Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 232-455-8 | CAS number: 8042-47-5 A highly refined petroleum mineral oil consisting of a complex combination of hydrocarbons obtained from the intensive treatment of a petroleum fraction with sulfuric acid and oleum, or by hydrogenation, or by a combination of hydrogenation and acid treatment. Additional washing and treating steps may be included in the processing operation. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C50.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 164.56 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 468.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL (7 x oral rat 90 day repeat dose studies); x [6.7/10 {light work ventilation rate}] x [1/0.38{adjust for human inhalation rate from oral}] x 7 days per week adjusted [7/5{days/week}] = 2468 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 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:
- 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:
- 217.05 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 255.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL (7 x oral rat 90 day repeat dose studies); x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] x 7 times per week adjusted [7/5 {days/week}] = 3255 mg/kg
- 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:
- 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
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:
- 34.78 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL (7 x oral rat 90 day repeat dose studies); x [1/1.15 {Allometric scaling rat to human and oral to inhalation} = 869 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 AF (ECHA R.8)
- 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:
- 93.02 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 325.6 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL (7 x oral rat 90 day repeat dose studies); x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] = 2325 mg/kg
- 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:
- 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point NOAEL (7 x oral rat 90 day repeat dose studies); no required changes from POD.
- 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 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.
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.
