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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 265-206-7 | CAS number: 64743-01-7 A complex combination of organic compounds, predominantly high molecular weight carboxylic acids, obtained by the air oxidation of petrolatum.
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 REACH guidance procedure but 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 study); x [6.7/10 {light work ventilation rate}] 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{adjust for human inhalation rate from dermal}] = 123 mg/m3
- 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 guidance)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R.8 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
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:
- 5.81 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 ECETOC intraspecies AF
- Overall assessment factor (AF):
- 12
- 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 (rat 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}] = 69.8 mg/kg
- AF for dose response relationship:
- 1
- Justification:
- Not required; starting point was a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- Not required
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Interspecies rat to human (ECHA R8 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}] = 89.3mg/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
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
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