Registration Dossier
Registration Dossier
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EC number: 248-777-7 | CAS number: 28015-99-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.23 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 167 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- assuming 10% absorption via oral and 10% via inhalative route the NOAEL of 95 mg/kg bw/d from a subacute study with the analogue BaDNNSA is corrected by multiplying with 10/10 and division by 0.38 m3/kg for air consumption and multiplication with 6.7/10 for light work adjustment --> NOAECcorr = 55 mg/kg bw/d * 10/10 * 6.7/10 / 0.38 m3/kg/d = 96 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling is not applied for the derivation of inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific data are available.
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from analogue fulfilling scientific principle is used .
- AF for remaining uncertainties:
- 1
- Justification:
- no other uncertainties needed to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.316 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 95 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- In general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation and absorption rates are assumed 10% for both routes.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific effects are available
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Available data fulfill the scientific requirements
- AF for remaining uncertainties:
- 1
- Justification:
- no other uncertainties need to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Magnesium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate) has a low vapour pressure and is not expected to volatilize. Inhalation exposure to the vapour or aerosols (see uses) is unlikely to be a relevant route of exposure to human in regular use.
A worst case scenario is assumed in which the absorption rate for the dermal route is considered to be same as oral route, and for both routes assumed to be 10% (see toxicokinetic assessment).
OECD 422 studies were conducted with 2 analogues: DNNSA (di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid) and BaDNNSA (Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate). The NOAEL for DNNSA is 95 mg/kg/day and the NOAEL for BaDNNSA is 55 mg/kg/day.
DNNSA provides the best read-across for MgDNNSA because DNNSA is the major component of MgDNNSA and the presence of the magnesium
moiety, which is considered to be of low toxicity, would not contribute significantly to the toxicity. The NOAEL for Barium DNNSA is lower than the NOAEL for DNNSA principally related to the presence of the barium moiety. The NOAEL for Barium DNNSA is based on effects on the kidney which is known as the target organ for barium toxicity.Based on these results, the No Observed Adverse Effect Levels (NOAEL) used as starting point for the derivation of the DNELs was established as 95 mg/kg, the NOAEL for DNNSA.
According to ECHA guidance document the oral NOAEL is converted to an inhalation NOAECWorkerof 167 mg/m3(0.38 m3/kg in case of 8 h exposure/d for worker and 6.7/10 for light work adjustment), and as inhalative and dermal absorption both are assumed being 10% no correction was applied.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
- Value:
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
No consumer exposure is anticipated
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