Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
310 µg/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):
216
Modified dose descriptor starting point:
NOAEL
DNEL value:
67 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1.Tables R.8-3 and R.8-4, pages 30-32.
Justification:
NOAEL is used.
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic as per According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1. Table R.8-5, page 35.
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1.Tables R.8-3 and R.8-4, pages 30-32.
AF for intraspecies differences:
3
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1. Appendix R.8-3. Table R.8-19, page76-77.
AF for the quality of the whole database:
3
Justification:
Lack of long-term repeated dose 90-day study, reproductive and developmental study data and use of read-across.
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Use of read-across to fill data gaps for the subject of Registration,Neononanoic acid glycidyl ester (2,3 -epoxypropyl neonoanoate) CAS No. 144548 -01-6, from 2,3 -epoxypropyl neodecanoate (EC No. 247-979-2/CAS No. 26761-45-5/REACH Registration: 01-2119431597-33-0000) is justified in the attachment.

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

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
185 µg/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):
360
Modified dose descriptor starting point:
NOAEL
DNEL value:
67 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1.Tables R.8-3 and R.8-4, pages 30-32.
Justification:
NOAEL was used.
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic as per According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1. Table R.8-5, page 35.
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1.Tables R.8-3 and R.8-4, pages 30-32.
AF for intraspecies differences:
5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1. Appendix R.8-3. Table R.8-19, page76-77.
AF for the quality of the whole database:
3
Justification:
Lack of long-term repeated dose 90-day study, reproductive and developmental study data and use of read-across.
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
185 µg/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):
360
Modified dose descriptor starting point:
NOAEL
DNEL value:
67 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1.Tables R.8-3 and R.8-4, pages 30-32.
Justification:
NOAEL was used.
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic as per According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1. Table R.8-5, page 35.
AF for interspecies differences (allometric scaling):
4
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1.Tables R.8-3 and R.8-4, pages 30-32.
AF for intraspecies differences:
5
Justification:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Characterisation of dose [concentration]-response for human health, Section R.8.4.3.1. Appendix R.8-3. Table R.8-19, page76-77.
AF for the quality of the whole database:
3
Justification:
Lack of long-term repeated dose 90-day study, reproductive and developmental study data and use of read-across.
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Use of read-across to fill data gaps for the subject of Registration,Neononanoic acid glycidyl ester (2,3 -epoxypropyl neonoanoate) CAS No. 144548 -01-6, from 2,3 -epoxypropyl neodecanoate (EC No. 247-979-2/CAS No. 26761-45-5/REACH Registration: 01-2119431597-33-0000) is justified in the attachment.