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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-874-0 | CAS number: 100-64-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.8 µg/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):
- 50
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 441 µg/m³
- Explanation for the modification of the dose descriptor starting point:
- no data for inhalation pathway available, absorption rate of 100% for both inhalation and oral absorption assumed
- AF for dose response relationship:
- 2
- Justification:
- Acc. to authors, the effects are not severe and possibly reversible, so a reduced factor of 2 was chosen in deviation from ECHA guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling is already included in the route-to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA guidance
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:
- 25 µg/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):
- 200
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 5 000 µg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no data for dermal pathway available, absorption rate of 5% for dermal absorption and 100% for oral absorption assumed
- AF for dose response relationship:
- 2
- Justification:
- Acc. to authors, the effects are not severe and possibly reversible, so a reduced factor of 2 was chosen in deviation from ECHA guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA guidance
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
The key toxicological endpoint is haematotoxicity, a systemic effect, which is expected to be relevant via all exposure routes. Starting point for deriving DNELs is a LOAEL, associated with slight, reversible effects, of 0.25 mg/kg bw/day, from a 90-day rat gavage study.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 µg/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):
- 100
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 155 µg/m³
- Explanation for the modification of the dose descriptor starting point:
- no data for inhalation pathway available, absorption rate of 100% for both inhalation and oral absorption assumed
- AF for dose response relationship:
- 2
- Justification:
- Acc. to authors, the effects are not severe and possibly reversible, so a reduced factor of 2 was chosen in deviation from ECHA guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling is already included in the route-to route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA guidance
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:
- 8.9 µg/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):
- 400
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 3 570 µg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no data for dermal pathway available, absorption rate of 5% for dermal absorption and 100% for oral absorption assumed
- AF for dose response relationship:
- 2
- Justification:
- Acc. to authors, the effects are not severe and possibly reversible, so a reduced factor of 2 was chosen in deviation from ECHA guidance
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 0.45 µg/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):
- 400
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 179 µg/kg bw/day
- AF for dose response relationship:
- 2
- Justification:
- Acc. to authors, the effects are not severe and possibly reversible, so a reduced factor of 2 was chosen in deviation from ECHA guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA guidance
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
The key toxicological endpoint is haematotoxicity, a systemic effect, which is expected to be relevant via all exposure routes. Starting point for deriving DNELs is a LOAEL, associated with slight, reversible effects, of 0.25 mg/kg bw/day, from a 90-day rat gavage study.
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