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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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