Registration Dossier
Registration Dossier
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EC number: 407-330-8 | CAS number: 61571-06-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.526 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
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:
- 1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
In general, the calculation of DNEL is based on the observed effect level which has to be modified as described in RIP.8 (ECHA, May 2008). To correct the interspecies difference between rat and human the observed effect level has to be corrected by the risk assessors 0.38 mg/m3and 6.7 m3/10 m3regarding breathing volume and frequency. Thus, the corrected starting point for workers was 264 mg/m3for inhalation. Subsequently other assessment factors are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (5), exposure duration (6). The DNEL is calculated according the formula DNEL = (corrected starting point)/(overall AF) as stated in RIP.8 (ECHA, May 2008). For systemic oral effects, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), intraspecies differences (5), exposure duration (6). An additional assessment factor (0.5) was used to consider the difference in dermal absorption properties of human and rat skin. The resulting DNEL for long-term dermal systemic effects of the test substance was 1.0 mg/kg bw for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.87 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
Acute/short term exposure
DNEL related information
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:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
In general, the calculation of DNEL based on the observed effect level which has to be modified as described in RIP.8 (ECHA, May 2008). To correct the interspecies difference between rat and human the observed effect level has to be corrected by the risk assessors 1.15 m3regarding breathing volume and frequency. Thus, the corrected starting point for the general population was 130 mg/m3for inhalation. Subsequently other assessment factors are listed, which have to be taken into account for the final DNEL calculation: remaining interspecies-differences (2.5), intraspecies differences (5), exposure duration (6). The DNEL is calculated according the formula DNEL = (corrected starting point)/(overall AF) as stated in RIP.8 (ECHA, May 2008). Thus, the resulting DNEL for long-term inhalative systemic effects of the test substance is 0.87 mg/m3for the general population. For systemic oral effects, following assessment factors are taken into account for the final DNEL calculation: interspecies differences (4), intraspecies differences (10), exposure duration (6). The resulting DNEL for long-term oral systemic effects of the test substance is 0.25 mg/kg bw for the general population. An additional assessment factor (0.5) was used to consider the difference in dermal absorption properties of human and rat skin. The resulting DNEL for long-term dermal systemic effects of the test substance is 0.50 mg/kg bw for the general population.
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