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Registration Dossier
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EC number: 265-110-5 | CAS number: 64742-10-5 A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly higher than C25.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 136.68 mg/m³
- 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):
- 15
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 050 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL (Dermal rat 13 week repeat dose study); x [6.7/10 {light work ventilation rate}] x [1/0.38{adjust for human inhalation rate from dermal}] x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] = 2050 mg/m3
- 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 value)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- 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:
- 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:
- 48.45 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):
- 24
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 163 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point (13 week 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}] = 1163 mg/kg/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 value)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance R.8 value
- 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:
- no hazard identified
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:
- DNEL (Derived No Effect Level)
- Value:
- 28.89 mg/m³
- 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 722 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL (Dermal rat 13 week repeat dose study); x 5 days per week adjusted [5/7{days/week}] x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] x [1/1.15 {Allometric scaling rat to human and dermal to inhalation}] = 14.5 mg/m3
- 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 value)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- 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:
- 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:
- 5.19 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 208 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point (13 week dermal rat study); x 7 days per week adjusted [7/5 {days/week}] x 6 hours per day adjusted [6/24{hours/day}] x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] = 207 mg/kg/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 value)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies rat to human (ECHA R.8 value)
- AF for other interspecies differences:
- 1
- Justification:
- Not required
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC intrapsecies 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.19 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 208 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point (13 week dermal rat study); x 7 days per week adjusted [7/5 {days/week}] x 6 hours per day adjusted [6/24{hours/day}] x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] = 207 mg/kg/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 value
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance R.8 value
- AF for other interspecies differences:
- 1
- Justification:
- Not required
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC intrapsecies 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
