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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-037-7 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.16 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA Reach guidance; the NOAEL was corrected by a factor of 1,77 (=1/0,566) as the registered substance contains only 56,6 % of active and the dose in the repeated dose toxicity study was calculated for the active alone.
- Overall assessment factor (AF):
- 72
- Dose descriptor starting point:
- other: NOAEL, corrected for active content of 56.6 %
- Value:
- 177 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 156 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEC(corrected, inhal) = [NOAEL(Rat oral) * respiratoy volume (human)] / [respiratoy volume rat)* AF (inhal rat =2x) * respiratoy volume (human = 10m³ (in 8h))
=NOAEL(oral) * 6,7m³ / 0,38 m³ * 2 * 10 m³ for Workers
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 6
- Justification:
- default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for other interspecies differences:
- 1
- Justification:
- included in allometric scaling; ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.16 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 72
- Dose descriptor:
- NOAEC
- Value:
- 88.16 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- default
- AF for differences in duration of exposure:
- 6
- Justification:
- default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC Technical Report 110 recomendation; ECETOC 2010
- AF for the quality of the whole database:
- 1
- Justification:
- deafult Reach Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- deafult Reach Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 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:
- 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 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.
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.
