Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.7 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):
75
Modified dose descriptor starting point:
other: NAEC human worker
Value:
52.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
NAEC human worker=[(NOEL rep. oral tox / allometric scale) x standard human body weight ] / standard human worker breathing volume (8h) = [(30 mg/kg bw day /4) x 70 kg]/10 m^3=315 mg/m^3
AF for dose response relationship:
1
Justification:
dose-response curve is consistent with toxicity behaviour
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
NAEC human worker
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
NAEC human worker
AF for the quality of the whole database:
1
Justification:
GLP compliant with international guideline
AF for remaining uncertainties:
1
Justification:
assuming 100 % absorption
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 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):
150
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
repeated oral study is the best way to assess the dermal route in absence of a repeated dermal study
AF for dose response relationship:
1
Justification:
dose-response curve is consistent with toxicity behaviour
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
human worker
AF for the quality of the whole database:
1
Justification:
GLP compliant with international guideline
AF for remaining uncertainties:
0.5
Justification:
assuming 50 % absorption
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)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium 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:
0.175 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):
150
Modified dose descriptor starting point:
other: NAEC human g.p.
Value:
26.25 mg/m³
Explanation for the modification of the dose descriptor starting point:
NAEC human general population=[(NOEL rep. oral tox / allometric scale) x standard human body weight ] / standard human general population breathing volume (24h) = [(30 mg/kg bw day /4)70 kg]/20 m^3=157.5 mg/m^3
AF for dose response relationship:
1
Justification:
dose-response curve is consistent with toxicity behaviour
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
NAEC general population
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
NAEC general population
AF for the quality of the whole database:
1
Justification:
GLP compliant with international guideline
AF for remaining uncertainties:
1
Justification:
assuming 100 % absorption
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:
DNEL (Derived No Effect Level)
Value:
0.1 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:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
AF for oral to dermal = 1
AF for dose response relationship:
1
Justification:
dose-response curve is consistent with toxicity behaviour
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
human standard to human general population
AF for the quality of the whole database:
1
Justification:
GLP compliant with international guideline
AF for remaining uncertainties:
0.5
Justification:
assuming 50 % absorption
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)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.05 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
from oral to dermal the assessment factor is 1
AF for dose response relationship:
1
Justification:
dose-response curve is consistent with toxicity behaviour
AF for differences in duration of exposure:
6
Justification:
sub acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
human standard to human general population
AF for the quality of the whole database:
1
Justification:
GLP compliant with international guideline
AF for remaining uncertainties:
1
Justification:
assuming 100 % absorption
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The read across justification with sodium salt and evaluation of impurities document is attached on section 13 of the dossier.

The main constituent -thelong chlorinated paraffinic chain with one sulphonic group- is in common, because raw materials and the production process are the same. Therefore, a read-across approach between the sodium and the ammonium salt can be considered reliable, considering also that the portion of the on ammonium ions is less, ca. 2 %. Impurities have been evaluated.