1000 mg/kg bw/d * (1/sRVrat) * (Oral absorbance in the rat/Inhalatory absorbance in human)] i.e. [1000 mg/ kg bw/d * (1/1.15 m^3/kg bw/d) * (50%/100%)].

 

This gives a modified NOAEC for assessment of the inhalatory effects as 434.78 mg/m^3.

AF for dose response relationship:
1
Justification:
The starting point is a NOAEL from a reliable study
AF for differences in duration of exposure:
2
Justification:
Default value as NOAEL used is based on a subchronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Use of allometric scaling is not appropriate when route to route extrapolation is used since the species differences are accounted for in the breathing adjustments in the calculation.
AF for other interspecies differences:
2.5
Justification:
Default value for toxicokinetic and toxicodynamic interspecies differences
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value: good quality database
AF for remaining uncertainties:
1
Justification:
Default value: no significant remaining uncertainties
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:
5 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):
200
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL is based on the 2-generation study in rats with sodium formate. The value corresponded to a NOAEL of 1000 mg/kg bw/d. The animals were dosed orally. It is considered that the oral absorption is equal to the dermal absorption. This gives a modified NOAEL for assessment of the dermal effects as 1000 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
No adjustments are necessary as the starting point is a NOAEL from a relaible study
AF for differences in duration of exposure:
2
Justification:
Default value as NOAEL used is based on a sub chronic study with dosing for at least 90 days
AF for interspecies differences (allometric scaling):
4
Justification:
Default value: starting point is from a study in the rat
AF for other interspecies differences:
2.5
Justification:
Default value for toxicokinetic and toxicodynamic interspecies differences
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Default value: good quality database
AF for remaining uncertainties:
1
Justification:
Default value: no significant remaining uncertainties
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:
5 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):
200
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL is based on the 2 generation oral study in rats with sodium formate. The value corresponded to a NOAEL of 1000 mg/kg bw/day. Modification of the starting point is not required.

AF for dose response relationship:
1
Justification:
No adjustments are necessary as the starting point is a NOAEL from a reliable study
AF for differences in duration of exposure:
2
Justification:
Default value as NOAEL used is based on a sub chronic study with dosing for at least 90 days
AF for interspecies differences (allometric scaling):
4
Justification:
Default value as the starting point is derived from a study in the rat
AF for other interspecies differences:
2.5
Justification:
Default value for toxicokinetic and toxicodynamic interspecies differences
AF for intraspecies differences:
10
Justification:
Default value for the general population
AF for the quality of the whole database:
1
Justification:
Default value: good quality database
AF for remaining uncertainties:
1
Justification:
Default value: no significant remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

The NOAEL of 1000 mg/kg bw/d from a reproductive/fertility study where dosing was conducted orally for at least 90 days is considered to be the relevant starting point for DNEL derivation.

 

Following the default assumption that inhalation absorption is twice the oral absorption, the inhalatory modified dose descriptor starting point of 434.78 mg/m3 is derived for the general population based on 20 m3/24 hour period and 60 kg body weight.

 

Following the assumption that the dermal absorption is equal to the oral absorption, the modified dose descriptor starting point of 1000 mg/kg bw/day is relevant for dermal DNEL derivation.

The use of assessment factors according to REACH guidance is considered below:

Intraspecies differences (allometric scaling): a default assessment factor of 4 is used as starting point is derived from a rat study, where appropriate.

Intraspecies differences (remaining differences): a default assessment factor of 2.5 is used.

Interspecies differences: a default assessment factor of 10 is used for the general population

Duration: an additional assessment factor of 2 is used long-term DNEL values as the starting point is derived from a subchronic study

Dose-response: a default assessment of 1 is used as the original study is reliable.

Database quality: a default assessment factor of 1 is used

Sodium formate is of low acute toxicity and is not classified for acute toxicity by any route of exposure. No hazard is identified and short-term systemic DNELs are not required.

Sodium formate is not a skin irritant or sensitiser. Local dermal DNELs are not required in the absence of any hazard.

Sodium formate is not a respiratory irritant or sensitiser. Local inhalation DNELs are not required in the absence of any hazard.

Long-term systemic dermal DNEL

The derivation of dermal DNEL values assumes dermal absorption is equal to oral absorption. Applying the overall assessment factor of 200 for the general population to the modified starting point of 1000 mg/kg bw/d gives a DNEL value of 5.0 mg/kg bw/d.

Long-term systemic inhalation DNEL

The derivation of inhalation DNEL values assumes that the extent of inhalation absorption is twice that of oral absorption. Applying the overall assessment factor of 50 for the general population to the modified starting point of 434.78 mg/m3gives a DNEL value of 8.70 mg/m3 (assuming a bodyweight of 60 kg and a breathing rate of 20 m3/24h).

Long term systemic oral DNEL

Applying the overall assessment factor of 200 for the general population to the modified starting point of 1000 mg/kg bw/d gives a DNEL value of 5.0 mg/kg bw/d.

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