Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
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
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
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.