Registration Dossier
Registration Dossier
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: 273-179-8 | CAS number: 68952-95-4 A complex combination of fatty acids, neutral vegetable-oil, proteins, and other minor components produced by boiling vegetable-oil soapstock with mineral acid and, optionally, further separating the oil phase acidulated soapstock from the aqueous phase.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 912.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 9 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 11 400 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Chronic and sub-chronic dietary studies were conducted in rodents with various glycerides and fatty acids which are representative of the REVODS category members and covering the fatty acid chain length of C8 to C18. In these studies, no treatment-related effects were seen in the test animals due to supplementation of the diet with these substances and consequently, the no observed effect levels for these studies were the respective highest tested dose levels. For perspective, the highest free standing NOAEL from the long term studies is 18.5% in diet from the 47-week study with coconut oil, equivalent to 9250 mg/kg bw/day (Harkins, 1968). This NOAEL is supported by free standing NOAELs from other chronic and sub-chronic studies (Morin, 1967; Nolen, 1981; Speijers, 2009; Coquet, 1977 and Manorama and Rukmini, 1991).
The tocopherols, in general, contribute less to the composition of deodorizer distillates than the phytosterols and sterol esters. The sterols and sterol esters are generally poorly absorbed from the gastro-intestinal tract and slowly absorbed through the skin. As a result, in spite of their relative greater extent of absorption through oral well as dermal routes, overall contribution of the tocopherols to the systemic dose of the deodorizer distillates could be considered to be low. On the other hand, major constituents of the deodorizer distillates are glycerides and fatty acids of C8 to C18 chain length. Systemic absorption of the shorter chain fatty acids is greater than the longer chain counterparts. Therefore, C8-C12 fatty acids could be considered to show higher degree of systemic absorption compared to the longer chains. With this in mind, coconut oil (rich in C12 and C14 fatty acids) as a representative of the constituent glycerides, C8 -18 and C18 -unsatd.’ would be appropriate and studies conducted with coconut oil as test substance can be regarded as major contributor in the evaluation of repeated dose exposure.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 300 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 9 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 64 800 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Chronic and sub-chronic dietary studies were conducted in rodents with various glycerides and fatty acids which are representative of the REVODS category members and covering the fatty acid chain length of C8 to C18. In these studies, no treatment-related effects were seen in the test animals due to supplementation of the diet with these substances and consequently, the no observed effect levels for these studies were the respective highest tested dose levels. For perspective, the highest free standing NOAEL from the long term studies is 18.5% in diet from the 47-week study with coconut oil, equivalent to 9250 mg/kg bw/day (Harkins, 1968). This NOAEL is supported by free standing NOAELs from other chronic and sub-chronic studies (Morin, 1967; Nolen, 1981; Speijers, 2009; Coquet, 1977 and Manorama and Rukmini, 1991).
The tocopherols, in general, contribute less to the composition of deodorizer distillates than the phytosterols and sterol esters. The sterols and sterol esters are generally poorly absorbed from the gastro-intestinal tract and slowly absorbed through the skin. As a result, inspite of their relative greater extent of absorption through oral well as dermal routes, overall contribution of the tocopherols to the systemic dose of the deodorizer distillates could be considered to be low. On the other hand, major constituents of the deodorizer distillates are glycerides and fatty acids of C8 to C18 chain length. Systemic absorption of the shorter chain fatty acids is greater than the longer chain counterparts. Therefore, C8-C12 fatty acids could be considered to show higher degree of systemic absorption compared to the longer chains. With this in mind, coconut oil (rich in C12 and C14 fatty acids) as a representative of the constituent glycerides, C8 -18 and C18 -unsatd.’ would be appropriate and studies conducted with coconut oil as test substance can be regarded as major contributor in the evaluation of repeated dose exposure.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- Not required additionally
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 136.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 9 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3 420 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Chronic and sub-chronic dietary studies were conducted in rodents with various glycerides and fatty acids which are representative of the REVODS category members and covering the fatty acid chain length of C8 to C18. In these studies, no treatment-related effects were seen in the test animals due to supplementation of the diet with these substances and consequently, the no observed effect levels for these studies were the respective highest tested dose levels. For perspective, the highest free standing NOAEL from the long term studies is 18.5% in diet from the 47-week study with coconut oil, equivalent to 9250 mg/kg bw/day (Harkins, 1968). This NOAEL is supported by free standing NOAELs from other chronic and sub-chronic studies (Morin, 1967; Nolen, 1981; Speijers, 2009; Coquet, 1977 and Manorama and Rukmini, 1991).
The tocopherols, in general, contribute less to the composition of deodorizer distillates than the phytosterols and sterol esters. The sterols and sterol esters are generally poorly absorbed from the gastro-intestinal tract and slowly absorbed through the skin. As a result, in spite of their relative greater extent of absorption through oral well as dermal routes, overall contribution of the tocopherols to the systemic dose of the deodorizer distillates could be considered to be low. On the other hand, major constituents of the deodorizer distillates are glycerides and fatty acids of C8 to C18 chain length. Systemic absorption of the shorter chain fatty acids is greater than the longer chain counterparts. Therefore, C8-C12 fatty acids could be considered to show higher degree of systemic absorption compared to the longer chains. With this in mind, coconut oil (rich in C12 and C14 fatty acids) as a representative of the constituent glycerides, C8 -18 and C18 -unsatd.’ would be appropriate and studies conducted with coconut oil as test substance can be regarded as major contributor in the evaluation of repeated dose exposure.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- Not required additionally, considering that the POD is a very conservative ADI
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 462.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 9 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 46 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Chronic and sub-chronic dietary studies were conducted in rodents with various glycerides and fatty acids which are representative of the REVODS category members and covering the fatty acid chain length of C8 to C18. In these studies, no treatment-related effects were seen in the test animals due to supplementation of the diet with these substances and consequently, the no observed effect levels for these studies were the respective highest tested dose levels. For perspective, the highest free standing NOAEL from the long term studies is 18.5% in diet from the 47-week study with coconut oil, equivalent to 9250 mg/kg bw/day (Harkins, 1968). This NOAEL is supported by free standing NOAELs from other chronic and sub-chronic studies (Morin, 1967; Nolen, 1981; Speijers, 2009; Coquet, 1977 and Manorama and Rukmini, 1991).
The tocopherols, in general, contribute less to the composition of deodorizer distillates than the phytosterols and sterol esters. The sterols and sterol esters are generally poorly absorbed from the gastro-intestinal tract and slowly absorbed through the skin. As a result, in spite of their relative greater extent of absorption through oral well as dermal routes, overall contribution of the tocopherols to the systemic dose of the deodorizer distillates could be considered to be low. On the other hand, major constituents of the deodorizer distillates are glycerides and fatty acids of C8 to C18 chain length. Systemic absorption of the shorter chain fatty acids is greater than the longer chain counterparts. Therefore, C8-C12 fatty acids could be considered to show higher degree of systemic absorption compared to the longer chains. With this in mind, coconut oil (rich in C12 and C14 fatty acids) as a representative of the constituent glycerides, C8 -18 and C18 -unsatd.’ would be appropriate and studies conducted with coconut oil as test substance can be regarded as major contributor in the evaluation of repeated dose exposure.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- Not required additionally
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 92.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 9 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 9 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Chronic and sub-chronic dietary studies were conducted in rodents with various glycerides and fatty acids which are representative of the REVODS category members and covering the fatty acid chain length of C8 to C18. In these studies, no treatment-related effects were seen in the test animals due to supplementation of the diet with these substances and consequently, the no observed effect levels for these studies were the respective highest tested dose levels. For perspective, the highest free standing NOAEL from the long term studies is 18.5% in diet from the 47-week study with coconut oil, equivalent to 9250 mg/kg bw/day (Harkins, 1968). This NOAEL is supported by free standing NOAELs from other chronic and sub-chronic studies (Morin, 1967; Nolen, 1981; Speijers, 2009; Coquet, 1977 and Manorama and Rukmini, 1991).
The tocopherols, in general, contribute less to the composition of deodorizer distillates than the phytosterols and sterol esters. The sterols and sterol esters are generally poorly absorbed from the gastro-intestinal tract and slowly absorbed through the skin. As a result, in spite of their relative greater extent of absorption through oral well as dermal routes, overall contribution of the tocopherols to the systemic dose of the deodorizer distillates could be considered to be low. On the other hand, major constituents of the deodorizer distillates are glycerides and fatty acids of C8 to C18 chain length. Systemic absorption of the shorter chain fatty acids is greater than the longer chain counterparts. Therefore, C8-C12 fatty acids could be considered to show higher degree of systemic absorption compared to the longer chains. With this in mind, coconut oil (rich in C12 and C14 fatty acids) as a representative of the constituent glycerides, C8 -18 and C18 -unsatd.’ would be appropriate and studies conducted with coconut oil as test substance can be regarded as major contributor in the evaluation of repeated dose exposure.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 1
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- AF for remaining uncertainties:
- 1
- Justification:
- Not required additionally
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
See the discussion under worker DNEL.
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.
