Registration Dossier
Registration Dossier
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EC number: 306-227-4 | CAS number: 96690-34-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.11 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 225
- Dose descriptor starting point:
- LOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 24.68 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral LOAEL obtained from an OECD 422 study conducted with the read-across substance Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates (CAS 80939-62-4) (WIL Research, 2013).
To take into account the interspecies difference between the rat and human the lowest observed adverse effect level (LOAEL) has to be corrected as follows according to ECHA guidance R.8 (2012):
Corrected starting point for the inhalative route for workers:
= LOAEL(oral) * (1/0.38 m³/kg bw/day) * (ABSoral-rat/ABSinh-human) * 6.7 m³ (8h) /10 m³ (8h) * (days of exposure per week in rats / days of exposure per week worker)
= 10 mg/kg bw/day * (1/0.38 m³/kg bw/day) * (1/1) * 0.67 m³ * (7/5) = 24.68 mg/m³.
(ABSoral-rat = oral absorption in rats, ABSinh-human = inhalation absorption rate in humans)
Therefore, the corrected starting point for workers was 24.68 mg/m³ for inhalation.
- AF for dose response relationship:
- 3
- Justification:
- The dose descriptor starting point is based on a LOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for the inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.02 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 450
- Dose descriptor starting point:
- LOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 8.69 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an oral LOAEL obtained from an OECD 422 study conducted with the read-across substance Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates (CAS 80939-62-4) (WIL Research, 2013).
To take into account the interspecies difference between the rat and human the lowest observed adverse effect level (LOAEL) has to be corrected as follows according to ECHA guidance R.8 (2012):
Corrected starting point for the inhalative route for the general population:
= LOAEL(oral) * (1/1.15 m³/kg bw/day) * (ABSoral-rat/ABSinh-human)
= 10 mg/kg bw/day * (1/1.15 m³/kg bw/day) * (1/1) = 8.69 mg/m³
(ABSoral-rat = oral absorption in rats, ABSinh-human = inhalation absorption rate in humans)
Therefore, the corrected starting point for the general population was 8.69 mg/m³ for inhalation.
- AF for dose response relationship:
- 3
- Justification:
- The dose descriptor starting point is based on a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for the inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.006 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 800
- Dose descriptor starting point:
- LOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation not necesary.
- AF for dose response relationship:
- 3
- Justification:
- The dose descriptor starting point is based on a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- The DNEL is based on a subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The DNEL is based on a high-quality study.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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