Registration Dossier
Registration Dossier
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EC number: 254-996-9 | CAS number: 40601-76-1
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 70.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Based on Guidance Document, Chapter R.8, Appendix R.8-2. A 10% absorption via oral vs. inhalation was assumed
- AF for dose response relationship:
- 1
- Justification:
- Clear NOAEL value was assigned
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation of sub-chronic to chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, correction of oral to inhalation (rat to human) already performed
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable
- AF for intraspecies differences:
- 5
- Justification:
- Default value
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database was considered adequate
- AF for remaining uncertainties:
- 1
- Justification:
- None identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Assumed equivalent bioavailability between oral and dermal routes of exposure
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL value was assigned
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation for sub-chronic to chronic toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for the rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database was considered adequate
- AF for remaining uncertainties:
- 1
- Justification:
- None identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Default procedures for the calculation of DNEL values were employed as described in the REACH technical guidance documents (Chapter 8).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 34.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Based on Guidance Document, Chapter R.8, Appendix R.8-2. A 10% absorption via oral vs. inhalation was assumed
- AF for dose response relationship:
- 1
- Justification:
- Clear NOAEL value was assigned
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation of sub-chronic to chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable, correction of oral to inhalation (rat to human) already performed
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database was considered adequate
- AF for remaining uncertainties:
- 1
- Justification:
- None identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Assumed equivalent bioavailability between oral and dermal routes of exposure
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL value was assigned
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation of sub-chronic to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for the rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database was considered adequate
- AF for remaining uncertainties:
- 1
- Justification:
- None identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL value was assigned
- AF for differences in duration of exposure:
- 2
- Justification:
- Extrapolation of sub-chronic to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value for the rat
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database was considered adequate
- AF for remaining uncertainties:
- 1
- Justification:
- None identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Default procedures for the calculation of DNEL values were employed as described in the REACH technical guidance documents (Chapter 8).
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.
