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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.12 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Additional information - workers

Starting point: NOAEL 256 mg/kg bw/day from a chronic oral study in rats with ammonium sulfate.

Route-to-route extrapolation

For the derivation of the DNELs:

Long-term – dermal, systemic effects

Long-term – inhalation, systemic effects

Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).

Absorption oral (rat) = Absorption oral (human) = 50%

Absorption dermal (human) = 50%

Absorption inhalation (human) = 50%

 

The DNELs for human exposure are derived according to the method proposed in the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.

Dermal DNEL

Route-to-route extrapolation:

Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 256 * 50/50 = 256 mg/kg bw

-   Assessment factors:

   Interspecies differences (mainly toxicokinetic): 4 (default value for rats)

   Remaining interspecies differences (mainly toxicodynamic): 2.5 (default value)

   Intraspecies differences: 5 (default value for workers)

   Differences in duration of exposure: 1 (chronic animal data)

   Issues related to severity and dose-response: 1 (because of the use of NOAEL as a starting point)

   Quality of whole database: 1 (reliability 1 study)  

Global assessment factor (workers) = 4 x 2.5 x 5 x 1 x 1 x 1 = 50

Based on the above, the long-term DNEL for systemic effects after dermal worker exposure is set at 5.12 mg/kg bw/day.

Inhalation DNEL

Route-to-route extrapolation:

Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 256 * 50/50 = 256 mg/kg bw

Corrected inhalatory NOAEC = 256 * 1/0.38 * 6.7 m3/10 m3= 451 mg/m3

-   Assessment factors:

   Interspecies differences (mainly toxicokinetic): 4 (default value for rats)

   Remaining interspecies differences (mainly toxicodynamic): 2.5 (default value)

   Intraspecies differences: 5 (default value for workers)

   Differences in duration of exposure: 1 (chronic animal data)

   Issues related to severity and dose-response: 1 (because of the use of NOAEL as a starting point)

   Quality of whole database: 1 (reliability 1 study)

 

Global assessment factor (workers) = 4 x 2.5 x 10 x 1 x 1 x 1 = 100

Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the worker, is set at 9 mg/m3.

General Population - 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
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.56 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.56 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Starting point: NOAEL 256 mg/kg bw/day from a chronic oral study in rats with ammonium sulfate.

Route-to-route extrapolation

For the derivation of the DNELs:

Long-term – dermal, systemic effects

Long-term – inhalation, systemic effects

Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).

Absorption oral (rat) = Absorption oral (human) = 50%

Absorption dermal (human) = 50%

Absorption inhalation (human) = 50%

 

The DNELs for human exposure are derived according to the method proposed in the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.

Oral DNEL

-   Assessment factors:

   Interspecies differences (mainly toxicokinetic): 4 (default value for rats)

   Remaining interspecies differences (mainly toxicodynamic): 2.5 (default value)

   Intraspecies differences: 10 (default value for general population)

   Differences in duration of exposure: 1 (chronic animal data)

   Issues related to severity and dose-response: 1 (because of the use of NOAEL as a starting point)

   Quality of whole database: 1 (reliability 1 study)

Global assessment factor (workers) = 4 x 2.5 x10x 1 x 1 x 1 = 100 

Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population, is set at 2.56 mg/kg bw/d.

Dermal DNEL

Route-to-route extrapolation:

Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 256 * 50/50 = 256 mg/kg bw

-   Assessment factors:

   Interspecies differences (mainly toxicokinetic): 4 (default value for rats)

   Remaining interspecies differences (mainly toxicodynamic): 2.5 (default value)

   Intraspecies differences: 10 (default value for general population)

   Differences in duration of exposure: 1 (chronic animal data)

   Issues related to severity and dose-response: 1 (because of the use of NOAEL as a starting point)

   Quality of whole database: 1 (reliability 1 study)

Global assessment factor (workers) = 4 x 2.5 x 10 x 1 x 1 x 1 = 100 

Based on the above, the long-term DNEL for systemic effects after dermal exposure of the general population, is set at 2.56 mg/kg bw/d.

Inhalation DNEL

Route-to-route extrapolation:

Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 256 * 50/50 = 256 mg/kg bw

Corrected inhalatory NOAEC = 256 * 1/1.15 = 223 mg/m3

-   Assessment factors:

   Interspecies differences (mainly toxicokinetic): 4 (default value for rats)

   Remaining interspecies differences (mainly toxicodynamic): 2.5 (default value)

   Intraspecies differences: 10 (default value for general population)

   Differences in duration of exposure: 1 (chronic animal data)

   Issues related to severity and dose-response: 1 (because of the use of NOAEL as a starting point)

   Quality of whole database: 1 (reliability 1 study)

Global assessment factor (workers) = 4 x 2.5 x10x 1 x 1 x 1 = 100 

Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the general population is set at 2.23 mg/m3.