Registration Dossier
Registration Dossier
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EC number: 915-656-1 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.29 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):
- 450
- Dose descriptor starting point:
- other: NOEL
- Value:
- 73 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 128.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (100% /100%) = 73 × 2.63 × 0.67 × 1
Inhalation NOEChuman= 128.6 mg/m3
- AF for dose response relationship:
- 2
- Justification:
- QSAR predicted NOEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NA for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of the starting dose
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 3
- Justification:
- QSAR prediction
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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:
- 1.6 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):
- 1 800
- Dose descriptor starting point:
- other: NOEL
- Value:
- 73 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 292 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOELrat× (100% /25%) = 73 × 4
Dermal NOELhuman= 292 mg/kg bw/day
- AF for dose response relationship:
- 2
- Justification:
- QSAR predicted NOEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Defauly value for workers
- AF for the quality of the whole database:
- 3
- Justification:
- QSAR prediction
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
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:
- medium 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:
- 0.07 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):
- 900
- Dose descriptor starting point:
- other: NOEL
- Value:
- 73 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 63.51 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral LOAELrat× (1/1.15 m3/kg bw) × (10% /100%) = 73 × 0.87 × 1
Inhalation NOEChuman= 63.51 mg/m3
- AF for dose response relationship:
- 2
- Justification:
- QSAR predicted NOEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NA for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification to starting dose
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 3
- Justification:
- QSAR predictions
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 0.08 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):
- 3 600
- Dose descriptor starting point:
- other: NOEL
- Value:
- 73 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 292 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOELrat× (100% /25%) = 73 × 4
Dermal NOELhuman= 292 mg/kg bw/day
- AF for dose response relationship:
- 2
- Justification:
- QSAR predicted NOEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting dose
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population
- AF for the quality of the whole database:
- 3
- Justification:
- QSAR predictions
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
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:
- 0.02 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):
- 3 600
- Dose descriptor starting point:
- other: NOEL
- Value:
- 73 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 73 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOELrat= Oral NOELhuman= 73
Oral NOELhuman= 73 mg/kg bw/day
- AF for dose response relationship:
- 2
- Justification:
- QSAR predicted NOEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting dose
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 3
- Justification:
- QSAR predictions
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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.
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