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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 240-539-0 | CAS number: 16484-77-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.071 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- 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:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.882 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The corrected dose descriptor for inhalation for workers = [1 mg/kg bw/day] / [0.38 m3/kg bw/day] × [6.7 m3/10m3] × [50% /100%] =0.882 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a clear NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low 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:
- 0.556 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):
- 180
- 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:
The dose descriptor for dermal for workers: dermal NOAELrabbit=1000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a clear NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbit to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.017 mg/m³
- Most sensitive endpoint:
- carcinogenicity
- 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:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The corrected dose descriptor for inhalation for general population = [1 mg/kg bw/day] / [1.15 m3/kg bw/day] × (50% /100%) =0.435mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The starting point is a clear NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.778 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):
- 360
- 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:
The dose descriptor for dermal for general population: dermal NOAELrabbit=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:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbit to human
- AF for other interspecies differences:
- 1
- Justification:
- Addressed by modification of starting point
- AF for intraspecies differences:
- 10
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.01 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
- 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:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The dose descriptor for oral for general population: oral NOAELrat=1 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:
- 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:
- 10
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on the test substance appropriate for the tonnage band
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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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