Registration Dossier
Registration Dossier
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EC number: 286-490-9 | CAS number: 85251-77-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 125.04 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 25
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:
- 17.73 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 100
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
The long-term DNELs are based on a 90 -day oral feeding study performed in F344/N rats with Castor oil (CAS-No. 8001 -79 -4) as a Read Across substance. The NOAEL in this study was found to be 5000 mg/kg bw/d (highest dose tested).
The molecular weight of Castor oil (CAS 8001 -79 -4) is 933.43.
The molecular weight range of Mono- and diglycerides of fatty acids (Glycerides, C16-18 mono- and di-, CAS 85251 -77 -0) is 330.51 - 625.03. Using the smallest MW of 330.51 as worst case a molar ratio factor of 2.82 (933.43/330.51) was used to assume a NOAEL of 1773 mg/kg bw/d for Glycerides, C16-18 mono- and di-.
Therefore the corrected NOAEL of 1773 mg/kg bw/d was used for DNEL calculations.
Assessment factors were used as follows according to the "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose[concentration]-response for human health", ECHA, May 2008. The NAEC was determined by calculating from oral exposure to 8 hours inhalation exposure by factor 0.38 and allometric scaling from rat to human worker by factor 0.67.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30.83 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 50
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:
- 8.86 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 200
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:
- 8.86 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 200
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
For details on NOAEL and DNEL calculations see explanations above.
Assessment factors were used as follows according to the "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose[concentration]-response for human health", ECHA, May 2008. The NAEC was determined by calculating from oral exposure to 8h inhalation and allometric scaling from rat to human worker by factor 1.15.
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