Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.7 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):
18
Modified dose descriptor starting point:
NOAEC
DNEL value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response forhuman health, Modification of the starting point, Figure R.8-3, page 27.
Justification:
Dose starting point is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Table R. 8-5, page 35.
AF for intraspecies differences:
3
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Appendix R.8-3, Table R.8-19, page77.
AF for the quality of the whole database:
3
Justification:
Due to lack of reproductive study data.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
240 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
3
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
240 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
3
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.2 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):
72
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Section R.8.4.3.1. pages 30-32, Tables R.8-3 & R.8-4.
Justification:
Not applicable, starting concentration is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Table R.8-5, page 35
AF for interspecies differences (allometric scaling):
4
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Table R.8-3 for the rat.
Justification:
.Allometric scalling was employeed.
AF for intraspecies differences:
3
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Appendix R.8-3, Table R.8-19, page 77.
AF for the quality of the whole database:
3
Justification:
Due to lack of reproductive study data.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.2 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):
72
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Section R.8.4.3.1. pages 30-32, Tables R.8-
Justification:
Not applicable, starting concentration is a NOAEL.
AF for interspecies differences (allometric scaling):
4
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Table R.8-3 for the rat.
AF for other interspecies differences:
3
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Appendix R.8-3, Table R.8-19, page 77.
Justification:
Allometric scalling was employeed.
AF for the quality of the whole database:
3
Justification:
Due to lack of reproductive study data.

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:
low hazard (no threshold derived)

Additional information - workers

The rat GLP, O.E.C.D. Testing Guideline 408 oral 90-Day Subchronic Toxicity study is most appropriate for the establishment of both Inhalation and dermal long-term systemic Worker DNELs. The NOAEL for this study was 300 mg/kg/day. E.C.H.A. R.I.P. 3.2 Chapter R.8: "Characterization of dose [concentration]-response for human health" guidance was followed in the establishment of the Worker DNELs. Where appropriate Allometric Scaling was applied to estimate the DNEL. There were no "local" adverse effects identified in laboratory animals upon which "Local" DNELs could be based.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.8 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):
30
Modified dose descriptor starting point:
NOAEC
DNEL value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Section 8.4.2. Figure R.8-3, page 27.
Justification:
Not apllicable, starting point is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Table R. 8-5, page 35.
Justification:
SEE, Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Section 8.4.2. Figure R.8-3, page 27.
AF for intraspecies differences:
5
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Appendix R.8-3, Table R.8-19, page77.
AF for the quality of the whole database:
3
Justification:
Due to lack of reproductive study data.
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:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
DNEL value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Section R.8.4.3.1. pages 30-32, Tables R.8-3 & R.8-4.
Justification:
Not applicable, starting point is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Table R.8-5, page 35
AF for interspecies differences (allometric scaling):
4
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Table R.8-3 for the rat.
Justification:
Allometric scalling was employeed.
AF for intraspecies differences:
5
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Appendix R.8-3, Table R.8-19, page 77.
AF for the quality of the whole database:
3
Justification:
Due to lack of reproductive study data.
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:
2.5 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):
120
Modified dose descriptor starting point:
NOAEL
DNEL value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Section R.8.4.3.1. pages 30-32, Tables R.8-3 & R.8-4.
Justification:
Not applicable, starting point is a NOAEL.
AF for differences in duration of exposure:
2
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Table R.8-5, page 35
AF for interspecies differences (allometric scaling):
4
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Table R.8-3 for the rat.
Justification:
Allometric scalling was employeed.
AF for intraspecies differences:
5
Justification:
Based on E.C.H.A. “Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterization of dose [concentration]-response for human health, Appendix R.8-3, Table R.8-19, page 77.
AF for the quality of the whole database:
3
Justification:
Due to lack of reproductive study data.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

There were no "local" hazards observed for vinyl neononanoate in laboratory animal studies upon which to base "Local" DNELs.

The rat oral GLP, O.E.C.D. Testing Guideline 408 90-Day Subchronic Toxicity study is most appropriate for the establishment of both Inhalation, oral and dermal long-term systemic General Population DNELs. The NOAEL for this study was 300 mg/kg/day. E.C.H.A. R.I.P. 3.2 Chapter R.8: "Characterization of dose [concentration]-response for human health" guidance was followed in the establishment of the General Population DNELs. Allometric Scaling was applied to estimate the oral and dermal long-term systemic DNELs. General Population short-term DNELs are not required as per E.C.H.A. guidance. Short-Term exposure limits are generally only set to protect the work force (SEE E.C.H.A. Guidance Chapter R.8. Section R.8.1.2.5. page 16.).