Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.88 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Modified dose descriptor starting point:
LOAEC
Value:
220 mg/m³
Explanation for the modification of the dose descriptor starting point:
Transformation from oral to inhalation & Comp. for Route & Comp. for increased respiratory rate for workers
AF for dose response relationship:
3
Justification:
Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
AF for differences in duration of exposure:
1
Justification:
ECHA default (based on chronic studies)
AF for interspecies differences (allometric scaling):
2.5
Justification:
ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
AF for other interspecies differences:
1
Justification:
No indication that a factor is needed
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
No indication that a factor for quality is needed
AF for remaining uncertainties:
1
Justification:
No indication that a factor for quality is needed
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no 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:
15.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
LOAEL
Value:
2 273 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Compensation for route-to-route extrapolation: 90% oral absorption versus 10% dermal absorption are estimated.
AF for dose response relationship:
3
Justification:
Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
AF for differences in duration of exposure:
1
Justification:
ECHA default (based on chronic studies)
AF for interspecies differences (allometric scaling):
10
Justification:
ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
AF for other interspecies differences:
1
Justification:
No indication that a factor is needed
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
No indication that a factor for quality is needed
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Weight-of-Evidence for repeated dose oral toxicity was obtained from subacute and chronic toxicity studies with read-across substances Epoxidized tall-oil 2 -EH (ETP: subacute oral combined repeated dose toxicity and reproductive screening study in rats) and Epoxidized soybean oil (ESBO: chronic oral toxicity in rats and dogs). Read-across data from ESBO indicate that increased liver and kidney effects in rats (1 and 5% in the diet) and fatty infiltration in the liver of dogs (5% in the diet at 12 months) were identified after 12 and 24 months, respectively. A LOAEL of 250 mg/kg/d was identified in rats after 24 months dosing, whereas in dogs a NOAEL of 250 mg/kg/d was identified after 12 months dosing. For ETP, subacute dosing in rats did not result in any parental or reproductive changes up to 1000 mg/kg/d, therefore this dose was considered as subacute NOAEL. For PSLG-5, a chronic LOAEL of 250 mg/kg/d in rats was retained as most relevant descriptor.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.45 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
LOAEC
Value:
109 mg/m³
Explanation for the modification of the dose descriptor starting point:
Correction: 250 / (1,150 * 2) = 108,696 mg/kg bw (Transformation from oral to inhalation & Comp. for Route)
AF for dose response relationship:
3
Justification:
Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
AF for differences in duration of exposure:
1
Justification:
ECHA default (based on chronic studies)
AF for interspecies differences (allometric scaling):
2.5
Justification:
ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
AF for other interspecies differences:
1
Justification:
No indication that a factor is needed
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
No indication that a factor for quality is needed
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no 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:
7.58 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
LOAEL
Value:
2 273 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Compensation for route-to-route extrapolation: 90% oral absorption versus 10% dermal absorption are estimated.
AF for dose response relationship:
3
Justification:
Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
AF for differences in duration of exposure:
1
Justification:
ECHA default (based on chronic studies)
AF for interspecies differences (allometric scaling):
10
Justification:
ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
AF for other interspecies differences:
1
Justification:
No indication that a factor is needed
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
No indication that a factor for quality is needed
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
LOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Correction: 250 / (1) = 250 mg/kg bw (No comp. for route)
AF for dose response relationship:
3
Justification:
Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
AF for differences in duration of exposure:
1
Justification:
EECHA default (based on chronic studies)
AF for interspecies differences (allometric scaling):
10
Justification:
ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
AF for other interspecies differences:
1
Justification:
No indication that a factor is needed
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
No indication that a factor for quality is needed
AF for remaining uncertainties:
1
Justification:
No indication that a factor is needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Weight-of-Evidence for repeated dose oral toxicity was obtained from subacute and chronic toxicity studies with read-across substances Epoxidized tall-oil 2 -EH (ETP: subacute oral combined repeated dose toxicity and reproductive screening study in rats) and Epoxidized soybean oil (ESBO: chronic oral toxicity in rats and dogs). Read-across data from ESBO indicate that increased liver and kidney effects in rats (1 and 5% in the diet) and fatty infiltration in the liver of dogs (5% in the diet at 12 months) were identified after 12 and 24 months, respectively. A LOAEL of 250 mg/kg/d was identified in rats after 24 months dosing, whereas in dogs a NOAEL of 250 mg/kg/d was identified after 12 months dosing. For ETP, subacute dosing in rats did not result in any parental or reproductive changes up to 1000 mg/kg/d, therefore this dose was considered as subacute NOAEL. For PSLG-5, a chronic LOAEL of 250 mg/kg/d in rats was retained as most relevant descriptor.