Registration Dossier
Registration Dossier
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EC number: 619-447-3 | CAS number: 99607-70-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.303 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 4.33 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 3.79 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In the absence of a suitable repeated dose inhalation toxicity studies, the dose descriptor starting point was derived from the most stringent NOAEL obtained in the available, fully reliable oral repeated dose toxicity studies in accordance with ECHA guidance R.8.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- A chronic NOAEL is used.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling for inhalation route.
- 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:
- Data from fully reliable studies are used.
- AF for remaining uncertainties:
- 1
- Justification:
- Remaining uncertainty is low.
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:
- 3.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
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:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A fully reliable 28-day dermal repeated dose toxicity study is available, which provided a NOAEL of 1000 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value.
- 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:
- A fully reliable study is available.
- AF for remaining uncertainties:
- 1
- Justification:
- The remaining uncertainty is low.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 0.075 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 4.33 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In the absence of a suitable repeated dose inhalation toxicity studies, the dose descriptor starting point was derived from the most stringent NOAEL obtained in the available, fully reliable oral repeated dose toxicity studies in accordance with ECHA guidance R.8.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- A chronic NOAEL is used.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling of inhalation route.
- 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:
- Data from fully reliable studies are used.
- AF for remaining uncertainties:
- 1
- Justification:
- The remaining uncertainty is low.
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:
- Dermal
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:
A fully reliable 28-day dermal repeated dose toxicity study is available, which provided a NOAEL of 1000 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value.
- 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:
- A fully reliable study is available.
- AF for remaining uncertainties:
- 1
- Justification:
- The remaining uncertainty is low.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.043 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 4.33 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4.33 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a NOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- A chronic NOAEL is used.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value.
- 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:
- Fully reliable data on oral repeated dose toxicity are available.
- AF for remaining uncertainties:
- 1
- Justification:
- The remaining uncertainty is low.
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.
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