Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.76 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
132.24 mg/m³
Explanation for the modification of the dose descriptor starting point:
The results of the oral combined repeated toxicity/reproscreening study with Standolized Linseed Oil are read across to Standolized Soybean Oil. The oral NOAEL for developmental toxicity of 150 mg/kg was used to base the inhalation DNEL on. Route-to-route extrapolation is applied in accordance with the ECHA REACH Guidance on Information Requirements R.8 by dividing by the 8-hr respiratory volume of the rat (0.38 m3/kg bw), and corrected for light activity of the worker (6.7 m3/ 10 m3). The derived concentration is corrected for differences in oral and inhalation absorption with a default factor of 2, in accordance with the ECHA REACH Guidance, arriving at a NOAEC worker of 132.24 mg/m3.
AF for dose response relationship:
1
Justification:
Default assessment factor as a NOAEL is used
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for duration of exposure (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Not necessary as allometric scaling is taken into account in the route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for other interspecies differences
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies differences workers
AF for the quality of the whole database:
1
Justification:
Study was a reliable OECD 421 study under GLP-conditions with structural similar substance Standolized Linseed OIl. It is not deemed necessary to apply an extra assessment factor for read across purposes as due to higher level of polyunsaturated fatty acid chains, Standolized Linseed Oil presents the worst case scenario in terms of toxicology.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties were identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - 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:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The results of the oral combined repeated toxicity/reproscreening study with Standolized Linseed Oil are read across to Standolized Soybean Oil. The oral NOAEL for developmental toxicity of 150 mg/kg was used to base the dermal DNEL on. Route-to-route extrapolation is applied in accordance with the ECHA REACH Guidance on Information Requirements R.8 by correcting for 10% dermal absorption
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for duration of exposure (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor for allometric scaling (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for other interspecies differences
AF for intraspecies differences:
5
Justification:
Default assessment factor for intraspecies differences workers
AF for the quality of the whole database:
1
Justification:
Study was a reliable OECD 421 study under GLP-conditions with structural similar substance Standolized Linseed OIl. It is not deemed necessary to apply an extra assessment factor for read across purposes as due to higher level of polyunsaturated fatty acid chains, Standolized Linseed Oil presents the worst case scenario in terms of toxicology.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties were identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.43 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
65.22 mg/m³
Explanation for the modification of the dose descriptor starting point:
The results of the oral combined repeated toxicity/reproscreening study with Standolized Linseed Oil are read across to Standolized Soybean Oil. The oral NOAEL for developmental toxicity of 150 mg/kg was used to base the inhalation DNEL on. Route-to-route extrapolation is applied in accordance with ECHA’s Guidance R.8 (November, 2012). In the route to route extrapolation via the inhalation route a correction for respiratory volume is applied by using 1.15 m3/kg bw (ECHA’s guidance R.8, November, 2012). The derived concentration is corrected for differences in oral and inhalation absorption with a default factor of 2, in accordance with the ECHA REACH Guidance, arriving at a NOAEC general population of 65.22 mg/m3.
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for duration of exposure (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
Not necessary as allometric scaling is taken into account in the route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for other interspecies differences
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies differences general population
AF for the quality of the whole database:
1
Justification:
Study was a reliable OECD 421 study under GLP-conditions with structural similar substance Standolized Linseed OIl. It is not deemed necessary to apply an extra assessment factor for read across purposes as due to higher level of polyunsaturated fatty acid chains, Standolized Linseed Oil presents the worst case scenario in terms of toxicology.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties were identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The results of the oral combined repeated toxicity/reproscreening study with Standolized Linseed Oil are read across to Standolized Soybean Oil. The oral NOAEL for developmental toxicity of 150 mg/kg was used to base the dermal DNEL on. Route-to-route extrapolation is applied in accordance with the ECHA REACH Guidance on Information Requirements R.8 by correcting for 10% dermal absorption
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for duration of exposure (sub-acute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor for interspecies differences (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for other interspecies differences
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies differences general population
AF for the quality of the whole database:
1
Justification:
Study was a reliable OECD 421 study under GLP-conditions with structural similar substance Standolized Linseed OIl. It is not deemed necessary to apply an extra assessment factor for read across purposes as due to higher level of polyunsaturated fatty acid chains, Standolized Linseed Oil presents the worst case scenario in terms of toxicology.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties were identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
0.25 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable, route of original study is oral.
AF for dose response relationship:
1
Justification:
Default assessment factor for dose response relationship
AF for differences in duration of exposure:
6
Justification:
Default assessment factor for duration of exposure (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor for interspecies differences (rat to human)
AF for other interspecies differences:
2.5
Justification:
Default assessment factor for other interspecies differences
AF for intraspecies differences:
10
Justification:
Default assessment factor for intraspecies differences (general population)
AF for the quality of the whole database:
1
Justification:
Study was a reliable OECD 421 study under GLP-conditions with structural similar substance Standolized Linseed OIl. It is not deemed necessary to apply an extra assessment factor for read across purposes as due to higher level of polyunsaturated fatty acid chains, Standolized Linseed Oil presents the worst case scenario in terms of toxicology.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties were identified
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