Registration Dossier
Registration Dossier
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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: 252-512-0 | CAS number: 35325-02-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 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
- Value:
- 529 mg/m³
- Explanation for the modification of the dose descriptor starting point:
here is a key oral repeated dose toxicity study; no inhalation toxicity study present.
- AF for dose response relationship:
- 1
- Justification:
- start from NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default factor for subacute toxicity
- AF for interspecies differences (allometric scaling):
- 2
- Justification:
- ECHA default factor for Oral to inhalation
- 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 but no further hazard information necessary as no exposure expected
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Inhalation testing is waved based on low exposure
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 12 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal absoption is 4 times slower as oral
- AF for dose response relationship:
- 1
- Justification:
- Start from NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default factor for subacute 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
- Explanation for the modification of the dose descriptor starting point:
LD50> 2000 mg/kg bw
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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 (28 day oral gavage) in Wistar rats was performed by oral gavage at the doses of 150, 300 and 600 mg/kg b.w.The NOAEL of this study was considered to be 300 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:
- 1.39 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:
- 209 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:
- 6
- Justification:
- ECHA default factor for subacute 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 but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
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:
- 6
- Justification:
- ECHA default factor for subacute 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 but no further hazard information necessary as no exposure expected
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:
- 0.5 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
- AF for dose response relationship:
- 1
- Justification:
- Start from NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA default factor for subacute 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:
- no hazard identified
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 (28 day oral gavage) in Wistar rats was performed by oral gavage at the doses of 150, 300 and 600mg/kg b.w. , the NOAEL of this study was considered to be 300 mg/kg body weight/day.
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