Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
88 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):
5
Modified dose descriptor starting point:
NOAEC
DNEL value:
441 mg/m³
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
1
Justification:
NOAEL based on chronic data
AF for interspecies differences (allometric scaling):
1
Justification:
Scaling addressed in route to route extrapolation) in accordance with REACH Guidance R.8
AF for other interspecies differences:
1
Justification:
The toxicity of metal complexing agents, of which this substance is an example, is associated with their ability to complex metals and either enhance their excretion or prevent their absorption. They are not metabolised and are rapidly excreted. As such there are likely to be no ‘Toxicodynamic’ differences between animals and humans that would justify use an addition factor
AF for intraspecies differences:
5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

DNEL derivation for each of the relevant endpoints was based on the most conservative value obtained from available animal toxicity studies and the application of relevant assessment factors.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
22 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):
10
Modified dose descriptor starting point:
NOAEC
DNEL value:
217 mg/m³
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
1
Justification:
NOAEL based on chronic data
AF for interspecies differences (allometric scaling):
1
Justification:
Scaling addressed in route to route extrapolation in accordance with REACH Guidance R.8
AF for other interspecies differences:
1
Justification:
The toxicity of metal complexing agents, of which this substance is an example, is associated with their ability to complex metals and either enhance their excretion or prevent their absorption. They are not metabolised and are rapidly excreted. As such there are likely to be no ‘Toxicodynamic’ differences between animals and humans that would justify use an addition factor
AF for intraspecies differences:
10
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12 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):
40
Modified dose descriptor starting point:
NOAEL
DNEL value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
1
Justification:
NOAEL based on chronic data
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor (rat to human), in accordance with REACH Guidance R.8
AF for other interspecies differences:
1
Justification:
The toxicity of metal complexing agents, of which this substance is an example, is associated with their ability to complex metals and either enhance their excretion or prevent their absorption. They are not metabolised and are rapidly excreted. As such there are likely to be no ‘Toxicodynamic’ differences between animals and humans that would justify use an addition factor
AF for intraspecies differences:
10
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

DNEL derivation for each of the relevant endpoints was based on the most conservative value obtained from available animal toxicity studies and the application of relevant assessment factors.