Registration Dossier
Registration Dossier
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EC number: 481-730-0 | CAS number: 848301-65-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 274.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- NOAEC
- Value:
- 8 200 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4 120.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhalation): Correction for experiemental exposure duration (6 h/d to 8 h/d), Correction for respiratory volume (worker): 6.7 m³/10 m³. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 8200*(6 h/8 h) *(6.7 m³/10 m³) = 4120.5 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 3
- Justification:
- Hydrocarbon-specific Informed Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 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):
- 24
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction to dose descriptor starting point was made.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to dermal human)
- AF for other interspecies differences:
- 1
- Justification:
- Hydrocarbon-specific Informed Assessment Factors
- AF for intraspecies differences:
- 3
- Justification:
- Hydrocarbon-specific Informed Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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)
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:
- DNEL (Derived No Effect Level)
- Value:
- 58.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 8 200 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 464.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhalation): Correction for exposure duration (6 h/d to 24 h/d). Correction for dosing frequency: 5 days/ 7 days. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 8200*(6 h/ 24 h)*(5/7) = 1464.3 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhaled human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Hydrocarbon-specific Informed Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification to the dose descriptor starting point was made.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to dermal human)
- AF for other interspecies differences:
- 1
- Justification:
- Hydrocarbon-specific Informed Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Hydrocarbon-specific Informed Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of the dose descriptor starting point was made.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to oral human)
- AF for other interspecies differences:
- 1
- Justification:
- Hydrocarbon-specific Informed Assessment Factors
- AF for intraspecies differences:
- 5
- Justification:
- Hydrocarbon-specific Informed Assessment Factors
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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
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