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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-466-0 | CAS number: 141-18-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.82 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:
- NOAEC
- Value:
- 50 ng/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 70.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There is a key oral repeated dose toxicity study; no inhalation toxicity study present.
- AF for dose response relationship:
- 1
- Justification:
- Start from NOAEC
- AF for differences in duration of exposure:
- 3
- Justification:
- ECHA default factor for subchronic toxicity
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling already in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default factor
- AF for the quality of the whole database:
- 1
- Justification:
- High quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no 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:
- 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 ng/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There is a key oral repeated dose toxicity study; no repeated dermal toxicity study present.
- AF for dose response relationship:
- 1
- Justification:
- Start from NOAEL
- AF for differences in duration of exposure:
- 3
- Justification:
- ECHA default factor for subchrinic toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default factor for toxicokinetic differences
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default factor
- AF for the quality of the whole database:
- 1
- Justification:
- High quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
A key study repeated dose toxicity study (90 day oral gavage) in Wistar rats was performed by oral gavage at the doses of 50, 200 and 350 mg/kg b.w. marked changes to haematological parameters beyond historical control data in at 200 and 350 mg/kg body weight/day in terms of reduced blood cell mass, regenerative processes and other associated changes to red blood cell parameters were considered as test item related, adverse effects. Thus, the NOAEL of this study was considered to be 50 mg/kg body weight/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 ng/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 34.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There is a key oral repeated dose toxicity study; no inhalation toxicity study present.
- AF for dose response relationship:
- 1
- Justification:
- Start from NOAEC
- AF for differences in duration of exposure:
- 3
- Justification:
- ECHA default factor for subchronic toxicity
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- ECHA default factor for remaining differences
- AF for other interspecies differences:
- 1
- Justification:
- Allometric scaling already in route-to-route extrapolation
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default factor
- AF for the quality of the whole database:
- 1
- Justification:
- High quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no 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:
- 1 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 ng/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There is a key oral repeated dose toxicity study; no repeated dermal toxicity study present.
- AF for dose response relationship:
- 1
- Justification:
- Start from NOAEL
- AF for differences in duration of exposure:
- 3
- Justification:
- ECHA default factor for subchronic toxicity
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- ECHA default factor for remaining differences
- AF for other interspecies differences:
- 4
- Justification:
- ECHA default factor for toxicokinetic differences
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default factor
- AF for the quality of the whole database:
- 1
- Justification:
- High quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 0.25 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 ng/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Start from NOAEL
- AF for differences in duration of exposure:
- 3
- Justification:
- ECHA default factor for subchronic toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default factor
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default factor
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default factor
- AF for the quality of the whole database:
- 1
- Justification:
- High quality study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
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:
- no hazard identified
Additional information - General Population
A key study repeated dose toxicity study (90 day oral gavage) in Wistar rats was performed by oral gavage at the doses of 50, 200 and 350 mg/kg b.w. Marked changes to haematological parameters beyond historical control data in at 200 and 350 mg/kg body weight/day in terms of reduced blood cell mass, regenerative processes and other associated changes to red blood cell parameters were considered as test item related, adverse effects. Thus, the NOAEL of this study was considered to be 50 mg/kg body weight/day.
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