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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-696-0 | 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:
- 7 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:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 529 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOAELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (100% /100%) = 300 × 2.63 × 0.67 × 1
Inhalation NOAEChuman= 529 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL defined
- 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 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 test substance
- 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:
- 4 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:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOAELrat× (100% /25%) = 300 × 4
Dermal NOAELhuman= 1200 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL defined
- 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:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on test substance
- 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:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high 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:
- 1.7 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:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 261 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOAELrat× (1/1.15 m3/kg bw) × (100% /100%) = 300 × 0.87 × 1
Inhalation NOAEChuman= 261 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL defined
- 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 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 test substance
- 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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2 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:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOAELrat× (100% /25%) = 300 × 4
Dermal NOAELhuman= 1200 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL defined
- 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:
- 10
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Data on test substance available
- 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:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral NOAELrat= Oral NOAELhuman= 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL defined
- 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:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Data available on test substance
- 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:
- high hazard (no threshold derived)
Additional information - General Population
An oral repeat dose rat study identified a NOAEL for local effects of 100 mg/kg/day; there were marked effects at the portal-of-entry (stomach). It is therefore considered relevant to calculate a DNELoral-local for the general population:
Modification of starting point:
Oral NOAELrat= Oral NOAELhuman= 100 mg/kg bw/day
Adjustment factors |
Value |
Justification |
Total AF |
Dose response |
1 |
NOAEL defined |
150 |
Difference in duration |
6 |
Subacute to chronic |
|
Allometric scaling |
1 |
NA for local effects |
|
Other interspecies differences |
1 |
Addressed by modification of starting point |
|
Intraspecies differences |
10 |
Default value for workers |
|
Quality of database |
1 |
Data available on test substance |
|
Remaining uncertanities |
2.5 |
Default value |
DNELoral= 100/150 DNELoral-systemic= 0.67 mg/kg bw/day
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