Registration Dossier
Registration Dossier
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EC number: 265-078-2 | CAS number: 64741-77-1 A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C10 through C18, and boiling in the range of approximately 160°C to 320°C (320°F to 608°F).
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 68.34 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
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:
- other: NOEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 512.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOEL = 125 mg/kg (rat dermal developmental tox study); [1/0.43 {RVM}] x [1/0.38{ convert to inhal dose}] x [6.7/10 {adjustment for ligh exercise}] = 512 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Not required: starting point was a NOEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Not required
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (R8 guidance)
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC Intrapsecies AF
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study available
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4 288 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:
- other: NOEC
- Value:
- 6 000 mg/m³
- Modified dose descriptor starting point:
- other: NOEC
- Value:
- 32 160 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOEC = 6,000 mg/m3 (rat acute study); 120 minutes/day, adjusted for duration of work [120/15 {minutes/day}] x [6.7/10 {light work ventilation rate}] = 32,160 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Not required: Starting point was a NOEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (R8 guidance)
- 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:
- 2.91 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 procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 24
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 69.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL [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:
- 1
- Justification:
- Not required, starting point was a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic (ECHA R.8 guidance)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies rat to human (R8 guidance)
- 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:
- 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:
- 20.22 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- other: NOEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 252.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOEL = 125 mg/kg (rat dermal development tox study); x [1/0.43 {for RVM}] x [1/1.15 {convert to inhal dose}] = 252 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Not required, starting point was a NOEL
- 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 rat to human (R8 guidance)
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 2 572.8 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):
- 12.5
- Dose descriptor starting point:
- other: NOEC
- Value:
- 6 000 mg/m³
- Modified dose descriptor starting point:
- other: NOEC
- Value:
- 32 160 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOEC = 6,000 mg/m3 (rat acute study); 120 minutes/day, adjusted for duration of work [120/15 {minutes/day}] x [6.7/10 {light work ventilation rate}] = 32,160 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Not required: Starting point was a NOEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (R8 guidance)
- 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
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:
- 1.25 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 procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 49.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL= 30 mg/Kg, (90 day dermal rat study); 5 days/wk adjusted for duration of exposure [5/7{days/week} x 1/0.43 {animal absorption factor} = 49.9 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Not required: starting point was a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic (ECHA R.8 guidance)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies rat to human (R.8 guidance)
- 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:
- 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:
- 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:
- 1.25 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 procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 49.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL= 30 mg/Kg, (90 day dermal rat study); 5 days/wk adjusted for duration of exposure [5/7{days/week}] x [1/0.43 {animal absorption factor}] = 49.9 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Not required: starting point was a NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic (ECHA R.8 guidance)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies rat to human (R.8 guidance)
- 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:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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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