Registration Dossier
Registration Dossier
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EC number: 944-399-8 | CAS number: -
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:
- 7.08 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:
- 602 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 061.728 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction: 602 / (0.380*(10 / 6.7)) = 1061.728 mg/m3
(Transformation from oral to inhalation & Compensation for increased respiratory rate for workers)
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The allometric scaling factor is already applied in the rout to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 2
- Justification:
- Based on read-across data
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor is needed
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.01 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:
- 602 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 204 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Correction: 602 / (1*(50/100)) = 1204 mg/kg bw
(Compensation for absorption)
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 2
- Justification:
- Based on read-across data
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor is needed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 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:
- 1.74 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 602 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 523.478 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Correction: 602 / (1.150) = 523.478 mg/m3
(Transformation from oral to inhalation)
- AF for dose response relationship:
- 1
- Justification:
- ECHA/ECETOC default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA/ECETOC default
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- The allometric scaling factor is already applied in the rout to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 2
- Justification:
- Based on read-across data
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor is needed
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:
- DNEL (Derived No Effect Level)
- Value:
- 1 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):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 602 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 204 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Correction: 602 / (1*(50/100))
(Compensation for absorption)
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA/ECETOC default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 2
- Justification:
- Based on read-across data
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor is needed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 602 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 602 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Correction: 602 / (1) = 602 mg/kg bw
(No compensation for route)
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 2
- Justification:
- Based on read-across data
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor is needed
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.
