Registration Dossier
Registration Dossier
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EC number: 479-330-6 | CAS number: 67226-45-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.73 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 71.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL is based on Aluminum and thus it was converted to the relevant dose for the dossier compound, BPyrAl2Cl7, taking the molar masses into account: i.e.: NOAEL = 5 mg Al/kg bw (Molar mass = 27 g/mol); Molar Mass of BPyrAl2Cl7 / Molar Mass of Al / Molar Mass Al equivalents = 8,12; NOAEL (corrected) = 5 mg Al /kg bw *8.12 = 40.6 mg BPyrAl2Cl7 / kg bw. Taking a standard body weight of 70 kg/person, a standard breathing volume of 10 m3 / per 8 hours shift (worker) and an AF of 4 for the allometric scaling (default rat - human) into account yields a NAEC human of 71 mg/m3 as point of departure.
- AF for dose response relationship:
- 1
- Justification:
- Standard factor for using NOAEL as starting point
- AF for differences in duration of exposure:
- 1
- Justification:
- Standard Factor for long term studies (full lifecycle covering the most sensitive life stages)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable for oral to inhalation extrapolation [ECHA default, Chapter R8 guidance].
- AF for other interspecies differences:
- 2.5
- Justification:
- [ECHA default, Chapter R8 guidance].
- AF for intraspecies differences:
- 5
- Justification:
- [ECHA default, Chapter R8 guidance].
- AF for the quality of the whole database:
- 1
- Justification:
- Lowest NOAEL of any degradation product was taken into account
- AF for remaining uncertainties:
- 1
- Justification:
- Lowest NOAEL of any degradation product was taken into account
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:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
- Route of original study:
- Dermal
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The test material is corrosive, therefore no threshold is derived.
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:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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:
- no hazard identified
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.
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