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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 289-296-2 | CAS number: 87061-04-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.98 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):
- 225
- Dose descriptor starting point:
- LOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 220 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral LOAELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (50% /100%) = 250 × 2.63 × 0.67 × 0.5
Inhalation LOAEChuman= 220 mg/m3
- AF for dose response relationship:
- 3
- Justification:
- LOAEL used, insufficient data available to calculate a BMD
- 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 the test substance appropriate for the tonnage band
- 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:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.28 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):
- 900
- Dose descriptor starting point:
- LOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral LOAELrat× (50% /50%) = 250 × 1
Dermal LOAELhuman= 250 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL used, insufficient data available to calculate a BMD
- 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 appropriate for the tonnage band
- 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)
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:
- 0.24 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:
- LOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 109 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral LOAELrat× (1/1.15 m3/kg bw) × (50% /100%) = 250 × 0.87 × 0.5
Inhalation LOAEChuman= 109 mg/m3
- AF for dose response relationship:
- 3
- Justification:
- LOAEL used, insufficient data available to calculate a BMD
- 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 appropriate for the tonnage band
- 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:
- insufficient hazard data available (further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.14 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:
- LOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral LOAELrat× (50% /50%) = 250 × 1
Dermal LOAELhuman= 250 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL used, insufficient data available to calculate a BMD
- 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 on test substance available appropriate for the tonnage band
- 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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.28 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):
- 900
- Dose descriptor starting point:
- LOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification of starting point:
Oral LOAELrat= Oral LOAELhuman= 250 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL used, insufficient data available to calculate a BMD
- 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 on test substance available appropriate for the tonnage band
- 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
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