Registration Dossier
Registration Dossier
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EC number: 265-064-6 | CAS number: 64741-62-4 A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.18 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 22.5
- Dose descriptor starting point:
- LOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 4.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point LOAEL (dermal teratology study): x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] x [1/0.38]{for route to route extrapolation}] x [6.7/10]{light activity rate}] = 4.5 mg/m3
- AF for dose response relationship:
- 3
- Justification:
- LOAEL to NOAEL conversion
- AF for differences in duration of exposure:
- 1
- Justification:
- Not required
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies AF (ECHA R.8)
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC intraspecies AF
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 716.8 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 7.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 3 300 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 35 376 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEC (acute rat LC50 inhalation study): x 4 hrs/day; adjusted for duration of work [4/0.25 {hrs/day}] x [6.7/10 {light work ventilation rate}]
- AF for dose response relationship:
- 1
- Justification:
- Not required: starting point was a NOAEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies AF (ECHA R.8)
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC intraspecies AF
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
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:
- 0.065 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating CONCAWE intra/interspecies AF
- Overall assessment factor (AF):
- 36
- Dose descriptor starting point:
- LOAEL
- Value:
- 1 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 2.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point LOAEL (dermal teratology study): x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}]
- AF for dose response relationship:
- 3
- Justification:
- LOAEL to NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Not required
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies rat to human
- AF for other interspecies differences:
- 1
- Justification:
- Not required
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC intraspecies AF
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.015 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 1.06 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.61 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL (Subchronic dermal rat study): x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] x 8 hours per Day, 5 days per week [8/24{hours per day} {5/7{days per week}]
- AF for dose response relationship:
- 1
- Justification:
- Not required: starting point a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic (ECHA R.8)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies rat to human (ECHA R.8)
- AF for other interspecies differences:
- 1
- Justification:
- Not required
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC intraspecies AF
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study available
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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