Registration Dossier
Registration Dossier
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Reaction product of Crude sludge and Calcium oxide. Crude sludge is the mixture of by-products of petroleum hydrocarbons refining (especially Total petroleum hydrocarbons, Polycyclic aromatic hydrocarbons, acid-refined heavy petroleum distillates). The Crude sludge is neutralised by calcium oxide in the ratio 80:20. The maturing process proceeds under ambient conditions and takes for at least 3 days. Subsequently, the reaction product is processed mechanically.
EC number: 930-592-4 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.82 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
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:
- 0.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Based on data available, DNELs for repeated dose toxicity (based on kidney and liver toxicity and haematological alteration) and reproductive toxicity (based on the fertility impairment as the sensitive endpoint) were calculated.
Despite the fact that DNELs calculated from reproductive toxicity screening study dose descriptors were lower than DNELs derived from repeated dose toxicity study, limit values based on repeated dose toxicity study were chosen as critical DNELs. This decision was based on the fact that uncertainty in the extrapolation of experimental data to the real human exposure situation – expressed in the form of assessment factors – from repeated dose toxicity study was much lower, if compared to uncertainty from reproductive toxicity screening study.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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
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:
- 0.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 400
- 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:
- 0.8 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Based on data available, DNELs for repeated dose toxicity (based on kidney and liver toxicity and haematological alteration) and reproductive toxicity (based on the fertility impairment as the sensitive endpoint) were calculated.
Despite the fact that DNELs calculated from reproductive toxicity screening study dose descriptors were lower than DNELs derived from repeated dose toxicity study, limit values based on repeated dose toxicity study were chosen as critical DNELs. This decision was based on the fact that uncertainty in the extrapolation of experimental data to the real human exposure situation – expressed in the form of assessment factors – from repeated dose toxicity study was much lower, if compared to uncertainty from reproductive toxicity screening study.
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