Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.375 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
Modified dose descriptor starting point:
NOAEC
DNEL value:
34.382 mg/m³
Explanation for the modification of the dose descriptor starting point:
only oral study available
AF for dose response relationship:
1
Justification:
correction via route, factor 1
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance; subchronic - chronic: 2
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, Differences in species addressed in calculation of dose descriptor starting point
AF for other interspecies differences:
5
Justification:
ECHA REACH Guidance, worker: 5
AF for intraspecies differences:
2.5
Justification:
ECHA REACH Guidance,, default value: 2.5
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.75 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):
100
Modified dose descriptor starting point:
NOAEC
DNEL value:
34.382 mg/m³
Explanation for the modification of the dose descriptor starting point:
value form long term systems inhaltion without time scaling
AF for dose response relationship:
4
Justification:
ECHA REACH Guidance; rat-human: 4
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, Differences in species addressed in calculation of dose descriptor starting point
AF for other interspecies differences:
5
Justification:
ECHA REACH Guidance, worker: 5
AF for intraspecies differences:
2.5
Justification:
ECHA REACH Guidance,, default value: 2.5
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance, worker: 1
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.51 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: German MAK Value; see assessment report in attachment
Overall assessment factor (AF):
1
Dose descriptor:
other: German MAK Value; see assessment report in attachment
AF for dose response relationship:
1
Justification:
German MAK Value; see assessment report in attachment
AF for differences in duration of exposure:
1
Justification:
German MAK Value; see assessment report in attachment
AF for interspecies differences (allometric scaling):
1
Justification:
German MAK Value; see assessment report in attachment
AF for other interspecies differences:
1
Justification:
German MAK Value; see assessment report in attachment
AF for intraspecies differences:
1
Justification:
German MAK Value; see assessment report in attachment
AF for the quality of the whole database:
1
Justification:
German MAK Value; see assessment report in attachment
AF for remaining uncertainties:
1
Justification:
German MAK Value; see assessment report in attachment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.51 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: German MAK Value; see assessment report in attachment
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: German MAK Value; see assessment report in attachment
AF for dose response relationship:
1
Justification:
German MAK Value; see assessment report in attachment
AF for interspecies differences (allometric scaling):
1
Justification:
German MAK Value; see assessment report in attachment
AF for other interspecies differences:
1
Justification:
German MAK Value; see assessment report in attachment
AF for intraspecies differences:
1
Justification:
German MAK Value; see assessment report in attachment
AF for the quality of the whole database:
1
Justification:
German MAK Value; see assessment report in attachment
AF for remaining uncertainties:
1
Justification:
German MAK Value; see assessment report in attachment

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.39 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
Modified dose descriptor starting point:
NOAEL
DNEL value:
39 ng/kg bw/day
Explanation for the modification of the dose descriptor starting point:
ECHA REACH Guidance, only oral values available
AF for dose response relationship:
4
Justification:
ECHA REACH Guidance; rat-human: 4,
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance; subchronic - chronic: 2
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, only relevant for inhalation
AF for other interspecies differences:
5
Justification:
ECHA REACH Guidance, worker: 5
AF for intraspecies differences:
2.5
Justification:
ECHA REACH Guidance,, default value: 2.5
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance,
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance,
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.78 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
Modified dose descriptor starting point:
NOAEL
DNEL value:
2.28 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
ECHA REACH Guidance, only oral values available
AF for dose response relationship:
4
Justification:
ECHA REACH Guidance; rat-human: 4
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, only relevant for inhalation
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance,, default value: 2.5
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance, worker: 5
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance,
AF for remaining uncertainties:
2
Justification:
factor for exposure tine, see justification

Local effects

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

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:
0.289 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:
34.382 ng/m³
Explanation for the modification of the dose descriptor starting point:
only oral study available
AF for dose response relationship:
1
Justification:
correction via route, factor 1
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance; subchronic - chronic: 2
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, Differences in species addressed in calculation of dose descriptor starting point
AF for other interspecies differences:
1
Justification:
correction via route, factor 1
AF for intraspecies differences:
2.5
Justification:
ECHA REACH Guidance, default value: 2.5
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.57 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):
12.5
Modified dose descriptor starting point:
NOAEC
DNEL value:
34.382 mg/m³
Explanation for the modification of the dose descriptor starting point:
no inhalation data available, starting point oral subchronic 2.28mg SnSO4 kg bw /day, f(oral-inhalation) 1/0.38
AF for dose response relationship:
1
Justification:
ECHA REACH Guidance; rat-human: 4
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, Differences in species addressed in calculation of dose descriptor starting point
AF for other interspecies differences:
10
Justification:
ECHA REACH Guidance, default value: 10
AF for intraspecies differences:
2.5
Justification:
ECHA REACH Guidance, default value: 2.5
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance, default value: 1
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
3.05 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: German MAK Value; see assessment report in attachment
Overall assessment factor (AF):
1
Dose descriptor:
other: German MAK Value; see assessment report in attachment
AF for dose response relationship:
1
Justification:
German MAK Value; see assessment report in attachment
AF for differences in duration of exposure:
1
Justification:
German MAK Value; see assessment report in attachment
AF for interspecies differences (allometric scaling):
1
Justification:
German MAK Value; see assessment report in attachment
AF for other interspecies differences:
1
Justification:
German MAK Value; see assessment report in attachment
AF for intraspecies differences:
1
Justification:
German MAK Value; see assessment report in attachment
AF for the quality of the whole database:
1
Justification:
German MAK Value; see assessment report in attachment
AF for remaining uncertainties:
1
Justification:
German MAK Value; see assessment report in attachment
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.05 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: German MAK Value; see assessment report in attachment
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: German MAK Value; see assessment report in attachment
AF for dose response relationship:
1
Justification:
German MAK Value; see assessment report in attachment
AF for interspecies differences (allometric scaling):
1
Justification:
German MAK Value; see assessment report in attachment
AF for other interspecies differences:
1
Justification:
German MAK Value; see assessment report in attachment
AF for intraspecies differences:
1
Justification:
German MAK Value; see assessment report in attachment
AF for the quality of the whole database:
1
Justification:
German MAK Value; see assessment report in attachment
AF for remaining uncertainties:
1
Justification:
German MAK Value; see assessment report in attachment

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.195 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
Modified dose descriptor starting point:
NOAEL
DNEL value:
39 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
ECHA REACH Guidance, only oral values available
AF for dose response relationship:
4
Justification:
ECHA REACH Guidance; rat-human: 4,
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance, subchronic - chronic 2
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, only relevant for inhalation
AF for other interspecies differences:
10
Justification:
ECHA REACH Guidance, general population: 10
AF for intraspecies differences:
2.5
Justification:
ECHA REACH Guidance,, default value: 2.5
AF for the quality of the whole database:
1
Justification:
, default value: 2.5 ECHA REACH Guidance,
AF for remaining uncertainties:
1
Justification:
, default value: 2.5 ECHA REACH Guidance,
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.39 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
Modified dose descriptor starting point:
NOAEL
DNEL value:
39 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
ECHA REACH Guidance, only oral values available
AF for dose response relationship:
4
Justification:
ECHA REACH Guidance; rat-human: 4,
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, only relevant for inhalation
AF for other interspecies differences:
10
Justification:
ECHA REACH Guidance, general population: 10
AF for intraspecies differences:
2.5
Justification:
ECHA REACH Guidance,, default value: 2.5
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance, 1
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance, 1

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.195 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
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:
39 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not relevant, oral data
AF for dose response relationship:
4
Justification:
ECHA REACH Guidance; rat-human: 4,
AF for differences in duration of exposure:
2
Justification:
ECHA REACH Guidance, subchronic - chronic 2
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, only relevant for inhalation
AF for other interspecies differences:
10
Justification:
ECHA REACH Guidance, general population: 10
AF for intraspecies differences:
2.5
Justification:
ECHA REACH Guidance,, default value: 2.5
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance,
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance,
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.39 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):
6.6
Modified dose descriptor starting point:
NOAEL
DNEL value:
2.28 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not relevant, oral data
AF for dose response relationship:
4
Justification:
ECHA REACH Guidance; rat-human: 4,
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA REACH Guidance, only relevant for inhalation
AF for other interspecies differences:
10
Justification:
ECHA REACH Guidance, general population: 10
AF for intraspecies differences:
2.5
Justification:
ECHA REACH Guidance,, default value: 2.5
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance,: efault = 1
AF for remaining uncertainties:
12
Justification:
ECHA REACH Guidance,: efault = 1

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population