Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.29 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
Modified dose descriptor starting point:
NOAEC
DNEL value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:
No factor 2 route extrapolation from oral to inhalation. Due to low vp, exposure is only possible as aerosol (no fine spraying, only larger droplets). Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal difference in absorption compared oral route.
AF for dose response relationship:
1
Justification:
No specific concerns. Effects at LOAEL are not severe and probably only of local nature (irritation stomach)
AF for differences in duration of exposure:
4
Justification:
Duration 43 days: sub-acute to sub-chronic: 2 (rather than 3 when starting 28 days); sub-chronic to chronic: 2
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
Default remaining factor
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
1
Justification:
Although based on basic data confidence in results is high due to data on separate ionic parts of salt. Due to use as intermediate exposures will be limited.
AF for remaining uncertainties:
1
Justification:
Although based on structural homologue, confidence in results is high also due to confirmation of toxicity data for the separate ionic parts of the salt. Further protection for the most critical effect concerns local irritation in stomach; no real systemic toxicity was observed. Finally, due to use as intermediate exposures will be limited.
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:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.75 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Worst case, as dermal absorption is considered to be lower compared to oral absorption.
AF for dose response relationship:
1
Justification:
No specific concerns. Effects at LOAEL are not severe and probably only of local nature (irritation stomach)
AF for differences in duration of exposure:
4
Justification:
Duration 43 days: sub-acute to sub-chronic: 2 (rather than 3 when starting 28 days); sub-chronic to chronic: 2
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat to human
AF for other interspecies differences:
2.5
Justification:
Default remaining factor
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
1
Justification:
Although based on basic data confidence in results is high due to data on seperate ionic parts of salt. Due to use as intermediate exposures will be limited.
AF for remaining uncertainties:
1
Justification:
Although based on structural homologue, confidence in results is high also due to confirmation of toxicity data for the separate ionic parts of the salt. Further protection for the most critical effect concerns local irritation in stomach; no real systemic toxicity was observed. Finally, due to use as intermediate exposures will be limited.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.3 mg/m³
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
NOAEC
DNEL value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:
No factor 2 route extrapolation from oral to inhalation. Due to low vp, exposure is only possible as aerosol (no fine spraying, only larger droplets). Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal difference in absorption compared oral route.
AF for dose response relationship:
1
Justification:
No specific concerns. Effects at LOAEL are not severe and probably only of local nature (irritation stomach)
AF for differences in duration of exposure:
4
Justification:
Duration 43 days: sub-acute to sub-chronic: 2 (rather than 3 when starting 28 days); sub-chronic to chronic: 2
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
Default remaining factor
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Although based on basic data confidence in results is high due to data on separate ionic parts of salt. Due to use as intermediate exposures will be limited.
AF for remaining uncertainties:
1
Justification:
Although based on structural homologue, confidence in results is high also due to confirmation of toxicity data for the separate ionic parts of the salt. Further protection for the most critical effect concerns local irritation in stomach; no real systemic toxicity was observed. Finally, due to use as intermediate exposures will be limited.
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:
0.375 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Modified dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Worst case, as dermal absorption is considered to be lower compared to oral absorption.
AF for dose response relationship:
1
Justification:
No specific concerns. Effects at LOAEL are not severe and probably only of local nature (irritation stomach)
AF for differences in duration of exposure:
4
Justification:
Duration 43 days: sub-acute to sub-chronic: 2 (rather than 3 when starting 28 days); sub-chronic to chronic: 2
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat to human
AF for other interspecies differences:
2.5
Justification:
Default remaining factor
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Although based on basic data confidence in results is high due to data on separate ionic parts of salt. Due to use as intermediate exposures will be limited.
AF for remaining uncertainties:
1
Justification:
Although based on structural homologue, confidence in results is high also due to confirmation of toxicity data for the separate ionic parts of the salt. Further protection for the most critical effect concerns local irritation in stomach; no real systemic toxicity was observed. Finally, due to use as intermediate exposures will be limited.
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:
0.375 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Modified dose descriptor starting point:
NOAEL
DNEL value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No rout to route extrapolation
AF for dose response relationship:
1
Justification:
No specific concerns. Effects at LOAEL are not severe and probably only of local nature (irritation stomach)
AF for differences in duration of exposure:
4
Justification:
Duration 43 days: sub-acute to sub-chronic: 2 (rather than 3 when starting 28 days); sub-chronic to chronic: 2
AF for interspecies differences (allometric scaling):
4
Justification:
Default rat to human
AF for other interspecies differences:
2.5
Justification:
Default remaining factor
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
Although based on basic data confidence in results is high due to data on separate ionic parts of salt. Due to use as intermediate exposures will be limited.
AF for remaining uncertainties:
1
Justification:
Although based on structural homologue, confidence in results is high also due to confirmation of toxicity data for the separate ionic parts of the salt. Further protection for the most critical effect concerns local irritation in stomach; no real systemic toxicity was observed. Finally, due to use as intermediate exposures will be limited.
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

Substance is monomer and used only as intermediate in the production of polymers. No exposures to consumers or general public are actually considered relevant.