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Diss Factsheets
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EC number: 941-396-3 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard 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:
- 16.667 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- AF for differences in duration of exposure:
- 6
- Justification:
- Default value according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Default value according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for other interspecies differences:
- 4
- Justification:
- Default value according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for intraspecies differences:
- 5
- Justification:
- Default value according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health)
- AF for remaining uncertainties:
- 2
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 48.41 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 90
- Dose descriptor:
- other: EC3
- AF for dose response relationship:
- 3
- Justification:
- Default value according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for differences in duration of exposure:
- 1
- Justification:
- Default value according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for other interspecies differences:
- 10
- Justification:
- Default value according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health
- AF for remaining uncertainties:
- 3
- Justification:
- AF for matrix effects, according to Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
No adverse effects up to the highest dose tested have been found in any available study on repeated-dose toxicity or toxicity on reproduction/developmental toxicity used for assessment to High oleic sunflower oil, maleated. As all used limit doses in the studies were all >1000 mg/kg bw/day, the statement “no hazard identified” is applicable a derivation of DNEL for acute and long-term systemic effect via inhalation route is not required in accordance with ECHA Practical Guide 14.
However, High oleic sunflower oil, maleated was found to be sensitizing to skin as it showed positive results in a local lymph node assay perfumed according to OECD 429.
Therefore the DNEL for dermal long-term systemic effects is derived in addition to the DNEL for dermal local effects to cover the overall toxicological effects of sensitizing.
Acute toxicity
ECHA Guidance R.8 (Chapter R.8.1.2.5) indicates that DNELs for acute toxicity are not required if no acute toxicity hazard leading to classification has been identified. The substance High oleic sunflower oil, maleated was not found to be acutely harmful while a low vapour pressure precludes inhalation exposure indicating a low of concern for this route of exposure. No DNELs for acute toxicity are therefore necessary.
Repeated dose toxicity
No adverse effects up to the highest dose tested have been found in any available study on repeated-dose toxicity or toxicity on reproduction/developmental toxicity used for assessment to High oleic sunflower oil, maleated. As all used limit doses in the studies were all >1000 mg/kg bw/day, the statement “no hazard identified” is applicable a derivation of DNEL for acute and long-term systemic effect via inhalation route is not required in accordance with ECHA Practical Guide 14.
However, High oleic sunflower oil, maleated was found to be sensitizing to skin as it showed positive results in a local lymph node assay perfumed according to OECD 429.
Dermal
The NOAEL for oral repeated dose toxicity of was found to be 1000 mg/kg bw/d. and used for the purposes of DNEL derivation for the dermal route.
Based on the toxicokinetic profile the dermal absorption can be regarded as low (10%).
Additional assessment factors (AF) are applied to derive the DNEL. The AFs were based on the procedures described ECHA Guidance R.8
Long-term DNEL Assessment Factors (Dermal) |
|
Assessment Factor |
Worker |
Differences in metabolic rate per b. w. (allometric scaling) |
2.5 |
Interspecies remaining differences (toxicodynamic and toxicokinetic) |
4 |
Intraspecies differences |
5 |
Duration extrapolation (sub-acute/sub-chronic/chronic) |
6 (subchronic) |
Issues related to dose-response |
2 |
Quality of whole database |
1 |
Overall AF |
600 |
Sensitisation
The sensitisation potential of the High oleic sunflower oil, maleated was found to be sensitizing to skin as it showed positive results in a local lymph node assay perfumed according to OECD 429.
ECHA Guidance R.8, Appendix R.8-10, (ECHA, 2010) states that skin sensitisation is generally regarded as a threshold effect and thus it may be very difficult to derive a threshold and to set a DNEL. The general approach for sensitizers therefore involves a qualitative approach where a DNEL is used to judge any remaining/residual risks after the implementation of appropriate risk management measures (RMM) and occupational controls (OC).
The extent of the RMM and OC required is dependent on the intrinsic sensitising potency of the substance.
For results obtained using the LLNA, intrinsic sensitising potency is based on the EC3 and defined (ECHA (2010), Appendix R.8-10) as follows:
Category |
EC3 (%) |
Extreme |
<0.2% |
Strong |
>0.2 - <2 |
Moderate |
>2 |
Based on the derived EC3 value of 17.43% the substance High oleic sunflower oil, maleated is regarded to have moderate potential to cause skin sensitisation.
Derivation of a DNEL for sensitisation
ECHA Guidance R.8, Appendix R.8-10 (ECHA, 2010), indicates that the EC3 concentration from a LLNA test can be taken as a LOAEL for the induction of skin sensitisation (ECHA, 2010) after conversion into an equivalent dose per unit area of skin (ug/cm2). Assuming (i) a dose volume of 25 μl (according to the standard LLNA protocol); (ii) an estimated treatment area of 1 cm² for the mouse ear; and (iii) an assumed density of 1, the conversion is performed as follows: EC3[%]*250 [ug/cm²/% ] = EC3[ug/cm²]
The equivalent EC3 [ug/cm²] is therefore: 17.43%*250 = 4357.5 ug/cm²
The EC3 of 4357.5 ug/cm² is used to assess the magnitude of any remaining/residual risks after the use of RMMs and OCs recommended in the Qualitative Risk Assessment.
Additional assessment factors (AF) are applied to derive the DNEL. The AFs were based on the procedures described ECHA Guidance R.8.
Sensitisation DNEL Assessment Factors |
|
Assessment Factor |
Value |
Matrix effects |
3 |
Inerspecies differences |
10 |
Issues related to dose-response |
2 |
Overall AF |
60 |
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
As no consumer application is foreseen, exposure assessment for the general population are not relevant.
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.
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