Registration Dossier
Registration Dossier
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EC number: 209-162-9 | CAS number: 557-21-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.14 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):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 24.3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 21.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health), Appendix R-8 -2, example B.3, the corrected NOAEC (inhalation) can be calculated as follow:
For workers:
Corrected NOAEC (inhalation) = NOAEL(oral)*(1/sRVrat)*(absorption oral rat/absorption inhal human)*(sRVhuman/wRV)=24.3*(1/0.38)*(0.5/1)*(6.7/10) = 21.4 mg/m3, taking into account worst case factors (absorption oral rat of 50% and absorption inhalation human of 100%) and a NOAEL(oral) of 24.3 mg/kg bw/d.
- AF for dose response relationship:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 2
- Justification:
- NOAEL based on read-accross
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.14 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):
- 10
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- NOAEL
- Value:
- 24.3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 21.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health), Appendix R-8 -2, example B.3, the corrected NOAEC (inhalation) can be calculated as follow:
For workers:
Corrected NOAEC (inhalation) = NOAEL(oral)*(1/sRVrat)*(absorption oral rat/absorption inhal human)*(sRVhuman/wRV)= 24.3*(1/0.38)*(0.5/1)*(6.7/10) = 21.4 mg/m3, taking into account worst case factors (absorption oral rat of 50% and absorption inhalation human of 100%) and a NOAEL(oral) of 24.3 mg/kg bw/d.
- AF for dose response relationship:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 2
- Justification:
- NOAEL based on read-accross
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:
- 0.6 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 24.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
According to ECHA's Guidance R8 (Characterisation of dose [concentration]-response for human health), Appendix R-8 -2, example B.5, the corrected NOAEL (dermal) can be calculated as follow:
Corrected NOAEL (dermal) = NOAEL(oral) * (absorption oral rat/absorption dermal human) = 24.3 * (1/1) = 24.3 mg/kg bw/d, taking into account worst case factors (absorption oral rat = absorption dermal human) and a NOAEL(oral) of 24.3 mg/kg bw/d.
- AF for dose response relationship:
- 1
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- NOAEL obtained in a study carried out on rats
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 2
- Justification:
- NOAEL based on read-accross
Acute/short term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
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:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic 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
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:
- 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
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
General Population - Hazard via oral route
Systemic 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 for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
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