Registration Dossier
Registration Dossier
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EC number: 271-239-8 | CAS number: 68526-91-0 A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isotridecanal from the hydroformylation of dodecene. It consists predominantly of C13-14 primary aliphatic alcohols, C22-28 dimer alcohols, C26 acetals and esters, and C>10 acid sodium salts and boils in the range of approximately 250°C to 450°C (482°F to 842°F).
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29.39 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 18
- 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:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Acute, short-term, systemic effects:
Since Oxooel 13 is of low acute toxicity with the median lethal dose values (LD50) being significantly greater than 2000 mg/kg by oral and dermal routes the dermal and inhalation DNELs derived for long-term exposure are considered sufficiently protective of acute exposure.
Acute, short-term exposure - local effects:
A LLNA indicated that Oxooel 13 is a sensitizer. But there are no reliable data (i.e. dose-relationship) available for quantitative assessment. Therefore a qualitative assessment is assumed.
Long-term exposure – systemic effects:
In a 28-day subacute toxicity study in the rat, potentially treatment-related hematologic signs of systemic toxicity were observed in male animals of the high dose group (1000 mg/kg bw/day). Based on these findings the "no observed adverse effect level" (NOAEL) for the test article is assessed to 300 mg/kg bw/day. The DNELs for inhalation and dermal long-term exposure are derived from the no observed adverse effect level obtained from this oral repeated dose toxicity study with this test item. In general, the calculation of DNEL is based on the no observed adverse effect level which has to be modified. To correct the interspecies difference between rat and human the no observed adverse effect level has to be corrected as follows:
Corrected starting point for the inhalative route for workers: = NOAEL * (1/0.38 m³/kg bw) * 6.7 m³/10 m³ (0.38 m³/kg bw: default respiratory volume for the rat corresponding to the daily duration of human exposure). For workers a correction is needed for the difference between respiratory rates under standard conditions and under conditions of light activity. Thus, the corrected starting point for workers was 528.9 mg/m³/d for inhalation. Further AFs are listed, which have to be taken into account for the final DNEL calculation: remaining differences (1), intraspecies differences: worker (3), exposure duration: subacute to chronic (6). The DNEL for long-term inhalative exposure, systemic effects is therefore considered to be 29.39 mg/m³/d.
Corrected starting point for the dermal route for workers: = NOAEL/0.5* = 600 mg/kg bw/day (an AF of 0.5 was used to consider the difference in absorption properties of gastrointestinal tract and rat skin.) Subsequently, the following assessment factors are taken into account for the final DNEL calculation of systemic dermal effects: interspecies differences: human-rat (4), remaining differences (1), intraspecies differences: worker (3), exposure duration: subacute to chronic (6). The resulting DNEL for long-term dermal systemic effects of the test item was 8.33 mg/kg bw/d for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- 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:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- 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:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Acute, short-term, systemic effects:
Since Oxooel 13 is of low acute toxicity with the median lethal dose values (LD50) being significantly greater than 2000 mg/kg by oral and dermal routes the dermal and inhalation DNELs derived for long-term exposure are considered sufficiently protective of acute exposure.
Acute, short-term exposure - local effects:
A LLNA indicated that Oxooel 13 is a sensitizer. But there are no reliable data (i.e. dose-relationship) available for quantitative assessment. Therefore a qualitative assessment is assumed.
Long-term exposure – systemic effects:
In a 28-day subacute toxicity study in the rat, potentially treatment-related hematologic signs of systemic toxicity were observed in male animals of the high dose group (1000 mg/kg bw/day). Based on these findings the "no observed adverse effect level" (NOAEL) for the test article is assessed to 300 mg/kg bw/day. The DNELs for inhalation and dermal long-term exposure are derived from the no observed adverse effect level obtained from this oral repeated dose toxicity study with this test item. In general, the calculation of DNEL is based on the no observed adverse effect level which has to be modified. To correct the interspecies difference between rat and human the no observed adverse effect level has to be corrected as follows:
Corrected starting point for the inhalative route for the general population: = NOAEC (inhalation) = NOAEL (oral) /1.15 m3/kg bw. Thus, the corrected starting point for the general population was 260.9 mg/m³/d for inhalation. Further AFs are listed, which have to be taken into account for the final DNEL calculation: remaining differences (1), intraspecies differences: general population (5), exposure duration: subacute to chronic (6).The DNEL for long-term inhalative exposure, systemic effects is therefore considered to be (260.9/30) 8.7 mg/m³/d.
Corrected starting point for the dermal route for the general population: = NOAEL/0.5* = 600 mg/kg bw/day (an AF of 0.5 was used to consider the difference in dermal absorption properties of gastrointestinal tract and rat skin.)Subsequently, the following assessment factors are taken into account for the final DNEL calculation of systemic dermal effects: interspecies differences: human-rat (4), remaining differences (1), intraspecies differences: general population (5), exposure duration: subacute to chronic (6).The resulting DNEL for long-term dermal systemic effects of the test item was 5 mg/kg bw/d for the general population.
DNEL derivation for the oral route for the general population: the following assessment factors are taken into account for the final DNEL calculation of systemic oral effects: interspecies differences: human-rat (4), remaining differences (1), intraspecies differences: general population (5), exposure duration: subacute to chronic (6).The resulting DNEL for long-term dermal systemic effects of the test item was 2.5 mg/kg bw/d for the general population.
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