Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
60 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
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
60 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.9 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
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL

Workers - Hazard for the eyes

Additional information - workers

The values above were calculated based on the read-across data generated from the analogue substance 5,5 -dimethylhydantoin (DMH). Considering that oral and dermal exposure to DMH does not produce any toxic effects, time scaling for adjustment to the substance

5,5 -dimethylhydantoin, sodium salt (NaDMH) was considered to be unnecessary, therefore these results can be seen to be relevant to the registration substance NaDMH.

Workers:

Dermal exposure (workers):

The starting value is the NOAEL derived from the 90 day dermal study. The NOAEL was 390 mg/kg.

The assessment factor is calculated as follows:

Interspecies: 2.5

Allometric scaling: 4.0

Intraspecies factor for workers: 5

Exposure duration (subchronic-chronic): 2

Total assessment factor: 100

Inhalation exposure (workers):

The starting value is the NOEL derived from the chronic dog study. NOEL was 300 mg/kg. To convert this into a NAEC for workers the following calculation is applied:

300/1.4 x 70/10m3 = 1500 (NAEC worker 8 h)

Interspecies factor: 2.5

Intraspecies factor for workers: 5

AF of 2 for route to route extrapolation from oral to inhalation

Total assessment factor: 25

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15 mg/m³
DNEL related information
Overall assessment factor (AF):
50
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15 mg/m³
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.95 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.95 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.57 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
35
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.57 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
35
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

As with the previous results, the values above were calculated based on the read-across data generated from the analogue substance 5,5 -dimethylhydantoin (DMH). Considering that oral and dermal exposure to DMH does not produce any toxic effects, time scaling for adjustment to the substance 5,5 -dimethylhydantoin, sodium salt (NaDMH) was considered to be unnecessary, therefore these results can be seen to be relevant to the registration substance NaDMH.

Oral exposure (general population):

The starting value is the NOAEL derived from the chronic oral study. The NOAEL was 300 mg/kg.

The assessment factor is calculated as follows:

Interspecies factor: 2.5

Allometric scaling: 1.4

Intraspecies factor for general population: 10

Total assessment factor: 35

Dermal exposure (general population):

The starting value is the NOAEL derived from the 90 day dermal study. The NOAEL was 390 mg/kg.

The assessment factor is calculated as follows:

Interspecies factor: 2.5

Allometric scaling: 4.0

Intraspecies factor for general population: 10

Exposure duration (subchronic - chronic): 2

Total assessment factor: 200

Inhalation exposure (general population):

The starting value is the NOEL derived from the chronic dog study. NOEL was 300 mg/kg.

To convert this into a NAEC for workers the following calculation is applied:

300/1.4 x 70/20m3 = 750 (NAEC general population 24 h)

Interspecies factor: 2.5

Intraspecies factor for general population: 10

AF of 2 for route extrapolation from oral to inhalation

Total assessment factor: 50