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.
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.
