Registration Dossier
Registration Dossier
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EC number: 940-029-4 | CAS number: 1474044-86-4
Toxicological Summary
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.
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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