Registration Dossier
Registration Dossier
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EC number: 265-111-0 | CAS number: 64742-11-6 A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. 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:
- 2.73 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- other: ECHA R.8 guidance incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 45
- Dose descriptor starting point:
- LOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 123 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point LOAEL (dermal rat 13 week 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 [6.7/10 {light work ventilation rate}] x [1/0.38{adjust for human inhalation rate from dermal}] = 123 mg/m3
- AF for dose response relationship:
- 3
- Justification:
- LOAEL converted to a NOAEL (ECHA R.8 guidance)
- 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:
- 0.97 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):
- 72
- Dose descriptor starting point:
- LOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 69.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point LOAEL (dermal rat 13 week repeat dose study); x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] = 69.8 mg/kg/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL converted to NOAEL (ECHA R.8 guidance)
- 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:
- 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:
- 0.74 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 incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- LOAEL
- Value:
- 125 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 89.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point LOAEL (oral rat 13 week repeat dose study); x 5 days per week adjusted [5/7 {5 days/7 days}] = 89.3 mg/kg/day
- AF for dose response relationship:
- 3
- Justification:
- LOAEL converted to NOAEL (ECHA R.8 guidance)
- 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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No DNEL has been calculated for this route of exposure; the substance is a carcinogen and therefore no exposure to the general population is expected and no DNEL is required.
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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