Registration Dossier
Registration Dossier
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EC number: 281-468-5 | CAS number: 83950-14-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.9 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:
- 441 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation taking into account that oral and inhalation absorption are set at 10%
The corrected NOAEC = oral NOAEL *1/0.38*10/10*6.7/10= 441 mg/m3
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- the derivation of the starting point (NOAEC) already includes a factor for allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- worker exposure
- AF for the quality of the whole database:
- 1
- Justification:
- based on a guideline study under GLP
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.167 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation taking into account that dermal absorption is set at 50%, while oral absorption is set at 10% (see toxicokinetic assessment) leads to the NOAEL of 50 mg/kg bw that is taken as starting point for the calculation of the DNEL.
- 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:
- species tested is the rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 5
- Justification:
- worker exposure
- AF for the quality of the whole database:
- 1
- Justification:
- based on guideline study under GLP
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 180
- Dose descriptor:
- other: EC3 --> LOAEL
- AF for dose response relationship:
- 3
- Justification:
- EC3 is considered to be a LOAEL, default factor to extrapolate LOAEL to NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- not applicable
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable
- AF for other interspecies differences:
- 10
- Justification:
- default
- AF for intraspecies differences:
- 1
- Justification:
- default
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 6
- Justification:
- 3 for effects of the matrix; 2 as additional factor because no actual EC3 was derived
Acute/short term exposure
- Hazard assessment conclusion:
- low 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 83 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation taking into account that dermal absorption is set at 50%, while oral absorption is set at 10% (see toxicokinetic assessment) leads to the NOAEL of 50 mg/kg bw that is taken as starting point for the calculation of the DNEL.
- 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:
- The species tested is the rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- consumer exposure
- AF for the quality of the whole database:
- 1
- Justification:
- Based on guidelines study under GLP
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 180
- Dose descriptor:
- other: EC3 --> LOAEL
- AF for dose response relationship:
- 3
- Justification:
- LOAEL to NOAEL default value
- AF for differences in duration of exposure:
- 1
- Justification:
- not applicable
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable
- AF for other interspecies differences:
- 10
- Justification:
- default
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 6
- Justification:
- 3 for matrix effects; 2 for the absence of an EC3 value
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- DNEL (Derived No Effect Level)
- Value:
- 17 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- other: LD50/NOAEL
- Value:
- 1 700 mg/kg bw/day
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- study in rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value
- AF for intraspecies differences:
- 10
- Justification:
- consumer exposure
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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