Registration Dossier
Registration Dossier
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EC number: 269-789-9 | CAS number: 68333-79-9
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:
- 18.06 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 451.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The dose descriptor is corrected using the equations detailed in Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose[concentration]-response for human health. Figure R.8-3.
- AF for dose response relationship:
- 1
- Justification:
- Starting point for DNEL calculation is a NOAEL and dose spacing is considered acceptable so a default value of 1 is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic study is used, differences in duration of exposure do not need to be accounted for.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling required because route to route extrapolation (oral to inhalation) takes this into account
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value used
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers used
- AF for the quality of the whole database:
- 2
- Justification:
- Modified to 2 to account for read across
- AF for remaining uncertainties:
- 1
- Justification:
- Default value used
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:
- no hazard identified
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.45 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 222.6
- Explanation for the modification of the dose descriptor starting point:
- The dose descriptor is corrected using the equations detailed in Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose[concentration]-response for human health. Figure R.8-3.
- AF for dose response relationship:
- 1
- Justification:
- Starting point for DNEL calculation is a NOAEL and dose spacing is considered acceptable so a default value of 1 is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic study is used, differences in duration of exposure do not need to be accounted for.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling required because route to route extrapolation (oral to inhalation) takes this into account
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value used
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population used
- AF for the quality of the whole database:
- 2
- Justification:
- Modified to 2 to account for read across
- AF for remaining uncertainties:
- 1
- Justification:
- Default value used
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.28 mg/kg bw/day
- Most sensitive endpoint:
- acute 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:
- 256 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation not required.
- AF for dose response relationship:
- 1
- Justification:
- Starting point for DNEL calculation is a LOAEL and dose spacing is considered acceptable so a default value of 1 is used.
- AF for differences in duration of exposure:
- 1
- Justification:
- hronic study is used, differences in duration of exposure do not need to be accounted for.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor of 4 used to cover interspecies differences between rats and humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value used
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population used
- AF for the quality of the whole database:
- 2
- Justification:
- Modified to 2 to account for read across
- AF for remaining uncertainties:
- 1
- Justification:
- Default value used
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
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.
