Registration Dossier
Registration Dossier
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EC number: 265-314-4 | CAS number: 65036-46-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16.4 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Value:
- 1 230 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL is derived based on an OECD 422 study in rats via the oral route using default assessment factors.
- AF for dose response relationship:
- 1
- Justification:
- Default AF used in the absence of effects
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Covered by route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value sufficient
- AF for intraspecies differences:
- 5
- Justification:
- Default value sufficient
- AF for the quality of the whole database:
- 1
- Justification:
- No additional AF necessary as the OECD 422 study used is of good quality and applicability
- AF for remaining uncertainties:
- 1
- Justification:
- No further AF required.
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.67 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The OECD 422 study is of good quality and applicability and no uncertainties are foreseen.
- AF for dose response relationship:
- 1
- Justification:
- Default AF- no uncertainties related to reliability for dose response.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for interspecies fifferences
- AF for intraspecies differences:
- 5
- Justification:
- Default for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- No gaps in the database
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No DNEL is derived as no hazards to the skin or eye were identified nor effects seen via the dermal route and there are no acute effects seen via the oral route.
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:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Value:
- 435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default modification factor used for the corresponding air concentration.
- AF for dose response relationship:
- 1
- Justification:
- No uncertainties exist regarding the dose response relationship.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default value, covered by route to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- No additional AF necessary for the quality of the database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties requiring additional AFs necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No studies via inhalation exposure are available. The substance is not classified for acute oral toxicity and so no acute effects via inhalation exposure are expected.
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:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default AF used, no uncertainties regarding dose response relationship.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rat to human scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default AF, no additional uncertainties regarding the database
- AF for remaining uncertainties:
- 1
- Justification:
- No further AF required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is not classified for local effects.
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:
- 1.67 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default- no additional uncertainties
- AF for differences in duration of exposure:
- 6
- Justification:
- Default for subacute to chronic exposure extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for rat to human scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default- no additional uncertainties related to the quality of the database
- AF for remaining uncertainties:
- 1
- Justification:
- No additional AFs necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
References:
ECHA (2012). Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterization of dose [concentration]-response for human health. Version 2.1, November 2012
ECHA (2016). Guidance on information requirements and chemical
safety assessment. Part E: Risk Characterization, Version 3.0, May 2016
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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