Registration Dossier
Registration Dossier
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EC number: 930-859-5 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.93 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 220 mg/m³
- Explanation for the modification of the dose descriptor starting point:
250 x 1/0.38 x 6.7/10 x 0.5 [50% oral absorption rat / 100% inhalation absorption human].
- AF for dose response relationship:
- 1
- Justification:
- NOAEL derived
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- corrected starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Systemic
- AF for intraspecies differences:
- 5
- Justification:
- Workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining 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:
- 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:
- 0.83 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:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As stated in ECHA guidance R8, it is assumed that dermal absorption will not be higher than oral absorpion, therefore no default factor should be used when oral-to-dermal extrapolation.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat species
- AF for other interspecies differences:
- 2.5
- Justification:
- systemic effects
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- medium 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:
- 0.72 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:
- NOAEC
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 109 mg/m³
- Explanation for the modification of the dose descriptor starting point:
250 x 1/1.15 x 0.5 [50% oral absorption rat / 100% inhalation absorption human].
- AF for dose response relationship:
- 1
- Justification:
- Dose response
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- modified starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- For effects on skin, eye and GI tract via local metabolism, for effects on respiratory tract.
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
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:
- 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:
- 0.42 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:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As stated in ECHA guidance R8, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- dose response
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat species
- AF for other interspecies differences:
- 2.5
- Justification:
- systemic effects
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
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:
- 0.42 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:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As this is an oral study, no modification of the starting point is needed.
- AF for dose response relationship:
- 1
- Justification:
- dose response
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat species
- AF for other interspecies differences:
- 2.5
- Justification:
- systemic effects
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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