Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 617-879-7 | CAS number: 865536-03-4
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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 230 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Conversion of an oral rat NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure
Corretion factor diffrence in resperatory volumes: 2.63
Corretion factor light activity for workers: 0.67
Correction factor for bioavailability (oral-inhalation worst case): 0.5
Correction factor for difference in human and exposure of worker: 1.4
(ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for dose response relationship:
- 1
- Justification:
- Starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scalling during modification of the starting point (resperatory Volumes human/rat) (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for intraspecies differences:
- 5
- Justification:
- Standard factor for workers (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for the quality of the whole database:
- 1
- Justification:
- good standard quality (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Correction factor for difference in human and exposure of worker: 1.4
- AF for dose response relationship:
- 1
- Justification:
- Starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor from rat to human (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for intraspecies differences:
- 5
- Justification:
- Standard factor for workers (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for the quality of the whole database:
- 1
- Justification:
- good stadard quality (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
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:
- 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:
- 2.47 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:
- 370 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Conversion of an oral rat NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure:
Corretion factor diffrence in resperatory volumes: 0.74
Correction factor for bioavailability (oral-inhalation worst case): 0.5
(ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for dose response relationship:
- 1
- Justification:
- Starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- standard factor from rat to human (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for intraspecies differences:
- 10
- Justification:
- standard factor for difference in population (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for the quality of the whole database:
- 1
- Justification:
- good standard quality (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
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:
- 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
- Explanation for the modification of the dose descriptor starting point:
no modifications
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor from rat to human (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for intraspecies differences:
- 10
- Justification:
- standard factor for difference in population (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for the quality of the whole database:
- 1
- Justification:
- good standard quality
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:
- 1.67 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
- Explanation for the modification of the dose descriptor starting point:
no modifications
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute (28 Days study) to chronic (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Standard factor from rat to human (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance -sepcific data for metabolic rate are available (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for intraspecies differences:
- 10
- Justification:
- standard factor for difference in population (ECHA Guidance on informationrequiremnts and chemical safety assessment Chapter R.8)
- AF for the quality of the whole database:
- 1
- Justification:
- good standard quality
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
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.
