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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 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
Value:
30 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:
2.01 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
Value:
30.427 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:
DMEL (Derived Minimum Effect Level)
Value:
12 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:
12.84 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:
0.34 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
Value:
34 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:
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:
0.69 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
Value:
2 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:
DMEL (Derived Minimum Effect Level)
Value:
0.256 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
Value:
30.427 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:
0.5 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
Value:
30.427 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:
2 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:
2 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:
0.172 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
Value:
34.51 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:
0.35 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
Value:
34.51 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:
0.172 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
Value:
34.51 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:
34.51 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
Value:
2.11 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