Registration Dossier
Registration Dossier
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EC number: 256-260-2 | CAS number: 46235-93-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.76 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 44 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Standard guidance calculations were employed.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default; a clear dose response was observed for the key findings.
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation from a mid-term study period to a chronic study period. In the 2011 pulication of Batke et al. (2011) an analysis of the RepDose database to derive appropriate assessment factors for extrapolating a NOEL from a shorter to longer term study was presented. The study determined that in many cases the default factors proposed in the ECHA guidance document are unnecessarily conservative and that in the case of rapidly metabolised substances that do not have the potential to bioaccumulate lower factors can be used to extrapolate from shorter to longer durations. The available data for OXEMA indicates it is metabolised well and does not have the potential to bioaccumulate. Consequently a lower factor of 2 is considered appropriate for the duration extrapolation.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- route to route extrapolation addresses allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable well performed studies form the basis of the DNEL derivation
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default factor used
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default factor used
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default factor used
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default factor used
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
- Justification:
- ECHA guidance
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
There are no general population and consumer uses for the registered substance.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
