Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
