Registration Dossier
Registration Dossier
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EC number: 476-160-4 | CAS number: 54807-34-0
Toxicological Summary
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
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